Trial Outcomes & Findings for A Study of Belantamab Mafodotin Monotherapy in Multiple Myeloma Participants With Normal and Varying Degree of Impaired Renal Function (NCT NCT04398745)
NCT ID: NCT04398745
Last Updated: 2026-07-01
Results Overview
Blood samples were collected for PK analysis of belantamab mafodotin ADC. As pre-specified in protocol, only specified treatment arms were planned to be analyzed for this outcome measure. As first dose of belantamab mafodotin was administered on Day 1, cycle length correlates to Day 1 plus 21 days i.e., Day 22 in timeframe. Only those participants who were measured and analyzed (i.e., contributed to data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified timepoints.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE1
Target enrollment
36 participants
Primary outcome timeframe
Pre-dose, end of infusion (EOI), start of infusion (SOI)+2hour (h), SOI+4h, SOI+8h and SOI+24h on Cycle(C) 1 Day(D) 1 and C3D1; Anytime on C1 D4, D8, D15, D22; Anytime on C3 D4, D8, D15, D22; Pre-dose on C2D1 and C4D1.
Results posted on
2026-07-01
Participant Flow
The results presented are based on the data cut-off date of 21 April 2025. Those participants still benefiting from study drug in the opinion of their treating physician continue to receive study drug in the Post Analysis Continuation of Treatment (PACT) phase. Additional safety results will be provided within one year of study completion.
Participant milestones
| Measure |
Part 1: Belantamab Mafodotin 2.5 mg/kg (Normal/Mildly Impaired Renal Function)
Participants with Relapsed/Refractory Multiple Myeloma (RRMM) who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and normal/mildly impaired renal function received intravenous (IV) infusion of 2.5 milligram (mg)/kilogram (kg) belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to adverse event (AE), lost to follow-up, death, whichever occurs first.
|
Part 1: Belantamab Mafodotin 2.5 mg/kg (Severely Impaired Renal Function)
Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and severe renal impairment renal function received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
|
Part 1: Belantamab Mafodotin 2.5 mg/kg (Other Renal Function)
Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and other renal impairment renal function received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
|
Part 2: Belantamab Mafodotin 2.5 mg/kg End Stage Renal Disease (Not on Dialysis)
Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and end stage renal disease (ESRD) (not on hemodialysis) received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
|
Part 2: Belantamab Mafodotin 2.5 mg/kg ESRD (On Dialysis)
Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and ESRD (on hemodialysis) received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
10
|
9
|
4
|
5
|
8
|
|
Overall Study
Safety Population
|
10
|
9
|
4
|
5
|
8
|
|
Overall Study
Pharmacokinetic (PK) Evaluable Population
|
8
|
8
|
0
|
5
|
8
|
|
Overall Study
COMPLETED
|
8
|
7
|
1
|
3
|
4
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
3
|
2
|
4
|
Reasons for withdrawal
| Measure |
Part 1: Belantamab Mafodotin 2.5 mg/kg (Normal/Mildly Impaired Renal Function)
Participants with Relapsed/Refractory Multiple Myeloma (RRMM) who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and normal/mildly impaired renal function received intravenous (IV) infusion of 2.5 milligram (mg)/kilogram (kg) belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to adverse event (AE), lost to follow-up, death, whichever occurs first.
|
Part 1: Belantamab Mafodotin 2.5 mg/kg (Severely Impaired Renal Function)
Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and severe renal impairment renal function received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
|
Part 1: Belantamab Mafodotin 2.5 mg/kg (Other Renal Function)
Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and other renal impairment renal function received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
|
Part 2: Belantamab Mafodotin 2.5 mg/kg End Stage Renal Disease (Not on Dialysis)
Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and end stage renal disease (ESRD) (not on hemodialysis) received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
|
Part 2: Belantamab Mafodotin 2.5 mg/kg ESRD (On Dialysis)
Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and ESRD (on hemodialysis) received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
|
|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
2
|
2
|
0
|
1
|
|
Overall Study
Ongoing at time of analysis
|
0
|
0
|
1
|
2
|
3
|
Baseline Characteristics
A Study of Belantamab Mafodotin Monotherapy in Multiple Myeloma Participants With Normal and Varying Degree of Impaired Renal Function
Baseline characteristics by cohort
| Measure |
Part 1: Belantamab Mafodotin 2.5 mg/kg (Normal/Mildly Impaired Renal Function)
n=10 Participants
Participants with Relapsed/Refractory Multiple Myeloma (RRMM) who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and normal/mildly impaired renal function received intravenous (IV) infusion of 2.5 milligram (mg)/kilogram (kg) belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to adverse event (AE), lost to follow-up, death, whichever occurs first.
|
Part 1: Belantamab Mafodotin 2.5 mg/kg (Severely Impaired Renal Function)
n=9 Participants
Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and severe renal impairment renal function received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
|
Part 1: Belantamab Mafodotin 2.5 mg/kg (Other Renal Function)
n=4 Participants
Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and other renal impairment renal function received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
|
Part 2: Belantamab Mafodotin 2.5 mg/kg End Stage Renal Disease (Not on Dialysis)
n=5 Participants
Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and end stage renal disease (ESRD) (not on hemodialysis) received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
|
Part 2: Belantamab Mafodotin 2.5 mg/kg ESRD (On Dialysis)
n=8 Participants
Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and ESRD (on hemodialysis) received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
|
Total
n=36 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
60.3 YEARS
STANDARD_DEVIATION 8.21 • n=9 Participants
|
74.6 YEARS
STANDARD_DEVIATION 6.11 • n=27 Participants
|
67.5 YEARS
STANDARD_DEVIATION 10.79 • n=267 Participants
|
81.4 YEARS
STANDARD_DEVIATION 5.22 • n=265 Participants
|
70.9 YEARS
STANDARD_DEVIATION 6.83 • n=568 Participants
|
69.9 YEARS
STANDARD_DEVIATION 10.00 • n=22 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=9 Participants
|
1 Participants
n=27 Participants
|
3 Participants
n=267 Participants
|
1 Participants
n=265 Participants
|
2 Participants
n=568 Participants
|
11 Participants
n=22 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=9 Participants
|
8 Participants
n=27 Participants
|
1 Participants
n=267 Participants
|
4 Participants
n=265 Participants
|
6 Participants
n=568 Participants
|
25 Participants
n=22 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
0 Participants
n=568 Participants
|
0 Participants
n=22 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=9 Participants
|
2 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
3 Participants
n=265 Participants
|
1 Participants
n=568 Participants
|
11 Participants
n=22 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
0 Participants
n=568 Participants
|
0 Participants
n=22 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=9 Participants
|
2 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
4 Participants
n=568 Participants
|
7 Participants
n=22 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=9 Participants
|
5 Participants
n=27 Participants
|
4 Participants
n=267 Participants
|
2 Participants
n=265 Participants
|
3 Participants
n=568 Participants
|
18 Participants
n=22 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
0 Participants
n=568 Participants
|
0 Participants
n=22 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
0 Participants
n=568 Participants
|
0 Participants
n=22 Participants
|
PRIMARY outcome
Timeframe: Pre-dose, end of infusion (EOI), start of infusion (SOI)+2hour (h), SOI+4h, SOI+8h and SOI+24h on Cycle(C) 1 Day(D) 1 and C3D1; Anytime on C1 D4, D8, D15, D22; Anytime on C3 D4, D8, D15, D22; Pre-dose on C2D1 and C4D1.Population: Pharmacokinetic Evaluable population included all participants in the safety analysis set who had at least 80% non-missing expected plasma PK data during the Cycle 1 profile (i.e., all Cycle 1 timepoints and Cycle 2 Day 1 pre-dose). 'Cycle 1' and 'Cycle 3' include the full first and third cycles, along with Day 1 of Cycle 2 (C2D1) and Cycle 4 (C4D1) Predose periods, respectively.
Blood samples were collected for PK analysis of belantamab mafodotin ADC. As pre-specified in protocol, only specified treatment arms were planned to be analyzed for this outcome measure. As first dose of belantamab mafodotin was administered on Day 1, cycle length correlates to Day 1 plus 21 days i.e., Day 22 in timeframe. Only those participants who were measured and analyzed (i.e., contributed to data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified timepoints.
Outcome measures
| Measure |
Part 1: Belantamab Mafodotin 2.5 mg/kg (Normal/Mildly Impaired Renal Function)
n=8 Participants
Participants with Relapsed/Refractory Multiple Myeloma (RRMM) who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and normal/mildly impaired renal function received intravenous (IV) infusion of 2.5 milligram (mg)/kilogram (kg) belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to adverse event (AE), lost to follow-up, death, whichever occurs first.
|
Part 1: Belantamab Mafodotin 2.5 mg/kg (Severely Impaired Renal Function)
n=8 Participants
Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and severe renal impairment renal function received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
|
Part 1: Belantamab Mafodotin 2.5 mg/kg (Other Renal Function)
Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and other renal impairment renal function received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
|
Part 2: Belantamab Mafodotin 2.5 mg/kg End Stage Renal Disease (Not on Dialysis)
Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and end stage renal disease (ESRD) (not on hemodialysis) received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
|
Part 2: Belantamab Mafodotin 2.5 mg/kg ESRD (On Dialysis)
Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and ESRD (on hemodialysis) received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
|
|---|---|---|---|---|---|
|
Part 1: Area Under the Concentration-time Curve to Last Quantifiable Timepoint (AUC(0-tlast)) Following Administration of Belantamab Mafodotin (Antibody-drug Conjugate (ADC))
Cycle 1
|
4021.3 hour*microgram/millitre(h*ug/mL)
Geometric Coefficient of Variation 54.3
|
3704.7 hour*microgram/millitre(h*ug/mL)
Geometric Coefficient of Variation 32.4
|
—
|
—
|
—
|
|
Part 1: Area Under the Concentration-time Curve to Last Quantifiable Timepoint (AUC(0-tlast)) Following Administration of Belantamab Mafodotin (Antibody-drug Conjugate (ADC))
Cycle 3
|
6729.9 hour*microgram/millitre(h*ug/mL)
Geometric Coefficient of Variation 32.1
|
4127.8 hour*microgram/millitre(h*ug/mL)
Geometric Coefficient of Variation 30.4
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, end of infusion (EOI), start of infusion (SOI)+2hour (h), SOI+4h, SOI+8h and SOI+24h on Cycle(C) 1 Day(D) 1 and C3D1; Anytime on C1 D4, D8, D15, D22; Anytime on C3 D4, D8, D15, D22; Pre-dose on C2D1 and C4D1.Population: Pharmacokinetic Evaluable population. 'Cycle 1' and 'Cycle 3' include the full first and third cycles, along with the Day 1 of Cycle 2 (C2D1) and Cycle 4 (C4D1) Predose periods, respectively. Only those participants who were measured and analyzed (i.e., contributed to data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified timepoints.
Blood samples were collected for PK analysis of belantamab mafodotin ADC. As pre-specified in protocol, only specified treatment arms were planned to be analyzed for this outcome measure. As first dose of belantamab mafodotin was administered on Day 1, cycle length correlates to Day 1 plus 21 days i.e., Day 22 in timeframe.
Outcome measures
| Measure |
Part 1: Belantamab Mafodotin 2.5 mg/kg (Normal/Mildly Impaired Renal Function)
n=4 Participants
Participants with Relapsed/Refractory Multiple Myeloma (RRMM) who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and normal/mildly impaired renal function received intravenous (IV) infusion of 2.5 milligram (mg)/kilogram (kg) belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to adverse event (AE), lost to follow-up, death, whichever occurs first.
|
Part 1: Belantamab Mafodotin 2.5 mg/kg (Severely Impaired Renal Function)
n=8 Participants
Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and severe renal impairment renal function received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
|
Part 1: Belantamab Mafodotin 2.5 mg/kg (Other Renal Function)
Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and other renal impairment renal function received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
|
Part 2: Belantamab Mafodotin 2.5 mg/kg End Stage Renal Disease (Not on Dialysis)
Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and end stage renal disease (ESRD) (not on hemodialysis) received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
|
Part 2: Belantamab Mafodotin 2.5 mg/kg ESRD (On Dialysis)
Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and ESRD (on hemodialysis) received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
|
|---|---|---|---|---|---|
|
Part 1: Area Under the Concentration-time Curve During the Dosing Interval (AUC(0-tau)) Following Administration of Belantamab Mafodotin (ADC)
Cycle 1
|
4379.2 h*ug/mL
Geometric Coefficient of Variation 32.4
|
3683.1 h*ug/mL
Geometric Coefficient of Variation 32.6
|
—
|
—
|
—
|
|
Part 1: Area Under the Concentration-time Curve During the Dosing Interval (AUC(0-tau)) Following Administration of Belantamab Mafodotin (ADC)
Cycle 3
|
7245.1 h*ug/mL
Geometric Coefficient of Variation 42.2
|
3731.4 h*ug/mL
Geometric Coefficient of Variation 17.8
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: End of infusion on C1D1 and C3D1Population: Pharmacokinetic Evaluable population. Only those participants who were measured and analyzed (i.e., contributed to data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified timepoints.
Blood samples were collected for PK analysis of belantamab mafodotin ADC. As pre-specified in protocol, only specified treatment arms were planned to be analyzed for this outcome measure.
Outcome measures
| Measure |
Part 1: Belantamab Mafodotin 2.5 mg/kg (Normal/Mildly Impaired Renal Function)
n=8 Participants
Participants with Relapsed/Refractory Multiple Myeloma (RRMM) who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and normal/mildly impaired renal function received intravenous (IV) infusion of 2.5 milligram (mg)/kilogram (kg) belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to adverse event (AE), lost to follow-up, death, whichever occurs first.
|
Part 1: Belantamab Mafodotin 2.5 mg/kg (Severely Impaired Renal Function)
n=8 Participants
Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and severe renal impairment renal function received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
|
Part 1: Belantamab Mafodotin 2.5 mg/kg (Other Renal Function)
Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and other renal impairment renal function received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
|
Part 2: Belantamab Mafodotin 2.5 mg/kg End Stage Renal Disease (Not on Dialysis)
Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and end stage renal disease (ESRD) (not on hemodialysis) received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
|
Part 2: Belantamab Mafodotin 2.5 mg/kg ESRD (On Dialysis)
Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and ESRD (on hemodialysis) received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
|
|---|---|---|---|---|---|
|
Part 1: Observed Plasma Concentration at the End of Infusion (C-EOI) Following Administration of Belantamab Mafodotin (ADC)
Cycle 1 Day 1
|
54.43 ug/mL
Geometric Coefficient of Variation 31.5
|
45.66 ug/mL
Geometric Coefficient of Variation 20.8
|
—
|
—
|
—
|
|
Part 1: Observed Plasma Concentration at the End of Infusion (C-EOI) Following Administration of Belantamab Mafodotin (ADC)
Cycle 3 Day 1
|
48.07 ug/mL
Geometric Coefficient of Variation 39.4
|
32.70 ug/mL
Geometric Coefficient of Variation 39.8
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, end of infusion (EOI), start of infusion (SOI)+2hour (h), SOI+4h, SOI+8h and SOI+24h on Cycle(C) 1 Day(D) 1 and C3D1; Anytime on C1 D4, D8, D15, D22; Anytime on C3 D4, D8, D15, D22; Pre-dose on C2D1 and C4D1.Population: Pharmacokinetic Evaluable population. 'Cycle 1' and 'Cycle 3' include the full first and third cycles, along with the Day 1 of Cycle 2 (C2D1) and Cycle 4 (C4D1) Predose periods, respectively. Only those participants who were measured and analyzed (i.e., contributed to data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified timepoints.
Blood samples were collected for PK analysis of belantamab mafodotin ADC. As pre-specified in protocol, only specified treatment arms were planned to be analyzed for this outcome measure. As first dose of belantamab mafodotin was administered on Day 1, cycle length correlates to Day 1 plus 21 days i.e., Day 22 in timeframe.
Outcome measures
| Measure |
Part 1: Belantamab Mafodotin 2.5 mg/kg (Normal/Mildly Impaired Renal Function)
n=8 Participants
Participants with Relapsed/Refractory Multiple Myeloma (RRMM) who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and normal/mildly impaired renal function received intravenous (IV) infusion of 2.5 milligram (mg)/kilogram (kg) belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to adverse event (AE), lost to follow-up, death, whichever occurs first.
|
Part 1: Belantamab Mafodotin 2.5 mg/kg (Severely Impaired Renal Function)
n=8 Participants
Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and severe renal impairment renal function received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
|
Part 1: Belantamab Mafodotin 2.5 mg/kg (Other Renal Function)
Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and other renal impairment renal function received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
|
Part 2: Belantamab Mafodotin 2.5 mg/kg End Stage Renal Disease (Not on Dialysis)
Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and end stage renal disease (ESRD) (not on hemodialysis) received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
|
Part 2: Belantamab Mafodotin 2.5 mg/kg ESRD (On Dialysis)
Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and ESRD (on hemodialysis) received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
|
|---|---|---|---|---|---|
|
Part 1: Maximum Observed Concentration (Cmax) Following Administration of Belantamab Mafodotin (ADC)
Cycle 1
|
62.01 ug/mL
Geometric Coefficient of Variation 38.4
|
47.62 ug/mL
Geometric Coefficient of Variation 24.8
|
—
|
—
|
—
|
|
Part 1: Maximum Observed Concentration (Cmax) Following Administration of Belantamab Mafodotin (ADC)
Cycle 3
|
74.18 ug/mL
Geometric Coefficient of Variation 15.9
|
42.17 ug/mL
Geometric Coefficient of Variation 58.0
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, end of infusion (EOI), start of infusion (SOI)+2hour (h), SOI+4h, SOI+8h and SOI+24h on Cycle(C) 1 Day(D) 1 and C3D1; Anytime on C1 D4, D8, D15, D22; Anytime on C3 D4, D8, D15, D22; Pre-dose on C2D1 and C4D1.Population: Pharmacokinetic Evaluable population. 'Cycle 1' and 'Cycle 3' include the full first and third cycles, along with the Day 1 of Cycle 2 (C2D1) and Cycle 4 (C4D1) Predose periods, respectively. Only those participants who were measured and analyzed (i.e., contributed to data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified timepoints.
Blood samples were collected for PK analysis of belantamab mafodotin ADC. As pre-specified in protocol, only specified treatment arms were planned to be analyzed for this outcome measure. As first dose of belantamab mafodotin was administered on Day 1, cycle length correlates to Day 1 plus 21 days i.e., Day 22 in timeframe.
Outcome measures
| Measure |
Part 1: Belantamab Mafodotin 2.5 mg/kg (Normal/Mildly Impaired Renal Function)
n=8 Participants
Participants with Relapsed/Refractory Multiple Myeloma (RRMM) who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and normal/mildly impaired renal function received intravenous (IV) infusion of 2.5 milligram (mg)/kilogram (kg) belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to adverse event (AE), lost to follow-up, death, whichever occurs first.
|
Part 1: Belantamab Mafodotin 2.5 mg/kg (Severely Impaired Renal Function)
n=8 Participants
Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and severe renal impairment renal function received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
|
Part 1: Belantamab Mafodotin 2.5 mg/kg (Other Renal Function)
Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and other renal impairment renal function received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
|
Part 2: Belantamab Mafodotin 2.5 mg/kg End Stage Renal Disease (Not on Dialysis)
Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and end stage renal disease (ESRD) (not on hemodialysis) received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
|
Part 2: Belantamab Mafodotin 2.5 mg/kg ESRD (On Dialysis)
Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and ESRD (on hemodialysis) received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
|
|---|---|---|---|---|---|
|
Part 1: Time to Reach Cmax (Tmax) Following Administration of Belantamab Mafodotin (ADC)
Cycle 1
|
1.508 Hour
Interval 0.65 to 2.083
|
3.000 Hour
Interval 0.667 to 7.4
|
—
|
—
|
—
|
|
Part 1: Time to Reach Cmax (Tmax) Following Administration of Belantamab Mafodotin (ADC)
Cycle 3
|
4.000 Hour
Interval 2.0 to 8.0
|
2.083 Hour
Interval 0.7 to 4.017
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, end of infusion (EOI), start of infusion (SOI)+2hour (h), SOI+4h, SOI+8h and SOI+24h on Cycle(C) 1 Day(D) 1 and C3D1; Anytime on C1 D4, D8, D15, D22; Anytime on C3 D4, D8, D15, D22; Pre-dose on C2D1 and C4D1.Population: Pharmacokinetic Evaluable population. 'Cycle 1' and 'Cycle 3' include the full first and third cycles, along with the Day 1 of Cycle 2 (C2D1) and Cycle 4 (C4D1) Predose periods, respectively. Only those participants who were measured and analyzed (i.e., contributed to data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified timepoints.
Blood samples were collected for PK analysis of belantamab mafodotin ADC. As pre-specified in protocol, only specified treatment arms were planned to be analyzed for this outcome measure. As first dose of belantamab mafodotin was administered on Day 1, cycle length correlates to Day 1 plus 21 days i.e., Day 22 in timeframe.
Outcome measures
| Measure |
Part 1: Belantamab Mafodotin 2.5 mg/kg (Normal/Mildly Impaired Renal Function)
n=4 Participants
Participants with Relapsed/Refractory Multiple Myeloma (RRMM) who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and normal/mildly impaired renal function received intravenous (IV) infusion of 2.5 milligram (mg)/kilogram (kg) belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to adverse event (AE), lost to follow-up, death, whichever occurs first.
|
Part 1: Belantamab Mafodotin 2.5 mg/kg (Severely Impaired Renal Function)
n=8 Participants
Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and severe renal impairment renal function received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
|
Part 1: Belantamab Mafodotin 2.5 mg/kg (Other Renal Function)
Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and other renal impairment renal function received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
|
Part 2: Belantamab Mafodotin 2.5 mg/kg End Stage Renal Disease (Not on Dialysis)
Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and end stage renal disease (ESRD) (not on hemodialysis) received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
|
Part 2: Belantamab Mafodotin 2.5 mg/kg ESRD (On Dialysis)
Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and ESRD (on hemodialysis) received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
|
|---|---|---|---|---|---|
|
Part 1: Trough Concentration Prior to the Next Dose for Each Cycle (Ctrough) Following Administration of Belantamab Mafodotin (ADC)
Cycle 1
|
1.954 ug/mL
Geometric Coefficient of Variation 63.8
|
2.178 ug/mL
Geometric Coefficient of Variation 39.9
|
—
|
—
|
—
|
|
Part 1: Trough Concentration Prior to the Next Dose for Each Cycle (Ctrough) Following Administration of Belantamab Mafodotin (ADC)
Cycle 3
|
3.109 ug/mL
Geometric Coefficient of Variation 34.1
|
3.011 ug/mL
Geometric Coefficient of Variation 22.3
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, end of infusion (EOI), start of infusion (SOI)+2hour (h), SOI+4h, SOI+8h and SOI+24h on Cycle(C) 1 Day(D) 1 and C3D1; Anytime on C1 D4, D8, D15, D22; Anytime on C3 D4, D8, D15, D22; Pre-dose on C2D1 and C4D1 (up to Day 30 in C1 and C3)Population: Pharmacokinetic Evaluable population. 'Cycle 1' and 'Cycle 3' include the full first and third cycles, along with the Day 1 of Cycle 2 (C2D1) and Cycle 4 (C4D1) Predose periods, respectively. Only those participants who were measured and analyzed (i.e., contributed to data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified timepoints.
Blood samples were collected for PK analysis of belantamab mafodotin ADC. As pre-specified in protocol, only specified treatment arms were planned to be analyzed for this outcome measure. As first dose of belantamab mafodotin was administered on Day 1, cycle length correlates to Day 1 plus 21 days i.e., Day 22 in timeframe. For some participants, dosing in Cycle 2 or Cycle 4 was delayed, resulting in the pre-dose samples in these cycles (C2D1 or C4D1) being collected later than the protocol-defined planned days after dosing in C1D1 or C3D1. Consequently, the last PK samples for these participants were collected outside the pre-defined protocol time points, and certain Tlast values in the data table extend beyond the original protocol-defined Time Frame.
Outcome measures
| Measure |
Part 1: Belantamab Mafodotin 2.5 mg/kg (Normal/Mildly Impaired Renal Function)
n=8 Participants
Participants with Relapsed/Refractory Multiple Myeloma (RRMM) who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and normal/mildly impaired renal function received intravenous (IV) infusion of 2.5 milligram (mg)/kilogram (kg) belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to adverse event (AE), lost to follow-up, death, whichever occurs first.
|
Part 1: Belantamab Mafodotin 2.5 mg/kg (Severely Impaired Renal Function)
n=8 Participants
Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and severe renal impairment renal function received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
|
Part 1: Belantamab Mafodotin 2.5 mg/kg (Other Renal Function)
Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and other renal impairment renal function received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
|
Part 2: Belantamab Mafodotin 2.5 mg/kg End Stage Renal Disease (Not on Dialysis)
Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and end stage renal disease (ESRD) (not on hemodialysis) received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
|
Part 2: Belantamab Mafodotin 2.5 mg/kg ESRD (On Dialysis)
Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and ESRD (on hemodialysis) received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
|
|---|---|---|---|---|---|
|
Part 1: Time of Last Observed Quantifiable Concentration (Tlast) Following Administration of Belantamab Mafodotin (ADC)
Cycle 1
|
396.3 Hour
Interval 163.0 to 579.9
|
506.4 Hour
Interval 503.3 to 528.4
|
—
|
—
|
—
|
|
Part 1: Time of Last Observed Quantifiable Concentration (Tlast) Following Administration of Belantamab Mafodotin (ADC)
Cycle 3
|
501.3 Hour
Interval 334.8 to 697.7
|
482.5 Hour
Interval 335.4 to 505.2
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, end of infusion (EOI), start of infusion (SOI)+2hour (h), SOI+4h, SOI+8h and SOI+24h on Cycle(C) 1 Day(D) 1 and C3D1; Anytime on C1 D4, D8, D15, D22; Anytime on C3 D4, D8, D15, D22; Pre-dose on C2D1 and C4D1.Population: Pharmacokinetic Evaluable population. 'Cycle 1' and 'Cycle 3' include the full first and third cycles, along with the Day 1 of Cycle 2 (C2D1) and Cycle 4 (C4D1) Predose periods, respectively. Only those participants who were measured and analyzed (i.e., contributed to data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified timepoints.
Blood samples were collected for PK analysis of belantamab mafodotin Total Antibody. As pre-specified in protocol, only specified treatment arms were planned to be analyzed for this outcome measure. As first dose of belantamab mafodotin was administered on Day 1, cycle length correlates to Day 1 plus 21 days i.e., Day 22 in timeframe.
Outcome measures
| Measure |
Part 1: Belantamab Mafodotin 2.5 mg/kg (Normal/Mildly Impaired Renal Function)
n=7 Participants
Participants with Relapsed/Refractory Multiple Myeloma (RRMM) who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and normal/mildly impaired renal function received intravenous (IV) infusion of 2.5 milligram (mg)/kilogram (kg) belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to adverse event (AE), lost to follow-up, death, whichever occurs first.
|
Part 1: Belantamab Mafodotin 2.5 mg/kg (Severely Impaired Renal Function)
n=8 Participants
Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and severe renal impairment renal function received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
|
Part 1: Belantamab Mafodotin 2.5 mg/kg (Other Renal Function)
Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and other renal impairment renal function received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
|
Part 2: Belantamab Mafodotin 2.5 mg/kg End Stage Renal Disease (Not on Dialysis)
Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and end stage renal disease (ESRD) (not on hemodialysis) received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
|
Part 2: Belantamab Mafodotin 2.5 mg/kg ESRD (On Dialysis)
Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and ESRD (on hemodialysis) received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
|
|---|---|---|---|---|---|
|
Part 1: Area Under the Concentration-time Curve to Last Quantifiable Timepoint (AUC(0-tlast)) Following Administration of Belantamab Mafodotin (Total Antibody)
Cycle 1
|
5591.2 h*ug/mL
Geometric Coefficient of Variation 76.4
|
5443.7 h*ug/mL
Geometric Coefficient of Variation 27.4
|
—
|
—
|
—
|
|
Part 1: Area Under the Concentration-time Curve to Last Quantifiable Timepoint (AUC(0-tlast)) Following Administration of Belantamab Mafodotin (Total Antibody)
Cycle 3
|
9240.4 h*ug/mL
Geometric Coefficient of Variation 18.9
|
7579.4 h*ug/mL
Geometric Coefficient of Variation 35.1
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, end of infusion (EOI), start of infusion (SOI)+2hour (h), SOI+4h, SOI+8h and SOI+24h on Cycle(C) 1 Day(D) 1 and C3D1; Anytime on C1 D4, D8, D15, D22; Anytime on C3 D4, D8, D15, D22; Pre-dose on C2D1 and C4D1.Population: Pharmacokinetic Evaluable population. 'Cycle 1' and 'Cycle 3' include the full first and third cycles, along with the Day 1 of Cycle 2 (C2D1) and Cycle 4 (C4D1) Predose periods, respectively. Only those participants who were measured and analyzed (i.e., contributed to data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified timepoints.
Blood samples were collected for PK analysis of belantamab mafodotin total Antibody. As pre-specified in protocol, only specified treatment arms were planned to be analyzed for this outcome measure. As first dose of belantamab mafodotin was administered on Day 1, cycle length correlates to Day 1 plus 21 days i.e., Day 22 in timeframe.
Outcome measures
| Measure |
Part 1: Belantamab Mafodotin 2.5 mg/kg (Normal/Mildly Impaired Renal Function)
n=3 Participants
Participants with Relapsed/Refractory Multiple Myeloma (RRMM) who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and normal/mildly impaired renal function received intravenous (IV) infusion of 2.5 milligram (mg)/kilogram (kg) belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to adverse event (AE), lost to follow-up, death, whichever occurs first.
|
Part 1: Belantamab Mafodotin 2.5 mg/kg (Severely Impaired Renal Function)
n=7 Participants
Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and severe renal impairment renal function received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
|
Part 1: Belantamab Mafodotin 2.5 mg/kg (Other Renal Function)
Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and other renal impairment renal function received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
|
Part 2: Belantamab Mafodotin 2.5 mg/kg End Stage Renal Disease (Not on Dialysis)
Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and end stage renal disease (ESRD) (not on hemodialysis) received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
|
Part 2: Belantamab Mafodotin 2.5 mg/kg ESRD (On Dialysis)
Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and ESRD (on hemodialysis) received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
|
|---|---|---|---|---|---|
|
Part 1: Area Under the Concentration-time Curve During the Dosing Interval (AUC(0-tau)) Following Administration of Belantamab Mafodotin (Total Antibody)
Cycle 3
|
9615.3 h*ug/mL
Geometric Coefficient of Variation 19.0
|
7056.8 h*ug/mL
Geometric Coefficient of Variation 32.9
|
—
|
—
|
—
|
|
Part 1: Area Under the Concentration-time Curve During the Dosing Interval (AUC(0-tau)) Following Administration of Belantamab Mafodotin (Total Antibody)
Cycle 1
|
6543.6 h*ug/mL
Geometric Coefficient of Variation 69.0
|
5217.0 h*ug/mL
Geometric Coefficient of Variation 28.4
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: End of infusion on C1D1 and C3D1Population: Pharmacokinetic Evaluable population. Only those participants who were measured and analyzed (i.e., contributed to data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified timepoints.
Blood samples were collected for PK analysis of belantamab mafodotin Total Antibody. As pre-specified in protocol, only specified treatment arms were planned to be analyzed for this outcome measure.
Outcome measures
| Measure |
Part 1: Belantamab Mafodotin 2.5 mg/kg (Normal/Mildly Impaired Renal Function)
n=8 Participants
Participants with Relapsed/Refractory Multiple Myeloma (RRMM) who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and normal/mildly impaired renal function received intravenous (IV) infusion of 2.5 milligram (mg)/kilogram (kg) belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to adverse event (AE), lost to follow-up, death, whichever occurs first.
|
Part 1: Belantamab Mafodotin 2.5 mg/kg (Severely Impaired Renal Function)
n=8 Participants
Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and severe renal impairment renal function received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
|
Part 1: Belantamab Mafodotin 2.5 mg/kg (Other Renal Function)
Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and other renal impairment renal function received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
|
Part 2: Belantamab Mafodotin 2.5 mg/kg End Stage Renal Disease (Not on Dialysis)
Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and end stage renal disease (ESRD) (not on hemodialysis) received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
|
Part 2: Belantamab Mafodotin 2.5 mg/kg ESRD (On Dialysis)
Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and ESRD (on hemodialysis) received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
|
|---|---|---|---|---|---|
|
Part 1: Observed Plasma Concentration at the End of Infusion (C-EOI) Following Administration of Belantamab Mafodotin (Total Antibody)
Cycle 1 Day 1
|
46.72 ug/mL
Geometric Coefficient of Variation 35.0
|
29.61 ug/mL
Geometric Coefficient of Variation 71.4
|
—
|
—
|
—
|
|
Part 1: Observed Plasma Concentration at the End of Infusion (C-EOI) Following Administration of Belantamab Mafodotin (Total Antibody)
Cycle 3 Day 1
|
54.02 ug/mL
Geometric Coefficient of Variation 15.1
|
36.83 ug/mL
Geometric Coefficient of Variation 37.1
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, end of infusion (EOI), start of infusion (SOI)+2hour (h), SOI+4h, SOI+8h and SOI+24h on Cycle(C) 1 Day(D) 1 and C3D1; Anytime on C1 D4, D8, D15, D22; Anytime on C3 D4, D8, D15, D22; Pre-dose on C2D1 and C4D1.Population: Pharmacokinetic Evaluable population. 'Cycle 1' and 'Cycle 3' include the full first and third cycles, along with the Day 1 of Cycle 2 (C2D1) and Cycle 4 (C4D1) Predose periods, respectively. Only those participants who were measured and analyzed (i.e., contributed to data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified timepoints.
Blood samples were collected for PK analysis of belantamab mafodotin Total Antibody. As pre-specified in protocol, only specified treatment arms were planned to be analyzed for this outcome measure. As first dose of belantamab mafodotin was administered on Day 1, cycle length correlates to Day 1 plus 21 days i.e., Day 22 in timeframe.
Outcome measures
| Measure |
Part 1: Belantamab Mafodotin 2.5 mg/kg (Normal/Mildly Impaired Renal Function)
n=8 Participants
Participants with Relapsed/Refractory Multiple Myeloma (RRMM) who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and normal/mildly impaired renal function received intravenous (IV) infusion of 2.5 milligram (mg)/kilogram (kg) belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to adverse event (AE), lost to follow-up, death, whichever occurs first.
|
Part 1: Belantamab Mafodotin 2.5 mg/kg (Severely Impaired Renal Function)
n=8 Participants
Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and severe renal impairment renal function received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
|
Part 1: Belantamab Mafodotin 2.5 mg/kg (Other Renal Function)
Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and other renal impairment renal function received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
|
Part 2: Belantamab Mafodotin 2.5 mg/kg End Stage Renal Disease (Not on Dialysis)
Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and end stage renal disease (ESRD) (not on hemodialysis) received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
|
Part 2: Belantamab Mafodotin 2.5 mg/kg ESRD (On Dialysis)
Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and ESRD (on hemodialysis) received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
|
|---|---|---|---|---|---|
|
Part 1: Maximum Observed Concentration (Cmax) Following Administration of Belantamab Mafodotin (Total Antibody)
Cycle 1
|
49.49 ug/mL
Geometric Coefficient of Variation 30.3
|
39.33 ug/mL
Geometric Coefficient of Variation 33.6
|
—
|
—
|
—
|
|
Part 1: Maximum Observed Concentration (Cmax) Following Administration of Belantamab Mafodotin (Total Antibody)
Cycle 3
|
54.63 ug/mL
Geometric Coefficient of Variation 14.9
|
38.25 ug/mL
Geometric Coefficient of Variation 32.0
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, end of infusion (EOI), start of infusion (SOI)+2hour (h), SOI+4h, SOI+8h and SOI+24h on Cycle(C) 1 Day(D) 1 and C3D1; Anytime on C1 D4, D8, D15, D22; Anytime on C3 D4, D8, D15, D22; Pre-dose on C2D1 and C4D1.Population: Pharmacokinetic Evaluable population. 'Cycle 1' and 'Cycle 3' include the full first and third cycles, along with the Day 1 of Cycle 2 (C2D1) and Cycle 4 (C4D1) Predose periods, respectively. Only those participants who were measured and analyzed (i.e., contributed to data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified timepoints.
Blood samples were collected for PK analysis of belantamab mafodotin total antibody. As pre-specified in protocol, only specified treatment arms were planned to be analyzed for this outcome measure. As first dose of belantamab mafodotin was administered on Day 1, cycle length correlates to Day 1 plus 21 days i.e., Day 22 in timeframe.
Outcome measures
| Measure |
Part 1: Belantamab Mafodotin 2.5 mg/kg (Normal/Mildly Impaired Renal Function)
n=8 Participants
Participants with Relapsed/Refractory Multiple Myeloma (RRMM) who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and normal/mildly impaired renal function received intravenous (IV) infusion of 2.5 milligram (mg)/kilogram (kg) belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to adverse event (AE), lost to follow-up, death, whichever occurs first.
|
Part 1: Belantamab Mafodotin 2.5 mg/kg (Severely Impaired Renal Function)
n=8 Participants
Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and severe renal impairment renal function received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
|
Part 1: Belantamab Mafodotin 2.5 mg/kg (Other Renal Function)
Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and other renal impairment renal function received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
|
Part 2: Belantamab Mafodotin 2.5 mg/kg End Stage Renal Disease (Not on Dialysis)
Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and end stage renal disease (ESRD) (not on hemodialysis) received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
|
Part 2: Belantamab Mafodotin 2.5 mg/kg ESRD (On Dialysis)
Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and ESRD (on hemodialysis) received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
|
|---|---|---|---|---|---|
|
Part 1: Time to Reach Cmax (Tmax) Following Administration of Belantamab Mafodotin (Total Antibody)
Cycle 1
|
2.050 Hour
Interval 0.583 to 4.067
|
2.008 Hour
Interval 0.467 to 7.0
|
—
|
—
|
—
|
|
Part 1: Time to Reach Cmax (Tmax) Following Administration of Belantamab Mafodotin (Total Antibody)
Cycle 3
|
0.667 Hour
Interval 0.65 to 2.0
|
2.017 Hour
Interval 0.633 to 4.083
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, end of infusion (EOI), start of infusion (SOI)+2hour (h), SOI+4h, SOI+8h and SOI+24h on Cycle(C) 1 Day(D) 1 and C3D1; Anytime on C1 D4, D8, D15, D22; Anytime on C3 D4, D8, D15, D22; Pre-dose on C2D1 and C4D1.Population: Pharmacokinetic Evaluable population. 'Cycle 1' and 'Cycle 3' include the full first and third cycles, along with the Day 1 of Cycle 2 (C2D1) and Cycle 4 (C4D1) Predose periods, respectively. Only those participants who were measured and analyzed (i.e., contributed to data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified timepoints.
Blood samples were collected for PK analysis of belantamab mafodotin Total Antibody. As pre-specified in protocol, only specified treatment arms were planned to be analyzed for this outcome measure. As first dose of belantamab mafodotin was administered on Day 1, cycle length correlates to Day 1 plus 21 days i.e., Day 22 in timeframe.
Outcome measures
| Measure |
Part 1: Belantamab Mafodotin 2.5 mg/kg (Normal/Mildly Impaired Renal Function)
n=5 Participants
Participants with Relapsed/Refractory Multiple Myeloma (RRMM) who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and normal/mildly impaired renal function received intravenous (IV) infusion of 2.5 milligram (mg)/kilogram (kg) belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to adverse event (AE), lost to follow-up, death, whichever occurs first.
|
Part 1: Belantamab Mafodotin 2.5 mg/kg (Severely Impaired Renal Function)
n=8 Participants
Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and severe renal impairment renal function received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
|
Part 1: Belantamab Mafodotin 2.5 mg/kg (Other Renal Function)
Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and other renal impairment renal function received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
|
Part 2: Belantamab Mafodotin 2.5 mg/kg End Stage Renal Disease (Not on Dialysis)
Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and end stage renal disease (ESRD) (not on hemodialysis) received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
|
Part 2: Belantamab Mafodotin 2.5 mg/kg ESRD (On Dialysis)
Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and ESRD (on hemodialysis) received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
|
|---|---|---|---|---|---|
|
Part 1: Trough Concentration Prior to the Next Dose for Each Cycle (Ctrough) Following Administration of Belantamab Mafodotin (Total Antibody)
Cycle 1
|
8.785 ug/mL
Geometric Coefficient of Variation 185.8
|
6.489 ug/mL
Geometric Coefficient of Variation 103.2
|
—
|
—
|
—
|
|
Part 1: Trough Concentration Prior to the Next Dose for Each Cycle (Ctrough) Following Administration of Belantamab Mafodotin (Total Antibody)
Cycle 3
|
7.974 ug/mL
Geometric Coefficient of Variation 22.8
|
9.359 ug/mL
Geometric Coefficient of Variation 47.2
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, end of infusion (EOI), start of infusion (SOI)+2hour (h), SOI+4h, SOI+8h and SOI+24h on Cycle(C) 1 Day(D) 1 and C3D1; Anytime on C1 D4, D8, D15, D22; Anytime on C3 D4, D8, D15, D22; Pre-dose on C2D1 and C4D1 (up to Day 30 in C1 and C3)Population: Pharmacokinetic Evaluable population. 'Cycle 1' and 'Cycle 3' include the full first and third cycles, along with the Day 1 of Cycle 2 (C2D1) and Cycle 4 (C4D1) Predose periods, respectively. Only those participants who were measured and analyzed (i.e., contributed to data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified timepoints.
Blood samples were collected for PK analysis of belantamab mafodotin Total Antibody. As pre-specified in protocol, only specified treatment arms were planned to be analyzed for this outcome measure. As first dose of belantamab mafodotin was administered on Day 1, cycle length correlates to Day 1 plus 21 days i.e., Day 22 in timeframe. For some participants, dosing in Cycle 2 or Cycle 4 was delayed, resulting in the pre-dose samples in these cycles (C2D1 or C4D1) being collected later than the protocol-defined planned days after dosing in C1D1 or C3D1. Consequently, the last PK samples for these participants were collected outside the pre-defined protocol time points, and certain Tlast values in the data table extend beyond the original protocol-defined Time Frame.
Outcome measures
| Measure |
Part 1: Belantamab Mafodotin 2.5 mg/kg (Normal/Mildly Impaired Renal Function)
n=8 Participants
Participants with Relapsed/Refractory Multiple Myeloma (RRMM) who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and normal/mildly impaired renal function received intravenous (IV) infusion of 2.5 milligram (mg)/kilogram (kg) belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to adverse event (AE), lost to follow-up, death, whichever occurs first.
|
Part 1: Belantamab Mafodotin 2.5 mg/kg (Severely Impaired Renal Function)
n=8 Participants
Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and severe renal impairment renal function received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
|
Part 1: Belantamab Mafodotin 2.5 mg/kg (Other Renal Function)
Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and other renal impairment renal function received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
|
Part 2: Belantamab Mafodotin 2.5 mg/kg End Stage Renal Disease (Not on Dialysis)
Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and end stage renal disease (ESRD) (not on hemodialysis) received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
|
Part 2: Belantamab Mafodotin 2.5 mg/kg ESRD (On Dialysis)
Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and ESRD (on hemodialysis) received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
|
|---|---|---|---|---|---|
|
Part 1: Time of Last Observed Quantifiable Concentration (Tlast) Following Administration of Belantamab Mafodotin (Total Antibody)
Cycle 1
|
346.9 Hour
Interval 23.7 to 579.9
|
505.5 Hour
Interval 334.3 to 528.4
|
—
|
—
|
—
|
|
Part 1: Time of Last Observed Quantifiable Concentration (Tlast) Following Administration of Belantamab Mafodotin (Total Antibody)
Cycle 3
|
501.3 Hour
Interval 334.8 to 697.7
|
482.5 Hour
Interval 335.4 to 505.2
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, end of infusion (EOI), start of infusion (SOI)+2hour (h), SOI+4h, SOI+8h and SOI+24h on Cycle(C) 1 Day(D) 1 and C3D1; Anytime on C1 D4, D8, D15, D22; Anytime on C3 D4, D8, D15, D22; Pre-dose on C2D1 and C4D1.Population: Pharmacokinetic Evaluable population. 'Cycle 1' and 'Cycle 3' include the full first and third cycles, along with the Day 1 of Cycle 2 (C2D1) and Cycle 4 (C4D1) Predose periods, respectively. Only those participants who were measured and analyzed (i.e., contributed to data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified timepoints.
Blood samples were collected for PK analysis of belantamab mafodotin Cys-mcMMAF. As pre-specified in protocol, only specified treatment arms were planned to be analyzed for this outcome measure. As first dose of belantamab mafodotin was administered on Day 1, cycle length correlates to Day 1 plus 21 days i.e., Day 22 in timeframe.
Outcome measures
| Measure |
Part 1: Belantamab Mafodotin 2.5 mg/kg (Normal/Mildly Impaired Renal Function)
n=8 Participants
Participants with Relapsed/Refractory Multiple Myeloma (RRMM) who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and normal/mildly impaired renal function received intravenous (IV) infusion of 2.5 milligram (mg)/kilogram (kg) belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to adverse event (AE), lost to follow-up, death, whichever occurs first.
|
Part 1: Belantamab Mafodotin 2.5 mg/kg (Severely Impaired Renal Function)
n=8 Participants
Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and severe renal impairment renal function received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
|
Part 1: Belantamab Mafodotin 2.5 mg/kg (Other Renal Function)
Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and other renal impairment renal function received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
|
Part 2: Belantamab Mafodotin 2.5 mg/kg End Stage Renal Disease (Not on Dialysis)
Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and end stage renal disease (ESRD) (not on hemodialysis) received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
|
Part 2: Belantamab Mafodotin 2.5 mg/kg ESRD (On Dialysis)
Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and ESRD (on hemodialysis) received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
|
|---|---|---|---|---|---|
|
Part 1: Area Under the Concentration-time Curve to Last Quantifiable Timepoint (AUC(0-tlast)) Following Administration of Belantamab Mafodotin (Cysteine Maleimidocaproyl Monomethyl Auristatin F (Cys-mcMMAF))
Cycle 1
|
127.3 h*ng/mL
Geometric Coefficient of Variation 81.3
|
77.1 h*ng/mL
Geometric Coefficient of Variation 53.1
|
—
|
—
|
—
|
|
Part 1: Area Under the Concentration-time Curve to Last Quantifiable Timepoint (AUC(0-tlast)) Following Administration of Belantamab Mafodotin (Cysteine Maleimidocaproyl Monomethyl Auristatin F (Cys-mcMMAF))
Cycle 3
|
72.8 h*ng/mL
Geometric Coefficient of Variation 21.8
|
40.8 h*ng/mL
Geometric Coefficient of Variation 178.7
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, end of infusion (EOI), start of infusion (SOI)+2hour (h), SOI+4h, SOI+8h and SOI+24h on Cycle(C) 1 Day(D) 1 and C3D1; Anytime on C1 D4, D8, and D15; Anytime on C3 D4, D8, and D15Population: Pharmacokinetic Evaluable population. Only those participants who were measured and analyzed (i.e., contributed to data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified timepoints.
Blood samples were collected for PK analysis of belantamab mafodotin Cys-mcMMAF. As pre-specified in protocol, only specified treatment arms were planned to be analyzed for this outcome measure. In cases where the nominal Day 8 sample was collected prior to 168 hours and earlier time points did not permit reliable extrapolation to 168 hours, a later sample (e.g., Day 15) with a measurable concentration was used to support estimation of the concentration at 168 hours. Outcome data are reported only for AUC over 0-168 hours.
Outcome measures
| Measure |
Part 1: Belantamab Mafodotin 2.5 mg/kg (Normal/Mildly Impaired Renal Function)
n=6 Participants
Participants with Relapsed/Refractory Multiple Myeloma (RRMM) who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and normal/mildly impaired renal function received intravenous (IV) infusion of 2.5 milligram (mg)/kilogram (kg) belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to adverse event (AE), lost to follow-up, death, whichever occurs first.
|
Part 1: Belantamab Mafodotin 2.5 mg/kg (Severely Impaired Renal Function)
n=8 Participants
Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and severe renal impairment renal function received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
|
Part 1: Belantamab Mafodotin 2.5 mg/kg (Other Renal Function)
Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and other renal impairment renal function received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
|
Part 2: Belantamab Mafodotin 2.5 mg/kg End Stage Renal Disease (Not on Dialysis)
Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and end stage renal disease (ESRD) (not on hemodialysis) received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
|
Part 2: Belantamab Mafodotin 2.5 mg/kg ESRD (On Dialysis)
Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and ESRD (on hemodialysis) received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
|
|---|---|---|---|---|---|
|
Part 1: Area Under the Concentration-time Curve During the Dosing Interval up to 168 Hours (AUC (0-168h)) Following Administration of Belantamab Mafodotin (Cys-mcMMAF)
Cycle 1
|
134.7 h*ng/mL
Geometric Coefficient of Variation 99.8
|
75.2 h*ng/mL
Geometric Coefficient of Variation 48.2
|
—
|
—
|
—
|
|
Part 1: Area Under the Concentration-time Curve During the Dosing Interval up to 168 Hours (AUC (0-168h)) Following Administration of Belantamab Mafodotin (Cys-mcMMAF)
Cycle 3
|
61.2 h*ng/mL
Geometric Coefficient of Variation 6.0
|
79.6 h*ng/mL
Geometric Coefficient of Variation 39.3
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: End of infusion on C1D1 and C3D1Population: Pharmacokinetic Evaluable population. Only those participants who were measured and analyzed (i.e., contributed to data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified timepoints.
Blood samples were collected for PK analysis of belantamab mafodotin Cys-mcMMAF. As pre-specified in protocol, only specified treatment arms were planned to be analyzed for this outcome measure.
Outcome measures
| Measure |
Part 1: Belantamab Mafodotin 2.5 mg/kg (Normal/Mildly Impaired Renal Function)
n=8 Participants
Participants with Relapsed/Refractory Multiple Myeloma (RRMM) who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and normal/mildly impaired renal function received intravenous (IV) infusion of 2.5 milligram (mg)/kilogram (kg) belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to adverse event (AE), lost to follow-up, death, whichever occurs first.
|
Part 1: Belantamab Mafodotin 2.5 mg/kg (Severely Impaired Renal Function)
n=7 Participants
Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and severe renal impairment renal function received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
|
Part 1: Belantamab Mafodotin 2.5 mg/kg (Other Renal Function)
Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and other renal impairment renal function received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
|
Part 2: Belantamab Mafodotin 2.5 mg/kg End Stage Renal Disease (Not on Dialysis)
Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and end stage renal disease (ESRD) (not on hemodialysis) received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
|
Part 2: Belantamab Mafodotin 2.5 mg/kg ESRD (On Dialysis)
Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and ESRD (on hemodialysis) received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
|
|---|---|---|---|---|---|
|
Part 1: Observed Plasma Concentration at the End of Infusion (C-EOI) Following Administration of Belantamab Mafodotin (Cys-mcMMAF)
Cycle 1 Day 1
|
0.84 ng/mL
Geometric Coefficient of Variation 61.4
|
0.41 ng/mL
Geometric Coefficient of Variation 78.2
|
—
|
—
|
—
|
|
Part 1: Observed Plasma Concentration at the End of Infusion (C-EOI) Following Administration of Belantamab Mafodotin (Cys-mcMMAF)
Cycle 3 Day 1
|
0.54 ng/mL
Geometric Coefficient of Variation 83.1
|
0.32 ng/mL
Geometric Coefficient of Variation 174.1
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, end of infusion (EOI), start of infusion (SOI)+2hour (h), SOI+4h, SOI+8h and SOI+24h on Cycle(C) 1 Day(D) 1 and C3D1; Anytime on C1 D4, D8, D15, D22; Anytime on C3 D4, D8, D15, D22; Pre-dose on C2D1 and C4D1.Population: Pharmacokinetic Evaluable population. 'Cycle 1' and 'Cycle 3' include the full first and third cycles, along with the Day 1 of Cycle 2 (C2D1) and Cycle 4 (C4D1) Predose periods, respectively. Only those participants who were measured and analyzed (i.e., contributed to data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified timepoints.
Blood samples were collected for PK analysis of belantamab mafodotin Cys-mcMMAF. As pre-specified in protocol, only specified treatment arms were planned to be analyzed for this outcome measure. As first dose of belantamab mafodotin was administered on Day 1, cycle length correlates to Day 1 plus 21 days i.e., Day 22 in timeframe.
Outcome measures
| Measure |
Part 1: Belantamab Mafodotin 2.5 mg/kg (Normal/Mildly Impaired Renal Function)
n=8 Participants
Participants with Relapsed/Refractory Multiple Myeloma (RRMM) who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and normal/mildly impaired renal function received intravenous (IV) infusion of 2.5 milligram (mg)/kilogram (kg) belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to adverse event (AE), lost to follow-up, death, whichever occurs first.
|
Part 1: Belantamab Mafodotin 2.5 mg/kg (Severely Impaired Renal Function)
n=8 Participants
Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and severe renal impairment renal function received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
|
Part 1: Belantamab Mafodotin 2.5 mg/kg (Other Renal Function)
Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and other renal impairment renal function received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
|
Part 2: Belantamab Mafodotin 2.5 mg/kg End Stage Renal Disease (Not on Dialysis)
Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and end stage renal disease (ESRD) (not on hemodialysis) received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
|
Part 2: Belantamab Mafodotin 2.5 mg/kg ESRD (On Dialysis)
Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and ESRD (on hemodialysis) received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
|
|---|---|---|---|---|---|
|
Part 1: Maximum Observed Concentration (Cmax) Following Administration of Belantamab Mafodotin (Cys-mcMMAF)
Cycle 1
|
1.63 ng/mL
Geometric Coefficient of Variation 64.0
|
0.71 ng/mL
Geometric Coefficient of Variation 48.2
|
—
|
—
|
—
|
|
Part 1: Maximum Observed Concentration (Cmax) Following Administration of Belantamab Mafodotin (Cys-mcMMAF)
Cycle 3
|
0.74 ng/mL
Geometric Coefficient of Variation 19.2
|
0.50 ng/mL
Geometric Coefficient of Variation 100.6
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, end of infusion (EOI), start of infusion (SOI)+2hour (h), SOI+4h, SOI+8h and SOI+24h on Cycle(C) 1 Day(D) 1 and C3D1; Anytime on C1 D4, D8, D15, D22; Anytime on C3 D4, D8, D15, D22; Pre-dose on C2D1 and C4D1.Population: Pharmacokinetic Evaluable population. 'Cycle 1' and 'Cycle 3' include the full first and third cycles, along with the Day 1 of Cycle 2 (C2D1) and Cycle 4 (C4D1) Predose periods, respectively. Only those participants who were measured and analyzed (i.e., contributed to data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified timepoints.
Blood samples were collected for PK analysis of belantamab mafodotin Cys-mcMMAF. As pre-specified in protocol, only specified treatment arms were planned to be analyzed for this outcome measure. As first dose of belantamab mafodotin was administered on Day 1, cycle length correlates to Day 1 plus 21 days i.e., Day 22 in timeframe.
Outcome measures
| Measure |
Part 1: Belantamab Mafodotin 2.5 mg/kg (Normal/Mildly Impaired Renal Function)
n=8 Participants
Participants with Relapsed/Refractory Multiple Myeloma (RRMM) who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and normal/mildly impaired renal function received intravenous (IV) infusion of 2.5 milligram (mg)/kilogram (kg) belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to adverse event (AE), lost to follow-up, death, whichever occurs first.
|
Part 1: Belantamab Mafodotin 2.5 mg/kg (Severely Impaired Renal Function)
n=8 Participants
Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and severe renal impairment renal function received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
|
Part 1: Belantamab Mafodotin 2.5 mg/kg (Other Renal Function)
Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and other renal impairment renal function received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
|
Part 2: Belantamab Mafodotin 2.5 mg/kg End Stage Renal Disease (Not on Dialysis)
Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and end stage renal disease (ESRD) (not on hemodialysis) received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
|
Part 2: Belantamab Mafodotin 2.5 mg/kg ESRD (On Dialysis)
Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and ESRD (on hemodialysis) received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
|
|---|---|---|---|---|---|
|
Part 1: Time to Reach Cmax (Tmax) Following Administration of Belantamab Mafodotin (Cys-mcMMAF)
Cycle 1
|
16.017 Hour
Interval 0.917 to 92.6
|
23.400 Hour
Interval 7.4 to 30.7
|
—
|
—
|
—
|
|
Part 1: Time to Reach Cmax (Tmax) Following Administration of Belantamab Mafodotin (Cys-mcMMAF)
Cycle 3
|
8.000 Hour
Interval 0.583 to 22.167
|
23.967 Hour
Interval 0.6 to 72.583
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, end of infusion (EOI), start of infusion (SOI)+2hour (h), SOI+4h, SOI+8h and SOI+24h on Cycle(C) 1 Day(D) 1 and C3D1; Anytime on C1 D4, D8, D15, D22; Anytime on C3 D4, D8, D15, D22; Pre-dose on C2D1 and C4D1.Population: Pharmacokinetic Evaluable population. 'Cycle 1' and 'Cycle 3' include the full first and third cycles, along with the Day 1 of Cycle 2 (C2D1) and Cycle 4 (C4D1) Predose periods, respectively. Only those participants who were measured and analyzed (i.e., contributed to data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified timepoints.
Blood samples were collected for PK analysis of belantamab mafodotin Cys-mcMMAF. As pre-specified in protocol, only specified treatment arms were planned to be analyzed for this outcome measure. As first dose of belantamab mafodotin was administered on Day 1, cycle length correlates to Day 1 plus 21 days i.e., Day 22 in timeframe.
Outcome measures
| Measure |
Part 1: Belantamab Mafodotin 2.5 mg/kg (Normal/Mildly Impaired Renal Function)
n=8 Participants
Participants with Relapsed/Refractory Multiple Myeloma (RRMM) who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and normal/mildly impaired renal function received intravenous (IV) infusion of 2.5 milligram (mg)/kilogram (kg) belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to adverse event (AE), lost to follow-up, death, whichever occurs first.
|
Part 1: Belantamab Mafodotin 2.5 mg/kg (Severely Impaired Renal Function)
n=8 Participants
Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and severe renal impairment renal function received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
|
Part 1: Belantamab Mafodotin 2.5 mg/kg (Other Renal Function)
Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and other renal impairment renal function received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
|
Part 2: Belantamab Mafodotin 2.5 mg/kg End Stage Renal Disease (Not on Dialysis)
Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and end stage renal disease (ESRD) (not on hemodialysis) received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
|
Part 2: Belantamab Mafodotin 2.5 mg/kg ESRD (On Dialysis)
Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and ESRD (on hemodialysis) received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
|
|---|---|---|---|---|---|
|
Part 1: Time of Last Observed Quantifiable Concentration (Tlast) Following Administration of Belantamab Mafodotin (Cys-mcMMAF)
Cycle 1
|
190.6 Hour
Interval 163.0 to 359.5
|
167.7 Hour
Interval 166.6 to 334.3
|
—
|
—
|
—
|
|
Part 1: Time of Last Observed Quantifiable Concentration (Tlast) Following Administration of Belantamab Mafodotin (Cys-mcMMAF)
Cycle 3
|
334.8 Hour
Interval 144.0 to 358.3
|
167.4 Hour
Interval 45.7 to 335.4
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, end of infusion (EOI), start of infusion (SOI)+2hour (h), SOI+4h, SOI+8h and SOI+24h on Cycle(C) 1 Day(D) 1 and C3D1; Anytime on C1 D4, D8, D15, D22; Anytime on C3 D4, D8, D15, D22; Pre-dose on C2D1 and C4D1.Population: Pharmacokinetic Evaluable population. 'Cycle 1' and 'Cycle 3' include the full first and third cycles, along with the Day 1 of Cycle 2 (C2D1) and Cycle 4 (C4D1) Predose periods, respectively. Only those participants who were measured and analyzed (i.e., contributed to data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified timepoints.
Blood samples were collected for PK analysis of belantamab mafodotin ADC. As first dose of belantamab mafodotin was administered on Day 1, cycle length correlates to Day 1 plus 21 days i.e., Day 22 in timeframe.
Outcome measures
| Measure |
Part 1: Belantamab Mafodotin 2.5 mg/kg (Normal/Mildly Impaired Renal Function)
n=5 Participants
Participants with Relapsed/Refractory Multiple Myeloma (RRMM) who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and normal/mildly impaired renal function received intravenous (IV) infusion of 2.5 milligram (mg)/kilogram (kg) belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to adverse event (AE), lost to follow-up, death, whichever occurs first.
|
Part 1: Belantamab Mafodotin 2.5 mg/kg (Severely Impaired Renal Function)
n=7 Participants
Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and severe renal impairment renal function received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
|
Part 1: Belantamab Mafodotin 2.5 mg/kg (Other Renal Function)
Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and other renal impairment renal function received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
|
Part 2: Belantamab Mafodotin 2.5 mg/kg End Stage Renal Disease (Not on Dialysis)
Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and end stage renal disease (ESRD) (not on hemodialysis) received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
|
Part 2: Belantamab Mafodotin 2.5 mg/kg ESRD (On Dialysis)
Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and ESRD (on hemodialysis) received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
|
|---|---|---|---|---|---|
|
Part 2: Area Under the Concentration-time Curve to Last Quantifiable Timepoint (AUC(0-tlast)) Following Administration of Belantamab Mafodotin (Antibody-drug Conjugate (ADC))
Cycle 1
|
4077.6 h*ug/mL
Geometric Coefficient of Variation 19.7
|
3065.6 h*ug/mL
Geometric Coefficient of Variation 66.2
|
—
|
—
|
—
|
|
Part 2: Area Under the Concentration-time Curve to Last Quantifiable Timepoint (AUC(0-tlast)) Following Administration of Belantamab Mafodotin (Antibody-drug Conjugate (ADC))
Cycle 3
|
5773.6 h*ug/mL
Geometric Coefficient of Variation 18.8
|
4798.2 h*ug/mL
Geometric Coefficient of Variation 56.2
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, end of infusion (EOI), start of infusion (SOI)+2hour (h), SOI+4h, SOI+8h and SOI+24h on Cycle(C) 1 Day(D) 1 and C3D1; Anytime on C1 D4, D8, D15, D22; Anytime on C3 D4, D8, D15, D22; Pre-dose on C2D1 and C4D1.Population: Pharmacokinetic Evaluable population. 'Cycle 1' and 'Cycle 3' include the full first and third cycles, along with the Day 1 of Cycle 2 (C2D1) and Cycle 4 (C4D1) Predose periods, respectively. Only those participants who were measured and analyzed (i.e., contributed to data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified timepoints.
Blood samples were collected for PK analysis of belantamab mafodotin ADC. As first dose of belantamab mafodotin was administered on Day 1, cycle length correlates to Day 1 plus 21 days i.e., Day 22 in timeframe.
Outcome measures
| Measure |
Part 1: Belantamab Mafodotin 2.5 mg/kg (Normal/Mildly Impaired Renal Function)
n=5 Participants
Participants with Relapsed/Refractory Multiple Myeloma (RRMM) who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and normal/mildly impaired renal function received intravenous (IV) infusion of 2.5 milligram (mg)/kilogram (kg) belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to adverse event (AE), lost to follow-up, death, whichever occurs first.
|
Part 1: Belantamab Mafodotin 2.5 mg/kg (Severely Impaired Renal Function)
n=5 Participants
Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and severe renal impairment renal function received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
|
Part 1: Belantamab Mafodotin 2.5 mg/kg (Other Renal Function)
Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and other renal impairment renal function received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
|
Part 2: Belantamab Mafodotin 2.5 mg/kg End Stage Renal Disease (Not on Dialysis)
Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and end stage renal disease (ESRD) (not on hemodialysis) received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
|
Part 2: Belantamab Mafodotin 2.5 mg/kg ESRD (On Dialysis)
Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and ESRD (on hemodialysis) received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
|
|---|---|---|---|---|---|
|
Part 2: Area Under the Concentration-time Curve During the Dosing Interval (AUC(0-tau)) Following Administration of Belantamab Mafodotin (ADC)
Cycle 1
|
3998.5 h*ug/mL
Geometric Coefficient of Variation 18.4
|
3717.5 h*ug/mL
Geometric Coefficient of Variation 61.3
|
—
|
—
|
—
|
|
Part 2: Area Under the Concentration-time Curve During the Dosing Interval (AUC(0-tau)) Following Administration of Belantamab Mafodotin (ADC)
Cycle 3
|
5764.2 h*ug/mL
Geometric Coefficient of Variation 19.2
|
5633.7 h*ug/mL
Geometric Coefficient of Variation 40.0
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: End of infusion on C1D1 and C3D1Population: Pharmacokinetic Evaluable population. Only those participants who were measured and analyzed (i.e., contributed to data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified timepoints.
Blood samples were collected for PK analysis of belantamab mafodotin ADC.
Outcome measures
| Measure |
Part 1: Belantamab Mafodotin 2.5 mg/kg (Normal/Mildly Impaired Renal Function)
n=5 Participants
Participants with Relapsed/Refractory Multiple Myeloma (RRMM) who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and normal/mildly impaired renal function received intravenous (IV) infusion of 2.5 milligram (mg)/kilogram (kg) belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to adverse event (AE), lost to follow-up, death, whichever occurs first.
|
Part 1: Belantamab Mafodotin 2.5 mg/kg (Severely Impaired Renal Function)
n=8 Participants
Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and severe renal impairment renal function received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
|
Part 1: Belantamab Mafodotin 2.5 mg/kg (Other Renal Function)
Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and other renal impairment renal function received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
|
Part 2: Belantamab Mafodotin 2.5 mg/kg End Stage Renal Disease (Not on Dialysis)
Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and end stage renal disease (ESRD) (not on hemodialysis) received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
|
Part 2: Belantamab Mafodotin 2.5 mg/kg ESRD (On Dialysis)
Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and ESRD (on hemodialysis) received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
|
|---|---|---|---|---|---|
|
Part 2: Observed Plasma Concentration at the End of Infusion (C-EOI) Following Administration of Belantamab Mafodotin (ADC)
Cycle 1 Day 1
|
62.81 ug/mL
Geometric Coefficient of Variation 64.5
|
40.30 ug/mL
Geometric Coefficient of Variation 38.3
|
—
|
—
|
—
|
|
Part 2: Observed Plasma Concentration at the End of Infusion (C-EOI) Following Administration of Belantamab Mafodotin (ADC)
Cycle 3 Day 1
|
61.28 ug/mL
Geometric Coefficient of Variation 37.4
|
46.38 ug/mL
Geometric Coefficient of Variation 37.7
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, end of infusion (EOI), start of infusion (SOI)+2hour (h), SOI+4h, SOI+8h and SOI+24h on Cycle(C) 1 Day(D) 1 and C3D1; Anytime on C1 D4, D8, D15, D22; Anytime on C3 D4, D8, D15, D22; Pre-dose on C2D1 and C4D1.Population: Pharmacokinetic Evaluable population. 'Cycle 1' and 'Cycle 3' include the full first and third cycles, along with the Day 1 of Cycle 2 (C2D1) and Cycle 4 (C4D1) Predose periods, respectively. Only those participants who were measured and analyzed (i.e., contributed to data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified timepoints.
Blood samples were collected for PK analysis of belantamab mafodotin ADC. As first dose of belantamab mafodotin was administered on Day 1, cycle length correlates to Day 1 plus 21 days i.e., Day 22 in timeframe.
Outcome measures
| Measure |
Part 1: Belantamab Mafodotin 2.5 mg/kg (Normal/Mildly Impaired Renal Function)
n=5 Participants
Participants with Relapsed/Refractory Multiple Myeloma (RRMM) who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and normal/mildly impaired renal function received intravenous (IV) infusion of 2.5 milligram (mg)/kilogram (kg) belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to adverse event (AE), lost to follow-up, death, whichever occurs first.
|
Part 1: Belantamab Mafodotin 2.5 mg/kg (Severely Impaired Renal Function)
n=8 Participants
Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and severe renal impairment renal function received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
|
Part 1: Belantamab Mafodotin 2.5 mg/kg (Other Renal Function)
Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and other renal impairment renal function received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
|
Part 2: Belantamab Mafodotin 2.5 mg/kg End Stage Renal Disease (Not on Dialysis)
Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and end stage renal disease (ESRD) (not on hemodialysis) received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
|
Part 2: Belantamab Mafodotin 2.5 mg/kg ESRD (On Dialysis)
Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and ESRD (on hemodialysis) received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
|
|---|---|---|---|---|---|
|
Part 2: Maximum Observed Concentration (Cmax) Following Administration of Belantamab Mafodotin (ADC)
Cycle 1
|
74.35 ug/mL
Geometric Coefficient of Variation 50.6
|
53.50 ug/mL
Geometric Coefficient of Variation 44.9
|
—
|
—
|
—
|
|
Part 2: Maximum Observed Concentration (Cmax) Following Administration of Belantamab Mafodotin (ADC)
Cycle 3
|
66.61 ug/mL
Geometric Coefficient of Variation 36.2
|
48.67 ug/mL
Geometric Coefficient of Variation 33.8
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, end of infusion (EOI), start of infusion (SOI)+2hour (h), SOI+4h, SOI+8h and SOI+24h on Cycle(C) 1 Day(D) 1 and C3D1; Anytime on C1 D4, D8, D15, D22; Anytime on C3 D4, D8, D15, D22; Pre-dose on C2D1 and C4D1.Population: Pharmacokinetic Evaluable population. 'Cycle 1' and 'Cycle 3' include the full first and third cycles, along with the Day 1 of Cycle 2 (C2D1) and Cycle 4 (C4D1) Predose periods, respectively. Only those participants who were measured and analyzed (i.e., contributed to data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified timepoints.
Blood samples were collected for PK analysis of belantamab mafodotin ADC. As first dose of belantamab mafodotin was administered on Day 1, cycle length correlates to Day 1 plus 21 days i.e., Day 22 in timeframe.
Outcome measures
| Measure |
Part 1: Belantamab Mafodotin 2.5 mg/kg (Normal/Mildly Impaired Renal Function)
n=5 Participants
Participants with Relapsed/Refractory Multiple Myeloma (RRMM) who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and normal/mildly impaired renal function received intravenous (IV) infusion of 2.5 milligram (mg)/kilogram (kg) belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to adverse event (AE), lost to follow-up, death, whichever occurs first.
|
Part 1: Belantamab Mafodotin 2.5 mg/kg (Severely Impaired Renal Function)
n=8 Participants
Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and severe renal impairment renal function received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
|
Part 1: Belantamab Mafodotin 2.5 mg/kg (Other Renal Function)
Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and other renal impairment renal function received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
|
Part 2: Belantamab Mafodotin 2.5 mg/kg End Stage Renal Disease (Not on Dialysis)
Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and end stage renal disease (ESRD) (not on hemodialysis) received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
|
Part 2: Belantamab Mafodotin 2.5 mg/kg ESRD (On Dialysis)
Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and ESRD (on hemodialysis) received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
|
|---|---|---|---|---|---|
|
Part 2: Time to Reach Cmax (Tmax) Following Administration of Belantamab Mafodotin (ADC)
Cycle 1
|
1.833 Hour
Interval 0.683 to 4.083
|
1.958 Hour
Interval 0.683 to 4.0
|
—
|
—
|
—
|
|
Part 2: Time to Reach Cmax (Tmax) Following Administration of Belantamab Mafodotin (ADC)
Cycle 3
|
1.417 Hour
Interval 0.5 to 2.117
|
2.050 Hour
Interval 0.633 to 7.833
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, end of infusion (EOI), start of infusion (SOI)+2hour (h), SOI+4h, SOI+8h and SOI+24h on Cycle(C) 1 Day(D) 1 and C3D1; Anytime on C1 D4, D8, D15, D22; Anytime on C3 D4, D8, D15, D22; Pre-dose on C2D1 and C4D1.Population: Pharmacokinetic Evaluable population. 'Cycle 1' and 'Cycle 3' include the full first and third cycles, along with the Day 1 of Cycle 2 (C2D1) and Cycle 4 (C4D1) Predose periods, respectively. Only those participants who were measured and analyzed (i.e., contributed to data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified timepoints.
Blood samples were collected for PK analysis of belantamab mafodotin ADC. As first dose of belantamab mafodotin was administered on Day 1, cycle length correlates to Day 1 plus 21 days i.e., Day 22 in timeframe.
Outcome measures
| Measure |
Part 1: Belantamab Mafodotin 2.5 mg/kg (Normal/Mildly Impaired Renal Function)
n=4 Participants
Participants with Relapsed/Refractory Multiple Myeloma (RRMM) who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and normal/mildly impaired renal function received intravenous (IV) infusion of 2.5 milligram (mg)/kilogram (kg) belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to adverse event (AE), lost to follow-up, death, whichever occurs first.
|
Part 1: Belantamab Mafodotin 2.5 mg/kg (Severely Impaired Renal Function)
n=6 Participants
Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and severe renal impairment renal function received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
|
Part 1: Belantamab Mafodotin 2.5 mg/kg (Other Renal Function)
Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and other renal impairment renal function received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
|
Part 2: Belantamab Mafodotin 2.5 mg/kg End Stage Renal Disease (Not on Dialysis)
Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and end stage renal disease (ESRD) (not on hemodialysis) received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
|
Part 2: Belantamab Mafodotin 2.5 mg/kg ESRD (On Dialysis)
Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and ESRD (on hemodialysis) received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
|
|---|---|---|---|---|---|
|
Part 2: Trough Concentration Prior to the Next Dose for Each Cycle (Ctrough) Following Administration of Belantamab Mafodotin (ADC)
Cycle 1
|
1.756 ug/mL
Geometric Coefficient of Variation 73.4
|
2.209 ug/mL
Geometric Coefficient of Variation 104.4
|
—
|
—
|
—
|
|
Part 2: Trough Concentration Prior to the Next Dose for Each Cycle (Ctrough) Following Administration of Belantamab Mafodotin (ADC)
Cycle 3
|
3.610 ug/mL
Geometric Coefficient of Variation 54.8
|
2.530 ug/mL
Geometric Coefficient of Variation 99.0
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, end of infusion (EOI), start of infusion (SOI)+2hour (h), SOI+4h, SOI+8h and SOI+24h on Cycle(C) 1 Day(D) 1 and C3D1; Anytime on C1 D4, D8, D15, D22; Anytime on C3 D4, D8, D15, D22; Pre-dose on C2D1 and C4D1 (up to Day 30 in C1 and C3)Population: Pharmacokinetic Evaluable population. 'Cycle 1' and 'Cycle 3' include the full first and third cycles, along with the Day 1 of Cycle 2 (C2D1) and Cycle 4 (C4D1) Predose periods, respectively. Only those participants who were measured and analyzed (i.e., contributed to data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified timepoints.
Blood samples were collected for PK analysis of belantamab mafodotin ADC. As first dose of belantamab mafodotin was administered on Day 1, cycle length correlates to Day 1 plus 21 days i.e., Day 22 in timeframe. For some participants, dosing in Cycle 2 or Cycle 4 was delayed, resulting in the pre-dose samples in these cycles (C2D1 or C4D1) being collected later than the protocol-defined planned days after dosing in C1D1 or C3D1. Consequently, the last PK samples for these participants were collected outside the pre-defined protocol time points, and certain Tlast values in the data table extend beyond the original protocol-defined Time Frame.
Outcome measures
| Measure |
Part 1: Belantamab Mafodotin 2.5 mg/kg (Normal/Mildly Impaired Renal Function)
n=5 Participants
Participants with Relapsed/Refractory Multiple Myeloma (RRMM) who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and normal/mildly impaired renal function received intravenous (IV) infusion of 2.5 milligram (mg)/kilogram (kg) belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to adverse event (AE), lost to follow-up, death, whichever occurs first.
|
Part 1: Belantamab Mafodotin 2.5 mg/kg (Severely Impaired Renal Function)
n=8 Participants
Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and severe renal impairment renal function received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
|
Part 1: Belantamab Mafodotin 2.5 mg/kg (Other Renal Function)
Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and other renal impairment renal function received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
|
Part 2: Belantamab Mafodotin 2.5 mg/kg End Stage Renal Disease (Not on Dialysis)
Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and end stage renal disease (ESRD) (not on hemodialysis) received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
|
Part 2: Belantamab Mafodotin 2.5 mg/kg ESRD (On Dialysis)
Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and ESRD (on hemodialysis) received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
|
|---|---|---|---|---|---|
|
Part 2: Time of Last Observed Quantifiable Concentration (Tlast) Following Administration of Belantamab Mafodotin (ADC)
Cycle 1
|
551.3 Hour
Interval 503.4 to 689.5
|
505.6 Hour
Interval 72.3 to 720.7
|
—
|
—
|
—
|
|
Part 2: Time of Last Observed Quantifiable Concentration (Tlast) Following Administration of Belantamab Mafodotin (ADC)
Cycle 3
|
502.6 Hour
Interval 500.6 to 529.4
|
503.0 Hour
Interval 213.4 to 528.3
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, end of infusion (EOI), start of infusion (SOI)+2hour (h), SOI+4h, SOI+8h and SOI+24h on Cycle(C) 1 Day(D) 1 and C3D1; Anytime on C1 D4, D8, D15, D22; Anytime on C3 D4, D8, D15, D22; Pre-dose on C2D1 and C4D1.Population: Pharmacokinetic Evaluable population. 'Cycle 1' and 'Cycle 3' include the full first and third cycles, along with the Day 1 of Cycle 2 (C2D1) and Cycle 4 (C4D1) Predose periods, respectively. Only those participants who were measured and analyzed (i.e., contributed to data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified timepoints.
Blood samples were collected for PK analysis of belantamab mafodotin Total Antibody. As first dose of belantamab mafodotin was administered on Day 1, cycle length correlates to Day 1 plus 21 days i.e., Day 22 in timeframe.
Outcome measures
| Measure |
Part 1: Belantamab Mafodotin 2.5 mg/kg (Normal/Mildly Impaired Renal Function)
n=5 Participants
Participants with Relapsed/Refractory Multiple Myeloma (RRMM) who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and normal/mildly impaired renal function received intravenous (IV) infusion of 2.5 milligram (mg)/kilogram (kg) belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to adverse event (AE), lost to follow-up, death, whichever occurs first.
|
Part 1: Belantamab Mafodotin 2.5 mg/kg (Severely Impaired Renal Function)
n=7 Participants
Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and severe renal impairment renal function received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
|
Part 1: Belantamab Mafodotin 2.5 mg/kg (Other Renal Function)
Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and other renal impairment renal function received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
|
Part 2: Belantamab Mafodotin 2.5 mg/kg End Stage Renal Disease (Not on Dialysis)
Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and end stage renal disease (ESRD) (not on hemodialysis) received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
|
Part 2: Belantamab Mafodotin 2.5 mg/kg ESRD (On Dialysis)
Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and ESRD (on hemodialysis) received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
|
|---|---|---|---|---|---|
|
Part 2: Area Under the Concentration-time Curve to Last Quantifiable Timepoint (AUC(0-tlast)) Following Administration of Belantamab Mafodotin (Total Antibody)
Cycle 1
|
7099.5 h*ug/mL
Geometric Coefficient of Variation 33.4
|
4018.0 h*ug/mL
Geometric Coefficient of Variation 86.3
|
—
|
—
|
—
|
|
Part 2: Area Under the Concentration-time Curve to Last Quantifiable Timepoint (AUC(0-tlast)) Following Administration of Belantamab Mafodotin (Total Antibody)
Cycle 3
|
9675.8 h*ug/mL
Geometric Coefficient of Variation 8.1
|
8551.8 h*ug/mL
Geometric Coefficient of Variation 79.0
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, end of infusion (EOI), start of infusion (SOI)+2hour (h), SOI+4h, SOI+8h and SOI+24h on Cycle(C) 1 Day(D) 1 and C3D1; Anytime on C1 D4, D8, D15, D22; Anytime on C3 D4, D8, D15, D22; Pre-dose on C2D1 and C4D1.Population: Pharmacokinetic Evaluable population. 'Cycle 1' and 'Cycle 3' include the full first and third cycles, along with the Day 1 of Cycle 2 (C2D1) and Cycle 4 (C4D1) Predose periods, respectively. Only those participants who were measured and analyzed (i.e., contributed to data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified timepoints.
Blood samples were collected for PK analysis of belantamab mafodotin Total Antibody. As first dose of belantamab mafodotin was administered on Day 1, cycle length correlates to Day 1 plus 21 days i.e., Day 22 in timeframe.
Outcome measures
| Measure |
Part 1: Belantamab Mafodotin 2.5 mg/kg (Normal/Mildly Impaired Renal Function)
n=5 Participants
Participants with Relapsed/Refractory Multiple Myeloma (RRMM) who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and normal/mildly impaired renal function received intravenous (IV) infusion of 2.5 milligram (mg)/kilogram (kg) belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to adverse event (AE), lost to follow-up, death, whichever occurs first.
|
Part 1: Belantamab Mafodotin 2.5 mg/kg (Severely Impaired Renal Function)
n=6 Participants
Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and severe renal impairment renal function received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
|
Part 1: Belantamab Mafodotin 2.5 mg/kg (Other Renal Function)
Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and other renal impairment renal function received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
|
Part 2: Belantamab Mafodotin 2.5 mg/kg End Stage Renal Disease (Not on Dialysis)
Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and end stage renal disease (ESRD) (not on hemodialysis) received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
|
Part 2: Belantamab Mafodotin 2.5 mg/kg ESRD (On Dialysis)
Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and ESRD (on hemodialysis) received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
|
|---|---|---|---|---|---|
|
Part 2: Area Under the Concentration-time Curve During the Dosing Interval (AUC(0-tau)) Following Administration of Belantamab Mafodotin (Total Antibody)
Cycle 1
|
6798.4 h*ug/mL
Geometric Coefficient of Variation 29.2
|
4798.2 h*ug/mL
Geometric Coefficient of Variation 65.3
|
—
|
—
|
—
|
|
Part 2: Area Under the Concentration-time Curve During the Dosing Interval (AUC(0-tau)) Following Administration of Belantamab Mafodotin (Total Antibody)
Cycle 3
|
9438.0 h*ug/mL
Geometric Coefficient of Variation 9.0
|
10318.8 h*ug/mL
Geometric Coefficient of Variation 63.8
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: End of infusion on C1D1 and C3D1Population: Pharmacokinetic Evaluable population. Only those participants who were measured and analyzed (i.e., contributed to data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified timepoints.
Blood samples were collected for PK analysis of belantamab mafodotin Total Antibody.
Outcome measures
| Measure |
Part 1: Belantamab Mafodotin 2.5 mg/kg (Normal/Mildly Impaired Renal Function)
n=5 Participants
Participants with Relapsed/Refractory Multiple Myeloma (RRMM) who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and normal/mildly impaired renal function received intravenous (IV) infusion of 2.5 milligram (mg)/kilogram (kg) belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to adverse event (AE), lost to follow-up, death, whichever occurs first.
|
Part 1: Belantamab Mafodotin 2.5 mg/kg (Severely Impaired Renal Function)
n=8 Participants
Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and severe renal impairment renal function received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
|
Part 1: Belantamab Mafodotin 2.5 mg/kg (Other Renal Function)
Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and other renal impairment renal function received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
|
Part 2: Belantamab Mafodotin 2.5 mg/kg End Stage Renal Disease (Not on Dialysis)
Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and end stage renal disease (ESRD) (not on hemodialysis) received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
|
Part 2: Belantamab Mafodotin 2.5 mg/kg ESRD (On Dialysis)
Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and ESRD (on hemodialysis) received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
|
|---|---|---|---|---|---|
|
Part 2: Observed Plasma Concentration at the End of Infusion (C-EOI) Following Administration of Belantamab Mafodotin (Total Antibody)
Cycle 1 Day 1
|
62.44 ug/mL
Geometric Coefficient of Variation 53.0
|
37.24 ug/mL
Geometric Coefficient of Variation 40.8
|
—
|
—
|
—
|
|
Part 2: Observed Plasma Concentration at the End of Infusion (C-EOI) Following Administration of Belantamab Mafodotin (Total Antibody)
Cycle 3 Day 1
|
61.26 ug/mL
Geometric Coefficient of Variation 41.1
|
38.80 ug/mL
Geometric Coefficient of Variation 35.7
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, end of infusion (EOI), start of infusion (SOI)+2hour (h), SOI+4h, SOI+8h and SOI+24h on Cycle(C) 1 Day(D) 1 and C3D1; Anytime on C1 D4, D8, D15, D22; Anytime on C3 D4, D8, D15, D22; Pre-dose on C2D1 and C4D1.Population: Pharmacokinetic Evaluable population. 'Cycle 1' and 'Cycle 3' include the full first and third cycles, along with the Day 1 of Cycle 2 (C2D1) and Cycle 4 (C4D1) Predose periods, respectively. Only those participants who were measured and analyzed (i.e., contributed to data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified timepoints.
Blood samples were collected for PK analysis of belantamab mafodotin Total Antibody. As first dose of belantamab mafodotin was administered on Day 1, cycle length correlates to Day 1 plus 21 days i.e., Day 22 in timeframe.
Outcome measures
| Measure |
Part 1: Belantamab Mafodotin 2.5 mg/kg (Normal/Mildly Impaired Renal Function)
n=5 Participants
Participants with Relapsed/Refractory Multiple Myeloma (RRMM) who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and normal/mildly impaired renal function received intravenous (IV) infusion of 2.5 milligram (mg)/kilogram (kg) belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to adverse event (AE), lost to follow-up, death, whichever occurs first.
|
Part 1: Belantamab Mafodotin 2.5 mg/kg (Severely Impaired Renal Function)
n=8 Participants
Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and severe renal impairment renal function received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
|
Part 1: Belantamab Mafodotin 2.5 mg/kg (Other Renal Function)
Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and other renal impairment renal function received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
|
Part 2: Belantamab Mafodotin 2.5 mg/kg End Stage Renal Disease (Not on Dialysis)
Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and end stage renal disease (ESRD) (not on hemodialysis) received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
|
Part 2: Belantamab Mafodotin 2.5 mg/kg ESRD (On Dialysis)
Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and ESRD (on hemodialysis) received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
|
|---|---|---|---|---|---|
|
Part 2: Maximum Observed Concentration (Cmax) Following Administration of Belantamab Mafodotin (Total Antibody)
Cycle 1
|
70.96 ug/mL
Geometric Coefficient of Variation 46.7
|
41.11 ug/mL
Geometric Coefficient of Variation 44.5
|
—
|
—
|
—
|
|
Part 2: Maximum Observed Concentration (Cmax) Following Administration of Belantamab Mafodotin (Total Antibody)
Cycle 3
|
70.67 ug/mL
Geometric Coefficient of Variation 41.8
|
42.83 ug/mL
Geometric Coefficient of Variation 40.4
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, end of infusion (EOI), start of infusion (SOI)+2hour (h), SOI+4h, SOI+8h and SOI+24h on Cycle(C) 1 Day(D) 1 and C3D1; Anytime on C1 D4, D8, D15, D22; Anytime on C3 D4, D8, D15, D22; Pre-dose on C2D1 and C4D1.Population: Pharmacokinetic Evaluable population. 'Cycle 1' and 'Cycle 3' include the full first and third cycles, along with the Day 1 of Cycle 2 (C2D1) and Cycle 4 (C4D1) Predose periods, respectively. Only those participants who were measured and analyzed (i.e., contributed to data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified timepoints.
Blood samples were collected for PK analysis of belantamab mafodotin Total Antibody. As first dose of belantamab mafodotin was administered on Day 1, cycle length correlates to Day 1 plus 21 days i.e., Day 22 in timeframe.
Outcome measures
| Measure |
Part 1: Belantamab Mafodotin 2.5 mg/kg (Normal/Mildly Impaired Renal Function)
n=5 Participants
Participants with Relapsed/Refractory Multiple Myeloma (RRMM) who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and normal/mildly impaired renal function received intravenous (IV) infusion of 2.5 milligram (mg)/kilogram (kg) belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to adverse event (AE), lost to follow-up, death, whichever occurs first.
|
Part 1: Belantamab Mafodotin 2.5 mg/kg (Severely Impaired Renal Function)
n=8 Participants
Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and severe renal impairment renal function received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
|
Part 1: Belantamab Mafodotin 2.5 mg/kg (Other Renal Function)
Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and other renal impairment renal function received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
|
Part 2: Belantamab Mafodotin 2.5 mg/kg End Stage Renal Disease (Not on Dialysis)
Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and end stage renal disease (ESRD) (not on hemodialysis) received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
|
Part 2: Belantamab Mafodotin 2.5 mg/kg ESRD (On Dialysis)
Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and ESRD (on hemodialysis) received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
|
|---|---|---|---|---|---|
|
Part 2: Time to Reach Cmax (Tmax) Following Administration of Belantamab Mafodotin (Total Antibody)
Cycle 1
|
1.833 Hour
Interval 0.667 to 2.05
|
2.025 Hour
Interval 0.683 to 6.0
|
—
|
—
|
—
|
|
Part 2: Time to Reach Cmax (Tmax) Following Administration of Belantamab Mafodotin (Total Antibody)
Cycle 3
|
3.025 Hour
Interval 0.783 to 7.033
|
2.050 Hour
Interval 0.7 to 19.783
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, end of infusion (EOI), start of infusion (SOI)+2hour (h), SOI+4h, SOI+8h and SOI+24h on Cycle(C) 1 Day(D) 1 and C3D1; Anytime on C1 D4, D8, D15, D22; Anytime on C3 D4, D8, D15, D22; Pre-dose on C2D1 and C4D1.Population: Pharmacokinetic Evaluable population. 'Cycle 1' and 'Cycle 3' include the full first and third cycles, along with the Day 1 of Cycle 2 (C2D1) and Cycle 4 (C4D1) Predose periods, respectively. Only those participants who were measured and analyzed (i.e., contributed to data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified timepoints.
Blood samples were collected for PK analysis of belantamab mafodotin Total Antibody. As first dose of belantamab mafodotin was administered on Day 1, cycle length correlates to Day 1 plus 21 days i.e., Day 22 in timeframe.
Outcome measures
| Measure |
Part 1: Belantamab Mafodotin 2.5 mg/kg (Normal/Mildly Impaired Renal Function)
n=4 Participants
Participants with Relapsed/Refractory Multiple Myeloma (RRMM) who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and normal/mildly impaired renal function received intravenous (IV) infusion of 2.5 milligram (mg)/kilogram (kg) belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to adverse event (AE), lost to follow-up, death, whichever occurs first.
|
Part 1: Belantamab Mafodotin 2.5 mg/kg (Severely Impaired Renal Function)
n=6 Participants
Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and severe renal impairment renal function received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
|
Part 1: Belantamab Mafodotin 2.5 mg/kg (Other Renal Function)
Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and other renal impairment renal function received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
|
Part 2: Belantamab Mafodotin 2.5 mg/kg End Stage Renal Disease (Not on Dialysis)
Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and end stage renal disease (ESRD) (not on hemodialysis) received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
|
Part 2: Belantamab Mafodotin 2.5 mg/kg ESRD (On Dialysis)
Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and ESRD (on hemodialysis) received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
|
|---|---|---|---|---|---|
|
Part 2: Trough Concentration Prior to the Next Dose for Each Cycle (Ctrough) Following Administration of Belantamab Mafodotin (Total Antibody)
Cycle 1
|
5.899 ug/mL
Geometric Coefficient of Variation 53.3
|
4.048 ug/mL
Geometric Coefficient of Variation 130.9
|
—
|
—
|
—
|
|
Part 2: Trough Concentration Prior to the Next Dose for Each Cycle (Ctrough) Following Administration of Belantamab Mafodotin (Total Antibody)
Cycle 3
|
12.551 ug/mL
Geometric Coefficient of Variation 35.9
|
7.846 ug/mL
Geometric Coefficient of Variation 133.1
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, end of infusion (EOI), start of infusion (SOI)+2hour (h), SOI+4h, SOI+8h and SOI+24h on Cycle(C) 1 Day(D) 1 and C3D1; Anytime on C1 D4, D8, D15, D22; Anytime on C3 D4, D8, D15, D22; Pre-dose on C2D1 and C4D1 (up to Day 30 in C1 and C3)Population: Pharmacokinetic Evaluable population. 'Cycle 1' and 'Cycle 3' include the full first and third cycles, along with the Day 1 of Cycle 2 (C2D1) and Cycle 4 (C4D1) Predose periods, respectively. Only those participants who were measured and analyzed (i.e., contributed to data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified timepoints.
Blood samples were collected for PK analysis of belantamab mafodotin Total Antibody. As first dose of belantamab mafodotin was administered on Day 1, cycle length correlates to Day 1 plus 21 days i.e., Day 22 in timeframe. For some participants, dosing in Cycle 2 or Cycle 4 was delayed, resulting in the pre-dose samples in these cycles (C2D1 or C4D1) being collected later than the protocol-defined planned days after dosing in C1D1 or C3D1. Consequently, the last PK samples for these participants were collected outside the pre-defined protocol time points, and certain Tlast values in the data table extend beyond the original protocol-defined Time Frame.
Outcome measures
| Measure |
Part 1: Belantamab Mafodotin 2.5 mg/kg (Normal/Mildly Impaired Renal Function)
n=5 Participants
Participants with Relapsed/Refractory Multiple Myeloma (RRMM) who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and normal/mildly impaired renal function received intravenous (IV) infusion of 2.5 milligram (mg)/kilogram (kg) belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to adverse event (AE), lost to follow-up, death, whichever occurs first.
|
Part 1: Belantamab Mafodotin 2.5 mg/kg (Severely Impaired Renal Function)
n=8 Participants
Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and severe renal impairment renal function received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
|
Part 1: Belantamab Mafodotin 2.5 mg/kg (Other Renal Function)
Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and other renal impairment renal function received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
|
Part 2: Belantamab Mafodotin 2.5 mg/kg End Stage Renal Disease (Not on Dialysis)
Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and end stage renal disease (ESRD) (not on hemodialysis) received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
|
Part 2: Belantamab Mafodotin 2.5 mg/kg ESRD (On Dialysis)
Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and ESRD (on hemodialysis) received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
|
|---|---|---|---|---|---|
|
Part 2: Time of Last Observed Quantifiable Concentration (Tlast) Following Administration of Belantamab Mafodotin (Total Antibody)
Cycle 1
|
551.3 Hour
Interval 503.4 to 689.5
|
505.8 Hour
Interval 72.3 to 720.7
|
—
|
—
|
—
|
|
Part 2: Time of Last Observed Quantifiable Concentration (Tlast) Following Administration of Belantamab Mafodotin (Total Antibody)
Cycle 3
|
501.6 Hour
Interval 359.9 to 529.4
|
503.0 Hour
Interval 213.4 to 528.3
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, end of infusion (EOI), start of infusion (SOI)+2hour (h), SOI+4h, SOI+8h and SOI+24h on Cycle(C) 1 Day(D) 1 and C3D1; Anytime on C1 D4, D8, D15, D22; Anytime on C3 D4, D8, D15, D22; Pre-dose on C2D1 and C4D1.Population: Pharmacokinetic Evaluable population. 'Cycle 1' and 'Cycle 3' include the full first and third cycles, along with the Day 1 of Cycle 2 (C2D1) and Cycle 4 (C4D1) Predose periods, respectively. Only those participants who were measured and analyzed (i.e., contributed to data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified timepoints.
Blood samples were collected for PK analysis of belantamab mafodotin Cys-mcMMAF. As first dose of belantamab mafodotin was administered on Day 1, cycle length correlates to Day 1 plus 21 days i.e., Day 22 in timeframe.
Outcome measures
| Measure |
Part 1: Belantamab Mafodotin 2.5 mg/kg (Normal/Mildly Impaired Renal Function)
n=5 Participants
Participants with Relapsed/Refractory Multiple Myeloma (RRMM) who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and normal/mildly impaired renal function received intravenous (IV) infusion of 2.5 milligram (mg)/kilogram (kg) belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to adverse event (AE), lost to follow-up, death, whichever occurs first.
|
Part 1: Belantamab Mafodotin 2.5 mg/kg (Severely Impaired Renal Function)
n=6 Participants
Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and severe renal impairment renal function received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
|
Part 1: Belantamab Mafodotin 2.5 mg/kg (Other Renal Function)
Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and other renal impairment renal function received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
|
Part 2: Belantamab Mafodotin 2.5 mg/kg End Stage Renal Disease (Not on Dialysis)
Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and end stage renal disease (ESRD) (not on hemodialysis) received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
|
Part 2: Belantamab Mafodotin 2.5 mg/kg ESRD (On Dialysis)
Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and ESRD (on hemodialysis) received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
|
|---|---|---|---|---|---|
|
Part 2: Area Under the Concentration-time Curve to Last Quantifiable Timepoint (AUC(0-tlast)) Following Administration of Belantamab Mafodotin (Cysteine Maleimidocaproyl Monomethyl Auristatin F (Cys-mcMMAF))
Cycle 1
|
264.5 h*ng/mL
Geometric Coefficient of Variation 57.1
|
147.7 h*ng/mL
Geometric Coefficient of Variation 76.3
|
—
|
—
|
—
|
|
Part 2: Area Under the Concentration-time Curve to Last Quantifiable Timepoint (AUC(0-tlast)) Following Administration of Belantamab Mafodotin (Cysteine Maleimidocaproyl Monomethyl Auristatin F (Cys-mcMMAF))
Cycle 3
|
126.8 h*ng/mL
Geometric Coefficient of Variation 42.1
|
112.2 h*ng/mL
Geometric Coefficient of Variation 53.6
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, end of infusion (EOI), start of infusion (SOI)+2hour (h), SOI+4h, SOI+8h and SOI+24h on Cycle(C) 1 Day(D) 1 and C3D1; Anytime on C1 D4, D8, and D15; Anytime on C3 D4, D8, and D15Population: Pharmacokinetic Evaluable population. Only those participants who were measured and analyzed (i.e., contributed to data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified timepoints.
Blood samples were collected for PK analysis of belantamab mafodotin Cys-mcMMAF. In cases where the nominal Day 8 sample was collected prior to 168 hours and earlier time points did not permit reliable extrapolation to 168 hours, a later sample (e.g., Day 15) with a measurable concentration was used to support estimation of the concentration at 168 hours. Outcome data are reported only for AUC over 0-168 hours.
Outcome measures
| Measure |
Part 1: Belantamab Mafodotin 2.5 mg/kg (Normal/Mildly Impaired Renal Function)
n=5 Participants
Participants with Relapsed/Refractory Multiple Myeloma (RRMM) who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and normal/mildly impaired renal function received intravenous (IV) infusion of 2.5 milligram (mg)/kilogram (kg) belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to adverse event (AE), lost to follow-up, death, whichever occurs first.
|
Part 1: Belantamab Mafodotin 2.5 mg/kg (Severely Impaired Renal Function)
n=4 Participants
Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and severe renal impairment renal function received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
|
Part 1: Belantamab Mafodotin 2.5 mg/kg (Other Renal Function)
Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and other renal impairment renal function received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
|
Part 2: Belantamab Mafodotin 2.5 mg/kg End Stage Renal Disease (Not on Dialysis)
Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and end stage renal disease (ESRD) (not on hemodialysis) received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
|
Part 2: Belantamab Mafodotin 2.5 mg/kg ESRD (On Dialysis)
Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and ESRD (on hemodialysis) received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
|
|---|---|---|---|---|---|
|
Part 2: Area Under the Concentration-time Curve During the Dosing Interval up to 168 Hours (AUC (0-168h)) Following Administration of Belantamab Mafodotin (Cys-mcMMAF)
Cycle 1
|
248.0 h*ng/mL
Geometric Coefficient of Variation 56.8
|
98.9 h*ng/mL
Geometric Coefficient of Variation 46.1
|
—
|
—
|
—
|
|
Part 2: Area Under the Concentration-time Curve During the Dosing Interval up to 168 Hours (AUC (0-168h)) Following Administration of Belantamab Mafodotin (Cys-mcMMAF)
Cycle 3
|
93.8 h*ng/mL
Geometric Coefficient of Variation 38.5
|
108.7 h*ng/mL
Geometric Coefficient of Variation 70.5
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: End of infusion on C1D1 and C3D1Population: Pharmacokinetic Evaluable population. Only those participants who were measured and analyzed (i.e., contributed to data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified timepoints.
Blood samples were collected for PK analysis of belantamab mafodotin Cys-mcMMAF.
Outcome measures
| Measure |
Part 1: Belantamab Mafodotin 2.5 mg/kg (Normal/Mildly Impaired Renal Function)
n=5 Participants
Participants with Relapsed/Refractory Multiple Myeloma (RRMM) who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and normal/mildly impaired renal function received intravenous (IV) infusion of 2.5 milligram (mg)/kilogram (kg) belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to adverse event (AE), lost to follow-up, death, whichever occurs first.
|
Part 1: Belantamab Mafodotin 2.5 mg/kg (Severely Impaired Renal Function)
n=8 Participants
Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and severe renal impairment renal function received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
|
Part 1: Belantamab Mafodotin 2.5 mg/kg (Other Renal Function)
Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and other renal impairment renal function received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
|
Part 2: Belantamab Mafodotin 2.5 mg/kg End Stage Renal Disease (Not on Dialysis)
Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and end stage renal disease (ESRD) (not on hemodialysis) received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
|
Part 2: Belantamab Mafodotin 2.5 mg/kg ESRD (On Dialysis)
Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and ESRD (on hemodialysis) received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
|
|---|---|---|---|---|---|
|
Part 2: Observed Plasma Concentration at the End of Infusion (C-EOI) Following Administration of Belantamab Mafodotin (Cys-mcMMAF)
Cycle 1 Day 1
|
0.66 ng/mL
Geometric Coefficient of Variation 174.5
|
0.35 ng/mL
Geometric Coefficient of Variation 113.1
|
—
|
—
|
—
|
|
Part 2: Observed Plasma Concentration at the End of Infusion (C-EOI) Following Administration of Belantamab Mafodotin (Cys-mcMMAF)
Cycle 3 Day 1
|
0.44 ng/mL
Geometric Coefficient of Variation 34.2
|
0.35 ng/mL
Geometric Coefficient of Variation 71.8
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, end of infusion (EOI), start of infusion (SOI)+2hour (h), SOI+4h, SOI+8h and SOI+24h on Cycle(C) 1 Day(D) 1 and C3D1; Anytime on C1 D4, D8, D15, D22; Anytime on C3 D4, D8, D15, D22; Pre-dose on C2D1 and C4D1.Population: Pharmacokinetic Evaluable population. 'Cycle 1' and 'Cycle 3' include the full first and third cycles, along with the Day 1 of Cycle 2 (C2D1) and Cycle 4 (C4D1) Predose periods, respectively. Only those participants who were measured and analyzed (i.e., contributed to data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified timepoints.
Blood samples were collected for PK analysis of belantamab mafodotin Cys-mcMMAF. As first dose of belantamab mafodotin was administered on Day 1, cycle length correlates to Day 1 plus 21 days i.e., Day 22 in timeframe.
Outcome measures
| Measure |
Part 1: Belantamab Mafodotin 2.5 mg/kg (Normal/Mildly Impaired Renal Function)
n=5 Participants
Participants with Relapsed/Refractory Multiple Myeloma (RRMM) who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and normal/mildly impaired renal function received intravenous (IV) infusion of 2.5 milligram (mg)/kilogram (kg) belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to adverse event (AE), lost to follow-up, death, whichever occurs first.
|
Part 1: Belantamab Mafodotin 2.5 mg/kg (Severely Impaired Renal Function)
n=7 Participants
Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and severe renal impairment renal function received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
|
Part 1: Belantamab Mafodotin 2.5 mg/kg (Other Renal Function)
Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and other renal impairment renal function received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
|
Part 2: Belantamab Mafodotin 2.5 mg/kg End Stage Renal Disease (Not on Dialysis)
Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and end stage renal disease (ESRD) (not on hemodialysis) received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
|
Part 2: Belantamab Mafodotin 2.5 mg/kg ESRD (On Dialysis)
Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and ESRD (on hemodialysis) received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
|
|---|---|---|---|---|---|
|
Part 2: Maximum Observed Concentration (Cmax) Following Administration of Belantamab Mafodotin (Cys-mcMMAF)
Cycle 1
|
3.09 ng/mL
Geometric Coefficient of Variation 46.1
|
0.93 ng/mL
Geometric Coefficient of Variation 97.6
|
—
|
—
|
—
|
|
Part 2: Maximum Observed Concentration (Cmax) Following Administration of Belantamab Mafodotin (Cys-mcMMAF)
Cycle 3
|
0.83 ng/mL
Geometric Coefficient of Variation 30.8
|
0.68 ng/mL
Geometric Coefficient of Variation 51.9
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, end of infusion (EOI), start of infusion (SOI)+2hour (h), SOI+4h, SOI+8h and SOI+24h on Cycle(C) 1 Day(D) 1 and C3D1; Anytime on C1 D4, D8, D15, D22; Anytime on C3 D4, D8, D15, D22; Pre-dose on C2D1 and C4D1.Population: Pharmacokinetic Evaluable population. 'Cycle 1' and 'Cycle 3' include the full first and third cycles, along with the Day 1 of Cycle 2 (C2D1) and Cycle 4 (C4D1) Predose periods, respectively. Only those participants who were measured and analyzed (i.e., contributed to data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified timepoints.
Blood samples were collected for PK analysis of belantamab mafodotin Cys-mcMMAF. As first dose of belantamab mafodotin was administered on Day 1, cycle length correlates to Day 1 plus 21 days i.e., Day 22 in timeframe.
Outcome measures
| Measure |
Part 1: Belantamab Mafodotin 2.5 mg/kg (Normal/Mildly Impaired Renal Function)
n=5 Participants
Participants with Relapsed/Refractory Multiple Myeloma (RRMM) who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and normal/mildly impaired renal function received intravenous (IV) infusion of 2.5 milligram (mg)/kilogram (kg) belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to adverse event (AE), lost to follow-up, death, whichever occurs first.
|
Part 1: Belantamab Mafodotin 2.5 mg/kg (Severely Impaired Renal Function)
n=7 Participants
Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and severe renal impairment renal function received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
|
Part 1: Belantamab Mafodotin 2.5 mg/kg (Other Renal Function)
Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and other renal impairment renal function received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
|
Part 2: Belantamab Mafodotin 2.5 mg/kg End Stage Renal Disease (Not on Dialysis)
Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and end stage renal disease (ESRD) (not on hemodialysis) received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
|
Part 2: Belantamab Mafodotin 2.5 mg/kg ESRD (On Dialysis)
Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and ESRD (on hemodialysis) received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
|
|---|---|---|---|---|---|
|
Part 2: Time to Reach Cmax (Tmax) Following Administration of Belantamab Mafodotin (Cys-mcMMAF)
Cycle 1
|
23.833 Hour
Interval 0.75 to 64.283
|
24.000 Hour
Interval 22.017 to 50.7
|
—
|
—
|
—
|
|
Part 2: Time to Reach Cmax (Tmax) Following Administration of Belantamab Mafodotin (Cys-mcMMAF)
Cycle 3
|
24.333 Hour
Interval 8.033 to 43.0
|
12.425 Hour
Interval 4.0 to 22.667
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, end of infusion (EOI), start of infusion (SOI)+2hour (h), SOI+4h, SOI+8h and SOI+24h on Cycle(C) 1 Day(D) 1 and C3D1; Anytime on C1 D4, D8, D15, D22; Anytime on C3 D4, D8, D15, D22; Pre-dose on C2D1 and C4D1.Population: Pharmacokinetic Evaluable population. 'Cycle 1' and 'Cycle 3' include the full first and third cycles, along with the Day 1 of Cycle 2 (C2D1) and Cycle 4 (C4D1) Predose periods, respectively. Only those participants who were measured and analyzed (i.e., contributed to data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified timepoints.
Blood samples were collected for PK analysis of belantamab mafodotin Cys-mcMMAF. As first dose of belantamab mafodotin was administered on Day 1, cycle length correlates to Day 1 plus 21 days i.e., Day 22 in timeframe.
Outcome measures
| Measure |
Part 1: Belantamab Mafodotin 2.5 mg/kg (Normal/Mildly Impaired Renal Function)
n=5 Participants
Participants with Relapsed/Refractory Multiple Myeloma (RRMM) who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and normal/mildly impaired renal function received intravenous (IV) infusion of 2.5 milligram (mg)/kilogram (kg) belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to adverse event (AE), lost to follow-up, death, whichever occurs first.
|
Part 1: Belantamab Mafodotin 2.5 mg/kg (Severely Impaired Renal Function)
n=8 Participants
Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and severe renal impairment renal function received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
|
Part 1: Belantamab Mafodotin 2.5 mg/kg (Other Renal Function)
Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and other renal impairment renal function received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
|
Part 2: Belantamab Mafodotin 2.5 mg/kg End Stage Renal Disease (Not on Dialysis)
Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and end stage renal disease (ESRD) (not on hemodialysis) received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
|
Part 2: Belantamab Mafodotin 2.5 mg/kg ESRD (On Dialysis)
Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and ESRD (on hemodialysis) received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
|
|---|---|---|---|---|---|
|
Part 2: Time of Last Observed Quantifiable Concentration (Tlast) Following Administration of Belantamab Mafodotin (Cys-mcMMAF)
Cycle 3
|
347.3 Hour
Interval 334.5 to 502.5
|
332.0 Hour
Interval 213.4 to 504.8
|
—
|
—
|
—
|
|
Part 2: Time of Last Observed Quantifiable Concentration (Tlast) Following Administration of Belantamab Mafodotin (Cys-mcMMAF)
Cycle 1
|
167.5 Hour
Interval 160.4 to 328.8
|
335.5 Hour
Interval 24.4 to 526.5
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and up to approx. 236 weeksPopulation: Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin. Only those participants who were measured and analyzed (i.e., contributed to data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified timepoints.
Blood pressures (DBP and SBP) were measured after resting for at least 5 minutes in a supine or semi-recumbent position. Baseline (Day 1) was defined as latest pre-dose assessment with a non-missing value, including unscheduled visits. Change from Baseline was calculated as post-dose visit value minus Baseline value. The "0" participants analyzed represents that data was not collected or available for analysis at that particular time point for the respective Arms/Groups.
Outcome measures
| Measure |
Part 1: Belantamab Mafodotin 2.5 mg/kg (Normal/Mildly Impaired Renal Function)
n=10 Participants
Participants with Relapsed/Refractory Multiple Myeloma (RRMM) who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and normal/mildly impaired renal function received intravenous (IV) infusion of 2.5 milligram (mg)/kilogram (kg) belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to adverse event (AE), lost to follow-up, death, whichever occurs first.
|
Part 1: Belantamab Mafodotin 2.5 mg/kg (Severely Impaired Renal Function)
n=9 Participants
Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and severe renal impairment renal function received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
|
Part 1: Belantamab Mafodotin 2.5 mg/kg (Other Renal Function)
n=4 Participants
Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and other renal impairment renal function received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
|
Part 2: Belantamab Mafodotin 2.5 mg/kg End Stage Renal Disease (Not on Dialysis)
n=5 Participants
Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and end stage renal disease (ESRD) (not on hemodialysis) received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
|
Part 2: Belantamab Mafodotin 2.5 mg/kg ESRD (On Dialysis)
n=8 Participants
Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and ESRD (on hemodialysis) received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
|
|---|---|---|---|---|---|
|
Part 1 and Part 2: Change From Baseline (CFB) in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
DBP, CFB to Cycle 7 Day 1, PRE-INFUSION
|
0.7 Millimeters of mercury (mmHg)
Standard Deviation 6.66
|
-0.5 Millimeters of mercury (mmHg)
Standard Deviation 4.95
|
2.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
17.5 Millimeters of mercury (mmHg)
Standard Deviation 9.19
|
-4.5 Millimeters of mercury (mmHg)
Standard Deviation 4.95
|
|
Part 1 and Part 2: Change From Baseline (CFB) in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
DBP, CFB to Cycle 8 Day 1, WITHIN 15 MINS AFTER EOI
|
-5.7 Millimeters of mercury (mmHg)
Standard Deviation 7.02
|
-6.5 Millimeters of mercury (mmHg)
Standard Deviation 14.85
|
2.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
21.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
-1.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
|
Part 1 and Part 2: Change From Baseline (CFB) in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
DBP, Baseline (Day 1)
|
72.5 Millimeters of mercury (mmHg)
Standard Deviation 9.45
|
70.9 Millimeters of mercury (mmHg)
Standard Deviation 10.20
|
77.8 Millimeters of mercury (mmHg)
Standard Deviation 13.57
|
64.4 Millimeters of mercury (mmHg)
Standard Deviation 5.55
|
74.8 Millimeters of mercury (mmHg)
Standard Deviation 8.86
|
|
Part 1 and Part 2: Change From Baseline (CFB) in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
DBP, CFB to Cycle 1 Day 1, 15 MINS AFTER SOI
|
-3.6 Millimeters of mercury (mmHg)
Standard Deviation 8.02
|
-4.2 Millimeters of mercury (mmHg)
Standard Deviation 8.70
|
1.3 Millimeters of mercury (mmHg)
Standard Deviation 2.87
|
1.6 Millimeters of mercury (mmHg)
Standard Deviation 1.95
|
-5.4 Millimeters of mercury (mmHg)
Standard Deviation 7.04
|
|
Part 1 and Part 2: Change From Baseline (CFB) in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
DBP, CFB to Cycle 1 Day 1, WITHIN 15 MINS AFTER EOI
|
0.2 Millimeters of mercury (mmHg)
Standard Deviation 10.21
|
-4.1 Millimeters of mercury (mmHg)
Standard Deviation 7.03
|
-2.8 Millimeters of mercury (mmHg)
Standard Deviation 2.75
|
3.2 Millimeters of mercury (mmHg)
Standard Deviation 2.59
|
-7.6 Millimeters of mercury (mmHg)
Standard Deviation 5.80
|
|
Part 1 and Part 2: Change From Baseline (CFB) in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
DBP, CFB to Cycle 1 Day 1, 1 HOUR AFTER EOI
|
0.8 Millimeters of mercury (mmHg)
Standard Deviation 12.06
|
-2.9 Millimeters of mercury (mmHg)
Standard Deviation 10.29
|
-1.3 Millimeters of mercury (mmHg)
Standard Deviation 5.19
|
2.0 Millimeters of mercury (mmHg)
Standard Deviation 2.92
|
-3.6 Millimeters of mercury (mmHg)
Standard Deviation 6.09
|
|
Part 1 and Part 2: Change From Baseline (CFB) in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
DBP, CFB to Cycle 2 Day 1, PRE-INFUSION
|
3.6 Millimeters of mercury (mmHg)
Standard Deviation 8.23
|
-5.6 Millimeters of mercury (mmHg)
Standard Deviation 13.67
|
0.7 Millimeters of mercury (mmHg)
Standard Deviation 0.58
|
8.4 Millimeters of mercury (mmHg)
Standard Deviation 6.88
|
-2.0 Millimeters of mercury (mmHg)
Standard Deviation 9.57
|
|
Part 1 and Part 2: Change From Baseline (CFB) in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
DBP, CFB to Cycle 2 Day 1, WITHIN 15 MINS AFTER EOI
|
-0.6 Millimeters of mercury (mmHg)
Standard Deviation 7.88
|
-5.5 Millimeters of mercury (mmHg)
Standard Deviation 14.81
|
1.3 Millimeters of mercury (mmHg)
Standard Deviation 2.52
|
11.0 Millimeters of mercury (mmHg)
Standard Deviation 7.62
|
-6.6 Millimeters of mercury (mmHg)
Standard Deviation 2.97
|
|
Part 1 and Part 2: Change From Baseline (CFB) in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
DBP, CFB to Cycle 3 Day 1, PRE-INFUSION
|
-5.3 Millimeters of mercury (mmHg)
Standard Deviation 11.15
|
0.8 Millimeters of mercury (mmHg)
Standard Deviation 15.51
|
2.0 Millimeters of mercury (mmHg)
Standard Deviation 1.41
|
9.5 Millimeters of mercury (mmHg)
Standard Deviation 9.11
|
1.4 Millimeters of mercury (mmHg)
Standard Deviation 10.15
|
|
Part 1 and Part 2: Change From Baseline (CFB) in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
DBP, CFB to Cycle 3 Day 1, WITHIN 15 MINS AFTER EOI
|
-7.3 Millimeters of mercury (mmHg)
Standard Deviation 9.46
|
1.0 Millimeters of mercury (mmHg)
Standard Deviation 11.73
|
5.0 Millimeters of mercury (mmHg)
Standard Deviation 1.41
|
5.0 Millimeters of mercury (mmHg)
Standard Deviation 6.98
|
-6.8 Millimeters of mercury (mmHg)
Standard Deviation 12.07
|
|
Part 1 and Part 2: Change From Baseline (CFB) in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
DBP, CFB to Cycle 4 Day 1, PRE-INFUSION
|
-1.0 Millimeters of mercury (mmHg)
Standard Deviation 2.65
|
-2.0 Millimeters of mercury (mmHg)
Standard Deviation 17.44
|
1.5 Millimeters of mercury (mmHg)
Standard Deviation 0.71
|
13.8 Millimeters of mercury (mmHg)
Standard Deviation 9.81
|
-5.8 Millimeters of mercury (mmHg)
Standard Deviation 9.41
|
|
Part 1 and Part 2: Change From Baseline (CFB) in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
DBP CFB to Cycle 4 Day 1, WITHIN 15 MINS AFTER EOI
|
-2.3 Millimeters of mercury (mmHg)
Standard Deviation 4.62
|
2.0 Millimeters of mercury (mmHg)
Standard Deviation 17.69
|
3.0 Millimeters of mercury (mmHg)
Standard Deviation 2.83
|
13.5 Millimeters of mercury (mmHg)
Standard Deviation 9.15
|
-9.4 Millimeters of mercury (mmHg)
Standard Deviation 7.40
|
|
Part 1 and Part 2: Change From Baseline (CFB) in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
DBP, CFB to Cycle 5 Day 1, PRE-INFUSION
|
-3.7 Millimeters of mercury (mmHg)
Standard Deviation 10.02
|
9.7 Millimeters of mercury (mmHg)
Standard Deviation 31.01
|
2.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
6.0 Millimeters of mercury (mmHg)
Standard Deviation 7.16
|
-1.8 Millimeters of mercury (mmHg)
Standard Deviation 7.63
|
|
Part 1 and Part 2: Change From Baseline (CFB) in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
DBP, CFB to Cycle 5 Day 1, WITHIN 15 MINS AFTER EOI
|
-2.0 Millimeters of mercury (mmHg)
Standard Deviation 10.44
|
11.3 Millimeters of mercury (mmHg)
Standard Deviation 23.46
|
3.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
7.0 Millimeters of mercury (mmHg)
Standard Deviation 6.48
|
-5.2 Millimeters of mercury (mmHg)
Standard Deviation 3.27
|
|
Part 1 and Part 2: Change From Baseline (CFB) in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
DBP, CFB to Cycle 6 Day 1, PRE-INFUSION
|
-2.3 Millimeters of mercury (mmHg)
Standard Deviation 10.07
|
-8.5 Millimeters of mercury (mmHg)
Standard Deviation 16.26
|
-2.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
13.3 Millimeters of mercury (mmHg)
Standard Deviation 12.42
|
-6.0 Millimeters of mercury (mmHg)
Standard Deviation 5.15
|
|
Part 1 and Part 2: Change From Baseline (CFB) in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
DBP, CFB to Cycle 6 Day 1, WITHIN 15 MINS AFTER EOI
|
0.0 Millimeters of mercury (mmHg)
Standard Deviation 10.58
|
11.5 Millimeters of mercury (mmHg)
Standard Deviation 9.19
|
2.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
9.5 Millimeters of mercury (mmHg)
Standard Deviation 12.40
|
-7.3 Millimeters of mercury (mmHg)
Standard Deviation 9.22
|
|
Part 1 and Part 2: Change From Baseline (CFB) in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
DBP, CFB to Cycle 7 Day 1, WITHIN 15 MINS AFTER EOI
|
2.0 Millimeters of mercury (mmHg)
Standard Deviation 1.73
|
-4.0 Millimeters of mercury (mmHg)
Standard Deviation 7.07
|
0.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
20.0 Millimeters of mercury (mmHg)
Standard Deviation 5.66
|
-1.0 Millimeters of mercury (mmHg)
Standard Deviation 1.41
|
|
Part 1 and Part 2: Change From Baseline (CFB) in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
DBP, CFB to Cycle 8 Day 1, PRE-INFUSION
|
-1.0 Millimeters of mercury (mmHg)
Standard Deviation 12.49
|
-6.5 Millimeters of mercury (mmHg)
Standard Deviation 13.44
|
1.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
14.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
-7.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
|
Part 1 and Part 2: Change From Baseline (CFB) in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
DBP, CFB to Cycle 9 Day 1, PRE-INFUSION
|
-10.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
3.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
0.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
11.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
-3.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
|
Part 1 and Part 2: Change From Baseline (CFB) in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
DBP, CFB to Cycle 9 Day 1, WITHIN 15 MINS AFTER EOI
|
-7.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
4.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
3.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
25.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
-8.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
|
Part 1 and Part 2: Change From Baseline (CFB) in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
DBP, CFB to Cycle 10 Day 1, PRE-INFUSION
|
-10.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
7.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
4.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
17.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
-4.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
|
Part 1 and Part 2: Change From Baseline (CFB) in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
DBP, CFB to Cycle 10 Day 1, WITHIN 15 MINS AFTER EOI
|
-11.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
6.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
2.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
15.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
-7.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
|
Part 1 and Part 2: Change From Baseline (CFB) in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
DBP, CFB to Cycle 11 Day 1, PRE-INFUSION
|
-7.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
7.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
1.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
3.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
-1.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
|
Part 1 and Part 2: Change From Baseline (CFB) in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
DBP, CFB to Cycle 11 Day 1, WITHIN 15 MINS AFTER EOI
|
-7.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
5.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
5.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
2.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
-7.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
|
Part 1 and Part 2: Change From Baseline (CFB) in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
DBP, CFB to Cycle 12 Day 1, PRE-INFUSION
|
-13.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
1.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
-2.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
-4.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
6.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
|
Part 1 and Part 2: Change From Baseline (CFB) in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
DBP, CFB to Cycle 12 Day 1, WITHIN 15 MINS AFTER EOI
|
-12.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
3.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
2.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
-3.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
-2.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
|
Part 1 and Part 2: Change From Baseline (CFB) in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
DBP, CFB to Cycle 13 Day 1, PRE-INFUSION
|
-17.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
1.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
5.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
34.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
6.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
|
Part 1 and Part 2: Change From Baseline (CFB) in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
DBP, CFB to Cycle 13 Day 1, WITHIN 15 MINS AFTER EOI
|
-25.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
5.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
5.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
25.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
9.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
|
Part 1 and Part 2: Change From Baseline (CFB) in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
DBP, CFB to Cycle 14 Day 1, PRE-INFUSION
|
-15.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
0.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
-1.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
3.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
-4.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
|
Part 1 and Part 2: Change From Baseline (CFB) in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
DBP, CFB to Cycle 14 Day 1, WITHIN 15 MINS AFTER EOI
|
-20.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
-2.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
4.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
-3.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
-7.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
|
Part 1 and Part 2: Change From Baseline (CFB) in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
DBP, CFB to Cycle 15 Day 1, PRE-INFUSION
|
-5.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
0.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
-1.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
11.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
-7.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
|
Part 1 and Part 2: Change From Baseline (CFB) in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
DBP, CFB to Cycle 15 Day 1, WITHIN 15 MINS AFTER EOI
|
-6.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
-1.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
2.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
9.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
-15.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
|
Part 1 and Part 2: Change From Baseline (CFB) in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
DBP, CFB to Cycle 16 Day 1, PRE-INFUSION
|
-15.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
0.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
0.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
7.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
-8.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
|
Part 1 and Part 2: Change From Baseline (CFB) in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
DBP, CFB to Cycle 16 Day 1, WITHIN 15 MINS AFTER EOI
|
-10.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
2.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
5.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
2.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
-14.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
|
Part 1 and Part 2: Change From Baseline (CFB) in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
DBP, CFB to Cycle 17 Day 1, PRE-INFUSION
|
-5.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
1.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
2.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
0.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
-1.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
|
Part 1 and Part 2: Change From Baseline (CFB) in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
DBP, CFB to Cycle 17 Day 1, WITHIN 15 MINS AFTER EOI
|
-13.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
5.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
5.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
1.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
-4.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
|
Part 1 and Part 2: Change From Baseline (CFB) in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
DBP, CFB to Cycle 18 Day 1, PRE-INFUSION
|
-15.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
-2.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
1.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
7.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
-8.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
|
Part 1 and Part 2: Change From Baseline (CFB) in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
DBP, CFB to Cycle 18 Day 1, WITHIN 15 MINS AFTER EOI
|
-5.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
2.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
3.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
1.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
-5.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
|
Part 1 and Part 2: Change From Baseline (CFB) in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
DBP, CFB to Cycle 19 Day 1, PRE-INFUSION
|
-17.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
1.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
3.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
5.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
—
|
|
Part 1 and Part 2: Change From Baseline (CFB) in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
DBP, CFB to Cycle 19 Day 1, WITHIN 15 MINS AFTER EOI
|
-15.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
6.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
6.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
9.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
—
|
|
Part 1 and Part 2: Change From Baseline (CFB) in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
DBP, CFB to Cycle 20 Day 1, PRE-INFUSION
|
-12.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
—
|
—
|
7.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
—
|
|
Part 1 and Part 2: Change From Baseline (CFB) in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
DBP, CFB to Cycle 20 Day 1, WITHIN 15 MINS AFTER EOI
|
-15.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
—
|
—
|
9.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
—
|
|
Part 1 and Part 2: Change From Baseline (CFB) in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
DBP, CFB to Cycle 21 Day 1, PRE-INFUSION
|
-7.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
—
|
—
|
—
|
—
|
|
Part 1 and Part 2: Change From Baseline (CFB) in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
DBP, CFB to Cycle 21 Day 1, WITHIN 15 MINS AFTER EOI
|
-7.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
—
|
—
|
—
|
—
|
|
Part 1 and Part 2: Change From Baseline (CFB) in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
DBP, CFB to Cycle 22 Day 1, PRE-INFUSION
|
-10.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
—
|
—
|
—
|
—
|
|
Part 1 and Part 2: Change From Baseline (CFB) in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
DBP, CFB to Cycle 22 Day 1, WITHIN 15 MINS AFTER EOI
|
-5.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
—
|
—
|
—
|
—
|
|
Part 1 and Part 2: Change From Baseline (CFB) in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
DBP, CFB to Cycle 23 Day 1, PRE-INFUSION
|
-10.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
—
|
—
|
—
|
—
|
|
Part 1 and Part 2: Change From Baseline (CFB) in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
DBP, CFB to Cycle 23 Day 1, WITHIN 15 MINS AFTER EOI
|
0.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
—
|
—
|
—
|
—
|
|
Part 1 and Part 2: Change From Baseline (CFB) in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
DBP, CFB to End of Treatment (Up to 236 weeks)
|
-4.5 Millimeters of mercury (mmHg)
Standard Deviation 10.79
|
-2.0 Millimeters of mercury (mmHg)
Standard Deviation 12.22
|
7.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
4.0 Millimeters of mercury (mmHg)
Standard Deviation 9.90
|
—
|
|
Part 1 and Part 2: Change From Baseline (CFB) in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
SBP, Baseline (Day 1)
|
120.0 Millimeters of mercury (mmHg)
Standard Deviation 6.99
|
129.9 Millimeters of mercury (mmHg)
Standard Deviation 21.32
|
116.8 Millimeters of mercury (mmHg)
Standard Deviation 8.42
|
121.0 Millimeters of mercury (mmHg)
Standard Deviation 5.29
|
121.9 Millimeters of mercury (mmHg)
Standard Deviation 17.50
|
|
Part 1 and Part 2: Change From Baseline (CFB) in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
SBP, CFB to Cycle 1 Day 1, 15 MINS AFTER SOI
|
-2.8 Millimeters of mercury (mmHg)
Standard Deviation 8.75
|
-2.8 Millimeters of mercury (mmHg)
Standard Deviation 17.04
|
3.8 Millimeters of mercury (mmHg)
Standard Deviation 4.19
|
15.8 Millimeters of mercury (mmHg)
Standard Deviation 15.94
|
1.9 Millimeters of mercury (mmHg)
Standard Deviation 1.95
|
|
Part 1 and Part 2: Change From Baseline (CFB) in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
SBP, CFB to Cycle 1 Day 1, WITHIN 15 MINS AFTER EOI
|
0.9 Millimeters of mercury (mmHg)
Standard Deviation 11.24
|
-1.7 Millimeters of mercury (mmHg)
Standard Deviation 14.94
|
5.0 Millimeters of mercury (mmHg)
Standard Deviation 7.12
|
10.0 Millimeters of mercury (mmHg)
Standard Deviation 15.44
|
0.7 Millimeters of mercury (mmHg)
Standard Deviation 3.73
|
|
Part 1 and Part 2: Change From Baseline (CFB) in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
SBP, CFB to Cycle 1 Day 1, 1 HOUR AFTER EOI
|
-0.6 Millimeters of mercury (mmHg)
Standard Deviation 11.04
|
-3.1 Millimeters of mercury (mmHg)
Standard Deviation 18.61
|
6.0 Millimeters of mercury (mmHg)
Standard Deviation 6.06
|
11.4 Millimeters of mercury (mmHg)
Standard Deviation 14.36
|
2.8 Millimeters of mercury (mmHg)
Standard Deviation 5.63
|
|
Part 1 and Part 2: Change From Baseline (CFB) in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
SBP, CFB to Cycle 2 Day 1, PRE-INFUSION
|
1.6 Millimeters of mercury (mmHg)
Standard Deviation 14.43
|
-2.0 Millimeters of mercury (mmHg)
Standard Deviation 19.76
|
3.7 Millimeters of mercury (mmHg)
Standard Deviation 3.06
|
27.0 Millimeters of mercury (mmHg)
Standard Deviation 24.27
|
9.0 Millimeters of mercury (mmHg)
Standard Deviation 17.47
|
|
Part 1 and Part 2: Change From Baseline (CFB) in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
SBP, CFB to Cycle 2 Day 1, WITHIN 15 MINS AFTER EOI
|
-0.9 Millimeters of mercury (mmHg)
Standard Deviation 5.46
|
-4.1 Millimeters of mercury (mmHg)
Standard Deviation 16.21
|
3.7 Millimeters of mercury (mmHg)
Standard Deviation 1.53
|
22.0 Millimeters of mercury (mmHg)
Standard Deviation 19.69
|
2.8 Millimeters of mercury (mmHg)
Standard Deviation 7.29
|
|
Part 1 and Part 2: Change From Baseline (CFB) in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
SBP, CFB to Cycle 3 Day 1, PRE-INFUSION
|
-5.8 Millimeters of mercury (mmHg)
Standard Deviation 4.99
|
2.4 Millimeters of mercury (mmHg)
Standard Deviation 16.38
|
6.5 Millimeters of mercury (mmHg)
Standard Deviation 6.36
|
22.8 Millimeters of mercury (mmHg)
Standard Deviation 16.88
|
10.0 Millimeters of mercury (mmHg)
Standard Deviation 11.72
|
|
Part 1 and Part 2: Change From Baseline (CFB) in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
SBP, CFB to Cycle 3 Day 1, WITHIN 15 MINS AFTER EOI
|
-3.8 Millimeters of mercury (mmHg)
Standard Deviation 5.44
|
-0.6 Millimeters of mercury (mmHg)
Standard Deviation 19.96
|
2.5 Millimeters of mercury (mmHg)
Standard Deviation 2.12
|
24.5 Millimeters of mercury (mmHg)
Standard Deviation 18.52
|
9.0 Millimeters of mercury (mmHg)
Standard Deviation 16.84
|
|
Part 1 and Part 2: Change From Baseline (CFB) in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
SBP, CFB to Cycle 4 Day 1, PRE-INFUSION
|
-0.3 Millimeters of mercury (mmHg)
Standard Deviation 2.52
|
-9.0 Millimeters of mercury (mmHg)
Standard Deviation 22.34
|
0.0 Millimeters of mercury (mmHg)
Standard Deviation 2.83
|
10.0 Millimeters of mercury (mmHg)
Standard Deviation 15.81
|
7.0 Millimeters of mercury (mmHg)
Standard Deviation 9.70
|
|
Part 1 and Part 2: Change From Baseline (CFB) in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
SBP, CFB to Cycle 4 Day 1, WITHIN 15 MINS AFTER EOI
|
-6.0 Millimeters of mercury (mmHg)
Standard Deviation 4.36
|
-9.0 Millimeters of mercury (mmHg)
Standard Deviation 25.71
|
-0.5 Millimeters of mercury (mmHg)
Standard Deviation 9.19
|
25.5 Millimeters of mercury (mmHg)
Standard Deviation 25.28
|
4.0 Millimeters of mercury (mmHg)
Standard Deviation 3.94
|
|
Part 1 and Part 2: Change From Baseline (CFB) in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
SBP, CFB to Cycle 5 Day 1, PRE-INFUSION
|
0.3 Millimeters of mercury (mmHg)
Standard Deviation 5.77
|
9.7 Millimeters of mercury (mmHg)
Standard Deviation 24.11
|
7.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
11.8 Millimeters of mercury (mmHg)
Standard Deviation 16.94
|
13.8 Millimeters of mercury (mmHg)
Standard Deviation 13.48
|
|
Part 1 and Part 2: Change From Baseline (CFB) in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
SBP, CFB to Cycle 5 Day 1, WITHIN 15 MINS AFTER EOI
|
5.7 Millimeters of mercury (mmHg)
Standard Deviation 10.69
|
-0.7 Millimeters of mercury (mmHg)
Standard Deviation 34.24
|
6.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
13.3 Millimeters of mercury (mmHg)
Standard Deviation 17.73
|
8.6 Millimeters of mercury (mmHg)
Standard Deviation 10.14
|
|
Part 1 and Part 2: Change From Baseline (CFB) in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
SBP, CFB to Cycle 6 Day 1, PRE-INFUSION
|
-4.3 Millimeters of mercury (mmHg)
Standard Deviation 1.53
|
-10.0 Millimeters of mercury (mmHg)
Standard Deviation 12.73
|
8.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
9.3 Millimeters of mercury (mmHg)
Standard Deviation 25.40
|
0.6 Millimeters of mercury (mmHg)
Standard Deviation 15.52
|
|
Part 1 and Part 2: Change From Baseline (CFB) in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
SBP, CFB to Cycle 6 Day 1, WITHIN 15 MINS AFTER EOI
|
4.7 Millimeters of mercury (mmHg)
Standard Deviation 12.42
|
-11.0 Millimeters of mercury (mmHg)
Standard Deviation 15.56
|
6.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
9.8 Millimeters of mercury (mmHg)
Standard Deviation 25.62
|
12.3 Millimeters of mercury (mmHg)
Standard Deviation 13.72
|
|
Part 1 and Part 2: Change From Baseline (CFB) in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
SBP, CFB to Cycle 7 Day 1, PRE-INFUSION
|
3.3 Millimeters of mercury (mmHg)
Standard Deviation 10.12
|
-6.0 Millimeters of mercury (mmHg)
Standard Deviation 2.83
|
6.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
23.5 Millimeters of mercury (mmHg)
Standard Deviation 30.41
|
-7.0 Millimeters of mercury (mmHg)
Standard Deviation 1.41
|
|
Part 1 and Part 2: Change From Baseline (CFB) in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
SBP, CFB to Cycle 7 Day 1, WITHIN 15 MINS AFTER EOI
|
3.0 Millimeters of mercury (mmHg)
Standard Deviation 8.72
|
-20.5 Millimeters of mercury (mmHg)
Standard Deviation 26.16
|
10.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
26.0 Millimeters of mercury (mmHg)
Standard Deviation 48.08
|
-9.0 Millimeters of mercury (mmHg)
Standard Deviation 11.31
|
|
Part 1 and Part 2: Change From Baseline (CFB) in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
SBP, CFB to Cycle 8 Day 1, PRE-INFUSION
|
-2.3 Millimeters of mercury (mmHg)
Standard Deviation 4.04
|
-8.5 Millimeters of mercury (mmHg)
Standard Deviation 12.02
|
1.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
30.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
0.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
|
Part 1 and Part 2: Change From Baseline (CFB) in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
SBP, CFB to Cycle 8 Day 1, WITHIN 15 MINS AFTER EOI
|
-6.3 Millimeters of mercury (mmHg)
Standard Deviation 5.86
|
-11.0 Millimeters of mercury (mmHg)
Standard Deviation 19.80
|
0.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
75.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
-1.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
|
Part 1 and Part 2: Change From Baseline (CFB) in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
SBP, CFB to Cycle 9 Day 1, PRE-INFUSION
|
-3.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
3.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
3.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
54.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
14.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
|
Part 1 and Part 2: Change From Baseline (CFB) in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
SBP, CFB to Cycle 9 Day 1, WITHIN 15 MINS AFTER EOI
|
3.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
5.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
5.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
80.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
4.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
|
Part 1 and Part 2: Change From Baseline (CFB) in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
SBP, CFB to Cycle 10 Day 1, PRE-INFUSION
|
-3.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
5.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
9.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
56.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
0.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
|
Part 1 and Part 2: Change From Baseline (CFB) in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
SBP, CFB to Cycle 10 Day 1, WITHIN 15 MINS AFTER EOI
|
-2.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
3.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
12.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
52.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
4.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
|
Part 1 and Part 2: Change From Baseline (CFB) in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
SBP, CFB to Cycle 11 Day 1, PRE-INFUSION
|
-13.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
-4.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
2.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
18.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
20.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
|
Part 1 and Part 2: Change From Baseline (CFB) in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
SBP, CFB to Cycle 11 Day 1, WITHIN 15 MINS AFTER EOI
|
-5.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
0.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
3.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
30.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
15.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
|
Part 1 and Part 2: Change From Baseline (CFB) in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
SBP, CFB to Cycle 12 Day 1, PRE-INFUSION
|
-13.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
5.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
8.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
15.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
5.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
|
Part 1 and Part 2: Change From Baseline (CFB) in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
SBP, CFB to Cycle 12 Day 1, WITHIN 15 MINS AFTER EOI
|
-8.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
4.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
12.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
17.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
3.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
|
Part 1 and Part 2: Change From Baseline (CFB) in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
SBP, CFB to Cycle 13 Day 1, PRE-INFUSION
|
5.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
-2.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
7.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
42.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
6.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
|
Part 1 and Part 2: Change From Baseline (CFB) in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
SBP, CFB to Cycle 13 Day 1, WITHIN 15 MINS AFTER EOI
|
-5.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
-1.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
6.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
44.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
4.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
|
Part 1 and Part 2: Change From Baseline (CFB) in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
SBP, CFB to Cycle 14 Day 1, PRE-INFUSION
|
-3.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
-4.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
12.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
19.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
0.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
|
Part 1 and Part 2: Change From Baseline (CFB) in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
SBP, CFB to Cycle 14 Day 1, WITHIN 15 MINS AFTER EOI
|
0.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
0.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
13.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
18.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
4.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
|
Part 1 and Part 2: Change From Baseline (CFB) in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
SBP, CFB to Cycle 15 Day 1, PRE-INFUSION
|
7.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
5.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
7.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
41.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
0.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
|
Part 1 and Part 2: Change From Baseline (CFB) in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
SBP, CFB to Cycle 15 Day 1, WITHIN 15 MINS AFTER EOI
|
6.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
4.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
9.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
42.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
4.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
|
Part 1 and Part 2: Change From Baseline (CFB) in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
SBP, CFB to Cycle 16 Day 1, PRE-INFUSION
|
-3.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
4.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
6.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
41.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
-6.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
|
Part 1 and Part 2: Change From Baseline (CFB) in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
SBP, CFB to Cycle 16 Day 1, WITHIN 15 MINS AFTER EOI
|
2.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
6.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
9.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
31.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
4.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
|
Part 1 and Part 2: Change From Baseline (CFB) in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
SBP, Cycle 17 Day 1, PRE-INFUSION
|
-3.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
4.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
3.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
23.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
25.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
|
Part 1 and Part 2: Change From Baseline (CFB) in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
SBP, Cycle 17 Day 1, WITHIN 15 MINS AFTER EOI
|
-5.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
2.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
8.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
35.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
23.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
|
Part 1 and Part 2: Change From Baseline (CFB) in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
SBP, CFB to Cycle 18 Day 1, PRE-INFUSION
|
-3.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
-3.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
4.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
48.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
0.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
|
Part 1 and Part 2: Change From Baseline (CFB) in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
SBP, CFB to Cycle 18 Day 1, WITHIN 15 MINS AFTER EOI
|
-3.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
1.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
8.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
33.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
15.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
|
Part 1 and Part 2: Change From Baseline (CFB) in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
SBP, CFB to Cycle 19 Day 1, PRE-INFUSION
|
-5.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
6.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
2.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
28.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
—
|
|
Part 1 and Part 2: Change From Baseline (CFB) in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
SBP, CFB to Cycle 19 Day 1, WITHIN 15 MINS AFTER EOI
|
-3.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
8.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
7.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
48.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
—
|
|
Part 1 and Part 2: Change From Baseline (CFB) in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
SBP, CFB to Cycle 20 Day 1, PRE-INFUSION
|
4.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
—
|
—
|
50.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
—
|
|
Part 1 and Part 2: Change From Baseline (CFB) in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
SBP, CFB to Cycle 20 Day 1, WITHIN 15 MINS AFTER EOI
|
3.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
—
|
—
|
48.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
—
|
|
Part 1 and Part 2: Change From Baseline (CFB) in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
SBP, CFB to Cycle 21 Day 1, PRE-INFUSION
|
26.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
—
|
—
|
—
|
—
|
|
Part 1 and Part 2: Change From Baseline (CFB) in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
SBP, CFB to Cycle 21 Day 1, WITHIN 15 MINS AFTER EOI
|
12.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
—
|
—
|
—
|
—
|
|
Part 1 and Part 2: Change From Baseline (CFB) in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
SBP, CFB to Cycle 22 Day 1, PRE-INFUSION
|
-1.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
—
|
—
|
—
|
—
|
|
Part 1 and Part 2: Change From Baseline (CFB) in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
SBP, CFB to Cycle 22 Day 1, WITHIN 15 MINS AFTER EOI
|
12.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
—
|
—
|
—
|
—
|
|
Part 1 and Part 2: Change From Baseline (CFB) in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
SBP, CFB to Cycle 23 Day 1, PRE-INFUSION
|
11.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
—
|
—
|
—
|
—
|
|
Part 1 and Part 2: Change From Baseline (CFB) in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
SBP, CFB to Cycle 23 Day 1, WITHIN 15 MINS AFTER EOI
|
9.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
—
|
—
|
—
|
—
|
|
Part 1 and Part 2: Change From Baseline (CFB) in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
SBP, CFB to End of Treatment (Up to 236 weeks)
|
-2.8 Millimeters of mercury (mmHg)
Standard Deviation 12.79
|
-5.9 Millimeters of mercury (mmHg)
Standard Deviation 15.39
|
1.0 Millimeters of mercury (mmHg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
31.0 Millimeters of mercury (mmHg)
Standard Deviation 29.70
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and up to approx. 236 weeksPopulation: Safety population. Only those participants who were measured and analyzed (i.e., contributed to data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified timepoints. The "0" participants analyzed represents that data was not collected or available for analysis at that particular time point for the respective Arms/Groups.
Heart rate was measured after resting for at least 5 minutes in a supine or semi-recumbent position. Baseline (Day 1) was defined as latest pre-dose assessment with a non-missing value, including unscheduled visits. Change from Baseline was calculated as post-dose visit value minus Baseline value.
Outcome measures
| Measure |
Part 1: Belantamab Mafodotin 2.5 mg/kg (Normal/Mildly Impaired Renal Function)
n=10 Participants
Participants with Relapsed/Refractory Multiple Myeloma (RRMM) who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and normal/mildly impaired renal function received intravenous (IV) infusion of 2.5 milligram (mg)/kilogram (kg) belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to adverse event (AE), lost to follow-up, death, whichever occurs first.
|
Part 1: Belantamab Mafodotin 2.5 mg/kg (Severely Impaired Renal Function)
n=9 Participants
Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and severe renal impairment renal function received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
|
Part 1: Belantamab Mafodotin 2.5 mg/kg (Other Renal Function)
n=4 Participants
Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and other renal impairment renal function received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
|
Part 2: Belantamab Mafodotin 2.5 mg/kg End Stage Renal Disease (Not on Dialysis)
n=5 Participants
Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and end stage renal disease (ESRD) (not on hemodialysis) received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
|
Part 2: Belantamab Mafodotin 2.5 mg/kg ESRD (On Dialysis)
n=8 Participants
Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and ESRD (on hemodialysis) received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
|
|---|---|---|---|---|---|
|
Part 1 and Part 2: Change From Baseline (CFB) in Vital Signs: Heart Rate
CFB to Cycle 3 Day 1, WITHIN 15 MINS AFTER EOI
|
-9.0 Beats per minute
Standard Deviation 9.45
|
0.6 Beats per minute
Standard Deviation 13.50
|
4.5 Beats per minute
Standard Deviation 6.36
|
-5.0 Beats per minute
Standard Deviation 7.79
|
5.8 Beats per minute
Standard Deviation 10.23
|
|
Part 1 and Part 2: Change From Baseline (CFB) in Vital Signs: Heart Rate
CFB to Cycle 4 Day 1, PRE-INFUSION
|
0.0 Beats per minute
Standard Deviation 6.00
|
-12.3 Beats per minute
Standard Deviation 25.74
|
5.5 Beats per minute
Standard Deviation 14.85
|
-6.5 Beats per minute
Standard Deviation 11.47
|
4.0 Beats per minute
Standard Deviation 5.37
|
|
Part 1 and Part 2: Change From Baseline (CFB) in Vital Signs: Heart Rate
CFB to Cycle 4 Day 1, WITHIN 15 MINS AFTER EOI
|
-1.3 Beats per minute
Standard Deviation 9.07
|
-15.7 Beats per minute
Standard Deviation 22.94
|
1.0 Beats per minute
Standard Deviation 11.31
|
-8.5 Beats per minute
Standard Deviation 12.87
|
6.0 Beats per minute
Standard Deviation 5.52
|
|
Part 1 and Part 2: Change From Baseline (CFB) in Vital Signs: Heart Rate
CFB to Cycle 5 Day 1, PRE-INFUSION
|
-3.7 Beats per minute
Standard Deviation 19.14
|
-3.3 Beats per minute
Standard Deviation 9.29
|
0.0 Beats per minute
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
-5.8 Beats per minute
Standard Deviation 8.96
|
5.7 Beats per minute
Standard Deviation 10.65
|
|
Part 1 and Part 2: Change From Baseline (CFB) in Vital Signs: Heart Rate
CFB to Cycle 5 Day 1, WITHIN 15 MINS AFTER EOI
|
-6.0 Beats per minute
Standard Deviation 11.14
|
-5.7 Beats per minute
Standard Deviation 9.07
|
-2.0 Beats per minute
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
-5.0 Beats per minute
Standard Deviation 9.24
|
4.2 Beats per minute
Standard Deviation 3.83
|
|
Part 1 and Part 2: Change From Baseline (CFB) in Vital Signs: Heart Rate
CFB to Cycle 6 Day 1, PRE-INFUSION
|
-6.0 Beats per minute
Standard Deviation 13.11
|
8.5 Beats per minute
Standard Deviation 7.78
|
-3.0 Beats per minute
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
-0.3 Beats per minute
Standard Deviation 7.41
|
6.2 Beats per minute
Standard Deviation 7.92
|
|
Part 1 and Part 2: Change From Baseline (CFB) in Vital Signs: Heart Rate
CFB to Cycle 6 Day 1, WITHIN 15 MINS AFTER EOI
|
-7.7 Beats per minute
Standard Deviation 9.61
|
3.5 Beats per minute
Standard Deviation 3.54
|
-4.0 Beats per minute
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
1.8 Beats per minute
Standard Deviation 7.27
|
4.5 Beats per minute
Standard Deviation 7.42
|
|
Part 1 and Part 2: Change From Baseline (CFB) in Vital Signs: Heart Rate
CFB to Cycle 7 Day 1, PRE-INFUSION
|
-5.3 Beats per minute
Standard Deviation 7.09
|
3.5 Beats per minute
Standard Deviation 2.12
|
-8.0 Beats per minute
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
-1.5 Beats per minute
Standard Deviation 6.36
|
5.5 Beats per minute
Standard Deviation 0.71
|
|
Part 1 and Part 2: Change From Baseline (CFB) in Vital Signs: Heart Rate
CFB to Cycle 7 Day 1, WITHIN 15 MINS AFTER EOI
|
-8.3 Beats per minute
Standard Deviation 12.86
|
2.5 Beats per minute
Standard Deviation 2.12
|
-3.0 Beats per minute
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
2.0 Beats per minute
Standard Deviation 9.90
|
6.5 Beats per minute
Standard Deviation 0.71
|
|
Part 1 and Part 2: Change From Baseline (CFB) in Vital Signs: Heart Rate
CFB to Cycle 8 Day 1, PRE-INFUSION
|
-9.7 Beats per minute
Standard Deviation 12.58
|
14.5 Beats per minute
Standard Deviation 16.26
|
-4.0 Beats per minute
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
-17.0 Beats per minute
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
6.0 Beats per minute
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
|
Part 1 and Part 2: Change From Baseline (CFB) in Vital Signs: Heart Rate
CFB to Cycle 8 Day 1, WITHIN 15 MINS AFTER EOI
|
-11.3 Beats per minute
Standard Deviation 9.29
|
15.0 Beats per minute
Standard Deviation 18.38
|
-2.0 Beats per minute
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
-18.0 Beats per minute
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
8.0 Beats per minute
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
|
Part 1 and Part 2: Change From Baseline (CFB) in Vital Signs: Heart Rate
CFB to Cycle 9 Day 1, PRE-INFUSION
|
-20.0 Beats per minute
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
5.0 Beats per minute
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
-8.0 Beats per minute
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
-22.0 Beats per minute
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
10.0 Beats per minute
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
|
Part 1 and Part 2: Change From Baseline (CFB) in Vital Signs: Heart Rate
CFB to Cycle 9 Day 1, WITHIN 15 MINS AFTER EOI
|
-22.0 Beats per minute
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
4.0 Beats per minute
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
-10.0 Beats per minute
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
-17.0 Beats per minute
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
12.0 Beats per minute
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
|
Part 1 and Part 2: Change From Baseline (CFB) in Vital Signs: Heart Rate
CFB to Cycle 10 Day 1, PRE-INFUSION
|
-23.0 Beats per minute
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
6.0 Beats per minute
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
-5.0 Beats per minute
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
-17.0 Beats per minute
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
5.0 Beats per minute
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
|
Part 1 and Part 2: Change From Baseline (CFB) in Vital Signs: Heart Rate
CFB to Cycle 10 Day 1, WITHIN 15 MINS AFTER EOI
|
-24.0 Beats per minute
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
4.0 Beats per minute
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
-2.0 Beats per minute
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
-16.0 Beats per minute
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
0.0 Beats per minute
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
|
Part 1 and Part 2: Change From Baseline (CFB) in Vital Signs: Heart Rate
CFB to Cycle 11 Day 1, PRE-INFUSION
|
-9.0 Beats per minute
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
7.0 Beats per minute
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
-4.0 Beats per minute
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
-12.0 Beats per minute
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
0.0 Beats per minute
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
|
Part 1 and Part 2: Change From Baseline (CFB) in Vital Signs: Heart Rate
CFB to Cycle 11 Day 1, WITHIN 15 MINS AFTER EOI
|
-20.0 Beats per minute
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
5.0 Beats per minute
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
-8.0 Beats per minute
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
-10.0 Beats per minute
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
1.0 Beats per minute
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
|
Part 1 and Part 2: Change From Baseline (CFB) in Vital Signs: Heart Rate
CFB to Cycle 12 Day 1, PRE-INFUSION
|
-10.0 Beats per minute
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
2.0 Beats per minute
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
1.0 Beats per minute
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
-2.0 Beats per minute
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
4.0 Beats per minute
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
|
Part 1 and Part 2: Change From Baseline (CFB) in Vital Signs: Heart Rate
CFB to Cycle 12 Day 1, WITHIN 15 MINS AFTER EOI
|
-9.0 Beats per minute
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
7.0 Beats per minute
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
2.0 Beats per minute
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
-5.0 Beats per minute
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
2.0 Beats per minute
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
|
Part 1 and Part 2: Change From Baseline (CFB) in Vital Signs: Heart Rate
CFB to Cycle 13 Day 1, PRE-INFUSION
|
-22.0 Beats per minute
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
3.0 Beats per minute
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
-2.0 Beats per minute
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
-6.0 Beats per minute
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
4.0 Beats per minute
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
|
Part 1 and Part 2: Change From Baseline (CFB) in Vital Signs: Heart Rate
CFB to Cycle 13 Day 1, WITHIN 15 MINS AFTER EOI
|
-33.0 Beats per minute
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
4.0 Beats per minute
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
1.0 Beats per minute
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
2.0 Beats per minute
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
2.0 Beats per minute
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
|
Part 1 and Part 2: Change From Baseline (CFB) in Vital Signs: Heart Rate
CFB to Cycle 14 Day 1, PRE-INFUSION
|
-28.0 Beats per minute
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
3.0 Beats per minute
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
-8.0 Beats per minute
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
-6.0 Beats per minute
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
6.0 Beats per minute
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
|
Part 1 and Part 2: Change From Baseline (CFB) in Vital Signs: Heart Rate
CFB to Cycle 14 Day 1, WITHIN 15 MINS AFTER EOI
|
-30.0 Beats per minute
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
4.0 Beats per minute
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
-6.0 Beats per minute
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
-5.0 Beats per minute
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
-2.0 Beats per minute
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
|
Part 1 and Part 2: Change From Baseline (CFB) in Vital Signs: Heart Rate
CFB to Cycle 15 Day 1, PRE-INFUSION
|
-24.0 Beats per minute
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
10.0 Beats per minute
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
0.0 Beats per minute
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
-15.0 Beats per minute
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
0.0 Beats per minute
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
|
Part 1 and Part 2: Change From Baseline (CFB) in Vital Signs: Heart Rate
CFB to Cycle 15 Day 1, WITHIN 15 MINS AFTER EOI
|
-24.0 Beats per minute
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
8.0 Beats per minute
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
-1.0 Beats per minute
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
-14.0 Beats per minute
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
-1.0 Beats per minute
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
|
Part 1 and Part 2: Change From Baseline (CFB) in Vital Signs: Heart Rate
CFB to Cycle 16 Day 1, PRE-INFUSION
|
-30.0 Beats per minute
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
6.0 Beats per minute
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
-5.0 Beats per minute
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
-17.0 Beats per minute
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
-2.0 Beats per minute
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
|
Part 1 and Part 2: Change From Baseline (CFB) in Vital Signs: Heart Rate
CFB to Cycle 16 Day 1, WITHIN 15 MINS AFTER EOI
|
-28.0 Beats per minute
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
2.0 Beats per minute
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
-3.0 Beats per minute
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
-11.0 Beats per minute
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
2.0 Beats per minute
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
|
Part 1 and Part 2: Change From Baseline (CFB) in Vital Signs: Heart Rate
CFB to Cycle 17 Day 1, PRE-INFUSION
|
-30.0 Beats per minute
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
3.0 Beats per minute
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
-2.0 Beats per minute
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
-3.0 Beats per minute
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
0.0 Beats per minute
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
|
Part 1 and Part 2: Change From Baseline (CFB) in Vital Signs: Heart Rate
CFB to Cycle 17 Day 1, WITHIN 15 MINS AFTER EOI
|
-28.0 Beats per minute
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
2.0 Beats per minute
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
0.0 Beats per minute
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
-3.0 Beats per minute
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
7.0 Beats per minute
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
|
Part 1 and Part 2: Change From Baseline (CFB) in Vital Signs: Heart Rate
CFB to Cycle 18 Day 1, PRE-INFUSION
|
-40.0 Beats per minute
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
5.0 Beats per minute
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
-1.0 Beats per minute
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
-9.0 Beats per minute
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
-4.0 Beats per minute
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
|
Part 1 and Part 2: Change From Baseline (CFB) in Vital Signs: Heart Rate
CFB to Cycle 18 Day 1, WITHIN 15 MINS AFTER EOI
|
-38.0 Beats per minute
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
6.0 Beats per minute
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
-2.0 Beats per minute
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
-1.0 Beats per minute
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
11.0 Beats per minute
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
|
Part 1 and Part 2: Change From Baseline (CFB) in Vital Signs: Heart Rate
CFB to Cycle 19 Day 1, PRE-INFUSION
|
-38.0 Beats per minute
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
6.0 Beats per minute
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
3.0 Beats per minute
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
-8.0 Beats per minute
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
—
|
|
Part 1 and Part 2: Change From Baseline (CFB) in Vital Signs: Heart Rate
CFB to Cycle 19 Day 1, WITHIN 15 MINS AFTER EOI
|
-40.0 Beats per minute
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
9.0 Beats per minute
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
2.0 Beats per minute
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
-2.0 Beats per minute
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
—
|
|
Part 1 and Part 2: Change From Baseline (CFB) in Vital Signs: Heart Rate
CFB to Cycle 20 Day 1, PRE-INFUSION
|
-20.0 Beats per minute
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
—
|
—
|
1.0 Beats per minute
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
—
|
|
Part 1 and Part 2: Change From Baseline (CFB) in Vital Signs: Heart Rate
CFB to Cycle 20 Day 1, WITHIN 15 MINS AFTER EOI
|
-17.0 Beats per minute
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
—
|
—
|
-2.0 Beats per minute
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
—
|
|
Part 1 and Part 2: Change From Baseline (CFB) in Vital Signs: Heart Rate
CFB to Cycle 21 Day 1, PRE-INFUSION
|
-16.0 Beats per minute
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
—
|
—
|
—
|
—
|
|
Part 1 and Part 2: Change From Baseline (CFB) in Vital Signs: Heart Rate
CFB to Cycle 21 Day 1, WITHIN 15 MINS AFTER EOI
|
-34.0 Beats per minute
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
—
|
—
|
—
|
—
|
|
Part 1 and Part 2: Change From Baseline (CFB) in Vital Signs: Heart Rate
CFB to Cycle 22 Day 1, PRE-INFUSION
|
-23.0 Beats per minute
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
—
|
—
|
—
|
—
|
|
Part 1 and Part 2: Change From Baseline (CFB) in Vital Signs: Heart Rate
CFB to Cycle 22 Day 1, WITHIN 15 MINS AFTER EOI
|
-18.0 Beats per minute
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
—
|
—
|
—
|
—
|
|
Part 1 and Part 2: Change From Baseline (CFB) in Vital Signs: Heart Rate
CFB to Cycle 23 Day 1, PRE-INFUSION
|
-19.0 Beats per minute
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
—
|
—
|
—
|
—
|
|
Part 1 and Part 2: Change From Baseline (CFB) in Vital Signs: Heart Rate
CFB to Cycle 23 Day 1, WITHIN 15 MINS AFTER EOI
|
-29.0 Beats per minute
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
—
|
—
|
—
|
—
|
|
Part 1 and Part 2: Change From Baseline (CFB) in Vital Signs: Heart Rate
CFB to End of Treatment (Up to 236 weeks)
|
8.8 Beats per minute
Standard Deviation 26.08
|
14.1 Beats per minute
Standard Deviation 10.61
|
3.0 Beats per minute
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
8.0 Beats per minute
Standard Deviation 22.63
|
—
|
|
Part 1 and Part 2: Change From Baseline (CFB) in Vital Signs: Heart Rate
CFB to Cycle 1 Day 1, WITHIN 15 MINS AFTER EOI
|
-1.1 Beats per minute
Standard Deviation 6.03
|
-0.9 Beats per minute
Standard Deviation 4.04
|
4.3 Beats per minute
Standard Deviation 7.41
|
1.8 Beats per minute
Standard Deviation 7.19
|
2.1 Beats per minute
Standard Deviation 2.27
|
|
Part 1 and Part 2: Change From Baseline (CFB) in Vital Signs: Heart Rate
CFB to Cycle 1 Day 1, 1 HOUR AFTER EOI
|
3.0 Beats per minute
Standard Deviation 5.72
|
-1.0 Beats per minute
Standard Deviation 4.30
|
4.8 Beats per minute
Standard Deviation 10.37
|
-1.2 Beats per minute
Standard Deviation 6.91
|
0.9 Beats per minute
Standard Deviation 3.56
|
|
Part 1 and Part 2: Change From Baseline (CFB) in Vital Signs: Heart Rate
CFB to Cycle 2 Day 1, PRE-INFUSION
|
1.2 Beats per minute
Standard Deviation 10.03
|
-5.0 Beats per minute
Standard Deviation 5.50
|
1.3 Beats per minute
Standard Deviation 9.29
|
-0.2 Beats per minute
Standard Deviation 9.15
|
1.2 Beats per minute
Standard Deviation 7.96
|
|
Part 1 and Part 2: Change From Baseline (CFB) in Vital Signs: Heart Rate
CFB to Cycle 2 Day 1, WITHIN 15 MINS AFTER EOI
|
-2.2 Beats per minute
Standard Deviation 13.34
|
-3.8 Beats per minute
Standard Deviation 7.67
|
-0.3 Beats per minute
Standard Deviation 7.37
|
-1.0 Beats per minute
Standard Deviation 10.49
|
6.4 Beats per minute
Standard Deviation 8.53
|
|
Part 1 and Part 2: Change From Baseline (CFB) in Vital Signs: Heart Rate
CFB to Cycle 3 Day 1, PRE-INFUSION
|
-12.3 Beats per minute
Standard Deviation 7.85
|
-2.4 Beats per minute
Standard Deviation 11.48
|
7.5 Beats per minute
Standard Deviation 9.19
|
5.3 Beats per minute
Standard Deviation 19.05
|
2.9 Beats per minute
Standard Deviation 9.12
|
|
Part 1 and Part 2: Change From Baseline (CFB) in Vital Signs: Heart Rate
Baseline (Day 1)
|
77.2 Beats per minute
Standard Deviation 14.67
|
74.9 Beats per minute
Standard Deviation 15.34
|
71.8 Beats per minute
Standard Deviation 4.57
|
69.0 Beats per minute
Standard Deviation 11.05
|
67.4 Beats per minute
Standard Deviation 6.78
|
|
Part 1 and Part 2: Change From Baseline (CFB) in Vital Signs: Heart Rate
CFB to Cycle 1 Day 1, 15 MINS AFTER SOI
|
-1.3 Beats per minute
Standard Deviation 3.65
|
-4.0 Beats per minute
Standard Deviation 6.22
|
2.0 Beats per minute
Standard Deviation 2.94
|
1.2 Beats per minute
Standard Deviation 5.45
|
2.3 Beats per minute
Standard Deviation 2.87
|
SECONDARY outcome
Timeframe: Up to approximately 236 weeksPopulation: Safety population
An AE is defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) coding system.
Outcome measures
| Measure |
Part 1: Belantamab Mafodotin 2.5 mg/kg (Normal/Mildly Impaired Renal Function)
n=10 Participants
Participants with Relapsed/Refractory Multiple Myeloma (RRMM) who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and normal/mildly impaired renal function received intravenous (IV) infusion of 2.5 milligram (mg)/kilogram (kg) belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to adverse event (AE), lost to follow-up, death, whichever occurs first.
|
Part 1: Belantamab Mafodotin 2.5 mg/kg (Severely Impaired Renal Function)
n=9 Participants
Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and severe renal impairment renal function received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
|
Part 1: Belantamab Mafodotin 2.5 mg/kg (Other Renal Function)
n=4 Participants
Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and other renal impairment renal function received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
|
Part 2: Belantamab Mafodotin 2.5 mg/kg End Stage Renal Disease (Not on Dialysis)
n=5 Participants
Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and end stage renal disease (ESRD) (not on hemodialysis) received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
|
Part 2: Belantamab Mafodotin 2.5 mg/kg ESRD (On Dialysis)
n=8 Participants
Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and ESRD (on hemodialysis) received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
|
|---|---|---|---|---|---|
|
Part 1 and Part 2: Number of Participants With Adverse Events (AEs)
|
10 Participants
|
9 Participants
|
3 Participants
|
5 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and up to approx. 236 weeksPopulation: Safety population. Only those participants who were measured and analyzed (i.e., contributed to data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified categories.
Blood samples were collected for the analysis of hematology parameters and are categorized in alignment with Common Terminology Criteria for Adverse Events (CTCAE) version 5 as Grade 1: mild; Grade 2: moderate; Grade 3: severe or medically significant; and Grade 4: life-threatening consequences. Higher grade indicates greater severity. An increase in grade was defined relative to the Baseline grade. Participants with missing baseline values are assumed to have baseline value of grade 0. Increase to a maximum grade of 3 and 4 is presented. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Worst Case Post-Baseline includes all scheduled and unscheduled visits post baseline.
Outcome measures
| Measure |
Part 1: Belantamab Mafodotin 2.5 mg/kg (Normal/Mildly Impaired Renal Function)
n=10 Participants
Participants with Relapsed/Refractory Multiple Myeloma (RRMM) who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and normal/mildly impaired renal function received intravenous (IV) infusion of 2.5 milligram (mg)/kilogram (kg) belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to adverse event (AE), lost to follow-up, death, whichever occurs first.
|
Part 1: Belantamab Mafodotin 2.5 mg/kg (Severely Impaired Renal Function)
n=8 Participants
Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and severe renal impairment renal function received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
|
Part 1: Belantamab Mafodotin 2.5 mg/kg (Other Renal Function)
n=3 Participants
Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and other renal impairment renal function received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
|
Part 2: Belantamab Mafodotin 2.5 mg/kg End Stage Renal Disease (Not on Dialysis)
n=5 Participants
Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and end stage renal disease (ESRD) (not on hemodialysis) received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
|
Part 2: Belantamab Mafodotin 2.5 mg/kg ESRD (On Dialysis)
n=7 Participants
Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and ESRD (on hemodialysis) received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
|
|---|---|---|---|---|---|
|
Part 1 and Part 2: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline
Anemia, Increase to Grade 3
|
2 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
3 Participants
|
|
Part 1 and Part 2: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline
Anemia, Increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1 and Part 2: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline
Eosinophilia, Increase to Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1 and Part 2: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline
Eosinophilia, Increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1 and Part 2: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline
Hemoglobin increased, Increase to Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Part 1 and Part 2: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline
Hemoglobin increased, Increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1 and Part 2: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline
Leukocytosis, Increase to Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1 and Part 2: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline
Leukocytosis, Increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1 and Part 2: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline
Lymphocyte count decreased, Increase to Grade 3
|
2 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
|
Part 1 and Part 2: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline
Lymphocyte count decreased, Increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1 and Part 2: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline
Lymphocyte count increased, Increase to Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Part 1 and Part 2: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline
Lymphocyte count increased, Increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1 and Part 2: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline
Neutrophil count decreased, Increase to Grade 3
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1 and Part 2: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline
Neutrophil count decreased, Increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Part 1 and Part 2: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline
Platelet count decreased, Increase to Grade 3
|
2 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Part 1 and Part 2: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline
Platelet count decreased, Increase to Grade 4
|
2 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1 and Part 2: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline
White blood cell decreased, Increase to Grade 3
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Part 1 and Part 2: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline
White blood cell decreased, Increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and up to approx. 236 weeksPopulation: Safety population. Only those participants who were measured and analyzed (i.e., contributed to data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified categories.
Blood samples were collected for the analysis of clinical chemistry parameters and are categorized in alignment with Common Terminology Criteria for Adverse Events (CTCAE) version 5 as Grade 1: mild; Grade 2: moderate; Grade 3: severe or medically significant; and Grade 4: life-threatening consequences. Higher grade indicates greater severity. An increase in grade was defined relative to the Baseline grade. Participants with missing baseline values are assumed to have baseline value of grade 0. Increase to a maximum grade of 3 and 4 is presented. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Worst Case Post-Baseline includes all scheduled and unscheduled visits post baseline.
Outcome measures
| Measure |
Part 1: Belantamab Mafodotin 2.5 mg/kg (Normal/Mildly Impaired Renal Function)
n=10 Participants
Participants with Relapsed/Refractory Multiple Myeloma (RRMM) who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and normal/mildly impaired renal function received intravenous (IV) infusion of 2.5 milligram (mg)/kilogram (kg) belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to adverse event (AE), lost to follow-up, death, whichever occurs first.
|
Part 1: Belantamab Mafodotin 2.5 mg/kg (Severely Impaired Renal Function)
n=9 Participants
Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and severe renal impairment renal function received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
|
Part 1: Belantamab Mafodotin 2.5 mg/kg (Other Renal Function)
n=3 Participants
Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and other renal impairment renal function received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
|
Part 2: Belantamab Mafodotin 2.5 mg/kg End Stage Renal Disease (Not on Dialysis)
n=5 Participants
Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and end stage renal disease (ESRD) (not on hemodialysis) received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
|
Part 2: Belantamab Mafodotin 2.5 mg/kg ESRD (On Dialysis)
n=7 Participants
Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and ESRD (on hemodialysis) received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
|
|---|---|---|---|---|---|
|
Part 1 and Part 2: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline
Hypoglycemia, Increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Part 1 and Part 2: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline
Alanine aminotransferase (ALT) increased, Increase to Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1 and Part 2: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline
ALT increased, Increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1 and Part 2: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline
Alkaline phosphatase (ALP) increased, Increase to Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1 and Part 2: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline
ALP increased, Increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1 and Part 2: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline
Aspartate aminotransferase (AST) increased, Increase to Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1 and Part 2: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline
AST increased, Increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1 and Part 2: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline
Blood bilirubin increased, Increase to Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1 and Part 2: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline
Blood bilirubin increased, Increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1 and Part 2: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline
Blood lactate dehydrogenase increased, Increase to Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1 and Part 2: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline
Blood lactate dehydrogenase increased, Increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1 and Part 2: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline
Creatine kinase (CPK) increased, Increase to Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1 and Part 2: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline
CPK increased, Increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1 and Part 2: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline
Chronic Kidney Disease eGFR, Increase to Grade 3
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1 and Part 2: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline
Chronic Kidney Disease eGFR, Increase to Grade 4
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Part 1 and Part 2: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline
Chronic Kidney Disease iGFR, Increase to Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1 and Part 2: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline
Chronic Kidney Disease iGFR, Increase to Grade 4
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Part 1 and Part 2: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline
Creatinine increased, Increase to Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1 and Part 2: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline
Creatinine increased, Increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1 and Part 2: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline
Gamma-glutamyltransferase (GGT) increased, Increase to Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1 and Part 2: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline
GGT increased, Increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1 and Part 2: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline
Hypercalcemia, Increase to Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1 and Part 2: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline
Hypercalcemia, Increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1 and Part 2: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline
Hyperkalemia, Increase to Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Part 1 and Part 2: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline
Hyperkalemia, Increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1 and Part 2: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline
Hypermagnesemia, Increase to Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1 and Part 2: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline
Hypermagnesemia, Increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1 and Part 2: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline
Hypernatremia, Increase to Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1 and Part 2: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline
Hypernatremia, Increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1 and Part 2: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline
Hypoalbuminemia, Increase to Grade 3
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1 and Part 2: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline
Hypoalbuminemia, Increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1 and Part 2: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline
Hypocalcemia, Increase to Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1 and Part 2: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline
Hypocalcemia, Increase to Grade 4
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1 and Part 2: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline
Hypoglycemia, Increase to Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1 and Part 2: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline
Hypomagnesemia, Increase to Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Part 1 and Part 2: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline
Hypomagnesemia, Increase to Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and up to approx. 236 weeksPopulation: Safety population. Only those participants who were measured and analyzed (i.e., contributed to data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified timepoints. The "0" participants analyzed represents that data was not collected or available for analysis at that particular time point for the respective Arms/Groups.
Physical examination parameter weight was assessed. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Worst Case Post-Baseline includes all scheduled and unscheduled visits post baseline
Outcome measures
| Measure |
Part 1: Belantamab Mafodotin 2.5 mg/kg (Normal/Mildly Impaired Renal Function)
n=10 Participants
Participants with Relapsed/Refractory Multiple Myeloma (RRMM) who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and normal/mildly impaired renal function received intravenous (IV) infusion of 2.5 milligram (mg)/kilogram (kg) belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to adverse event (AE), lost to follow-up, death, whichever occurs first.
|
Part 1: Belantamab Mafodotin 2.5 mg/kg (Severely Impaired Renal Function)
n=9 Participants
Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and severe renal impairment renal function received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
|
Part 1: Belantamab Mafodotin 2.5 mg/kg (Other Renal Function)
n=4 Participants
Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and other renal impairment renal function received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
|
Part 2: Belantamab Mafodotin 2.5 mg/kg End Stage Renal Disease (Not on Dialysis)
n=5 Participants
Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and end stage renal disease (ESRD) (not on hemodialysis) received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
|
Part 2: Belantamab Mafodotin 2.5 mg/kg ESRD (On Dialysis)
n=8 Participants
Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and ESRD (on hemodialysis) received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
|
|---|---|---|---|---|---|
|
Part 1 and Part 2: Change From Baseline (CFB) in Weight
CFB to Cycle 22 Day 1
|
1.00 Kilogram (Kg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
—
|
—
|
—
|
—
|
|
Part 1 and Part 2: Change From Baseline (CFB) in Weight
CFB to Cycle 23 Day 1
|
2.80 Kilogram (Kg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
—
|
—
|
—
|
—
|
|
Part 1 and Part 2: Change From Baseline (CFB) in Weight
CFB to Week 07
|
—
|
2.50 Kilogram (Kg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
—
|
—
|
—
|
|
Part 1 and Part 2: Change From Baseline (CFB) in Weight
CFB to Week 10
|
—
|
0.00 Kilogram (Kg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
—
|
—
|
—
|
|
Part 1 and Part 2: Change From Baseline (CFB) in Weight
CFB to Week 13
|
—
|
-3.00 Kilogram (Kg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
—
|
—
|
—
|
|
Part 1 and Part 2: Change From Baseline (CFB) in Weight
CFB to End of Treatment (Up to 236 weeks)
|
-1.38 Kilogram (Kg)
Standard Deviation 4.886
|
0.47 Kilogram (Kg)
Standard Deviation 2.856
|
0.00 Kilogram (Kg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
-0.80 Kilogram (Kg)
Standard Deviation 1.273
|
—
|
|
Part 1 and Part 2: Change From Baseline (CFB) in Weight
CFB to Cycle 3 Day 1
|
0.38 Kilogram (Kg)
Standard Deviation 0.624
|
0.52 Kilogram (Kg)
Standard Deviation 1.099
|
-0.15 Kilogram (Kg)
Standard Deviation 0.495
|
0.63 Kilogram (Kg)
Standard Deviation 1.040
|
-0.89 Kilogram (Kg)
Standard Deviation 3.302
|
|
Part 1 and Part 2: Change From Baseline (CFB) in Weight
CFB to Cycle 4 Day 1
|
-0.80 Kilogram (Kg)
Standard Deviation 3.863
|
1.10 Kilogram (Kg)
Standard Deviation 0.173
|
-0.75 Kilogram (Kg)
Standard Deviation 1.061
|
1.18 Kilogram (Kg)
Standard Deviation 1.195
|
-0.17 Kilogram (Kg)
Standard Deviation 2.967
|
|
Part 1 and Part 2: Change From Baseline (CFB) in Weight
CFB to Cycle 5 Day 1
|
0.07 Kilogram (Kg)
Standard Deviation 2.663
|
1.60 Kilogram (Kg)
Standard Deviation 0.656
|
0.50 Kilogram (Kg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
1.43 Kilogram (Kg)
Standard Deviation 1.338
|
0.47 Kilogram (Kg)
Standard Deviation 4.575
|
|
Part 1 and Part 2: Change From Baseline (CFB) in Weight
CFB to Cycle 6 Day 1
|
1.33 Kilogram (Kg)
Standard Deviation 3.889
|
1.45 Kilogram (Kg)
Standard Deviation 0.778
|
-0.80 Kilogram (Kg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
1.88 Kilogram (Kg)
Standard Deviation 4.785
|
-2.88 Kilogram (Kg)
Standard Deviation 3.664
|
|
Part 1 and Part 2: Change From Baseline (CFB) in Weight
CFB to Cycle 7 Day 1
|
0.13 Kilogram (Kg)
Standard Deviation 2.695
|
2.15 Kilogram (Kg)
Standard Deviation 0.212
|
-1.20 Kilogram (Kg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
1.95 Kilogram (Kg)
Standard Deviation 1.344
|
-2.20 Kilogram (Kg)
Standard Deviation 2.970
|
|
Part 1 and Part 2: Change From Baseline (CFB) in Weight
CFB to Cycle 8 Day 1
|
0.10 Kilogram (Kg)
Standard Deviation 3.843
|
-0.10 Kilogram (Kg)
Standard Deviation 3.394
|
-1.40 Kilogram (Kg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
3.00 Kilogram (Kg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
0.00 Kilogram (Kg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
|
Part 1 and Part 2: Change From Baseline (CFB) in Weight
CFB to Cycle 9 Day 1
|
5.00 Kilogram (Kg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
2.50 Kilogram (Kg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
-1.50 Kilogram (Kg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
3.50 Kilogram (Kg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
0.20 Kilogram (Kg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
|
Part 1 and Part 2: Change From Baseline (CFB) in Weight
CFB to Cycle 10 Day 1
|
3.30 Kilogram (Kg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
2.60 Kilogram (Kg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
-1.60 Kilogram (Kg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
3.60 Kilogram (Kg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
0.00 Kilogram (Kg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
|
Part 1 and Part 2: Change From Baseline (CFB) in Weight
CFB to Cycle 11 Day 1
|
3.40 Kilogram (Kg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
2.50 Kilogram (Kg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
-1.70 Kilogram (Kg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
3.00 Kilogram (Kg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
-0.40 Kilogram (Kg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
|
Part 1 and Part 2: Change From Baseline (CFB) in Weight
CFB to Cycle 12 Day 1
|
3.30 Kilogram (Kg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
2.30 Kilogram (Kg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
-1.70 Kilogram (Kg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
4.50 Kilogram (Kg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
-0.40 Kilogram (Kg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
|
Part 1 and Part 2: Change From Baseline (CFB) in Weight
CFB to Cycle 13 Day 1
|
2.90 Kilogram (Kg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
2.40 Kilogram (Kg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
-1.80 Kilogram (Kg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
4.80 Kilogram (Kg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
-0.40 Kilogram (Kg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
|
Part 1 and Part 2: Change From Baseline (CFB) in Weight
CFB to Cycle 14 Day 1
|
5.50 Kilogram (Kg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
2.50 Kilogram (Kg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
-1.60 Kilogram (Kg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
3.00 Kilogram (Kg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
-0.70 Kilogram (Kg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
|
Part 1 and Part 2: Change From Baseline (CFB) in Weight
CFB to Cycle 15 Day 1
|
6.50 Kilogram (Kg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
2.40 Kilogram (Kg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
-1.40 Kilogram (Kg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
2.00 Kilogram (Kg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
0.00 Kilogram (Kg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
|
Part 1 and Part 2: Change From Baseline (CFB) in Weight
CFB to Cycle 16 Day 1
|
4.80 Kilogram (Kg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
2.70 Kilogram (Kg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
-1.50 Kilogram (Kg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
1.30 Kilogram (Kg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
0.20 Kilogram (Kg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
|
Part 1 and Part 2: Change From Baseline (CFB) in Weight
CFB to Cycle 17 Day 1
|
3.00 Kilogram (Kg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
2.10 Kilogram (Kg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
-1.60 Kilogram (Kg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
1.60 Kilogram (Kg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
-0.20 Kilogram (Kg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
|
Part 1 and Part 2: Change From Baseline (CFB) in Weight
CFB to Cycle 18 Day 1
|
2.00 Kilogram (Kg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
2.00 Kilogram (Kg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
-1.80 Kilogram (Kg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
1.00 Kilogram (Kg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
0.30 Kilogram (Kg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
|
Part 1 and Part 2: Change From Baseline (CFB) in Weight
CFB to Cycle 19 Day 1
|
1.60 Kilogram (Kg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
2.30 Kilogram (Kg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
-1.70 Kilogram (Kg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
0.70 Kilogram (Kg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
—
|
|
Part 1 and Part 2: Change From Baseline (CFB) in Weight
CFB to Cycle 20 Day 1
|
0.70 Kilogram (Kg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
—
|
—
|
0.90 Kilogram (Kg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
—
|
|
Part 1 and Part 2: Change From Baseline (CFB) in Weight
CFB to Cycle 21 Day 1
|
1.00 Kilogram (Kg)
Standard Deviation NA
Standard Deviation is not evaluable as only a single participant was analyzed.
|
—
|
—
|
—
|
—
|
|
Part 1 and Part 2: Change From Baseline (CFB) in Weight
Baseline (Day 1)
|
73.44 Kilogram (Kg)
Standard Deviation 19.619
|
68.92 Kilogram (Kg)
Standard Deviation 12.143
|
84.03 Kilogram (Kg)
Standard Deviation 28.349
|
61.34 Kilogram (Kg)
Standard Deviation 15.536
|
68.41 Kilogram (Kg)
Standard Deviation 20.296
|
|
Part 1 and Part 2: Change From Baseline (CFB) in Weight
CFB to Cycle 2 Day 1
|
0.51 Kilogram (Kg)
Standard Deviation 2.750
|
0.34 Kilogram (Kg)
Standard Deviation 0.870
|
-0.43 Kilogram (Kg)
Standard Deviation 0.929
|
-0.22 Kilogram (Kg)
Standard Deviation 1.794
|
0.17 Kilogram (Kg)
Standard Deviation 0.695
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and up to approx. 236 weeksPopulation: Safety population. Only those participants who were measured and analyzed (i.e., contributed to data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified categories. The "0" participants analyzed represents that data was not collected or available for analysis at that particular time point for the respective Arms/Groups.
Urine samples were collected to assess occult blood and protein in urine by dipstick method. Data is presented as "No Change/Decreased" and "Any Increase" that includes Increase to TRACE, Increase to 1+, Increase to 2+ and Increase to 3+ indicating proportional concentrations in the urine sample. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Worst Case Post-Baseline includes all scheduled and unscheduled visits post baseline.
Outcome measures
| Measure |
Part 1: Belantamab Mafodotin 2.5 mg/kg (Normal/Mildly Impaired Renal Function)
n=5 Participants
Participants with Relapsed/Refractory Multiple Myeloma (RRMM) who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and normal/mildly impaired renal function received intravenous (IV) infusion of 2.5 milligram (mg)/kilogram (kg) belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to adverse event (AE), lost to follow-up, death, whichever occurs first.
|
Part 1: Belantamab Mafodotin 2.5 mg/kg (Severely Impaired Renal Function)
n=8 Participants
Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and severe renal impairment renal function received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
|
Part 1: Belantamab Mafodotin 2.5 mg/kg (Other Renal Function)
n=2 Participants
Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and other renal impairment renal function received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
|
Part 2: Belantamab Mafodotin 2.5 mg/kg End Stage Renal Disease (Not on Dialysis)
n=5 Participants
Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and end stage renal disease (ESRD) (not on hemodialysis) received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
|
Part 2: Belantamab Mafodotin 2.5 mg/kg ESRD (On Dialysis)
n=2 Participants
Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and ESRD (on hemodialysis) received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
|
|---|---|---|---|---|---|
|
Part 1 and Part 2: Number of Participants With Worst Case Urinalysis Results Post-Baseline Relative to Baseline
Occult Blood · No Change/Decreased
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1 and Part 2: Number of Participants With Worst Case Urinalysis Results Post-Baseline Relative to Baseline
Occult Blood · Any Increase
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1 and Part 2: Number of Participants With Worst Case Urinalysis Results Post-Baseline Relative to Baseline
Protein · No Change/Decreased
|
3 Participants
|
5 Participants
|
2 Participants
|
4 Participants
|
2 Participants
|
|
Part 1 and Part 2: Number of Participants With Worst Case Urinalysis Results Post-Baseline Relative to Baseline
Protein · Any Increase
|
2 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
Adverse Events
Part 1: Belantamab Mafodotin 2.5 mg/kg (Normal/Mildly Impaired Renal Function)
Serious events: 4 serious events
Other events: 10 other events
Deaths: 2 deaths
Part 1: Belantamab Mafodotin 2.5 mg/kg (Severely Impaired Renal Function)
Serious events: 4 serious events
Other events: 9 other events
Deaths: 3 deaths
Part 1: Belantamab Mafodotin 2.5 mg/kg (Other Renal Function)
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
Part 2: Belantamab Mafodotin 2.5 mg/kg End Stage Renal Disease (Not on Dialysis)
Serious events: 3 serious events
Other events: 5 other events
Deaths: 1 deaths
Part 2: Belantamab Mafodotin 2.5 mg/kg ESRD (On Dialysis)
Serious events: 4 serious events
Other events: 8 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Part 1: Belantamab Mafodotin 2.5 mg/kg (Normal/Mildly Impaired Renal Function)
n=10 participants at risk
Participants with Relapsed/Refractory Multiple Myeloma (RRMM) who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and normal/mildly impaired renal function received intravenous (IV) infusion of 2.5 milligram (mg)/kilogram (kg) belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to adverse event (AE), lost to follow-up, death, whichever occurs first.
|
Part 1: Belantamab Mafodotin 2.5 mg/kg (Severely Impaired Renal Function)
n=9 participants at risk
Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and severe renal impairment renal function received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
|
Part 1: Belantamab Mafodotin 2.5 mg/kg (Other Renal Function)
n=4 participants at risk
Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and other renal impairment renal function received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
|
Part 2: Belantamab Mafodotin 2.5 mg/kg End Stage Renal Disease (Not on Dialysis)
n=5 participants at risk
Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and end stage renal disease (ESRD) (not on hemodialysis) received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
|
Part 2: Belantamab Mafodotin 2.5 mg/kg ESRD (On Dialysis)
n=8 participants at risk
Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and ESRD (on hemodialysis) received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
|
|---|---|---|---|---|---|
|
Infections and infestations
COVID-19 pneumonia
|
10.0%
1/10 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
11.1%
1/9 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/8 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
11.1%
1/9 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
20.0%
1/5 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
25.0%
2/8 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
|
Infections and infestations
Atypical pneumonia
|
10.0%
1/10 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/8 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
|
Infections and infestations
COVID-19
|
10.0%
1/10 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
20.0%
1/5 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/8 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
|
Infections and infestations
Enterobacter sepsis
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
12.5%
1/8 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
|
Infections and infestations
Metapneumovirus pneumonia
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
12.5%
1/8 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
|
Infections and infestations
Septic shock
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
12.5%
1/8 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
22.2%
2/9 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/8 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
11.1%
1/9 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
25.0%
1/4 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/8 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
11.1%
1/9 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/8 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
|
Gastrointestinal disorders
Intestinal ischaemia
|
10.0%
1/10 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/8 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
12.5%
1/8 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
11.1%
1/9 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/8 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
|
General disorders
Asthenia
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
12.5%
1/8 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
|
General disorders
Sudden death
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
20.0%
1/5 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/8 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula occlusion
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
12.5%
1/8 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
25.0%
1/4 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/8 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
25.0%
1/4 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/8 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
20.0%
1/5 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/8 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
20.0%
1/5 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/8 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Plasma cell myeloma
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
12.5%
1/8 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
11.1%
1/9 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/8 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
11.1%
1/9 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/8 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
|
Hepatobiliary disorders
Hypertransaminasaemia
|
10.0%
1/10 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/8 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
|
Investigations
SARS-CoV-2 test positive
|
10.0%
1/10 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/8 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
|
Metabolism and nutrition disorders
Lactic acidosis
|
10.0%
1/10 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/8 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
20.0%
1/5 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/8 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
11.1%
1/9 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/8 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
Other adverse events
| Measure |
Part 1: Belantamab Mafodotin 2.5 mg/kg (Normal/Mildly Impaired Renal Function)
n=10 participants at risk
Participants with Relapsed/Refractory Multiple Myeloma (RRMM) who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and normal/mildly impaired renal function received intravenous (IV) infusion of 2.5 milligram (mg)/kilogram (kg) belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to adverse event (AE), lost to follow-up, death, whichever occurs first.
|
Part 1: Belantamab Mafodotin 2.5 mg/kg (Severely Impaired Renal Function)
n=9 participants at risk
Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and severe renal impairment renal function received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
|
Part 1: Belantamab Mafodotin 2.5 mg/kg (Other Renal Function)
n=4 participants at risk
Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and other renal impairment renal function received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
|
Part 2: Belantamab Mafodotin 2.5 mg/kg End Stage Renal Disease (Not on Dialysis)
n=5 participants at risk
Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and end stage renal disease (ESRD) (not on hemodialysis) received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
|
Part 2: Belantamab Mafodotin 2.5 mg/kg ESRD (On Dialysis)
n=8 participants at risk
Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and ESRD (on hemodialysis) received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
20.0%
2/10 • Number of events 4 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
25.0%
1/4 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/8 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
|
Gastrointestinal disorders
Oral pain
|
10.0%
1/10 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/8 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
|
Eye disorders
Vision blurred
|
60.0%
6/10 • Number of events 25 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
55.6%
5/9 • Number of events 16 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
25.0%
1/4 • Number of events 6 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
60.0%
3/5 • Number of events 6 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
37.5%
3/8 • Number of events 8 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
|
Eye disorders
Dry eye
|
50.0%
5/10 • Number of events 20 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
44.4%
4/9 • Number of events 8 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
50.0%
2/4 • Number of events 10 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
50.0%
4/8 • Number of events 9 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
|
Eye disorders
Eye irritation
|
50.0%
5/10 • Number of events 19 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
33.3%
3/9 • Number of events 8 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
25.0%
1/4 • Number of events 6 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
20.0%
1/5 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
37.5%
3/8 • Number of events 6 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
|
Eye disorders
Photophobia
|
30.0%
3/10 • Number of events 14 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
33.3%
3/9 • Number of events 6 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
25.0%
1/4 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
20.0%
1/5 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
25.0%
2/8 • Number of events 4 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
|
Eye disorders
Foreign body sensation in eyes
|
50.0%
5/10 • Number of events 26 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
22.2%
2/9 • Number of events 4 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
25.0%
1/4 • Number of events 9 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
20.0%
1/5 • Number of events 3 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
25.0%
2/8 • Number of events 3 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
|
Eye disorders
Cataract
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
11.1%
1/9 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/8 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
|
Eye disorders
Eye pain
|
40.0%
4/10 • Number of events 19 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
11.1%
1/9 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
20.0%
1/5 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
12.5%
1/8 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
|
Eye disorders
Blepharitis
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
25.0%
1/4 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/8 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
|
Eye disorders
Cataract cortical
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
12.5%
1/8 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
|
Eye disorders
Cataract nuclear
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
20.0%
1/5 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
25.0%
2/8 • Number of events 4 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
|
Eye disorders
Cataract subcapsular
|
10.0%
1/10 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
25.0%
1/4 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
12.5%
1/8 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
|
Eye disorders
Diplopia
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
12.5%
1/8 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
|
Eye disorders
Dry age-related macular degeneration
|
10.0%
1/10 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/8 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
|
Eye disorders
Lacrimation increased
|
10.0%
1/10 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/8 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
|
Eye disorders
Ocular discomfort
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
25.0%
1/4 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/8 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
|
Eye disorders
Posterior capsule opacification
|
20.0%
2/10 • Number of events 3 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
20.0%
1/5 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/8 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
|
Eye disorders
Retinal haemorrhage
|
10.0%
1/10 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/8 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
|
Eye disorders
Visual acuity reduced
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
20.0%
1/5 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
12.5%
1/8 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
|
Eye disorders
Visual impairment
|
30.0%
3/10 • Number of events 5 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
12.5%
1/8 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
|
Eye disorders
Vitreous detachment
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
25.0%
1/4 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/8 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
|
Eye disorders
Vitreous floaters
|
10.0%
1/10 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/8 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
20.0%
2/10 • Number of events 51 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
33.3%
3/9 • Number of events 12 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
20.0%
1/5 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
25.0%
2/8 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
|
Blood and lymphatic system disorders
Anaemia
|
40.0%
4/10 • Number of events 4 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
11.1%
1/9 • Number of events 4 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
25.0%
1/4 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
40.0%
2/5 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
25.0%
2/8 • Number of events 3 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
25.0%
1/4 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/8 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
25.0%
1/4 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/8 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
|
General disorders
Fatigue
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
11.1%
1/9 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
25.0%
1/4 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
37.5%
3/8 • Number of events 3 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
|
General disorders
Pyrexia
|
20.0%
2/10 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
11.1%
1/9 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
25.0%
1/4 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
80.0%
4/5 • Number of events 10 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
25.0%
2/8 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
|
General disorders
Asthenia
|
10.0%
1/10 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
25.0%
1/4 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
12.5%
1/8 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
|
General disorders
Chills
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
50.0%
2/4 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/8 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
|
General disorders
Mass
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
12.5%
1/8 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
|
General disorders
Oedema peripheral
|
20.0%
2/10 • Number of events 3 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
25.0%
1/4 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
12.5%
1/8 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
|
General disorders
Pain
|
10.0%
1/10 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/8 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
|
General disorders
Peripheral swelling
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
12.5%
1/8 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
10.0%
1/10 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
11.1%
1/9 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/8 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
|
Gastrointestinal disorders
Anal fissure
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
11.1%
1/9 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/8 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
|
Gastrointestinal disorders
Diarrhoea
|
10.0%
1/10 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
11.1%
1/9 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
20.0%
1/5 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
37.5%
3/8 • Number of events 3 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
12.5%
1/8 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
12.5%
1/8 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
20.0%
1/5 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/8 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
|
Gastrointestinal disorders
Constipation
|
10.0%
1/10 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
20.0%
1/5 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
12.5%
1/8 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
10.0%
1/10 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/8 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
|
Gastrointestinal disorders
Gingival bleeding
|
10.0%
1/10 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
20.0%
1/5 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/8 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
|
Gastrointestinal disorders
Vomiting
|
10.0%
1/10 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
25.0%
1/4 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
25.0%
2/8 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
|
Infections and infestations
COVID-19
|
20.0%
2/10 • Number of events 3 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
11.1%
1/9 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
12.5%
1/8 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
11.1%
1/9 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/8 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
12.5%
1/8 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
|
Infections and infestations
Bacterial infection
|
10.0%
1/10 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/8 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
|
Infections and infestations
Cryptococcosis
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
12.5%
1/8 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
|
Infections and infestations
Fungal skin infection
|
10.0%
1/10 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/8 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
|
Infections and infestations
Hepatitis B reactivation
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
20.0%
1/5 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
12.5%
1/8 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
|
Infections and infestations
Herpes simplex reactivation
|
10.0%
1/10 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/8 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
|
Infections and infestations
Oral herpes
|
10.0%
1/10 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/8 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
|
Infections and infestations
Parainfluenzae virus infection
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
12.5%
1/8 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
|
Infections and infestations
Periodontitis
|
10.0%
1/10 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/8 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
20.0%
1/5 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
12.5%
1/8 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
|
Infections and infestations
Pneumonia aspiration
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
12.5%
1/8 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
|
Infections and infestations
Purulent discharge
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
25.0%
1/4 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/8 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
12.5%
1/8 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
20.0%
1/5 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/8 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
|
Infections and infestations
Urinary tract infection
|
10.0%
1/10 • Number of events 4 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
25.0%
1/4 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
12.5%
1/8 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
20.0%
2/10 • Number of events 3 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
22.2%
2/9 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
25.0%
1/4 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
20.0%
1/5 • Number of events 3 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/8 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
11.1%
1/9 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/8 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
11.1%
1/9 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
20.0%
1/5 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/8 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
|
Metabolism and nutrition disorders
Tumour lysis syndrome
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
11.1%
1/9 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/8 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
10.0%
1/10 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
12.5%
1/8 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
|
Metabolism and nutrition disorders
Dyslipidaemia
|
10.0%
1/10 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/8 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
10.0%
1/10 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
50.0%
2/4 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/8 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
12.5%
1/8 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
10.0%
1/10 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
12.5%
1/8 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
25.0%
1/4 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/8 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
11.1%
1/9 • Number of events 3 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
20.0%
1/5 • Number of events 3 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
12.5%
1/8 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
10.0%
1/10 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
11.1%
1/9 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/8 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis chronic
|
10.0%
1/10 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/8 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
10.0%
1/10 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/8 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
20.0%
2/10 • Number of events 3 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
12.5%
1/8 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
12.5%
1/8 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
20.0%
1/5 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/8 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis aspiration
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
12.5%
1/8 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinalgia
|
10.0%
1/10 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/8 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
10.0%
1/10 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
20.0%
1/5 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/8 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
|
Investigations
Amylase increased
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
11.1%
1/9 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/8 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
|
Investigations
Alanine aminotransferase increased
|
10.0%
1/10 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
40.0%
2/5 • Number of events 3 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
12.5%
1/8 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
|
Investigations
Aspartate aminotransferase increased
|
10.0%
1/10 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
40.0%
2/5 • Number of events 3 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
12.5%
1/8 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
12.5%
1/8 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
|
Investigations
Blood potassium decreased
|
10.0%
1/10 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/8 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
|
Investigations
Blood urea increased
|
10.0%
1/10 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/8 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
|
Investigations
Candida test positive
|
10.0%
1/10 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/8 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
|
Investigations
Gamma-glutamyltransferase increased
|
10.0%
1/10 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/8 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
|
Investigations
Hepatic enzyme increased
|
10.0%
1/10 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/8 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
12.5%
1/8 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
|
Investigations
Neutrophil count decreased
|
10.0%
1/10 • Number of events 3 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
12.5%
1/8 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
|
Investigations
Platelet count decreased
|
10.0%
1/10 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
20.0%
1/5 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
25.0%
2/8 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
|
Investigations
White blood cell count decreased
|
20.0%
2/10 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/8 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
10.0%
1/10 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
11.1%
1/9 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
12.5%
1/8 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
20.0%
2/10 • Number of events 3 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
11.1%
1/9 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/8 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
12.5%
1/8 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
40.0%
2/5 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/8 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
|
Musculoskeletal and connective tissue disorders
Muscle tightness
|
10.0%
1/10 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/8 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
10.0%
1/10 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/8 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
10.0%
1/10 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/8 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
11.1%
1/9 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/8 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
|
Nervous system disorders
Sciatica
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
11.1%
1/9 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
12.5%
1/8 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
|
Nervous system disorders
Uraemic encephalopathy
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
11.1%
1/9 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/8 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
|
Nervous system disorders
Dizziness
|
10.0%
1/10 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/8 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
|
Nervous system disorders
Dysgeusia
|
10.0%
1/10 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/8 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
|
Nervous system disorders
Headache
|
20.0%
2/10 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/8 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
|
Nervous system disorders
Paraesthesia
|
10.0%
1/10 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/8 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
11.1%
1/9 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/8 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula site haemorrhage
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
12.5%
1/8 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
20.0%
1/5 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/8 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
20.0%
1/5 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/8 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
20.0%
1/5 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/8 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
10.0%
1/10 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/8 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
20.0%
1/5 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/8 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
12.5%
1/8 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
11.1%
1/9 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/8 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
|
Renal and urinary disorders
Acute kidney injury
|
10.0%
1/10 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
25.0%
1/4 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/8 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
|
Renal and urinary disorders
Albuminuria
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
20.0%
1/5 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/8 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
|
Renal and urinary disorders
Haematuria
|
10.0%
1/10 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
25.0%
1/4 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/8 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
|
Renal and urinary disorders
Hydronephrosis
|
10.0%
1/10 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/8 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
|
Vascular disorders
Hypertension
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
11.1%
1/9 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
25.0%
1/4 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
20.0%
1/5 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/8 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
|
Vascular disorders
Hypotension
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
11.1%
1/9 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
12.5%
1/8 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
25.0%
2/8 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
12.5%
1/8 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
|
Ear and labyrinth disorders
Cerumen impaction
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
11.1%
1/9 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/8 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
|
Hepatobiliary disorders
Hepatic failure
|
0.00%
0/10 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
12.5%
1/8 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
|
Immune system disorders
Hypogammaglobulinaemia
|
10.0%
1/10 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/8 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
|
Skin and subcutaneous tissue disorders
Nail deformation
|
10.0%
1/10 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/8 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
10.0%
1/10 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/9 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/5 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
0.00%
0/8 • All-cause mortality, non-serious adverse events (non-SAEs) and SAEs were collected up to approximately 236 weeks. The results presented are based on the data cut-off date of 21 April 2025. Additional safety results will be provided within one year of study completion.
Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER