Trial Outcomes & Findings for A Study of Belantamab Mafodotin to Investigate Safety, Tolerability, Pharmacokinetics, Immunogenicity and Clinical Activity in Participants With Relapsed/Refractory Multiple Myeloma (RRMM) (NCT NCT04177823)
NCT ID: NCT04177823
Last Updated: 2025-03-20
Results Overview
An AE is 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.
COMPLETED
PHASE1
6 participants
Up to 24 months and 21 days
2025-03-20
Participant Flow
Participants were not randomized to 3.4 mg/kg dose or de-escalated to the 1.9 mg/kg dose
Participant milestones
| Measure |
Belantamab Mafodotin
Participants with relapsed/refractory multiple myeloma (RRMM) were administered with 2.5 milligram per kilogram (mg/kg) belantamab mafodotin intravenous (IV) infusion over 30-60 minutes on day 1 of each 21-days cycle. Participants were treated until disease progression, intolerable toxicity, end of study or informed consent withdrawal.
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Overall Study
STARTED
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6
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Overall Study
COMPLETED
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4
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Overall Study
NOT COMPLETED
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2
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Reasons for withdrawal
| Measure |
Belantamab Mafodotin
Participants with relapsed/refractory multiple myeloma (RRMM) were administered with 2.5 milligram per kilogram (mg/kg) belantamab mafodotin intravenous (IV) infusion over 30-60 minutes on day 1 of each 21-days cycle. Participants were treated until disease progression, intolerable toxicity, end of study or informed consent withdrawal.
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Overall Study
Physician Decision
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1
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Overall Study
Withdrawal by Subject
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1
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Baseline Characteristics
A Study of Belantamab Mafodotin to Investigate Safety, Tolerability, Pharmacokinetics, Immunogenicity and Clinical Activity in Participants With Relapsed/Refractory Multiple Myeloma (RRMM)
Baseline characteristics by cohort
| Measure |
Belantamab Mafodotin
n=6 Participants
Participants with relapsed/refractory multiple myeloma (RRMM) were administered with 2.5 milligram per kilogram (mg/kg) belantamab mafodotin intravenous (IV) infusion over 30-60 minutes on day 1 of each 21-days cycle. Participants were treated until disease progression, intolerable toxicity, end of study or informed consent withdrawal.
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Age, Continuous
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66.5 Years
STANDARD_DEVIATION 8.83 • n=99 Participants
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Sex: Female, Male
Female
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1 Participants
n=99 Participants
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Sex: Female, Male
Male
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5 Participants
n=99 Participants
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Race/Ethnicity, Customized
Hispanic or Latino
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0 Participants
n=99 Participants
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Race/Ethnicity, Customized
Not Hispanic or Latino
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6 Participants
n=99 Participants
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PRIMARY outcome
Timeframe: Up to 24 months and 21 daysPopulation: All treated population included all eligible participants who received at least 1 dose of study treatment.
An AE is 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.
Outcome measures
| Measure |
Belantamab Mafodotin
n=6 Participants
Participants with relapsed/refractory multiple myeloma (RRMM) were administered with 2.5 milligram per kilogram (mg/kg) belantamab mafodotin intravenous (IV) infusion over 30-60 minutes on day 1 of each 21-days cycle. Participants were treated until disease progression, intolerable toxicity, end of study or informed consent withdrawal.
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Number of Participants With Adverse Events (AEs)
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6 Participants
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PRIMARY outcome
Timeframe: Up to 24 months and 21 daysPopulation: All treated population
An SAE is defined as any untoward medical occurrence that, at any dose: results in death; is life threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; is a congenital anomaly/birth defect; important medical events that may jeopardize the participant or may require medical or surgical intervention; is associated with liver injury and impaired liver function.
Outcome measures
| Measure |
Belantamab Mafodotin
n=6 Participants
Participants with relapsed/refractory multiple myeloma (RRMM) were administered with 2.5 milligram per kilogram (mg/kg) belantamab mafodotin intravenous (IV) infusion over 30-60 minutes on day 1 of each 21-days cycle. Participants were treated until disease progression, intolerable toxicity, end of study or informed consent withdrawal.
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Number of Participants With Serious Adverse Events (SAEs)
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1 Participants
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PRIMARY outcome
Timeframe: Day 1 to day 21 of cycle 1Population: DLT evaluable population included all the eligible participants who have received the 1st dose as planned and experienced a DLT during the cycle 1 or completed the cycle 1.
An event was considered DLT if it occurred within 21 days of treatment and met any of the following criteria within same period: * Any Grade (Gr.) 3 or greater non-hematologic toxicity as described in NCI-CTCAE Version 5.0, other than corneal events that persists for \>48 hours despite supportive treatment or leads to hospitalization. * Hematologic toxicity such as Gr. 3 or greater febrile neutropenia lasting \>48 hours despite adequate treatment (Gr. 3 defined as absolute neutrophil count (ANC) \<1000/millimeter cube (mm\^3) at a single temperature \>38.3 degree celsius or a sustained temperature \>=38 degree celsius for more than 1 hour) and, Gr. 4 thrombocytopenia defined as platelet count \<25000/mm\^3 with clinically significant bleeding, or if platelet transfusion is required. * Gr. 4 per the corneal grading scale. * Liver toxicity meeting pre-specified by GSK liver stopping criteria.
Outcome measures
| Measure |
Belantamab Mafodotin
n=6 Participants
Participants with relapsed/refractory multiple myeloma (RRMM) were administered with 2.5 milligram per kilogram (mg/kg) belantamab mafodotin intravenous (IV) infusion over 30-60 minutes on day 1 of each 21-days cycle. Participants were treated until disease progression, intolerable toxicity, end of study or informed consent withdrawal.
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Number of Participants With Dose Limited Toxicities (DLTs)
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1 Participants
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SECONDARY outcome
Timeframe: Pre-dose (within 30 minutes prior to start of infusion), end of infusion (EOI), 2, 4, 8 and 24 hours post start of infusion (HPS) on day 1, anytime on day 2, 4, 8, 15 and 22 of cycle 1 (each cycle is of 21 days)Population: Pharmacokinetic (PK) population, was defined as those participants in the "All treated" population from whom at least one PK sample was obtained, analyzed, and was measurable.
Blood samples were collected at indicated time points for pharmacokinetic analysis of belantamab mafodotin. PK parameters were analyzed using standard non-compartmental analysis. AUC\[0-t\] was calculated using the linear trapezoidal rule for each incremental trapezoid and the log trapezoidal rule for each decremental trapezoid.
Outcome measures
| Measure |
Belantamab Mafodotin
n=6 Participants
Participants with relapsed/refractory multiple myeloma (RRMM) were administered with 2.5 milligram per kilogram (mg/kg) belantamab mafodotin intravenous (IV) infusion over 30-60 minutes on day 1 of each 21-days cycle. Participants were treated until disease progression, intolerable toxicity, end of study or informed consent withdrawal.
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Area Under the Plasma Concentration-time Curve From Time Zero to Time of the Last Quantifiable Concentration (AUC[0-t]) of Belantamab Mafodotin Antibody-drug Conjugate (ADC)
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2819.39 Hours*microgram per milliliter (h*ug/mL)
Geometric Coefficient of Variation 30.32
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SECONDARY outcome
Timeframe: Pre-dose (within 30 minutes prior to start of infusion), end of infusion (EOI), 2, 4, 8 and 24 hours post start of infusion (HPS) on day 1, anytime on day 2, 4, 8, 15 and 22 of cycle 1 (each cycle is of 21 days)Population: Pharmacokinetic (PK) population
Blood samples were collected at indicated time points for pharmacokinetic analysis of belantamab mafodotin. PK parameters were analyzed using standard non-compartmental analysis. AUC\[0-t\] was calculated using the linear trapezoidal rule for each incremental trapezoid and the log trapezoidal rule for each decremental trapezoid.
Outcome measures
| Measure |
Belantamab Mafodotin
n=6 Participants
Participants with relapsed/refractory multiple myeloma (RRMM) were administered with 2.5 milligram per kilogram (mg/kg) belantamab mafodotin intravenous (IV) infusion over 30-60 minutes on day 1 of each 21-days cycle. Participants were treated until disease progression, intolerable toxicity, end of study or informed consent withdrawal.
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AUC[0-t] of Belantamab Mafodotin Total Antibody
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5407.64 h*ug/mL
Geometric Coefficient of Variation 33.03
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SECONDARY outcome
Timeframe: Pre-dose (within 30 minutes prior to start of infusion), end of infusion (EOI), 2, 4, 8 and 24 hours post start of infusion (HPS) on Day 1, anytime on Day 2, 4, 8, 15 and 22 of Cycle 1 (each cycle is of 21 days)Population: Pharmacokinetic (PK) population
Blood samples were collected at indicated time points for pharmacokinetic analysis of belantamab mafodotin. PK parameters were analyzed using standard non-compartmental analysis. AUC\[0-t\] was calculated using the linear trapezoidal rule for each incremental trapezoid and the log trapezoidal rule for each decremental trapezoid.
Outcome measures
| Measure |
Belantamab Mafodotin
n=6 Participants
Participants with relapsed/refractory multiple myeloma (RRMM) were administered with 2.5 milligram per kilogram (mg/kg) belantamab mafodotin intravenous (IV) infusion over 30-60 minutes on day 1 of each 21-days cycle. Participants were treated until disease progression, intolerable toxicity, end of study or informed consent withdrawal.
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AUC[0-t] of Belantamab Mafodotin Cys- Monomethyl Auristatin-F (Cys-mcMMAF)
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136.17 Hours*nanograms per milliliter (h*ng/mL)
Geometric Coefficient of Variation 48.66
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SECONDARY outcome
Timeframe: Pre-dose (within 30 minutes prior to start of infusion), end of infusion (EOI), 2, 4, 8 and 24 hours post start of infusion (HPS) on Day 1, anytime on Day 2, 4, 8, 15 and 22 of Cycle 1 (each cycle is of 21 days)Population: Pharmacokinetic (PK) population
Blood samples were collected at indicated time points for pharmacokinetic analysis of belantamab mafodotin. PK parameters were analyzed using standard non-compartmental analysis.
Outcome measures
| Measure |
Belantamab Mafodotin
n=6 Participants
Participants with relapsed/refractory multiple myeloma (RRMM) were administered with 2.5 milligram per kilogram (mg/kg) belantamab mafodotin intravenous (IV) infusion over 30-60 minutes on day 1 of each 21-days cycle. Participants were treated until disease progression, intolerable toxicity, end of study or informed consent withdrawal.
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Area Under the Concentration-time Curve During the Dosing Interval (AUC[0-tau]) of Belantamab Mafodotin Antibody-drug Conjugate (ADC)
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2853.73 h*ug/mL
Geometric Coefficient of Variation 28.81
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SECONDARY outcome
Timeframe: Pre-dose (within 30 minutes prior to start of infusion), end of infusion (EOI), 2, 4, 8 and 24 hours post start of infusion (HPS) on day 1, anytime on day 2, 4, 8, 15 and 22 of cycle 1 (each cycle is of 21 days)Population: Pharmacokinetic (PK) population. Only those participants with data available at specified time points were analyzed.
Blood samples were collected at indicated time points for pharmacokinetic analysis of belantamab mafodotin. PK parameters were analyzed using standard non-compartmental analysis.
Outcome measures
| Measure |
Belantamab Mafodotin
n=5 Participants
Participants with relapsed/refractory multiple myeloma (RRMM) were administered with 2.5 milligram per kilogram (mg/kg) belantamab mafodotin intravenous (IV) infusion over 30-60 minutes on day 1 of each 21-days cycle. Participants were treated until disease progression, intolerable toxicity, end of study or informed consent withdrawal.
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AUC[0-tau] of Belantamab Mafodotin Total Antibody
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4823.61 h*ug/mL
Geometric Coefficient of Variation 20.56
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SECONDARY outcome
Timeframe: Up to 168 hoursPopulation: Pharmacokinetic (PK) population. Only those participants with data available at specified time points were analyzed.
Blood samples were collected at indicated time points for pharmacokinetic analysis of belantamab mafodotin. PK parameters were analyzed using standard non-compartmental analysis.
Outcome measures
| Measure |
Belantamab Mafodotin
n=4 Participants
Participants with relapsed/refractory multiple myeloma (RRMM) were administered with 2.5 milligram per kilogram (mg/kg) belantamab mafodotin intravenous (IV) infusion over 30-60 minutes on day 1 of each 21-days cycle. Participants were treated until disease progression, intolerable toxicity, end of study or informed consent withdrawal.
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Area Under the Concentration-time Curve From Time 0 to 168h (AUC[0-168]) of Belantamab Mafodotin Cys- Monomethyl Auristatin-F (Cys-mcMMAF)
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133.94 h*ng/mL
Geometric Coefficient of Variation 53.14
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SECONDARY outcome
Timeframe: Pre-dose (within 30 minutes prior to start of infusion), end of infusion (EOI), 2, 4, 8 and 24 hours post start of infusion (HPS) on day 1, anytime on day 2, 4, 8, 15 and 22 of cycle 1 (each cycle is of 21 days)Population: Pharmacokinetic (PK) population. Only those participants with data available at specified time points were analyzed.
Blood samples were collected at indicated time points for pharmacokinetic analysis of belantamab mafodotin. PK parameters were analyzed using standard non-compartmental analysis.
Outcome measures
| Measure |
Belantamab Mafodotin
n=5 Participants
Participants with relapsed/refractory multiple myeloma (RRMM) were administered with 2.5 milligram per kilogram (mg/kg) belantamab mafodotin intravenous (IV) infusion over 30-60 minutes on day 1 of each 21-days cycle. Participants were treated until disease progression, intolerable toxicity, end of study or informed consent withdrawal.
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Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinity (AUC[0-infinity]) of Belantamab Mafodotin Antibody-drug Conjugate (ADC)
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3000.34 h*ug/mL
Geometric Coefficient of Variation 35.32
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SECONDARY outcome
Timeframe: Pre-dose (within 30 minutes prior to start of infusion), end of infusion (EOI), 2, 4, 8 and 24 hours post start of infusion (HPS) on day 1, anytime on day 2, 4, 8, 15 and 22 of cycle 1 (each cycle is of 21 days)Population: Pharmacokinetic (PK) population. Only those participants with data available at specified time points were analyzed.
Blood samples were collected at indicated time points for pharmacokinetic analysis of belantamab mafodotin. PK parameters were analyzed using standard non-compartmental analysis.
Outcome measures
| Measure |
Belantamab Mafodotin
n=4 Participants
Participants with relapsed/refractory multiple myeloma (RRMM) were administered with 2.5 milligram per kilogram (mg/kg) belantamab mafodotin intravenous (IV) infusion over 30-60 minutes on day 1 of each 21-days cycle. Participants were treated until disease progression, intolerable toxicity, end of study or informed consent withdrawal.
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AUC[0-infinity] of Belantamab Mafodotin Total Antibody
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5514.32 h*ug/mL
Geometric Coefficient of Variation 29.69
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SECONDARY outcome
Timeframe: Pre-dose (within 30 minutes prior to start of infusion), end of infusion (EOI), 2, 4, 8 and 24 hours post start of infusion (HPS) on Day 1, anytime on Day 2, 4, 8, 15 and 22 of Cycle 1 (each cycle is of 21 days)Population: Pharmacokinetic (PK) population. Only those participants with data available at specified time points were analyzed.
Blood samples were collected at indicated time points for pharmacokinetic analysis of belantamab mafodotin. PK parameters were analyzed using standard non-compartmental analysis.
Outcome measures
| Measure |
Belantamab Mafodotin
n=3 Participants
Participants with relapsed/refractory multiple myeloma (RRMM) were administered with 2.5 milligram per kilogram (mg/kg) belantamab mafodotin intravenous (IV) infusion over 30-60 minutes on day 1 of each 21-days cycle. Participants were treated until disease progression, intolerable toxicity, end of study or informed consent withdrawal.
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AUC[0-infinity] of Belantamab Mafodotin Cys- Monomethyl Auristatin-F (Cys-mcMMAF)
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172.75 h*ng/mL
Geometric Coefficient of Variation 62.22
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SECONDARY outcome
Timeframe: Pre-dose (within 30 minutes prior to start of infusion) on day 1 of cycle 2, 4, 6, 9 and 12 (each cycle is of 21 days)Population: Pharmacokinetic (PK) population. Only those participants with data available at specified time points were analyzed.
Blood samples were collected at indicated time points for pharmacokinetic analysis of belantamab mafodotin. PK parameters were analyzed using standard non-compartmental analysis.
Outcome measures
| Measure |
Belantamab Mafodotin
n=6 Participants
Participants with relapsed/refractory multiple myeloma (RRMM) were administered with 2.5 milligram per kilogram (mg/kg) belantamab mafodotin intravenous (IV) infusion over 30-60 minutes on day 1 of each 21-days cycle. Participants were treated until disease progression, intolerable toxicity, end of study or informed consent withdrawal.
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Observed Plasma Concentration at the End of Infusion (CEOI) of Belantamab Mafodotin Antibody-drug Conjugate (ADC)
Cycle 1
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41.50 Micrograms per milliliter (ug/mL)
Geometric Coefficient of Variation 59.71
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Observed Plasma Concentration at the End of Infusion (CEOI) of Belantamab Mafodotin Antibody-drug Conjugate (ADC)
Cycle 2
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36.99 Micrograms per milliliter (ug/mL)
Geometric Coefficient of Variation 76.89
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Observed Plasma Concentration at the End of Infusion (CEOI) of Belantamab Mafodotin Antibody-drug Conjugate (ADC)
Cycle 4
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41.76 Micrograms per milliliter (ug/mL)
Geometric Coefficient of Variation 17.35
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Observed Plasma Concentration at the End of Infusion (CEOI) of Belantamab Mafodotin Antibody-drug Conjugate (ADC)
Cycle 6
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43.69 Micrograms per milliliter (ug/mL)
Geometric Coefficient of Variation 7.61
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Observed Plasma Concentration at the End of Infusion (CEOI) of Belantamab Mafodotin Antibody-drug Conjugate (ADC)
Cycle 12
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33.20 Micrograms per milliliter (ug/mL)
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Observed Plasma Concentration at the End of Infusion (CEOI) of Belantamab Mafodotin Antibody-drug Conjugate (ADC)
Cycle 9
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40.10 Micrograms per milliliter (ug/mL)
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SECONDARY outcome
Timeframe: Pre-dose (within 30 minutes prior to start of infusion) on day 1 of cycle 2, 4, 6, 9 and 12 (each cycle is of 21 days)Population: Pharmacokinetic (PK) population. Only those participants with data available at specified time points were analyzed.
Blood samples were collected at indicated time points for pharmacokinetic analysis of belantamab mafodotin. PK parameters were analyzed using standard non-compartmental analysis.
Outcome measures
| Measure |
Belantamab Mafodotin
n=6 Participants
Participants with relapsed/refractory multiple myeloma (RRMM) were administered with 2.5 milligram per kilogram (mg/kg) belantamab mafodotin intravenous (IV) infusion over 30-60 minutes on day 1 of each 21-days cycle. Participants were treated until disease progression, intolerable toxicity, end of study or informed consent withdrawal.
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CEOI of Belantamab Mafodotin Total Antibody
Cycle 1
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33.78 ug/mL
Geometric Coefficient of Variation 48.20
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CEOI of Belantamab Mafodotin Total Antibody
Cycle 2
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60.36 ug/mL
Geometric Coefficient of Variation 47.69
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CEOI of Belantamab Mafodotin Total Antibody
Cycle 4
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58.75 ug/mL
Geometric Coefficient of Variation 26.32
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CEOI of Belantamab Mafodotin Total Antibody
Cycle 6
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67.70 ug/mL
Geometric Coefficient of Variation 1.67
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CEOI of Belantamab Mafodotin Total Antibody
Cycle 9
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66.00 ug/mL
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CEOI of Belantamab Mafodotin Total Antibody
Cycle 12
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64.70 ug/mL
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SECONDARY outcome
Timeframe: Pre-dose (within 30 minutes prior to start of infusion) on day 1 of cycle 2, 4, 6, 9 and 12 (each cycle is of 21 days)Population: Pharmacokinetic (PK) population. Only those participants with data available at specified time points were analyzed.
Blood samples were collected at indicated time points for pharmacokinetic analysis of belantamab mafodotin. PK parameters were analyzed using standard non-compartmental analysis.
Outcome measures
| Measure |
Belantamab Mafodotin
n=6 Participants
Participants with relapsed/refractory multiple myeloma (RRMM) were administered with 2.5 milligram per kilogram (mg/kg) belantamab mafodotin intravenous (IV) infusion over 30-60 minutes on day 1 of each 21-days cycle. Participants were treated until disease progression, intolerable toxicity, end of study or informed consent withdrawal.
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CEOI of Belantamab Mafodotin Cys- Monomethyl Auristatin-F (Cys-mcMMAF)
Cycle 1
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0.53 Nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 80.68
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CEOI of Belantamab Mafodotin Cys- Monomethyl Auristatin-F (Cys-mcMMAF)
Cycle 2
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0.74 Nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 75.24
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CEOI of Belantamab Mafodotin Cys- Monomethyl Auristatin-F (Cys-mcMMAF)
Cycle 4
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0.44 Nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 19.63
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CEOI of Belantamab Mafodotin Cys- Monomethyl Auristatin-F (Cys-mcMMAF)
Cycle 6
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0.47 Nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 10.34
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CEOI of Belantamab Mafodotin Cys- Monomethyl Auristatin-F (Cys-mcMMAF)
Cycle 9
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0.37 Nanograms per milliliter (ng/mL)
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CEOI of Belantamab Mafodotin Cys- Monomethyl Auristatin-F (Cys-mcMMAF)
Cycle 12
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0.38 Nanograms per milliliter (ng/mL)
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SECONDARY outcome
Timeframe: Pre-dose (within 30 minutes prior to start of infusion), end of infusion (EOI), 2, 4, 8 and 24 hours post start of infusion (HPS) on day 1, anytime on day 2, 4, 8, 15 and 22 of cycle 1 (each cycle is of 21 days)Population: Pharmacokinetic (PK) population
Blood samples were collected at indicated time points for pharmacokinetic analysis of belantamab mafodotin. PK parameters were analyzed using standard non-compartmental analysis. Maximum observed plasma concentration, determined directly from the concentration-time data for each cycle.
Outcome measures
| Measure |
Belantamab Mafodotin
n=6 Participants
Participants with relapsed/refractory multiple myeloma (RRMM) were administered with 2.5 milligram per kilogram (mg/kg) belantamab mafodotin intravenous (IV) infusion over 30-60 minutes on day 1 of each 21-days cycle. Participants were treated until disease progression, intolerable toxicity, end of study or informed consent withdrawal.
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Maximum Observed Concentration (Cmax) of Belantamab Mafodotin Antibody-drug Conjugate (ADC)
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45.36 ug/mL
Geometric Coefficient of Variation 54.69
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SECONDARY outcome
Timeframe: Pre-dose (within 30 minutes prior to start of infusion), end of infusion (EOI), 2, 4, 8 and 24 hours post start of infusion (HPS) on Day 1, anytime on Day 2, 4, 8, 15 and 22 of cycle 1 (each cycle is of 21 days)Population: Pharmacokinetic (PK) population
Blood samples were collected at indicated time points for pharmacokinetic analysis of belantamab mafodotin. PK parameters were analyzed using standard non-compartmental analysis. Maximum observed plasma concentration, determined directly from the concentration-time data for each cycle.
Outcome measures
| Measure |
Belantamab Mafodotin
n=6 Participants
Participants with relapsed/refractory multiple myeloma (RRMM) were administered with 2.5 milligram per kilogram (mg/kg) belantamab mafodotin intravenous (IV) infusion over 30-60 minutes on day 1 of each 21-days cycle. Participants were treated until disease progression, intolerable toxicity, end of study or informed consent withdrawal.
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|---|---|
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Cmax of Belantamab Mafodotin Total Antibody
|
42.21 ug/mL
Geometric Coefficient of Variation 19.65
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SECONDARY outcome
Timeframe: Pre-dose (within 30 minutes prior to start of infusion), end of infusion (EOI), 2, 4, 8 and 24 hours post start of infusion (HPS) on Day 1, anytime on Day 2, 4, 8, 15 and 22 of cycle 1 (each cycle is of 21 days)Population: Pharmacokinetic (PK) population
Blood samples were collected at indicated time points for pharmacokinetic analysis of belantamab mafodotin. PK parameters were analyzed using standard non-compartmental analysis. Maximum observed plasma concentration, determined directly from the concentration-time data for each cycle.
Outcome measures
| Measure |
Belantamab Mafodotin
n=6 Participants
Participants with relapsed/refractory multiple myeloma (RRMM) were administered with 2.5 milligram per kilogram (mg/kg) belantamab mafodotin intravenous (IV) infusion over 30-60 minutes on day 1 of each 21-days cycle. Participants were treated until disease progression, intolerable toxicity, end of study or informed consent withdrawal.
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|---|---|
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Cmax of Belantamab Mafodotin Cys- Monomethyl Auristatin-F (Cys-mcMMAF)
|
1.41 ng/mL
Geometric Coefficient of Variation 51.14
|
SECONDARY outcome
Timeframe: Pre-dose (within 30 minutes prior to start of infusion), end of infusion (EOI), 2, 4, 8 and 24 hours post start of infusion (HPS) on day 1, anytime on day 2, 4, 8, 15 and 22 of cycle 1 (each cycle is of 21 days)Population: Pharmacokinetic (PK) population
Blood samples were collected at indicated time points for pharmacokinetic analysis of belantamab mafodotin. PK parameters were analyzed using standard non-compartmental analysis.
Outcome measures
| Measure |
Belantamab Mafodotin
n=6 Participants
Participants with relapsed/refractory multiple myeloma (RRMM) were administered with 2.5 milligram per kilogram (mg/kg) belantamab mafodotin intravenous (IV) infusion over 30-60 minutes on day 1 of each 21-days cycle. Participants were treated until disease progression, intolerable toxicity, end of study or informed consent withdrawal.
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|---|---|
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Time to Reach Maximum Observed Concentration (Tmax) of Belantamab Mafodotin Antibody-drug Conjugate (ADC)
|
2.03 Hour
Interval 0.6 to 2.2
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SECONDARY outcome
Timeframe: Pre-dose (within 30 minutes prior to start of infusion), end of infusion (EOI), 2, 4, 8 and 24 hours post start of infusion (HPS) on day 1, anytime on day 2, 4, 8, 15 and 22 of cycle 1 (each cycle is of 21 days)Population: Pharmacokinetic (PK) population
Blood samples were collected at indicated time points for pharmacokinetic analysis of belantamab mafodotin. PK parameters were analyzed using standard non-compartmental analysis.
Outcome measures
| Measure |
Belantamab Mafodotin
n=6 Participants
Participants with relapsed/refractory multiple myeloma (RRMM) were administered with 2.5 milligram per kilogram (mg/kg) belantamab mafodotin intravenous (IV) infusion over 30-60 minutes on day 1 of each 21-days cycle. Participants were treated until disease progression, intolerable toxicity, end of study or informed consent withdrawal.
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|---|---|
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Tmax of Belantamab Mafodotin Total Antibody
|
2.03 Hour
Interval 1.0 to 2.2
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SECONDARY outcome
Timeframe: Pre-dose (within 30 minutes prior to start of infusion), end of infusion (EOI), 2, 4, 8 and 24 hours post start of infusion (HPS) on day 1, anytime on day 2, 4, 8, 15 and 22 of cycle 1 (each cycle is of 21 days)Population: Pharmacokinetic (PK) population
Blood samples were collected at indicated time points for pharmacokinetic analysis of belantamab mafodotin. PK parameters were analyzed using standard non-compartmental analysis.
Outcome measures
| Measure |
Belantamab Mafodotin
n=6 Participants
Participants with relapsed/refractory multiple myeloma (RRMM) were administered with 2.5 milligram per kilogram (mg/kg) belantamab mafodotin intravenous (IV) infusion over 30-60 minutes on day 1 of each 21-days cycle. Participants were treated until disease progression, intolerable toxicity, end of study or informed consent withdrawal.
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|---|---|
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Tmax of Belantamab Mafodotin Cys- Monomethyl Auristatin-F (Cys-mcMMAF)
|
7.96 Hour
Interval 0.6 to 46.6
|
SECONDARY outcome
Timeframe: Pre-dose (within 30 minutes prior to start of infusion), end of infusion (EOI), 2, 4, 8 and 24 hours post start of infusion (HPS) on day 1, anytime on day 2, 4, 8, 15 and 22 of cycle 1 (each cycle is of 21 days)Population: Pharmacokinetic (PK) population
Blood samples were collected at indicated time points for pharmacokinetic analysis of belantamab mafodotin. PK parameters were analyzed using standard non-compartmental analysis.
Outcome measures
| Measure |
Belantamab Mafodotin
n=6 Participants
Participants with relapsed/refractory multiple myeloma (RRMM) were administered with 2.5 milligram per kilogram (mg/kg) belantamab mafodotin intravenous (IV) infusion over 30-60 minutes on day 1 of each 21-days cycle. Participants were treated until disease progression, intolerable toxicity, end of study or informed consent withdrawal.
|
|---|---|
|
Last Time Point Where the Concentration is Above the Limit of Quantification (Tlast) of Belantamab Mafodotin Antibody-drug Conjugate (ADC)
|
504.54 Hour
Interval 329.8 to 509.9
|
SECONDARY outcome
Timeframe: Pre-dose (within 30 minutes prior to start of infusion), end of infusion (EOI), 2, 4, 8 and 24 hours post start of infusion (HPS) on day 1, anytime on day 2, 4, 8, 15 and 22 of cycle 1 (each cycle is of 21 days)Population: Pharmacokinetic (PK) population
Blood samples were collected at indicated time points for pharmacokinetic analysis of belantamab mafodotin. PK parameters were analyzed using standard non-compartmental analysis.
Outcome measures
| Measure |
Belantamab Mafodotin
n=6 Participants
Participants with relapsed/refractory multiple myeloma (RRMM) were administered with 2.5 milligram per kilogram (mg/kg) belantamab mafodotin intravenous (IV) infusion over 30-60 minutes on day 1 of each 21-days cycle. Participants were treated until disease progression, intolerable toxicity, end of study or informed consent withdrawal.
|
|---|---|
|
Tlast of Belantamab Mafodotin Total Antibody
|
507.23 Hour
Interval 478.2 to 545.7
|
SECONDARY outcome
Timeframe: Pre-dose (within 30 minutes prior to start of infusion), end of infusion (EOI), 2, 4, 8 and 24 hours post start of infusion (HPS) on day 1, anytime on day 2, 4, 8, 15 and 22 of cycle 1 (each cycle is of 21 days)Population: Pharmacokinetic (PK) population
Blood samples were collected at indicated time points for pharmacokinetic analysis of belantamab mafodotin. PK parameters were analyzed using standard non-compartmental analysis.
Outcome measures
| Measure |
Belantamab Mafodotin
n=6 Participants
Participants with relapsed/refractory multiple myeloma (RRMM) were administered with 2.5 milligram per kilogram (mg/kg) belantamab mafodotin intravenous (IV) infusion over 30-60 minutes on day 1 of each 21-days cycle. Participants were treated until disease progression, intolerable toxicity, end of study or informed consent withdrawal.
|
|---|---|
|
Tlast of Belantamab Mafodotin Cys- Monomethyl Auristatin-F (Cys-mcMMAF)
|
168.15 Hour
Interval 162.0 to 336.0
|
SECONDARY outcome
Timeframe: Pre-dose (within 30 minutes prior to start of infusion), end of infusion (EOI), 2, 4, 8 and 24 hours post start of infusion (HPS) on day 1, anytime on day 2, 4, 8, 15 and 22 of cycle 1 (each cycle is of 21 days)Population: Pharmacokinetic (PK) population. Only those participants with data available at specified time points were analyzed.
Blood samples were collected at indicated time points for pharmacokinetic analysis of belantamab mafodotin. PK parameters were analyzed using standard non-compartmental analysis.
Outcome measures
| Measure |
Belantamab Mafodotin
n=5 Participants
Participants with relapsed/refractory multiple myeloma (RRMM) were administered with 2.5 milligram per kilogram (mg/kg) belantamab mafodotin intravenous (IV) infusion over 30-60 minutes on day 1 of each 21-days cycle. Participants were treated until disease progression, intolerable toxicity, end of study or informed consent withdrawal.
|
|---|---|
|
Systemic Clearance (CL) of Belantamab Mafodotin Antibody-drug Conjugate (ADC)
|
0.0518 Liter per hour (L/h)
Geometric Coefficient of Variation 27.29
|
SECONDARY outcome
Timeframe: Pre-dose (within 30 minutes prior to start of infusion), end of infusion (EOI), 2, 4, 8 and 24 hours post start of infusion (HPS) on day 1, anytime on day 2, 4, 8, 15 and 22 of cycle 1 (each cycle is of 21 days)Population: Pharmacokinetic (PK) population. Only those participants with data available at specified time points were analyzed.
Blood samples were collected at indicated time points for pharmacokinetic analysis of belantamab mafodotin. PK parameters were analyzed using standard non-compartmental analysis.
Outcome measures
| Measure |
Belantamab Mafodotin
n=4 Participants
Participants with relapsed/refractory multiple myeloma (RRMM) were administered with 2.5 milligram per kilogram (mg/kg) belantamab mafodotin intravenous (IV) infusion over 30-60 minutes on day 1 of each 21-days cycle. Participants were treated until disease progression, intolerable toxicity, end of study or informed consent withdrawal.
|
|---|---|
|
CL of Belantamab Mafodotin Total Antibody
|
0.0300 L/h
Geometric Coefficient of Variation 25.15
|
SECONDARY outcome
Timeframe: Pre-dose (within 30 minutes prior to start of infusion), end of infusion (EOI), 2, 4, 8 and 24 hours post start of infusion (HPS) on day 1, anytime on day 2, 4, 8, 15 and 22 of cycle 1 (each cycle is of 21 days)Population: Pharmacokinetic (PK) population. Only those participants with data available at specified time points were analyzed.
Blood samples were collected at indicated time points for pharmacokinetic analysis of belantamab mafodotin. PK parameters were analyzed using standard non-compartmental analysis.
Outcome measures
| Measure |
Belantamab Mafodotin
n=5 Participants
Participants with relapsed/refractory multiple myeloma (RRMM) were administered with 2.5 milligram per kilogram (mg/kg) belantamab mafodotin intravenous (IV) infusion over 30-60 minutes on day 1 of each 21-days cycle. Participants were treated until disease progression, intolerable toxicity, end of study or informed consent withdrawal.
|
|---|---|
|
Systemic Clearance Normalized by Body Weight (CL/Weight) of Belantamab Mafodotin Antibody-drug Conjugate (ADC)
|
0.83 Milliliter per hour per kilogram
Geometric Coefficient of Variation 35.94
|
SECONDARY outcome
Timeframe: Pre-dose (within 30 minutes prior to start of infusion), end of infusion (EOI), 2, 4, 8 and 24 hours post start of infusion (HPS) on Day 1, anytime on Day 2, 4, 8, 15 and 22 of Cycle 1 (each cycle is of 21 days)Population: Pharmacokinetic (PK) population. Only those participants with data available at specified time points were analyzed.
Blood samples were collected at indicated time points for pharmacokinetic analysis of belantamab mafodotin. PK parameters were analyzed using standard non-compartmental analysis.
Outcome measures
| Measure |
Belantamab Mafodotin
n=4 Participants
Participants with relapsed/refractory multiple myeloma (RRMM) were administered with 2.5 milligram per kilogram (mg/kg) belantamab mafodotin intravenous (IV) infusion over 30-60 minutes on day 1 of each 21-days cycle. Participants were treated until disease progression, intolerable toxicity, end of study or informed consent withdrawal.
|
|---|---|
|
CL/Weight of Belantamab Mafodotin Total Antibody
|
0.46 Milliliter per hour per kilogram
Geometric Coefficient of Variation 29.08
|
SECONDARY outcome
Timeframe: Pre-dose (within 30 minutes prior to start of infusion), end of infusion (EOI), 2, 4, 8 and 24 hours post start of infusion (HPS) on day 1, anytime on day 2, 4, 8, 15 and 22 of cycle 1 (each cycle is of 21 days)Population: Pharmacokinetic (PK) population. Only those participants with data available at specified time points were analyzed.
Blood samples were collected at indicated time points for pharmacokinetic analysis of belantamab mafodotin. PK parameters were analyzed using standard non-compartmental analysis.
Outcome measures
| Measure |
Belantamab Mafodotin
n=5 Participants
Participants with relapsed/refractory multiple myeloma (RRMM) were administered with 2.5 milligram per kilogram (mg/kg) belantamab mafodotin intravenous (IV) infusion over 30-60 minutes on day 1 of each 21-days cycle. Participants were treated until disease progression, intolerable toxicity, end of study or informed consent withdrawal.
|
|---|---|
|
Volume of Distribution at Steady State (Vss) of Belantamab Mafodotin Antibody-drug Conjugate (ADC)
|
7.57 Liter (L)
Geometric Coefficient of Variation 10.63
|
SECONDARY outcome
Timeframe: Pre-dose (within 30 minutes prior to start of infusion), end of infusion (EOI), 2, 4, 8 and 24 hours post start of infusion (HPS) on day 1, anytime on day 2, 4, 8, 15 and 22 of cycle 1 (each cycle is of 21 days)Population: Pharmacokinetic (PK) population. Only those participants with data available at specified time points were analyzed.
Blood samples were collected at indicated time points for pharmacokinetic analysis of belantamab mafodotin. PK parameters were analyzed using standard non-compartmental analysis.
Outcome measures
| Measure |
Belantamab Mafodotin
n=4 Participants
Participants with relapsed/refractory multiple myeloma (RRMM) were administered with 2.5 milligram per kilogram (mg/kg) belantamab mafodotin intravenous (IV) infusion over 30-60 minutes on day 1 of each 21-days cycle. Participants were treated until disease progression, intolerable toxicity, end of study or informed consent withdrawal.
|
|---|---|
|
Vss of Belantamab Mafodotin Total Antibody
|
6.62 L
Geometric Coefficient of Variation 19.63
|
SECONDARY outcome
Timeframe: Pre-dose (within 30 minutes prior to start of infusion), end of infusion (EOI), 2, 4, 8 and 24 hours post start of infusion (HPS) on day 1, anytime on day 2, 4, 8, 15 and 22 of cycle 1 (each cycle is of 21 days)Population: Pharmacokinetic (PK) population. Only those participants with data available at specified time points were analyzed.
Blood samples were collected at indicated time points for pharmacokinetic analysis of belantamab mafodotin. PK parameters were analyzed using standard non-compartmental analysis.
Outcome measures
| Measure |
Belantamab Mafodotin
n=5 Participants
Participants with relapsed/refractory multiple myeloma (RRMM) were administered with 2.5 milligram per kilogram (mg/kg) belantamab mafodotin intravenous (IV) infusion over 30-60 minutes on day 1 of each 21-days cycle. Participants were treated until disease progression, intolerable toxicity, end of study or informed consent withdrawal.
|
|---|---|
|
Volume of Distribution at Steady State Normalized by Body Weight (Vss/Weight) of Belantamab Mafodotin Antibody-drug Conjugate (ADC)
|
122.11 Milliliter per kilogram (mL/kg)
Geometric Coefficient of Variation 18.60
|
SECONDARY outcome
Timeframe: Pre-dose (within 30 minutes prior to start of infusion), end of infusion (EOI), 2, 4, 8 and 24 hours post start of infusion (HPS) on day 1, anytime on day 2, 4, 8, 15 and 22 of cycle 1 (each cycle is of 21 days)Population: Pharmacokinetic (PK) population. Only those participants with data available at specified time points were analyzed.
Blood samples were collected at indicated time points for pharmacokinetic analysis of belantamab mafodotin. PK parameters were analyzed using standard non-compartmental analysis.
Outcome measures
| Measure |
Belantamab Mafodotin
n=4 Participants
Participants with relapsed/refractory multiple myeloma (RRMM) were administered with 2.5 milligram per kilogram (mg/kg) belantamab mafodotin intravenous (IV) infusion over 30-60 minutes on day 1 of each 21-days cycle. Participants were treated until disease progression, intolerable toxicity, end of study or informed consent withdrawal.
|
|---|---|
|
Vss/Weight of Belantamab Mafodotin Total Antibody
|
101.41 mL/kg
Geometric Coefficient of Variation 15.58
|
SECONDARY outcome
Timeframe: Pre-dose (within 30 minutes prior to start of infusion), end of infusion (EOI), 2, 4, 8 and 24 hours post start of infusion (HPS) on day 1, anytime on day 2, 4, 8, 15 and 22 of cycle 1 (each cycle is of 21 days)Population: Pharmacokinetic (PK) population. Only those participants with data available at specified time points were analyzed.
Blood samples were collected at indicated time points for pharmacokinetic analysis of belantamab mafodotin. PK parameters were analyzed using standard non-compartmental analysis.
Outcome measures
| Measure |
Belantamab Mafodotin
n=5 Participants
Participants with relapsed/refractory multiple myeloma (RRMM) were administered with 2.5 milligram per kilogram (mg/kg) belantamab mafodotin intravenous (IV) infusion over 30-60 minutes on day 1 of each 21-days cycle. Participants were treated until disease progression, intolerable toxicity, end of study or informed consent withdrawal.
|
|---|---|
|
Apparent Terminal Half-life (t1/2) of Belantamab Mafodotin Antibody-drug Conjugate (ADC)
|
128.25 Hour
Geometric Coefficient of Variation 23.52
|
SECONDARY outcome
Timeframe: Pre-dose (within 30 minutes prior to start of infusion), end of infusion (EOI), 2, 4, 8 and 24 hours post start of infusion (HPS) on day 1, anytime on day 2, 4, 8, 15 and 22 of cycle 1 (each cycle is of 21 days)Population: Pharmacokinetic (PK) population. Only those participants with data available at specified time points were analyzed.
Blood samples were collected at indicated time points for pharmacokinetic analysis of belantamab mafodotin. PK parameters were analyzed using standard non-compartmental analysis.
Outcome measures
| Measure |
Belantamab Mafodotin
n=4 Participants
Participants with relapsed/refractory multiple myeloma (RRMM) were administered with 2.5 milligram per kilogram (mg/kg) belantamab mafodotin intravenous (IV) infusion over 30-60 minutes on day 1 of each 21-days cycle. Participants were treated until disease progression, intolerable toxicity, end of study or informed consent withdrawal.
|
|---|---|
|
t1/2 of Belantamab Mafodotin Total Antibody
|
169.20 Hour
Geometric Coefficient of Variation 18.34
|
SECONDARY outcome
Timeframe: Pre-dose (within 30 minutes prior to start of infusion), end of infusion (EOI), 2, 4, 8 and 24 hours post start of infusion (HPS) on day 1, anytime on day 2, 4, 8, 15 and 22 of cycle 1 (each cycle is of 21 days)Population: Pharmacokinetic (PK) population. Only those participants with data available at specified time points were analyzed.
Blood samples were collected at indicated time points for pharmacokinetic analysis of belantamab mafodotin. PK parameters were analyzed using standard non-compartmental analysis.
Outcome measures
| Measure |
Belantamab Mafodotin
n=3 Participants
Participants with relapsed/refractory multiple myeloma (RRMM) were administered with 2.5 milligram per kilogram (mg/kg) belantamab mafodotin intravenous (IV) infusion over 30-60 minutes on day 1 of each 21-days cycle. Participants were treated until disease progression, intolerable toxicity, end of study or informed consent withdrawal.
|
|---|---|
|
t1/2 of Belantamab Mafodotin Cys- Monomethyl Auristatin-F (Cys-mcMMAF)
|
73.61 Hour
Geometric Coefficient of Variation 18.33
|
SECONDARY outcome
Timeframe: Pre-dose (within 30 minutes prior to start of infusion) on day 1 of cycle 1, 3, 5, 8 and 11 (each cycle is of 21 days)Population: Pharmacokinetic (PK) population. Only those participants with data available at specified time points were analyzed.
Blood samples were collected at indicated time points for pharmacokinetic analysis of belantamab mafodotin. PK parameters were analyzed using standard non-compartmental analysis.
Outcome measures
| Measure |
Belantamab Mafodotin
n=6 Participants
Participants with relapsed/refractory multiple myeloma (RRMM) were administered with 2.5 milligram per kilogram (mg/kg) belantamab mafodotin intravenous (IV) infusion over 30-60 minutes on day 1 of each 21-days cycle. Participants were treated until disease progression, intolerable toxicity, end of study or informed consent withdrawal.
|
|---|---|
|
Trough Concentration Prior to the Next Dose for Each Cycle (Ctrough) of Belantamab Mafodotin Antibody-drug Conjugate (ADC)
Cycle 1
|
1.14 ug/mL
Geometric Coefficient of Variation 73.76
|
|
Trough Concentration Prior to the Next Dose for Each Cycle (Ctrough) of Belantamab Mafodotin Antibody-drug Conjugate (ADC)
Cycle 3
|
2.43 ug/mL
Geometric Coefficient of Variation 104.26
|
|
Trough Concentration Prior to the Next Dose for Each Cycle (Ctrough) of Belantamab Mafodotin Antibody-drug Conjugate (ADC)
Cycle 5
|
5.70 ug/mL
Geometric Coefficient of Variation 4.09
|
|
Trough Concentration Prior to the Next Dose for Each Cycle (Ctrough) of Belantamab Mafodotin Antibody-drug Conjugate (ADC)
Cycle 8
|
4.59 ug/mL
|
|
Trough Concentration Prior to the Next Dose for Each Cycle (Ctrough) of Belantamab Mafodotin Antibody-drug Conjugate (ADC)
Cycle 11
|
4.41 ug/mL
|
SECONDARY outcome
Timeframe: Pre-dose (within 30 minutes prior to start of infusion) on day 1 of cycle 1, 3, 5, 8 and 11 (each cycle is of 21 days)Population: Pharmacokinetic (PK) population. Only those participants with data available at specified time points were analyzed.
Blood samples were collected at indicated time points for pharmacokinetic analysis of belantamab mafodotin. PK parameters were analyzed using standard non-compartmental analysis.
Outcome measures
| Measure |
Belantamab Mafodotin
n=6 Participants
Participants with relapsed/refractory multiple myeloma (RRMM) were administered with 2.5 milligram per kilogram (mg/kg) belantamab mafodotin intravenous (IV) infusion over 30-60 minutes on day 1 of each 21-days cycle. Participants were treated until disease progression, intolerable toxicity, end of study or informed consent withdrawal.
|
|---|---|
|
Ctrough of Belantamab Mafodotin Total Antibody
Cycle 1
|
3.76 ug/mL
Geometric Coefficient of Variation 79.96
|
|
Ctrough of Belantamab Mafodotin Total Antibody
Cycle 3
|
10.25 ug/mL
Geometric Coefficient of Variation 105.86
|
|
Ctrough of Belantamab Mafodotin Total Antibody
Cycle 5
|
24.50 ug/mL
Geometric Coefficient of Variation 1.15
|
|
Ctrough of Belantamab Mafodotin Total Antibody
Cycle 8
|
23.90 ug/mL
|
|
Ctrough of Belantamab Mafodotin Total Antibody
Cycle 11
|
26.40 ug/mL
|
SECONDARY outcome
Timeframe: Up to 21 monthsPopulation: All treated population
Abnormal vital signs were defined as any abnormal findings in the vital signs parameters (temperature, blood pressure and pulse rate).
Outcome measures
| Measure |
Belantamab Mafodotin
n=6 Participants
Participants with relapsed/refractory multiple myeloma (RRMM) were administered with 2.5 milligram per kilogram (mg/kg) belantamab mafodotin intravenous (IV) infusion over 30-60 minutes on day 1 of each 21-days cycle. Participants were treated until disease progression, intolerable toxicity, end of study or informed consent withdrawal.
|
|---|---|
|
Number of Participants With Abnormal Vital Signs
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline (day 1) and up to 21 monthsPopulation: All treated population
Blood samples were collected at indicated time points to assess change from baseline in hemoglobin, lymphocytes, neutrophils, platelets, leukocytes. Worst case grade increase from baseline grade was provided for all the hematology tests that were gradable by National Cancer Institute Common Terminology Criteria (NCI CTCAE, Version 5.0, 2017). Grade 1 = Mild AE; Grade 2 = Moderate AE; Grade 3 = Severe AE; Grade 4 = Life-threatening or disabling AE. Data for any participants with worst-case grade changes (Increase to Grade 3 or Increase to Grade 4) post-baseline were presented. Baseline was defined as latest pre-dose assessment (day 1) with a non-missing value, including those from unscheduled visits.
Outcome measures
| Measure |
Belantamab Mafodotin
n=6 Participants
Participants with relapsed/refractory multiple myeloma (RRMM) were administered with 2.5 milligram per kilogram (mg/kg) belantamab mafodotin intravenous (IV) infusion over 30-60 minutes on day 1 of each 21-days cycle. Participants were treated until disease progression, intolerable toxicity, end of study or informed consent withdrawal.
|
|---|---|
|
Number of Participants With Worst- Case Grade Changes Post-baseline in Hematology Parameter: Hemoglobin, Lymphocytes, Neutrophils, Platelets, Leukocytes
Hemoglobin, increase to grade 3
|
2 Participants
|
|
Number of Participants With Worst- Case Grade Changes Post-baseline in Hematology Parameter: Hemoglobin, Lymphocytes, Neutrophils, Platelets, Leukocytes
Hemoglobin, increase to grade 4
|
0 Participants
|
|
Number of Participants With Worst- Case Grade Changes Post-baseline in Hematology Parameter: Hemoglobin, Lymphocytes, Neutrophils, Platelets, Leukocytes
Lymphocytes, increase to grade 4
|
0 Participants
|
|
Number of Participants With Worst- Case Grade Changes Post-baseline in Hematology Parameter: Hemoglobin, Lymphocytes, Neutrophils, Platelets, Leukocytes
Neutrophils, increase to grade 3
|
1 Participants
|
|
Number of Participants With Worst- Case Grade Changes Post-baseline in Hematology Parameter: Hemoglobin, Lymphocytes, Neutrophils, Platelets, Leukocytes
Leukocytes, increase to grade 3
|
1 Participants
|
|
Number of Participants With Worst- Case Grade Changes Post-baseline in Hematology Parameter: Hemoglobin, Lymphocytes, Neutrophils, Platelets, Leukocytes
Leukocytes, increase to grade 4
|
0 Participants
|
|
Number of Participants With Worst- Case Grade Changes Post-baseline in Hematology Parameter: Hemoglobin, Lymphocytes, Neutrophils, Platelets, Leukocytes
Lymphocytes, increase to grade 3
|
0 Participants
|
|
Number of Participants With Worst- Case Grade Changes Post-baseline in Hematology Parameter: Hemoglobin, Lymphocytes, Neutrophils, Platelets, Leukocytes
Neutrophils, increase to grade 4
|
0 Participants
|
|
Number of Participants With Worst- Case Grade Changes Post-baseline in Hematology Parameter: Hemoglobin, Lymphocytes, Neutrophils, Platelets, Leukocytes
Platelets, increase to grade 3
|
1 Participants
|
|
Number of Participants With Worst- Case Grade Changes Post-baseline in Hematology Parameter: Hemoglobin, Lymphocytes, Neutrophils, Platelets, Leukocytes
Platelets, increase to grade 4
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline (day 1) and up to 21 monthsPopulation: All treated population
Blood samples were collected at indicated time points to assess change from baseline in albumin, alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, bilirubin, creatine kinase, gamma glutamyl transferase, potassium, lactate dehydrogenase, magnesium. Worst case grade (G) increase from baseline grade was provided for all the chemistry tests that were gradable by National Cancer Institute Common Terminology Criteria (NCI CTCAE, Version 5.0, 2017). Grade 1 = Mild AE; Grade 2 = Moderate AE; Grade 3 = Severe AE; Grade 4 = Life-threatening or disabling AE. Data for any participants with worst-case grade changes (Increase to Grade 3 or Increase to Grade 4) post-baseline were presented. Baseline was defined as latest pre-dose assessment (day 1) with a non-missing value, including those from unscheduled visits.
Outcome measures
| Measure |
Belantamab Mafodotin
n=6 Participants
Participants with relapsed/refractory multiple myeloma (RRMM) were administered with 2.5 milligram per kilogram (mg/kg) belantamab mafodotin intravenous (IV) infusion over 30-60 minutes on day 1 of each 21-days cycle. Participants were treated until disease progression, intolerable toxicity, end of study or informed consent withdrawal.
|
|---|---|
|
Number of Participants With Worst- Case Grade Changes Post-baseline in Clinical Chemistry Parameters
Albumin, increase to G4
|
0 Participants
|
|
Number of Participants With Worst- Case Grade Changes Post-baseline in Clinical Chemistry Parameters
Alkaline Phosphatase, increase to G3
|
0 Participants
|
|
Number of Participants With Worst- Case Grade Changes Post-baseline in Clinical Chemistry Parameters
Alkaline Phosphatase, increase to G4
|
0 Participants
|
|
Number of Participants With Worst- Case Grade Changes Post-baseline in Clinical Chemistry Parameters
Alanine Aminotransferase, increase to G3
|
0 Participants
|
|
Number of Participants With Worst- Case Grade Changes Post-baseline in Clinical Chemistry Parameters
Alanine Aminotransferase, increase to G4
|
0 Participants
|
|
Number of Participants With Worst- Case Grade Changes Post-baseline in Clinical Chemistry Parameters
Aspartate Aminotransferase, increase to G3
|
0 Participants
|
|
Number of Participants With Worst- Case Grade Changes Post-baseline in Clinical Chemistry Parameters
Aspartate Aminotransferase, increase to G4
|
0 Participants
|
|
Number of Participants With Worst- Case Grade Changes Post-baseline in Clinical Chemistry Parameters
Bilirubin, increase to G3
|
0 Participants
|
|
Number of Participants With Worst- Case Grade Changes Post-baseline in Clinical Chemistry Parameters
Creatine Kinase, increase to G3
|
0 Participants
|
|
Number of Participants With Worst- Case Grade Changes Post-baseline in Clinical Chemistry Parameters
Creatine Kinase, increase to G4
|
0 Participants
|
|
Number of Participants With Worst- Case Grade Changes Post-baseline in Clinical Chemistry Parameters
Gamma Glutamyl Transferase, increase to G4
|
0 Participants
|
|
Number of Participants With Worst- Case Grade Changes Post-baseline in Clinical Chemistry Parameters
Potassium, increase to G3
|
0 Participants
|
|
Number of Participants With Worst- Case Grade Changes Post-baseline in Clinical Chemistry Parameters
Potassium, increase to G4
|
0 Participants
|
|
Number of Participants With Worst- Case Grade Changes Post-baseline in Clinical Chemistry Parameters
Lactate Dehydrogenase, increase to G3
|
0 Participants
|
|
Number of Participants With Worst- Case Grade Changes Post-baseline in Clinical Chemistry Parameters
Lactate Dehydrogenase, increase to G4
|
0 Participants
|
|
Number of Participants With Worst- Case Grade Changes Post-baseline in Clinical Chemistry Parameters
Magnesium, increase to G4
|
0 Participants
|
|
Number of Participants With Worst- Case Grade Changes Post-baseline in Clinical Chemistry Parameters
Albumin, increase to G3
|
0 Participants
|
|
Number of Participants With Worst- Case Grade Changes Post-baseline in Clinical Chemistry Parameters
Bilirubin, increase to G4
|
0 Participants
|
|
Number of Participants With Worst- Case Grade Changes Post-baseline in Clinical Chemistry Parameters
Gamma Glutamyl Transferase, increase to G3
|
0 Participants
|
|
Number of Participants With Worst- Case Grade Changes Post-baseline in Clinical Chemistry Parameters
Magnesium, increase to G3
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 21 monthsPopulation: All treated population
ORR was defined as the percentage of participants with a confirmed partial response (PR) or better (i.e., very good partial response \[VGPR\], complete response \[CR\] and stringent complete response \[sCR\]) as assessed by International Myeloma Working Group (IMWG) Uniform Response Criteria for Multiple Myeloma 2016. PR=response greater than or equal to (\>=) 50 percent (%) reduction of serum M-protein and reduction in 24-hour urinary M-protein by \>=90% or to less than (\<) 200 mg per 24 hours. CR=negative immunofixation of serum and urine and disappearance of any soft tissue plasmacytomas and \<5% plasma cells in bone marrow aspirates. sCR=complete response below plus normal free light chain (FLC) ratio and absence of clonal plasma cells in bone marrow by immunohistochemistry or 8-color, 2 tube multiparametric flow cytometry. VGPR=Serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥90% reduction in serum M-protein plus urine M-component level \<100 mg/24 h.
Outcome measures
| Measure |
Belantamab Mafodotin
n=6 Participants
Participants with relapsed/refractory multiple myeloma (RRMM) were administered with 2.5 milligram per kilogram (mg/kg) belantamab mafodotin intravenous (IV) infusion over 30-60 minutes on day 1 of each 21-days cycle. Participants were treated until disease progression, intolerable toxicity, end of study or informed consent withdrawal.
|
|---|---|
|
Percentage of Participants With Objective Response Rate (ORR)
|
16.7 Percentage of Participants
Interval 0.4 to 64.1
|
SECONDARY outcome
Timeframe: Up to 24 months and 21 daysPopulation: All treated population
Serum samples were analyzed for the presence of anti-belantamab mafodotin antibodies by a validated electro chemiluminescent immunoassay. All samples were tested in a screening assay to identify potentially positive samples.
Outcome measures
| Measure |
Belantamab Mafodotin
n=6 Participants
Participants with relapsed/refractory multiple myeloma (RRMM) were administered with 2.5 milligram per kilogram (mg/kg) belantamab mafodotin intravenous (IV) infusion over 30-60 minutes on day 1 of each 21-days cycle. Participants were treated until disease progression, intolerable toxicity, end of study or informed consent withdrawal.
|
|---|---|
|
Number of Participants With Anti-drug Antibodies (ADAs) Against Belantamab Mafodotin
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to 24 months and 21 daysPopulation: All Treated Population. Only the participants who showed positive results for ADAs were analyzed.
Samples were analyzed for the presence of anti-belantamab mafodotin antibodies by a validated electro chemiluminescent immunoassay. All samples were tested in a screening assay to identify potentially positive samples. Screened positive was further characterized for the antibody titer values.
Outcome measures
| Measure |
Belantamab Mafodotin
n=1 Participants
Participants with relapsed/refractory multiple myeloma (RRMM) were administered with 2.5 milligram per kilogram (mg/kg) belantamab mafodotin intravenous (IV) infusion over 30-60 minutes on day 1 of each 21-days cycle. Participants were treated until disease progression, intolerable toxicity, end of study or informed consent withdrawal.
|
|---|---|
|
Titers of ADAs Against Belantamab Mafodotin
|
100 Titer
|
SECONDARY outcome
Timeframe: Baseline (day 1) Up to 24 months and 21 daysPopulation: All treated population
The OSDI instrument measures vision-related function. The total OSDI score was calculated as (sum of scores for all questions answered\*100) divided by (total number of questions answered\*4). The 12 items questionnaire assessed ocular symptoms, visual-related functioning and environmental triggers. Scores ranged from 0 to 100, with higher scores indicating a worse status. Baseline was defined as latest pre-dose assessment (day 1) with a non-missing value, including those from unscheduled visits.
Outcome measures
| Measure |
Belantamab Mafodotin
n=6 Participants
Participants with relapsed/refractory multiple myeloma (RRMM) were administered with 2.5 milligram per kilogram (mg/kg) belantamab mafodotin intravenous (IV) infusion over 30-60 minutes on day 1 of each 21-days cycle. Participants were treated until disease progression, intolerable toxicity, end of study or informed consent withdrawal.
|
|---|---|
|
Change From Baseline in Ocular Surface Disease Index (OSDI) Total Score
|
12.8 Scores on Scale
Standard Deviation 20.43
|
Adverse Events
Belantamab Mafodotin
Serious adverse events
| Measure |
Belantamab Mafodotin
n=6 participants at risk
Participants with relapsed/refractory multiple myeloma (RRMM) were administered with 2.5 milligram per kilogram (mg/kg) belantamab mafodotin intravenous (IV) infusion over 30-60 minutes on day 1 of each 21-days cycle. Participants were treated until disease progression, intolerable toxicity, end of study or informed consent withdrawal.
|
|---|---|
|
Blood and lymphatic system disorders
Myelosuppression
|
16.7%
1/6 • Number of events 1 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAE) were collected for up to 24 months and 21 days
All treated population included all eligible participants who received at least 1 dose of study treatment.
|
|
Hepatobiliary disorders
Liver injury
|
16.7%
1/6 • Number of events 1 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAE) were collected for up to 24 months and 21 days
All treated population included all eligible participants who received at least 1 dose of study treatment.
|
|
Investigations
Platelet count decreased
|
16.7%
1/6 • Number of events 1 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAE) were collected for up to 24 months and 21 days
All treated population included all eligible participants who received at least 1 dose of study treatment.
|
Other adverse events
| Measure |
Belantamab Mafodotin
n=6 participants at risk
Participants with relapsed/refractory multiple myeloma (RRMM) were administered with 2.5 milligram per kilogram (mg/kg) belantamab mafodotin intravenous (IV) infusion over 30-60 minutes on day 1 of each 21-days cycle. Participants were treated until disease progression, intolerable toxicity, end of study or informed consent withdrawal.
|
|---|---|
|
Investigations
Platelet count decreased
|
66.7%
4/6 • Number of events 10 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAE) were collected for up to 24 months and 21 days
All treated population included all eligible participants who received at least 1 dose of study treatment.
|
|
Investigations
Blood lactate dehydrogenase increased
|
66.7%
4/6 • Number of events 7 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAE) were collected for up to 24 months and 21 days
All treated population included all eligible participants who received at least 1 dose of study treatment.
|
|
Investigations
Lymphocyte count decreased
|
66.7%
4/6 • Number of events 7 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAE) were collected for up to 24 months and 21 days
All treated population included all eligible participants who received at least 1 dose of study treatment.
|
|
Investigations
Aspartate aminotransferase increased
|
50.0%
3/6 • Number of events 5 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAE) were collected for up to 24 months and 21 days
All treated population included all eligible participants who received at least 1 dose of study treatment.
|
|
Investigations
Neutrophil count decreased
|
50.0%
3/6 • Number of events 5 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAE) were collected for up to 24 months and 21 days
All treated population included all eligible participants who received at least 1 dose of study treatment.
|
|
Investigations
White blood cell count decreased
|
50.0%
3/6 • Number of events 4 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAE) were collected for up to 24 months and 21 days
All treated population included all eligible participants who received at least 1 dose of study treatment.
|
|
Investigations
Alanine aminotransferase increased
|
33.3%
2/6 • Number of events 6 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAE) were collected for up to 24 months and 21 days
All treated population included all eligible participants who received at least 1 dose of study treatment.
|
|
Investigations
Blood alkaline phosphatase increased
|
33.3%
2/6 • Number of events 3 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAE) were collected for up to 24 months and 21 days
All treated population included all eligible participants who received at least 1 dose of study treatment.
|
|
Investigations
Adenosine deaminase increased
|
16.7%
1/6 • Number of events 2 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAE) were collected for up to 24 months and 21 days
All treated population included all eligible participants who received at least 1 dose of study treatment.
|
|
Investigations
Alpha hydroxybutyrate dehydrogenase increased
|
16.7%
1/6 • Number of events 2 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAE) were collected for up to 24 months and 21 days
All treated population included all eligible participants who received at least 1 dose of study treatment.
|
|
Investigations
Blood creatine phosphokinase increased
|
16.7%
1/6 • Number of events 2 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAE) were collected for up to 24 months and 21 days
All treated population included all eligible participants who received at least 1 dose of study treatment.
|
|
Investigations
Glycocholic acid increased
|
16.7%
1/6 • Number of events 2 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAE) were collected for up to 24 months and 21 days
All treated population included all eligible participants who received at least 1 dose of study treatment.
|
|
Investigations
Protein total decreased
|
16.7%
1/6 • Number of events 2 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAE) were collected for up to 24 months and 21 days
All treated population included all eligible participants who received at least 1 dose of study treatment.
|
|
Investigations
Crystal urine present
|
16.7%
1/6 • Number of events 1 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAE) were collected for up to 24 months and 21 days
All treated population included all eligible participants who received at least 1 dose of study treatment.
|
|
Investigations
Electrocardiogram QT prolonged
|
16.7%
1/6 • Number of events 1 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAE) were collected for up to 24 months and 21 days
All treated population included all eligible participants who received at least 1 dose of study treatment.
|
|
Investigations
Gamma-glutamyltransferase increased
|
16.7%
1/6 • Number of events 1 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAE) were collected for up to 24 months and 21 days
All treated population included all eligible participants who received at least 1 dose of study treatment.
|
|
Investigations
Leucine aminopeptidase increased
|
16.7%
1/6 • Number of events 1 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAE) were collected for up to 24 months and 21 days
All treated population included all eligible participants who received at least 1 dose of study treatment.
|
|
Investigations
Lymphocyte count increased
|
16.7%
1/6 • Number of events 1 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAE) were collected for up to 24 months and 21 days
All treated population included all eligible participants who received at least 1 dose of study treatment.
|
|
Investigations
Prealbumin decreased
|
16.7%
1/6 • Number of events 1 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAE) were collected for up to 24 months and 21 days
All treated population included all eligible participants who received at least 1 dose of study treatment.
|
|
Investigations
Total bile acids increased
|
16.7%
1/6 • Number of events 1 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAE) were collected for up to 24 months and 21 days
All treated population included all eligible participants who received at least 1 dose of study treatment.
|
|
Investigations
Urinary occult blood
|
16.7%
1/6 • Number of events 1 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAE) were collected for up to 24 months and 21 days
All treated population included all eligible participants who received at least 1 dose of study treatment.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
66.7%
4/6 • Number of events 6 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAE) were collected for up to 24 months and 21 days
All treated population included all eligible participants who received at least 1 dose of study treatment.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
50.0%
3/6 • Number of events 4 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAE) were collected for up to 24 months and 21 days
All treated population included all eligible participants who received at least 1 dose of study treatment.
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
50.0%
3/6 • Number of events 3 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAE) were collected for up to 24 months and 21 days
All treated population included all eligible participants who received at least 1 dose of study treatment.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
33.3%
2/6 • Number of events 2 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAE) were collected for up to 24 months and 21 days
All treated population included all eligible participants who received at least 1 dose of study treatment.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
33.3%
2/6 • Number of events 2 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAE) were collected for up to 24 months and 21 days
All treated population included all eligible participants who received at least 1 dose of study treatment.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
33.3%
2/6 • Number of events 2 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAE) were collected for up to 24 months and 21 days
All treated population included all eligible participants who received at least 1 dose of study treatment.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
33.3%
2/6 • Number of events 2 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAE) were collected for up to 24 months and 21 days
All treated population included all eligible participants who received at least 1 dose of study treatment.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
16.7%
1/6 • Number of events 1 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAE) were collected for up to 24 months and 21 days
All treated population included all eligible participants who received at least 1 dose of study treatment.
|
|
Eye disorders
Punctate keratitis
|
33.3%
2/6 • Number of events 3 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAE) were collected for up to 24 months and 21 days
All treated population included all eligible participants who received at least 1 dose of study treatment.
|
|
Eye disorders
Vision blurred
|
33.3%
2/6 • Number of events 3 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAE) were collected for up to 24 months and 21 days
All treated population included all eligible participants who received at least 1 dose of study treatment.
|
|
Eye disorders
Visual impairment
|
16.7%
1/6 • Number of events 1 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAE) were collected for up to 24 months and 21 days
All treated population included all eligible participants who received at least 1 dose of study treatment.
|
|
General disorders
Pyrexia
|
50.0%
3/6 • Number of events 4 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAE) were collected for up to 24 months and 21 days
All treated population included all eligible participants who received at least 1 dose of study treatment.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
16.7%
1/6 • Number of events 1 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAE) were collected for up to 24 months and 21 days
All treated population included all eligible participants who received at least 1 dose of study treatment.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
16.7%
1/6 • Number of events 1 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAE) were collected for up to 24 months and 21 days
All treated population included all eligible participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Mouth ulceration
|
16.7%
1/6 • Number of events 1 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAE) were collected for up to 24 months and 21 days
All treated population included all eligible participants who received at least 1 dose of study treatment.
|
|
Nervous system disorders
Trigeminal neuralgia
|
16.7%
1/6 • Number of events 1 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAE) were collected for up to 24 months and 21 days
All treated population included all eligible participants who received at least 1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
16.7%
1/6 • Number of events 1 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAE) were collected for up to 24 months and 21 days
All treated population included all eligible participants who received at least 1 dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Purpura
|
16.7%
1/6 • Number of events 1 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAE) were collected for up to 24 months and 21 days
All treated population included all eligible participants who received at least 1 dose of study treatment.
|
|
Vascular disorders
Hypertension
|
16.7%
1/6 • Number of events 1 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAE) were collected for up to 24 months and 21 days
All treated population included all eligible participants who received at least 1 dose of study treatment.
|
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