Trial Outcomes & Findings for Study of Panobinostat in Combination With Bortezomib and Dexamethasone in Japanese Patients With Relapsed/Refractory Multiple Myeloma (NCT NCT02290431)
NCT ID: NCT02290431
Last Updated: 2019-11-18
Results Overview
nCR plus CR rate after 8 cycles of therapy as defined by the modified European Society for Bone and Marrow Transplantation (EBMT) criteria per investigator assessment as the proportion of participants with nCR or CR as their best overall response.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
31 participants
Primary outcome timeframe
after 24 weeks (8 cycles; cycle = 21 days)
Results posted on
2019-11-18
Participant Flow
Approximately 33 eligible subjects were planned to be enrolled. 31 eligible subjects were enrolled and treated with PAN+BTZ+Dex (Treatment phase 1), of which 17 subjects entered Treatment phase 2. All 31 subjects entered the post-treatment evaluation phase, of which 22 discontinued the study. 24 subjects entered the survival follow-up phase.
Participant milestones
| Measure |
LBH589 + Bortezomib + Dexamethasone
Participants were administered LBH589 (panobinostat)in combination with bortezomib and dexamethasone 2 weeks on/1 week off.
|
|---|---|
|
Overall Study
STARTED
|
31
|
|
Overall Study
Subjects. Discont. Prematurely
|
27
|
|
Overall Study
Subjects Completed Study Per Protocol
|
8
|
|
Overall Study
Subjs. Ntered Post-treatment Eval. Phase
|
31
|
|
Overall Study
Subjects Entered Survival f/u Phase
|
24
|
|
Overall Study
Entered Treatment Phase 2
|
17
|
|
Overall Study
COMPLETED
|
4
|
|
Overall Study
NOT COMPLETED
|
27
|
Reasons for withdrawal
| Measure |
LBH589 + Bortezomib + Dexamethasone
Participants were administered LBH589 (panobinostat)in combination with bortezomib and dexamethasone 2 weeks on/1 week off.
|
|---|---|
|
Overall Study
Adverse Event
|
20
|
|
Overall Study
Progressive disease
|
4
|
|
Overall Study
Study terminated by Sponsor
|
1
|
|
Overall Study
Physician Decision
|
2
|
Baseline Characteristics
Study of Panobinostat in Combination With Bortezomib and Dexamethasone in Japanese Patients With Relapsed/Refractory Multiple Myeloma
Baseline characteristics by cohort
| Measure |
LBH589 + Bortezomib + Dexamethasone
n=31 Participants
Participants were administered LBH589 (panobinostat)in combination with bortezomib and dexamethasone 2 weeks on/1 week off.
|
|---|---|
|
Age, Continuous
|
67.8 years
STANDARD_DEVIATION 6.09 • n=99 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Japanese
|
31 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: after 24 weeks (8 cycles; cycle = 21 days)Population: Full Analysis Set (FAS): The Full analysis set (FAS) comprised of all subjects who took at least one dose of any study treatment component.
nCR plus CR rate after 8 cycles of therapy as defined by the modified European Society for Bone and Marrow Transplantation (EBMT) criteria per investigator assessment as the proportion of participants with nCR or CR as their best overall response.
Outcome measures
| Measure |
LBH589 + Bortezomib + Dexamethasone
n=31 Participants
Participants were administered LBH589 (panobinostat)in combination with bortezomib and dexamethasone 2 weeks on/1 week off.
|
|---|---|
|
Percentage of Participants With Near Complete Response (nCR)/ Complete Response (CR) Rate
|
48.4 Percentage of participants
Interval 33.6 to 63.2
|
SECONDARY outcome
Timeframe: duration of study up to approx. 4 yearsPopulation: FAS: The FAS comprised of all subjects who took at least one dose of any study treatment component.
PFS is defined as time from first dose of study treatment to progression or death due to any cause, based on modified European Society for Bone and Marrow Transplantation (EBMT) criteria per Investigator's assessment
Outcome measures
| Measure |
LBH589 + Bortezomib + Dexamethasone
n=31 Participants
Participants were administered LBH589 (panobinostat)in combination with bortezomib and dexamethasone 2 weeks on/1 week off.
|
|---|---|
|
Progression Free Survival (PFS)
|
15.3 months
Interval 10.4 to 31.4
|
SECONDARY outcome
Timeframe: 24 weeks (8 cycles; cycle = 21 days)Population: FAS: The FAS comprised of all subjects who took at least one dose of any study treatment component.
ORR is defined as the proportion of participants with CR, nCR or partial response (PR) based on modified EBMT criteria per investigator assessment
Outcome measures
| Measure |
LBH589 + Bortezomib + Dexamethasone
n=31 Participants
Participants were administered LBH589 (panobinostat)in combination with bortezomib and dexamethasone 2 weeks on/1 week off.
|
|---|---|
|
Overall Response Rate (ORR)
|
80.6 Percentage of participants
Interval 62.5 to 92.5
|
SECONDARY outcome
Timeframe: up to 30 days after end of study, approx. 4 yearsPopulation: FAS: The FAS comprised of all subjects who took at least one dose of any study treatment component.
OS is defined as time from first dose of study treatment to death
Outcome measures
| Measure |
LBH589 + Bortezomib + Dexamethasone
n=31 Participants
Participants were administered LBH589 (panobinostat)in combination with bortezomib and dexamethasone 2 weeks on/1 week off.
|
|---|---|
|
Overall Survival (OS)
|
NA months
N/A = not estimable as most of the participants were still alive and censored.
|
SECONDARY outcome
Timeframe: after 24 weeks (8 cycles; cycle = 21 days)Population: FAS: The FAS comprised of all subjects who took at least one dose of any study treatment component.
MRR is based on modified EBMT criteria per investigator assessment
Outcome measures
| Measure |
LBH589 + Bortezomib + Dexamethasone
n=31 Participants
Participants were administered LBH589 (panobinostat)in combination with bortezomib and dexamethasone 2 weeks on/1 week off.
|
|---|---|
|
Minimal Response Rate (MRR) Per Investigator
|
9.7 Percentage of participants
|
SECONDARY outcome
Timeframe: duration of study up to approx. 4 yearsPopulation: FAS: The FAS comprised of all subjects who took at least one dose of any study treatment component.
TTR is defined as the time from the date of first dose of study treatment to first documented response (PR or nCR or CR) per modified EBMT criteria as assessed by investigator
Outcome measures
| Measure |
LBH589 + Bortezomib + Dexamethasone
n=31 Participants
Participants were administered LBH589 (panobinostat)in combination with bortezomib and dexamethasone 2 weeks on/1 week off.
|
|---|---|
|
Time to Response (TTR) Per Investigator
|
1.4 months
Interval 0.7 to 2.1
|
SECONDARY outcome
Timeframe: duration of study up to approx. 4 yearsPopulation: FAS: The FAS comprised of all subjects who took at least one dose of any study treatment component.
TTP is defined as the time from the date of the first dose of study treatment to the date of the first documented disease progression or relapse
Outcome measures
| Measure |
LBH589 + Bortezomib + Dexamethasone
n=31 Participants
Participants were administered LBH589 (panobinostat)in combination with bortezomib and dexamethasone 2 weeks on/1 week off.
|
|---|---|
|
Time to Progression/Relapse (TTP) Per Investigator
|
15.3 months
Interval 10.4 to 31.4
|
SECONDARY outcome
Timeframe: duration of study up to approx. 4 yearsPopulation: FAS: The FAS comprised of all subjects who took at least one dose of any study treatment component.
DOR is defined as the time from date of the first documented CR/nCR or PR to the date of the first documented progression or relapse or death due to MM
Outcome measures
| Measure |
LBH589 + Bortezomib + Dexamethasone
n=31 Participants
Participants were administered LBH589 (panobinostat)in combination with bortezomib and dexamethasone 2 weeks on/1 week off.
|
|---|---|
|
Duration of Response (DOR) Per Investigator
|
22.7 months
Interval 9.7 to 30.5
|
SECONDARY outcome
Timeframe: Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, and 156Population: FAS: The FAS comprised of all subjects who took at least one dose of any study treatment component.
QoL as measured by Functional Assessment of Cancer Therapy/ Gynecology Oncology Group Neurotoxicity (FACT/GOG-NTX) scale calculated scores and changes from baseline were summarized by visit. The FACT/GOG-Ntx is a measure to assess neurotoxicity from systemic chemotherapy. The recall period for this measure is the past 7 days. FACT/GOG-Ntx Total Score: 0 - 152 (28 + 28 + 24 + 28 + 44 = 152). (FACT-G Physical Well-Being Score: 0 - 28, FACT-G Social/Family Well-Being Score: 0 - 28, FACT-G Emotional Well-Being Score: 0 - 24, FACT-G Functional Well-Being Score: 0 - 28, FACT/GOG-Ntx Neurotoxicity Subscale Score: 0 - 44). 4. The scales are combined. The higher the score, the better the QOL.
Outcome measures
| Measure |
LBH589 + Bortezomib + Dexamethasone
n=31 Participants
Participants were administered LBH589 (panobinostat)in combination with bortezomib and dexamethasone 2 weeks on/1 week off.
|
|---|---|
|
Quality of Life (QoL) as Measured by FACT/GOG-Ntx Total Score
Baseline
|
112.33 scores on a scale
Interval 80.7 to 144.5
|
|
Quality of Life (QoL) as Measured by FACT/GOG-Ntx Total Score
Week 12
|
91.75 scores on a scale
Interval 65.7 to 147.0
|
|
Quality of Life (QoL) as Measured by FACT/GOG-Ntx Total Score
Week 24
|
100.33 scores on a scale
Interval 59.2 to 149.0
|
|
Quality of Life (QoL) as Measured by FACT/GOG-Ntx Total Score
Week 36
|
125.83 scores on a scale
Interval 91.0 to 149.0
|
|
Quality of Life (QoL) as Measured by FACT/GOG-Ntx Total Score
Week 48
|
114.25 scores on a scale
Interval 101.7 to 145.0
|
|
Quality of Life (QoL) as Measured by FACT/GOG-Ntx Total Score
Week 60
|
109.92 scores on a scale
Interval 82.5 to 137.3
|
|
Quality of Life (QoL) as Measured by FACT/GOG-Ntx Total Score
Week 72
|
108.00 scores on a scale
Interval 108.0 to 108.0
|
|
Quality of Life (QoL) as Measured by FACT/GOG-Ntx Total Score
Week 84
|
101.00 scores on a scale
Interval 92.0 to 110.0
|
|
Quality of Life (QoL) as Measured by FACT/GOG-Ntx Total Score
Week 96
|
121.67 scores on a scale
Interval 86.5 to 133.0
|
|
Quality of Life (QoL) as Measured by FACT/GOG-Ntx Total Score
Week 108
|
120.17 scores on a scale
Interval 117.0 to 123.3
|
|
Quality of Life (QoL) as Measured by FACT/GOG-Ntx Total Score
Week 120
|
125.25 scores on a scale
Interval 124.7 to 125.8
|
|
Quality of Life (QoL) as Measured by FACT/GOG-Ntx Total Score
Week 132
|
114.00 scores on a scale
Interval 109.3 to 118.7
|
|
Quality of Life (QoL) as Measured by FACT/GOG-Ntx Total Score
Week 156
|
119.8 scores on a scale
Interval 119.8 to 119.8
|
SECONDARY outcome
Timeframe: Predose, 0.5h, 1h, 2h, 3h, 4h 8h, 24h, 48h post dosePopulation: PAS: Pharmacokinetic Analysis Set (PAS): The PK analysis set for PAN (PAS-PAN) consisted of all subjects with at least one evaluable PK concentration of PAN. The PK analysis set for BTZ (PAS-BTZ) consisted of all subjects with at least one evaluable PK concentration of BTZ.
PK sample collection was performed in subjects who agreed to blood samplings for the PK assessments of PAN and BTZ. The order of administration of the 3 study treatment components was 1) PAN, 2) Dex, and 3) BTZ.
Outcome measures
| Measure |
LBH589 + Bortezomib + Dexamethasone
n=8 Participants
Participants were administered LBH589 (panobinostat)in combination with bortezomib and dexamethasone 2 weeks on/1 week off.
|
|---|---|
|
Composite PharmacoKinetics (PK) of Panobinostat and Bortezomib: AUClast, AUC0-24h, AUC0-48h, AUCinf
PAN: AUClast C1D1
|
106 h.ng/mL
Geometric Coefficient of Variation 14.7
|
|
Composite PharmacoKinetics (PK) of Panobinostat and Bortezomib: AUClast, AUC0-24h, AUC0-48h, AUCinf
PAN: AUClast C1D8
|
156 h.ng/mL
Geometric Coefficient of Variation 31.7
|
|
Composite PharmacoKinetics (PK) of Panobinostat and Bortezomib: AUClast, AUC0-24h, AUC0-48h, AUCinf
BJB432: AUClast C1D1
|
37.8 h.ng/mL
Geometric Coefficient of Variation 38.2
|
|
Composite PharmacoKinetics (PK) of Panobinostat and Bortezomib: AUClast, AUC0-24h, AUC0-48h, AUCinf
BJB432: AUClast C1D8
|
166 h.ng/mL
Geometric Coefficient of Variation 87.7
|
|
Composite PharmacoKinetics (PK) of Panobinostat and Bortezomib: AUClast, AUC0-24h, AUC0-48h, AUCinf
PAN: AUC0-24h C1D1
|
87.1 h.ng/mL
Geometric Coefficient of Variation 13.7
|
|
Composite PharmacoKinetics (PK) of Panobinostat and Bortezomib: AUClast, AUC0-24h, AUC0-48h, AUCinf
PAN: AUC0-24h C1D8
|
125 h.ng/mL
Geometric Coefficient of Variation 30.1
|
|
Composite PharmacoKinetics (PK) of Panobinostat and Bortezomib: AUClast, AUC0-24h, AUC0-48h, AUCinf
BJB432: AUC0-24h C1D1
|
18.5 h.ng/mL
Geometric Coefficient of Variation 33.9
|
|
Composite PharmacoKinetics (PK) of Panobinostat and Bortezomib: AUClast, AUC0-24h, AUC0-48h, AUCinf
BJB432: AUC0-24h C1D8
|
83.8 h.ng/mL
Geometric Coefficient of Variation 76.1
|
|
Composite PharmacoKinetics (PK) of Panobinostat and Bortezomib: AUClast, AUC0-24h, AUC0-48h, AUCinf
PAN: AUC0-48h C1D1
|
106 h.ng/mL
Geometric Coefficient of Variation 14.8
|
|
Composite PharmacoKinetics (PK) of Panobinostat and Bortezomib: AUClast, AUC0-24h, AUC0-48h, AUCinf
PAN: AUC0-48h C1D8
|
156 h.ng/mL
Geometric Coefficient of Variation 31.7
|
|
Composite PharmacoKinetics (PK) of Panobinostat and Bortezomib: AUClast, AUC0-24h, AUC0-48h, AUCinf
BJB432: AUC0-48h C1D1
|
36.8 h.ng/mL
Geometric Coefficient of Variation 40.6
|
|
Composite PharmacoKinetics (PK) of Panobinostat and Bortezomib: AUClast, AUC0-24h, AUC0-48h, AUCinf
BJB432: AUC0-48h C1D8
|
169 h.ng/mL
Geometric Coefficient of Variation 98.8
|
|
Composite PharmacoKinetics (PK) of Panobinostat and Bortezomib: AUClast, AUC0-24h, AUC0-48h, AUCinf
PAN: AUCinf C1D1
|
116 h.ng/mL
Geometric Coefficient of Variation 15.5
|
|
Composite PharmacoKinetics (PK) of Panobinostat and Bortezomib: AUClast, AUC0-24h, AUC0-48h, AUCinf
PAN: AUCinf C1D8
|
175 h.ng/mL
Geometric Coefficient of Variation 32.7
|
SECONDARY outcome
Timeframe: Predose, 0.5h, 1h, 2h, 3h, 4h 8h, 24h, 48h post dosePopulation: Pharmacokinetic Analysis Set (PAS): The PK analysis set for PAN (PAS-PAN) consisted of all subjects with at least one evaluable PK concentration of PAN. The PK analysis set for BTZ (PAS-BTZ) consisted of all subjects with at least one evaluable PK concentration of BTZ.
Cmax: The maximum (peak) observed plasma concentration. PK sample collection was performed in subjects who agreed to blood samplings for the PK assessments of PAN and BTZ. The order of administration of the 3 study treatment components was 1) PAN, 2) Dex, and 3) BTZ.
Outcome measures
| Measure |
LBH589 + Bortezomib + Dexamethasone
n=8 Participants
Participants were administered LBH589 (panobinostat)in combination with bortezomib and dexamethasone 2 weeks on/1 week off.
|
|---|---|
|
Composite PharmacoKinetics (PK) of Panobinostat and Bortezomib: Cmax
PAN: Cycle 1 Day 1 (C1D1)
|
11.5 ng/mL
Geometric Coefficient of Variation 30.4
|
|
Composite PharmacoKinetics (PK) of Panobinostat and Bortezomib: Cmax
PAN: Cycle 1 Day 8 (C1D8)
|
18.2 ng/mL
Geometric Coefficient of Variation 41.5
|
|
Composite PharmacoKinetics (PK) of Panobinostat and Bortezomib: Cmax
BJB432: C1D1
|
1.06 ng/mL
Geometric Coefficient of Variation 42.1
|
|
Composite PharmacoKinetics (PK) of Panobinostat and Bortezomib: Cmax
BJB432: C1D8
|
4.38 ng/mL
Geometric Coefficient of Variation 84.2
|
SECONDARY outcome
Timeframe: Predose, 0.5h, 1h, 2h, 3h, 4h 8h, 24h, 48h post dosePopulation: PAS: Pharmacokinetic Analysis Set (PAS): The PK analysis set for PAN (PAS-PAN) consisted of all subjects with at least one evaluable PK concentration of PAN. The PK analysis set for BTZ (PAS-BTZ) consisted of all subjects with at least one evaluable PK concentration of BTZ.
Tmax: The time to reach maximum (peak) plasma concentration. PK sample collection was performed in subjects who agreed to blood samplings for the PK assessments of PAN and BTZ. The order of administration of the 3 study treatment components was 1) PAN, 2) Dex, and 3) BTZ.
Outcome measures
| Measure |
LBH589 + Bortezomib + Dexamethasone
n=8 Participants
Participants were administered LBH589 (panobinostat)in combination with bortezomib and dexamethasone 2 weeks on/1 week off.
|
|---|---|
|
Composite PharmacoKinetics (PK) of Panobinostat and Bortezomib: Tmax
PAN: C1D1
|
2.00 hour (h)
Interval 1.0 to 4.0
|
|
Composite PharmacoKinetics (PK) of Panobinostat and Bortezomib: Tmax
PAN: C1D8
|
2.00 hour (h)
Interval 0.533 to 3.08
|
|
Composite PharmacoKinetics (PK) of Panobinostat and Bortezomib: Tmax
BJB432: C1D1
|
24.0 hour (h)
Interval 4.0 to 48.0
|
|
Composite PharmacoKinetics (PK) of Panobinostat and Bortezomib: Tmax
BJB432: C1D8
|
24.0 hour (h)
Interval 3.0 to 24.1
|
SECONDARY outcome
Timeframe: Predose, 0.5h, 1h, 2h, 3h, 4h 8h, 24h 48h post dosePopulation: PAS: Pharmacokinetic Analysis Set (PAS): The PK analysis set for PAN (PAS-PAN) consisted of all subjects with at least one evaluable PK concentration of PAN. The PK analysis set for BTZ (PAS-BTZ) consisted of all subjects with at least one evaluable PK concentration of BTZ.
T1/2: The elimination half-life associated with the terminal slope (Lambda\_z) of a semi logarithmic concentration-time curve
Outcome measures
| Measure |
LBH589 + Bortezomib + Dexamethasone
n=8 Participants
Participants were administered LBH589 (panobinostat)in combination with bortezomib and dexamethasone 2 weeks on/1 week off.
|
|---|---|
|
Composite PharmacoKinetics (PK) of Panobinostat and Bortezomib: T1/2
PAN: C1D1
|
13.7 hour (h)
Geometric Coefficient of Variation 21.7
|
|
Composite PharmacoKinetics (PK) of Panobinostat and Bortezomib: T1/2
PAN: C1D8
|
16.5 hour (h)
Geometric Coefficient of Variation 5.2
|
SECONDARY outcome
Timeframe: Predose, 0.5h, 1h, 2h, 3h, 4h 8h, 24h 48h post dosePopulation: PAS: Pharmacokinetic Analysis Set (PAS): The PK analysis set for PAN (PAS-PAN) consisted of all subjects with at least one evaluable PK concentration of PAN. The PK analysis set for BTZ (PAS-BTZ) consisted of all subjects with at least one evaluable PK concentration of BTZ.
Lambda\_z: The terminal elimination rate constant (h-1)
Outcome measures
| Measure |
LBH589 + Bortezomib + Dexamethasone
n=8 Participants
Participants were administered LBH589 (panobinostat)in combination with bortezomib and dexamethasone 2 weeks on/1 week off.
|
|---|---|
|
Composite PharmacoKinetics (PK) of Panobinostat and Bortezomib: Lambda_z
PAN: C1D1
|
0.0506 1/hour (1/h)
Geometric Coefficient of Variation 21.7
|
|
Composite PharmacoKinetics (PK) of Panobinostat and Bortezomib: Lambda_z
PAN: C1D8
|
0.0421 1/hour (1/h)
Geometric Coefficient of Variation 5.2
|
SECONDARY outcome
Timeframe: Predose, 0.5h, 1h, 2h, 3h, 4h 8h, 24h 48h post dosePopulation: PAS: Pharmacokinetic Analysis Set (PAS): The PK analysis set for PAN (PAS-PAN) consisted of all subjects with at least one evaluable PK concentration of PAN. The PK analysis set for BTZ (PAS-BTZ) consisted of all subjects with at least one evaluable PK concentration of BTZ.
CL/F: The apparent total body clearance of drug from the plasma
Outcome measures
| Measure |
LBH589 + Bortezomib + Dexamethasone
n=8 Participants
Participants were administered LBH589 (panobinostat)in combination with bortezomib and dexamethasone 2 weeks on/1 week off.
|
|---|---|
|
Composite PharmacoKinetics (PK) of Panobinostat and Bortezomib: CL/F
PAN: C1D1
|
172 Litre/hour (L/h)
Geometric Coefficient of Variation 15.5
|
|
Composite PharmacoKinetics (PK) of Panobinostat and Bortezomib: CL/F
PAN: C1D8
|
114 Litre/hour (L/h)
Geometric Coefficient of Variation 32.7
|
SECONDARY outcome
Timeframe: Predose, 0.5h, 1h, 2h, 3h, 4h 8h, 24h 48h post dosePopulation: PAS: Pharmacokinetic Analysis Set (PAS): The PK analysis set for PAN (PAS-PAN) consisted of all subjects with at least one evaluable PK concentration of PAN. The PK analysis set for BTZ (PAS-BTZ) consisted of all subjects with at least one evaluable PK concentration of BTZ.
Vz/F: The apparent volume of distribution during terminal phase (associated with Lambda\_z)
Outcome measures
| Measure |
LBH589 + Bortezomib + Dexamethasone
n=8 Participants
Participants were administered LBH589 (panobinostat)in combination with bortezomib and dexamethasone 2 weeks on/1 week off.
|
|---|---|
|
Composite PharmacoKinetics (PK) of Panobinostat and Bortezomib: Vz/F
PAN: C1D1
|
3390 Litre (L)
Geometric Coefficient of Variation 20.2
|
|
Composite PharmacoKinetics (PK) of Panobinostat and Bortezomib: Vz/F
PAN: C1D8
|
2720 Litre (L)
Geometric Coefficient of Variation 31.6
|
Adverse Events
LBH589 + Bortezomib + Dexamethasone
Serious events: 14 serious events
Other events: 31 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
LBH589 + Bortezomib + Dexamethasone
n=31 participants at risk
Participants were administered LBH589 (panobinostat)in combination with bortezomib and dexamethasone 2 weeks on/1 week off.
|
|---|---|
|
Blood and lymphatic system disorders
Coagulopathy
|
3.2%
1/31 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 985 days on panobinostat + bortezomib + dexamethasone (PAN + BTZ + Dex).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
6.5%
2/31 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 985 days on panobinostat + bortezomib + dexamethasone (PAN + BTZ + Dex).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Eye disorders
Cataract
|
3.2%
1/31 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 985 days on panobinostat + bortezomib + dexamethasone (PAN + BTZ + Dex).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
General disorders
Asthenia
|
3.2%
1/31 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 985 days on panobinostat + bortezomib + dexamethasone (PAN + BTZ + Dex).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
General disorders
Fatigue
|
6.5%
2/31 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 985 days on panobinostat + bortezomib + dexamethasone (PAN + BTZ + Dex).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
General disorders
Malaise
|
3.2%
1/31 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 985 days on panobinostat + bortezomib + dexamethasone (PAN + BTZ + Dex).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
General disorders
Pyrexia
|
3.2%
1/31 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 985 days on panobinostat + bortezomib + dexamethasone (PAN + BTZ + Dex).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Infections and infestations
Herpes zoster
|
3.2%
1/31 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 985 days on panobinostat + bortezomib + dexamethasone (PAN + BTZ + Dex).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Infections and infestations
Pneumonia
|
12.9%
4/31 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 985 days on panobinostat + bortezomib + dexamethasone (PAN + BTZ + Dex).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Infections and infestations
Pyelonephritis
|
3.2%
1/31 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 985 days on panobinostat + bortezomib + dexamethasone (PAN + BTZ + Dex).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Infections and infestations
Sepsis
|
3.2%
1/31 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 985 days on panobinostat + bortezomib + dexamethasone (PAN + BTZ + Dex).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Investigations
Platelet count decreased
|
6.5%
2/31 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 985 days on panobinostat + bortezomib + dexamethasone (PAN + BTZ + Dex).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Metabolism and nutrition disorders
Dehydration
|
3.2%
1/31 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 985 days on panobinostat + bortezomib + dexamethasone (PAN + BTZ + Dex).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Nervous system disorders
Dizziness
|
3.2%
1/31 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 985 days on panobinostat + bortezomib + dexamethasone (PAN + BTZ + Dex).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
3.2%
1/31 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 985 days on panobinostat + bortezomib + dexamethasone (PAN + BTZ + Dex).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
3.2%
1/31 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 985 days on panobinostat + bortezomib + dexamethasone (PAN + BTZ + Dex).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Vascular disorders
Hypertension
|
3.2%
1/31 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 985 days on panobinostat + bortezomib + dexamethasone (PAN + BTZ + Dex).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Vascular disorders
Orthostatic hypotension
|
3.2%
1/31 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 985 days on panobinostat + bortezomib + dexamethasone (PAN + BTZ + Dex).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
Other adverse events
| Measure |
LBH589 + Bortezomib + Dexamethasone
n=31 participants at risk
Participants were administered LBH589 (panobinostat)in combination with bortezomib and dexamethasone 2 weeks on/1 week off.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
32.3%
10/31 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 985 days on panobinostat + bortezomib + dexamethasone (PAN + BTZ + Dex).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Blood and lymphatic system disorders
Leukopenia
|
12.9%
4/31 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 985 days on panobinostat + bortezomib + dexamethasone (PAN + BTZ + Dex).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
16.1%
5/31 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 985 days on panobinostat + bortezomib + dexamethasone (PAN + BTZ + Dex).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Blood and lymphatic system disorders
Neutropenia
|
22.6%
7/31 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 985 days on panobinostat + bortezomib + dexamethasone (PAN + BTZ + Dex).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
54.8%
17/31 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 985 days on panobinostat + bortezomib + dexamethasone (PAN + BTZ + Dex).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Eye disorders
Cataract
|
9.7%
3/31 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 985 days on panobinostat + bortezomib + dexamethasone (PAN + BTZ + Dex).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Gastrointestinal disorders
Constipation
|
41.9%
13/31 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 985 days on panobinostat + bortezomib + dexamethasone (PAN + BTZ + Dex).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
80.6%
25/31 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 985 days on panobinostat + bortezomib + dexamethasone (PAN + BTZ + Dex).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Gastrointestinal disorders
Dyspepsia
|
6.5%
2/31 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 985 days on panobinostat + bortezomib + dexamethasone (PAN + BTZ + Dex).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Gastrointestinal disorders
Gastritis
|
9.7%
3/31 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 985 days on panobinostat + bortezomib + dexamethasone (PAN + BTZ + Dex).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Gastrointestinal disorders
Nausea
|
48.4%
15/31 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 985 days on panobinostat + bortezomib + dexamethasone (PAN + BTZ + Dex).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Gastrointestinal disorders
Stomatitis
|
6.5%
2/31 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 985 days on panobinostat + bortezomib + dexamethasone (PAN + BTZ + Dex).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Gastrointestinal disorders
Vomiting
|
29.0%
9/31 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 985 days on panobinostat + bortezomib + dexamethasone (PAN + BTZ + Dex).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
General disorders
Face oedema
|
6.5%
2/31 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 985 days on panobinostat + bortezomib + dexamethasone (PAN + BTZ + Dex).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
General disorders
Fatigue
|
32.3%
10/31 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 985 days on panobinostat + bortezomib + dexamethasone (PAN + BTZ + Dex).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
General disorders
Injection site reaction
|
9.7%
3/31 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 985 days on panobinostat + bortezomib + dexamethasone (PAN + BTZ + Dex).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
General disorders
Malaise
|
32.3%
10/31 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 985 days on panobinostat + bortezomib + dexamethasone (PAN + BTZ + Dex).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
General disorders
Oedema peripheral
|
25.8%
8/31 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 985 days on panobinostat + bortezomib + dexamethasone (PAN + BTZ + Dex).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
General disorders
Pyrexia
|
22.6%
7/31 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 985 days on panobinostat + bortezomib + dexamethasone (PAN + BTZ + Dex).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
12.9%
4/31 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 985 days on panobinostat + bortezomib + dexamethasone (PAN + BTZ + Dex).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Infections and infestations
Conjunctivitis
|
6.5%
2/31 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 985 days on panobinostat + bortezomib + dexamethasone (PAN + BTZ + Dex).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Infections and infestations
Gastroenteritis
|
6.5%
2/31 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 985 days on panobinostat + bortezomib + dexamethasone (PAN + BTZ + Dex).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Infections and infestations
Herpes zoster
|
12.9%
4/31 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 985 days on panobinostat + bortezomib + dexamethasone (PAN + BTZ + Dex).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Infections and infestations
Nasopharyngitis
|
22.6%
7/31 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 985 days on panobinostat + bortezomib + dexamethasone (PAN + BTZ + Dex).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Infections and infestations
Pharyngitis
|
6.5%
2/31 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 985 days on panobinostat + bortezomib + dexamethasone (PAN + BTZ + Dex).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Infections and infestations
Upper respiratory tract infection
|
16.1%
5/31 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 985 days on panobinostat + bortezomib + dexamethasone (PAN + BTZ + Dex).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Injury, poisoning and procedural complications
Contusion
|
9.7%
3/31 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 985 days on panobinostat + bortezomib + dexamethasone (PAN + BTZ + Dex).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Investigations
Alanine aminotransferase increased
|
6.5%
2/31 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 985 days on panobinostat + bortezomib + dexamethasone (PAN + BTZ + Dex).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Investigations
Blood alkaline phosphatase increased
|
6.5%
2/31 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 985 days on panobinostat + bortezomib + dexamethasone (PAN + BTZ + Dex).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Investigations
Blood creatinine increased
|
9.7%
3/31 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 985 days on panobinostat + bortezomib + dexamethasone (PAN + BTZ + Dex).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Investigations
C-reactive protein increased
|
9.7%
3/31 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 985 days on panobinostat + bortezomib + dexamethasone (PAN + BTZ + Dex).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Investigations
Gamma-glutamyltransferase increased
|
9.7%
3/31 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 985 days on panobinostat + bortezomib + dexamethasone (PAN + BTZ + Dex).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Investigations
Lymphocyte count decreased
|
22.6%
7/31 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 985 days on panobinostat + bortezomib + dexamethasone (PAN + BTZ + Dex).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Investigations
Neutrophil count decreased
|
29.0%
9/31 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 985 days on panobinostat + bortezomib + dexamethasone (PAN + BTZ + Dex).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Investigations
Platelet count decreased
|
29.0%
9/31 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 985 days on panobinostat + bortezomib + dexamethasone (PAN + BTZ + Dex).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Investigations
Weight decreased
|
12.9%
4/31 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 985 days on panobinostat + bortezomib + dexamethasone (PAN + BTZ + Dex).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Investigations
White blood cell count decreased
|
12.9%
4/31 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 985 days on panobinostat + bortezomib + dexamethasone (PAN + BTZ + Dex).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
58.1%
18/31 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 985 days on panobinostat + bortezomib + dexamethasone (PAN + BTZ + Dex).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Metabolism and nutrition disorders
Dehydration
|
6.5%
2/31 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 985 days on panobinostat + bortezomib + dexamethasone (PAN + BTZ + Dex).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Metabolism and nutrition disorders
Hypermagnesaemia
|
6.5%
2/31 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 985 days on panobinostat + bortezomib + dexamethasone (PAN + BTZ + Dex).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
6.5%
2/31 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 985 days on panobinostat + bortezomib + dexamethasone (PAN + BTZ + Dex).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
19.4%
6/31 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 985 days on panobinostat + bortezomib + dexamethasone (PAN + BTZ + Dex).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
6.5%
2/31 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 985 days on panobinostat + bortezomib + dexamethasone (PAN + BTZ + Dex).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
16.1%
5/31 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 985 days on panobinostat + bortezomib + dexamethasone (PAN + BTZ + Dex).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
12.9%
4/31 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 985 days on panobinostat + bortezomib + dexamethasone (PAN + BTZ + Dex).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
9.7%
3/31 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 985 days on panobinostat + bortezomib + dexamethasone (PAN + BTZ + Dex).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Nervous system disorders
Dysgeusia
|
22.6%
7/31 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 985 days on panobinostat + bortezomib + dexamethasone (PAN + BTZ + Dex).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Nervous system disorders
Neuropathy peripheral
|
19.4%
6/31 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 985 days on panobinostat + bortezomib + dexamethasone (PAN + BTZ + Dex).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
16.1%
5/31 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 985 days on panobinostat + bortezomib + dexamethasone (PAN + BTZ + Dex).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Nervous system disorders
Somnolence
|
6.5%
2/31 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 985 days on panobinostat + bortezomib + dexamethasone (PAN + BTZ + Dex).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Psychiatric disorders
Insomnia
|
22.6%
7/31 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 985 days on panobinostat + bortezomib + dexamethasone (PAN + BTZ + Dex).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Renal and urinary disorders
Pollakiuria
|
6.5%
2/31 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 985 days on panobinostat + bortezomib + dexamethasone (PAN + BTZ + Dex).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Renal and urinary disorders
Renal impairment
|
6.5%
2/31 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 985 days on panobinostat + bortezomib + dexamethasone (PAN + BTZ + Dex).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
6.5%
2/31 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 985 days on panobinostat + bortezomib + dexamethasone (PAN + BTZ + Dex).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
6.5%
2/31 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 985 days on panobinostat + bortezomib + dexamethasone (PAN + BTZ + Dex).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Skin and subcutaneous tissue disorders
Rash
|
16.1%
5/31 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 985 days on panobinostat + bortezomib + dexamethasone (PAN + BTZ + Dex).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Vascular disorders
Hypertension
|
12.9%
4/31 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 985 days on panobinostat + bortezomib + dexamethasone (PAN + BTZ + Dex).
Adverse Event: Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of pooled data (i.e.,data from all sites) in clinical trial or disclosure of trial results in their entirety
- Publication restrictions are in place
Restriction type: OTHER