Multiple Myeloma
Conditions
Keywords
Myeloma, DACi, Bortezomib, Combination, Panobinostat, LBH589D, relapsed, Velcade®, Combination,
Brief summary
Panobinostat (LBH589) is a highly potent pan-deacetylase inhibitor (pan-DACi), inclusive of HDAC6, which disrupts aggresome function, promotes accumulation of cytotoxic misfolded protein aggregates and triggers myeloma cell death. Combination of pan-DAC and protease inhibition by co-treatment with panobinostat (PAN) and bortezomib (BTZ) has demonstrated synergistic cytotoxicity in vitro and in vivo in pre-clinical experiments. Furthermore, clinical experience in advanced multiple myeloma (MM) patients treated by oral panobinostat and i.v bortezomib ± dexamethasone showed very encouraging results for efficacy and manageable toxicity profile. Given the medical need for improved treatment strategies for patients with previously treated and relapsed MM, the purpose of this prospective, multinational, randomized, double-blind, placebo-controlled, parallel group Phase III study is to compare the results in progression-free survival of 2 combination therapies, panobinostat with bortezomib and dexamethasone or placebo with bortezomib and dexamethasone, in patients with previously treated MM whose disease has recurred or progressed.
Interventions
DRUGPanobinostat
Panobinostat was administered 3x week ( 2 weeks on 1 week off)
DRUGBortezomib
Bortezomib was administered 2 x week ( 2weeks on 1 week off)
DRUGDexamethasone
Dexamethasone was adminstered on day of Bortezomib and the day after Bortezomib administration
DRUGPlacebo
Placebo was administered 3x week ( 2 weeks on 1 week off)
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patient has a previous diagnosis of multiple myeloma. 2. Patient requires retreatment for multiple myeloma 3. Patient has measurable M component in serum or urine at study screening
Exclusion criteria
1. Patient who has progressed under all prior lines of anti MM therapy 2. Patient who has been treated by bortezomib before, and did not reach at least a minor response under this therapy, or progressed under it or within 60 days of last dose 3. Patient has shown intolerance to bortezomib or to dexamethasone or components of these drugs or has any contraindication to one or the other drug , following locally applicable prescribing information 4. Patient received prior treatment with DAC inhibitors including panobinostat 5. Patient has impaired cardiac function, or a prolonged QTc interval at screening ECG 6. Patient taking medications with relative risk of prolonging the QT interval or inducing Torsade de pointes 7. Female patient who is pregnant or breast feeding or with childbearing potential and not willing to use a double method of contraception up to 3 months after the end of study treatment. Male patient who is not willing to use a barrier method of contraception up to 3 months after the end of study treatment. Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free Survival Events in Patients Treated With Panobinostat in Combination With Bortezomib and Dexamethasone vs. Patients Treated by Placebo in Combination With Bortezomib and Dexamethasone. | 45 months |
| Progression Free Survival in Patients Treated With Panobinostat in Combination With Bortezomib and Dexamethasone vs. Patients Treated by Placebo in Combination With Bortezomib and Dexamethasone. | 45 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Response Per Investigator Assessment (mEBMT Criteria) of Response Patients Treated With Panobinostat in Combination With Bortezomib and Dexamethasone vs. Patients Treated by Placebo in Combination With Bortezomib and Dexamethasone. | 45 months | — |
| Duration of Response Per Investigator Assessment (mEBMT Criteria) Patients Treated With Panobinostat in Combination With Bortezomib and Dexamethasone vs. Patients Treated by Placebo in Combination With Bortezomib and Dexamethasone. | 45 months | — |
| Time to Progression/Relapse Per Investigator Assessment (mEBMT Criteria) Patients Treated With Panobinostat in Combination With Bortezomib and Dexamethasone vs. Patients Treated by Placebo in Combination With Bortezomib and Dexamethasone. | 45 months | — |
| Overall Survival in Patients Treated With Panobinostat in Combination With Bortezomib and Dexamethasone vs. Patients Treated by Placebo in Combination With Bortezomib and Dexamethasone | 45 months | Number of OS events |
| European Organization for Research and Treatment of Cancer Multiple Myeloma Module (EORTC ) QLQ-C30 - Summary Statistics by Treatment Group | 12, 24 and 48 weeks | The EORTC QLQ-C30 measures functional dimensions (physical, role, emotional, cognitive, and social), three multi-item symptom scales (fatigue, nausea/vomiting, and pain), six single-item symptom scales (dyspnea, sleep disturbance, appetite loss, constipation, diarrhea and financial impact) and a global health status/QoL scale. Disease Symptom is the sum of 30 questions, total score ranges from 0 (best possible outcome) to 100 (worst possible outcome), All subscales of EORTC QLQ-C30 have the same score range of 0 -100. For global health status and other functional scales,an increase from baseline indicates improvement of QoL. Whereas for symptoms scales, fatigue, dyspnea, insomnia, appetite loss, constipation and diarrhea, decrease in scores from baseline indicate improvement in symptoms. |
| Functional Assessment of Chronic Illness Therapy (FACIT) Measurement System : FACT/GOG-NTX-Change From Baseline by Treatment Group | 12, 24 and 48 weeks | Chronic Illness Therapy (FACIT) Measurement System and focuses on four general quality of life domains for physical well being, functional well-being, social/family well-being, and emotional well-being, and includes additional items to characterize treatment-related neurotoxicity. Higher subscales/total scores represent higher QOL. In the case of the neurotoxicity subscale, lower scores correspond to higher neurotoxicity. The recall period referenced in the questionnaire is the past 7 days.Ranges for FACT-G subscales are as follows:.PWB, scale 0 -28, , NtxS scale 0-44, FACT/GOG-Ntx trial outcome index scale is 0-100 and FACT-G scale is also scaled 0-100. An increase from baseline in these scores indicate improvement. |
| European Organization for Research and Treatment of Cancer Multiple Myeloma Module (EORTC) QLQ-MY20-Change From Baseline by Treatment Group | 12, 24 and 48 weeks | Higher values in the disease symptoms and side effects of treatment scores indicate worsening. Higher scores in the future perspective and body image scores indicate improvement. LS Means and SEM are estimated from the repeated measures model. Following factors and covariates are included in the repeated measurement model: time, treatment, treatment by time interaction, number of prior lines of anti-MM therapy (1/ 2 and 3), prior use of BTZ (Yes/ No), baseline score.Disease Symptom is the sum of 20 questions, total score ranges from 0 (best possible outcome) to 100 (worst possible outcome), All subscales of EORTC QLQ-MY20 have the same score range of 0 -100. Decrease in symptom scores from baseline indicate improvement in symptoms. |
| Overall Response Rate in Patients Treated With Panobinostat in Combination With Bortezomib and Dexamethasone vs. Patients Treated by Placebo in Combination With Bortezomib and Dexamethasone. | 45 months | Best overall response based on mEBMT criteria per investigator assessment |
Countries
Argentina, Australia, Austria, Belgium, Brazil, Canada, China, Czechia, Denmark, Egypt, Finland, France, Germany, Greece, Hong Kong, Israel, Italy, Japan, Lebanon, Mexico, Netherlands, Norway, Poland, Russia, Singapore, South Africa, South Korea, Spain, Sweden, Taiwan, Thailand, Turkey (Türkiye), United Kingdom, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Panobinostat + Bortezomib Panobinostat was given 20 mg hard gelatin capsules . Bortezomib was given at 1.3 mg/m2 as a 3 to 5 second bolus intravenous (IV)injection. Dexamethasone was given as an oral dose of 20 mg/day. | 387 |
| Placebo + Bortezomib Placebo was given as a hard gelatin capsule in the image of Panobinostat . Bortezomib was given at 1.3 mg/m2 as a 3 to 5 second bolus intravenous (IV) injection. Dexamethasone was given as an oral dose of 20 mg/day. | 381 |
| Total | 768 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Abnormal test proceedure results | 3 | 8 |
| Overall Study | Administrative problems | 2 | 1 |
| Overall Study | Adverse Event | 130 | 66 |
| Overall Study | Death | 21 | 17 |
| Overall Study | Disease progression | 82 | 153 |
| Overall Study | Lost to Follow-up | 1 | 0 |
| Overall Study | New Cancer therapy | 4 | 7 |
| Overall Study | Protocol Violation | 3 | 4 |
| Overall Study | Untreated | 5 | 5 |
| Overall Study | Withdrawal by Subject | 34 | 18 |
Baseline characteristics
| Characteristic | Placebo + Bortezomib | Panobinostat + Bortezomib | Total |
|---|---|---|---|
| Age, Continuous | 61.8 years STANDARD_DEVIATION 9.43 | 62.4 years STANDARD_DEVIATION 9.34 | 62.1 years STANDARD_DEVIATION 9.38 |
| Race/Ethnicity, Customized Asian | 104 Participants | 128 Participants | 232 Participants |
| Race/Ethnicity, Customized Black | 17 Participants | 5 Participants | 22 Participants |
| Race/Ethnicity, Customized Caucasian | 250 Participants | 249 Participants | 499 Participants |
| Race/Ethnicity, Customized Other | 10 Participants | 5 Participants | 15 Participants |
| Sex: Female, Male Female | 176 Participants | 185 Participants | 361 Participants |
| Sex: Female, Male Male | 205 Participants | 202 Participants | 407 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 379 / 381 | 366 / 377 |
| serious Total, serious adverse events | 228 / 381 | 157 / 377 |
Outcome results
Primary
Progression-free Survival Events in Patients Treated With Panobinostat in Combination With Bortezomib and Dexamethasone vs. Patients Treated by Placebo in Combination With Bortezomib and Dexamethasone.
Time frame: 45 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Panobinostat + Bortezomib | Progression-free Survival Events in Patients Treated With Panobinostat in Combination With Bortezomib and Dexamethasone vs. Patients Treated by Placebo in Combination With Bortezomib and Dexamethasone. | 207 number of events |
| Placebo + Bortezomib | Progression-free Survival Events in Patients Treated With Panobinostat in Combination With Bortezomib and Dexamethasone vs. Patients Treated by Placebo in Combination With Bortezomib and Dexamethasone. | 260 number of events |
Primary
Progression Free Survival in Patients Treated With Panobinostat in Combination With Bortezomib and Dexamethasone vs. Patients Treated by Placebo in Combination With Bortezomib and Dexamethasone.
Time frame: 45 months
Population: Full Analysis Set
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Panobinostat + Bortezomib | Progression Free Survival in Patients Treated With Panobinostat in Combination With Bortezomib and Dexamethasone vs. Patients Treated by Placebo in Combination With Bortezomib and Dexamethasone. | 11.99 months |
| Placebo + Bortezomib | Progression Free Survival in Patients Treated With Panobinostat in Combination With Bortezomib and Dexamethasone vs. Patients Treated by Placebo in Combination With Bortezomib and Dexamethasone. | 8.80 months |
Secondary
Duration of Response Per Investigator Assessment (mEBMT Criteria) Patients Treated With Panobinostat in Combination With Bortezomib and Dexamethasone vs. Patients Treated by Placebo in Combination With Bortezomib and Dexamethasone.
Time frame: 45 months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Panobinostat + Bortezomib | Duration of Response Per Investigator Assessment (mEBMT Criteria) Patients Treated With Panobinostat in Combination With Bortezomib and Dexamethasone vs. Patients Treated by Placebo in Combination With Bortezomib and Dexamethasone. | 13.14 duration of response in months |
| Placebo + Bortezomib | Duration of Response Per Investigator Assessment (mEBMT Criteria) Patients Treated With Panobinostat in Combination With Bortezomib and Dexamethasone vs. Patients Treated by Placebo in Combination With Bortezomib and Dexamethasone. | 10.87 duration of response in months |
Secondary
European Organization for Research and Treatment of Cancer Multiple Myeloma Module (EORTC ) QLQ-C30 - Summary Statistics by Treatment Group
The EORTC QLQ-C30 measures functional dimensions (physical, role, emotional, cognitive, and social), three multi-item symptom scales (fatigue, nausea/vomiting, and pain), six single-item symptom scales (dyspnea, sleep disturbance, appetite loss, constipation, diarrhea and financial impact) and a global health status/QoL scale. Disease Symptom is the sum of 30 questions, total score ranges from 0 (best possible outcome) to 100 (worst possible outcome), All subscales of EORTC QLQ-C30 have the same score range of 0 -100. For global health status and other functional scales,an increase from baseline indicates improvement of QoL. Whereas for symptoms scales, fatigue, dyspnea, insomnia, appetite loss, constipation and diarrhea, decrease in scores from baseline indicate improvement in symptoms.
Time frame: 12, 24 and 48 weeks
Population: Full Analysis Set
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Panobinostat + Bortezomib | European Organization for Research and Treatment of Cancer Multiple Myeloma Module (EORTC ) QLQ-C30 - Summary Statistics by Treatment Group | Global health wk 24 change baseline (n=150,176) | -7.867 score on a scale |
| Panobinostat + Bortezomib | European Organization for Research and Treatment of Cancer Multiple Myeloma Module (EORTC ) QLQ-C30 - Summary Statistics by Treatment Group | Fatigue wk 48 chge(n=38,26) | 4.646 score on a scale |
| Panobinostat + Bortezomib | European Organization for Research and Treatment of Cancer Multiple Myeloma Module (EORTC ) QLQ-C30 - Summary Statistics by Treatment Group | Cognitive functioning wk 12 chge (n=216,240) | -4.464 score on a scale |
| Panobinostat + Bortezomib | European Organization for Research and Treatment of Cancer Multiple Myeloma Module (EORTC ) QLQ-C30 - Summary Statistics by Treatment Group | Dyspnea wk 12 chge (n=217,240) | 13.964 score on a scale |
| Panobinostat + Bortezomib | European Organization for Research and Treatment of Cancer Multiple Myeloma Module (EORTC ) QLQ-C30 - Summary Statistics by Treatment Group | Physical functioning wk 48 chge (n=38,26) | -2.88 score on a scale |
| Panobinostat + Bortezomib | European Organization for Research and Treatment of Cancer Multiple Myeloma Module (EORTC ) QLQ-C30 - Summary Statistics by Treatment Group | Dyspnea wk 24 chge (n=151,177) | 7.939 score on a scale |
| Panobinostat + Bortezomib | European Organization for Research and Treatment of Cancer Multiple Myeloma Module (EORTC ) QLQ-C30 - Summary Statistics by Treatment Group | Cognitive functioning wk 24 chge (n=149,176) | -6.053 score on a scale |
| Panobinostat + Bortezomib | European Organization for Research and Treatment of Cancer Multiple Myeloma Module (EORTC ) QLQ-C30 - Summary Statistics by Treatment Group | Dyspnea wk 48 chge (n=38,26) | 4.118 score on a scale |
| Panobinostat + Bortezomib | European Organization for Research and Treatment of Cancer Multiple Myeloma Module (EORTC ) QLQ-C30 - Summary Statistics by Treatment Group | Physical functioning wk 12 chge (n=217,242) | -9.67 score on a scale |
| Panobinostat + Bortezomib | European Organization for Research and Treatment of Cancer Multiple Myeloma Module (EORTC ) QLQ-C30 - Summary Statistics by Treatment Group | Insomnia wk 12 chge (n=216,239) | 6.283 score on a scale |
| Panobinostat + Bortezomib | European Organization for Research and Treatment of Cancer Multiple Myeloma Module (EORTC ) QLQ-C30 - Summary Statistics by Treatment Group | Cognitive functioning wk 48 chge (n=38,26) | -5.568 score on a scale |
| Panobinostat + Bortezomib | European Organization for Research and Treatment of Cancer Multiple Myeloma Module (EORTC ) QLQ-C30 - Summary Statistics by Treatment Group | Insomnia wk 24 chge (n=149,176) | 10.023 score on a scale |
| Panobinostat + Bortezomib | European Organization for Research and Treatment of Cancer Multiple Myeloma Module (EORTC ) QLQ-C30 - Summary Statistics by Treatment Group | Role functioning wk 12 chge (n=215,237) | -11.159 score on a scale |
| Panobinostat + Bortezomib | European Organization for Research and Treatment of Cancer Multiple Myeloma Module (EORTC ) QLQ-C30 - Summary Statistics by Treatment Group | Insomnia wk 48 chge (n=38,26) | -2.464 score on a scale |
| Panobinostat + Bortezomib | European Organization for Research and Treatment of Cancer Multiple Myeloma Module (EORTC ) QLQ-C30 - Summary Statistics by Treatment Group | Social functioning wk 12 chge (n=216,240) | -8.502 score on a scale |
| Panobinostat + Bortezomib | European Organization for Research and Treatment of Cancer Multiple Myeloma Module (EORTC ) QLQ-C30 - Summary Statistics by Treatment Group | Appetite loss wk 12 chge (n=217,239) | 15.167 score on a scale |
| Panobinostat + Bortezomib | European Organization for Research and Treatment of Cancer Multiple Myeloma Module (EORTC ) QLQ-C30 - Summary Statistics by Treatment Group | Global health wk 48 change baseline (n=38,26) | -2.986 score on a scale |
| Panobinostat + Bortezomib | European Organization for Research and Treatment of Cancer Multiple Myeloma Module (EORTC ) QLQ-C30 - Summary Statistics by Treatment Group | Appetite loss wk 24 chge (n=151,176) | 16.574 score on a scale |
| Panobinostat + Bortezomib | European Organization for Research and Treatment of Cancer Multiple Myeloma Module (EORTC ) QLQ-C30 - Summary Statistics by Treatment Group | Social functioning wk 24 chge (n=148,171) | -8.925 score on a scale |
| Panobinostat + Bortezomib | European Organization for Research and Treatment of Cancer Multiple Myeloma Module (EORTC ) QLQ-C30 - Summary Statistics by Treatment Group | Appetite loss wk 48 chge (n=38,26) | 3.999 score on a scale |
| Panobinostat + Bortezomib | European Organization for Research and Treatment of Cancer Multiple Myeloma Module (EORTC ) QLQ-C30 - Summary Statistics by Treatment Group | Role functioning wk 24 chge (n=150,176) | -11.875 score on a scale |
| Panobinostat + Bortezomib | European Organization for Research and Treatment of Cancer Multiple Myeloma Module (EORTC ) QLQ-C30 - Summary Statistics by Treatment Group | Constipation wk 12 chge (n=215,240) | 4.135 score on a scale |
| Panobinostat + Bortezomib | European Organization for Research and Treatment of Cancer Multiple Myeloma Module (EORTC ) QLQ-C30 - Summary Statistics by Treatment Group | Social functioning wk 48 chge (n=37,26) | -6.104 score on a scale |
| Panobinostat + Bortezomib | European Organization for Research and Treatment of Cancer Multiple Myeloma Module (EORTC ) QLQ-C30 - Summary Statistics by Treatment Group | Constipation wk 24 chge (n=151,177) | -0.153 score on a scale |
| Panobinostat + Bortezomib | European Organization for Research and Treatment of Cancer Multiple Myeloma Module (EORTC ) QLQ-C30 - Summary Statistics by Treatment Group | Physical functioning wk 24 chge (n=151,177) | -9.516 score on a scale |
| Panobinostat + Bortezomib | European Organization for Research and Treatment of Cancer Multiple Myeloma Module (EORTC ) QLQ-C30 - Summary Statistics by Treatment Group | Constipation wk 48 chge (n=38,25) | -0.358 score on a scale |
| Panobinostat + Bortezomib | European Organization for Research and Treatment of Cancer Multiple Myeloma Module (EORTC ) QLQ-C30 - Summary Statistics by Treatment Group | Fatigue wk 12 chge (n=217,241) | 15.122 score on a scale |
| Panobinostat + Bortezomib | European Organization for Research and Treatment of Cancer Multiple Myeloma Module (EORTC ) QLQ-C30 - Summary Statistics by Treatment Group | Diarrhea wk 12 chge (n=217,241) | 18.888 score on a scale |
| Panobinostat + Bortezomib | European Organization for Research and Treatment of Cancer Multiple Myeloma Module (EORTC ) QLQ-C30 - Summary Statistics by Treatment Group | Role functioning wk 48 chge (n=38,26) | -5.927 score on a scale |
| Panobinostat + Bortezomib | European Organization for Research and Treatment of Cancer Multiple Myeloma Module (EORTC ) QLQ-C30 - Summary Statistics by Treatment Group | Diarrhea wk 24 chge (n=150,177) | 23.163 score on a scale |
| Panobinostat + Bortezomib | European Organization for Research and Treatment of Cancer Multiple Myeloma Module (EORTC ) QLQ-C30 - Summary Statistics by Treatment Group | Fatigue wk 24 chge (n=151,176) | 12.677 score on a scale |
| Panobinostat + Bortezomib | European Organization for Research and Treatment of Cancer Multiple Myeloma Module (EORTC ) QLQ-C30 - Summary Statistics by Treatment Group | Diarrhea wk 48 chge (n=38,26) | 20.48 score on a scale |
| Panobinostat + Bortezomib | European Organization for Research and Treatment of Cancer Multiple Myeloma Module (EORTC ) QLQ-C30 - Summary Statistics by Treatment Group | Global health wk 12 change baseline (n=216,239) | -9.853 score on a scale |
| Placebo + Bortezomib | European Organization for Research and Treatment of Cancer Multiple Myeloma Module (EORTC ) QLQ-C30 - Summary Statistics by Treatment Group | Diarrhea wk 48 chge (n=38,26) | 10.996 score on a scale |
| Placebo + Bortezomib | European Organization for Research and Treatment of Cancer Multiple Myeloma Module (EORTC ) QLQ-C30 - Summary Statistics by Treatment Group | Global health wk 12 change baseline (n=216,239) | -4.044 score on a scale |
| Placebo + Bortezomib | European Organization for Research and Treatment of Cancer Multiple Myeloma Module (EORTC ) QLQ-C30 - Summary Statistics by Treatment Group | Global health wk 24 change baseline (n=150,176) | -1.518 score on a scale |
| Placebo + Bortezomib | European Organization for Research and Treatment of Cancer Multiple Myeloma Module (EORTC ) QLQ-C30 - Summary Statistics by Treatment Group | Global health wk 48 change baseline (n=38,26) | 4.345 score on a scale |
| Placebo + Bortezomib | European Organization for Research and Treatment of Cancer Multiple Myeloma Module (EORTC ) QLQ-C30 - Summary Statistics by Treatment Group | Physical functioning wk 12 chge (n=217,242) | -5.393 score on a scale |
| Placebo + Bortezomib | European Organization for Research and Treatment of Cancer Multiple Myeloma Module (EORTC ) QLQ-C30 - Summary Statistics by Treatment Group | Physical functioning wk 24 chge (n=151,177) | -6.456 score on a scale |
| Placebo + Bortezomib | European Organization for Research and Treatment of Cancer Multiple Myeloma Module (EORTC ) QLQ-C30 - Summary Statistics by Treatment Group | Physical functioning wk 48 chge (n=38,26) | 2.037 score on a scale |
| Placebo + Bortezomib | European Organization for Research and Treatment of Cancer Multiple Myeloma Module (EORTC ) QLQ-C30 - Summary Statistics by Treatment Group | Role functioning wk 12 chge (n=215,237) | -6.762 score on a scale |
| Placebo + Bortezomib | European Organization for Research and Treatment of Cancer Multiple Myeloma Module (EORTC ) QLQ-C30 - Summary Statistics by Treatment Group | Role functioning wk 24 chge (n=150,176) | -11.263 score on a scale |
| Placebo + Bortezomib | European Organization for Research and Treatment of Cancer Multiple Myeloma Module (EORTC ) QLQ-C30 - Summary Statistics by Treatment Group | Role functioning wk 48 chge (n=38,26) | -0.401 score on a scale |
| Placebo + Bortezomib | European Organization for Research and Treatment of Cancer Multiple Myeloma Module (EORTC ) QLQ-C30 - Summary Statistics by Treatment Group | Cognitive functioning wk 12 chge (n=216,240) | -1.023 score on a scale |
| Placebo + Bortezomib | European Organization for Research and Treatment of Cancer Multiple Myeloma Module (EORTC ) QLQ-C30 - Summary Statistics by Treatment Group | Cognitive functioning wk 24 chge (n=149,176) | -3.542 score on a scale |
| Placebo + Bortezomib | European Organization for Research and Treatment of Cancer Multiple Myeloma Module (EORTC ) QLQ-C30 - Summary Statistics by Treatment Group | Cognitive functioning wk 48 chge (n=38,26) | -4.042 score on a scale |
| Placebo + Bortezomib | European Organization for Research and Treatment of Cancer Multiple Myeloma Module (EORTC ) QLQ-C30 - Summary Statistics by Treatment Group | Social functioning wk 12 chge (n=216,240) | -3.991 score on a scale |
| Placebo + Bortezomib | European Organization for Research and Treatment of Cancer Multiple Myeloma Module (EORTC ) QLQ-C30 - Summary Statistics by Treatment Group | Social functioning wk 24 chge (n=148,171) | -6.338 score on a scale |
| Placebo + Bortezomib | European Organization for Research and Treatment of Cancer Multiple Myeloma Module (EORTC ) QLQ-C30 - Summary Statistics by Treatment Group | Social functioning wk 48 chge (n=37,26) | 4.617 score on a scale |
| Placebo + Bortezomib | European Organization for Research and Treatment of Cancer Multiple Myeloma Module (EORTC ) QLQ-C30 - Summary Statistics by Treatment Group | Fatigue wk 12 chge (n=217,241) | 7.939 score on a scale |
| Placebo + Bortezomib | European Organization for Research and Treatment of Cancer Multiple Myeloma Module (EORTC ) QLQ-C30 - Summary Statistics by Treatment Group | Fatigue wk 24 chge (n=151,176) | 9.203 score on a scale |
| Placebo + Bortezomib | European Organization for Research and Treatment of Cancer Multiple Myeloma Module (EORTC ) QLQ-C30 - Summary Statistics by Treatment Group | Fatigue wk 48 chge(n=38,26) | -2.625 score on a scale |
| Placebo + Bortezomib | European Organization for Research and Treatment of Cancer Multiple Myeloma Module (EORTC ) QLQ-C30 - Summary Statistics by Treatment Group | Dyspnea wk 12 chge (n=217,240) | 6.266 score on a scale |
| Placebo + Bortezomib | European Organization for Research and Treatment of Cancer Multiple Myeloma Module (EORTC ) QLQ-C30 - Summary Statistics by Treatment Group | Dyspnea wk 24 chge (n=151,177) | 5.308 score on a scale |
| Placebo + Bortezomib | European Organization for Research and Treatment of Cancer Multiple Myeloma Module (EORTC ) QLQ-C30 - Summary Statistics by Treatment Group | Dyspnea wk 48 chge (n=38,26) | 2.82 score on a scale |
| Placebo + Bortezomib | European Organization for Research and Treatment of Cancer Multiple Myeloma Module (EORTC ) QLQ-C30 - Summary Statistics by Treatment Group | Insomnia wk 12 chge (n=216,239) | 7.625 score on a scale |
| Placebo + Bortezomib | European Organization for Research and Treatment of Cancer Multiple Myeloma Module (EORTC ) QLQ-C30 - Summary Statistics by Treatment Group | Insomnia wk 24 chge (n=149,176) | 6.104 score on a scale |
| Placebo + Bortezomib | European Organization for Research and Treatment of Cancer Multiple Myeloma Module (EORTC ) QLQ-C30 - Summary Statistics by Treatment Group | Insomnia wk 48 chge (n=38,26) | -3.442 score on a scale |
| Placebo + Bortezomib | European Organization for Research and Treatment of Cancer Multiple Myeloma Module (EORTC ) QLQ-C30 - Summary Statistics by Treatment Group | Appetite loss wk 12 chge (n=217,239) | 5.383 score on a scale |
| Placebo + Bortezomib | European Organization for Research and Treatment of Cancer Multiple Myeloma Module (EORTC ) QLQ-C30 - Summary Statistics by Treatment Group | Appetite loss wk 24 chge (n=151,176) | 5.861 score on a scale |
| Placebo + Bortezomib | European Organization for Research and Treatment of Cancer Multiple Myeloma Module (EORTC ) QLQ-C30 - Summary Statistics by Treatment Group | Appetite loss wk 48 chge (n=38,26) | -2.963 score on a scale |
| Placebo + Bortezomib | European Organization for Research and Treatment of Cancer Multiple Myeloma Module (EORTC ) QLQ-C30 - Summary Statistics by Treatment Group | Constipation wk 12 chge (n=215,240) | 6.42 score on a scale |
| Placebo + Bortezomib | European Organization for Research and Treatment of Cancer Multiple Myeloma Module (EORTC ) QLQ-C30 - Summary Statistics by Treatment Group | Constipation wk 24 chge (n=151,177) | 0.524 score on a scale |
| Placebo + Bortezomib | European Organization for Research and Treatment of Cancer Multiple Myeloma Module (EORTC ) QLQ-C30 - Summary Statistics by Treatment Group | Constipation wk 48 chge (n=38,25) | -0.946 score on a scale |
| Placebo + Bortezomib | European Organization for Research and Treatment of Cancer Multiple Myeloma Module (EORTC ) QLQ-C30 - Summary Statistics by Treatment Group | Diarrhea wk 12 chge (n=217,241) | 10.206 score on a scale |
| Placebo + Bortezomib | European Organization for Research and Treatment of Cancer Multiple Myeloma Module (EORTC ) QLQ-C30 - Summary Statistics by Treatment Group | Diarrhea wk 24 chge (n=150,177) | 16.406 score on a scale |
Secondary
European Organization for Research and Treatment of Cancer Multiple Myeloma Module (EORTC) QLQ-MY20-Change From Baseline by Treatment Group
Higher values in the disease symptoms and side effects of treatment scores indicate worsening. Higher scores in the future perspective and body image scores indicate improvement. LS Means and SEM are estimated from the repeated measures model. Following factors and covariates are included in the repeated measurement model: time, treatment, treatment by time interaction, number of prior lines of anti-MM therapy (1/ 2 and 3), prior use of BTZ (Yes/ No), baseline score.Disease Symptom is the sum of 20 questions, total score ranges from 0 (best possible outcome) to 100 (worst possible outcome), All subscales of EORTC QLQ-MY20 have the same score range of 0 -100. Decrease in symptom scores from baseline indicate improvement in symptoms.
Time frame: 12, 24 and 48 weeks
Population: Full Analysis Set
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Panobinostat + Bortezomib | European Organization for Research and Treatment of Cancer Multiple Myeloma Module (EORTC) QLQ-MY20-Change From Baseline by Treatment Group | Body image wk 48 chge (n=37,26) | -2.161 score on a scale |
| Panobinostat + Bortezomib | European Organization for Research and Treatment of Cancer Multiple Myeloma Module (EORTC) QLQ-MY20-Change From Baseline by Treatment Group | Disease Symptom wk 12 change baseline (n=215,243) | -4.795 score on a scale |
| Panobinostat + Bortezomib | European Organization for Research and Treatment of Cancer Multiple Myeloma Module (EORTC) QLQ-MY20-Change From Baseline by Treatment Group | Disease Symptom wk 24 change baseline (n=148,177) | -4.401 score on a scale |
| Panobinostat + Bortezomib | European Organization for Research and Treatment of Cancer Multiple Myeloma Module (EORTC) QLQ-MY20-Change From Baseline by Treatment Group | Disease Symptom wk 48 change baseline (n=37,26) | -2.836 score on a scale |
| Panobinostat + Bortezomib | European Organization for Research and Treatment of Cancer Multiple Myeloma Module (EORTC) QLQ-MY20-Change From Baseline by Treatment Group | Side effects of treatment wk 12 chge (n=213,242) | 8.162 score on a scale |
| Panobinostat + Bortezomib | European Organization for Research and Treatment of Cancer Multiple Myeloma Module (EORTC) QLQ-MY20-Change From Baseline by Treatment Group | Side effects of treatment wk 24 chge (n=148,175) | 9.016 score on a scale |
| Panobinostat + Bortezomib | European Organization for Research and Treatment of Cancer Multiple Myeloma Module (EORTC) QLQ-MY20-Change From Baseline by Treatment Group | Side effects of treatment wk 48 chge (n=37,26) | 3.357 score on a scale |
| Panobinostat + Bortezomib | European Organization for Research and Treatment of Cancer Multiple Myeloma Module (EORTC) QLQ-MY20-Change From Baseline by Treatment Group | Future perspective wk 12 chge (n=214,242) | 5.319 score on a scale |
| Panobinostat + Bortezomib | European Organization for Research and Treatment of Cancer Multiple Myeloma Module (EORTC) QLQ-MY20-Change From Baseline by Treatment Group | Future perspective wk 24 chge (n=148,176) | 3.877 score on a scale |
| Panobinostat + Bortezomib | European Organization for Research and Treatment of Cancer Multiple Myeloma Module (EORTC) QLQ-MY20-Change From Baseline by Treatment Group | Future perspective wk 48 chge (n=37,26) | 4.331 score on a scale |
| Panobinostat + Bortezomib | European Organization for Research and Treatment of Cancer Multiple Myeloma Module (EORTC) QLQ-MY20-Change From Baseline by Treatment Group | Body image wk 12 chge (n=213,240) | -7.178 score on a scale |
| Panobinostat + Bortezomib | European Organization for Research and Treatment of Cancer Multiple Myeloma Module (EORTC) QLQ-MY20-Change From Baseline by Treatment Group | Body image wk 24 chge (n=147,175) | -11.463 score on a scale |
| Placebo + Bortezomib | European Organization for Research and Treatment of Cancer Multiple Myeloma Module (EORTC) QLQ-MY20-Change From Baseline by Treatment Group | Body image wk 12 chge (n=213,240) | -6.22 score on a scale |
| Placebo + Bortezomib | European Organization for Research and Treatment of Cancer Multiple Myeloma Module (EORTC) QLQ-MY20-Change From Baseline by Treatment Group | Body image wk 48 chge (n=37,26) | -4.666 score on a scale |
| Placebo + Bortezomib | European Organization for Research and Treatment of Cancer Multiple Myeloma Module (EORTC) QLQ-MY20-Change From Baseline by Treatment Group | Side effects of treatment wk 48 chge (n=37,26) | 3.654 score on a scale |
| Placebo + Bortezomib | European Organization for Research and Treatment of Cancer Multiple Myeloma Module (EORTC) QLQ-MY20-Change From Baseline by Treatment Group | Disease Symptom wk 12 change baseline (n=215,243) | -4.865 score on a scale |
| Placebo + Bortezomib | European Organization for Research and Treatment of Cancer Multiple Myeloma Module (EORTC) QLQ-MY20-Change From Baseline by Treatment Group | Future perspective wk 48 chge (n=37,26) | 6.951 score on a scale |
| Placebo + Bortezomib | European Organization for Research and Treatment of Cancer Multiple Myeloma Module (EORTC) QLQ-MY20-Change From Baseline by Treatment Group | Disease Symptom wk 24 change baseline (n=148,177) | -6.797 score on a scale |
| Placebo + Bortezomib | European Organization for Research and Treatment of Cancer Multiple Myeloma Module (EORTC) QLQ-MY20-Change From Baseline by Treatment Group | Future perspective wk 12 chge (n=214,242) | 6.194 score on a scale |
| Placebo + Bortezomib | European Organization for Research and Treatment of Cancer Multiple Myeloma Module (EORTC) QLQ-MY20-Change From Baseline by Treatment Group | Disease Symptom wk 48 change baseline (n=37,26) | -6.626 score on a scale |
| Placebo + Bortezomib | European Organization for Research and Treatment of Cancer Multiple Myeloma Module (EORTC) QLQ-MY20-Change From Baseline by Treatment Group | Body image wk 24 chge (n=147,175) | -7.358 score on a scale |
| Placebo + Bortezomib | European Organization for Research and Treatment of Cancer Multiple Myeloma Module (EORTC) QLQ-MY20-Change From Baseline by Treatment Group | Side effects of treatment wk 12 chge (n=213,242) | 5.524 score on a scale |
| Placebo + Bortezomib | European Organization for Research and Treatment of Cancer Multiple Myeloma Module (EORTC) QLQ-MY20-Change From Baseline by Treatment Group | Future perspective wk 24 chge (n=148,176) | 5.839 score on a scale |
| Placebo + Bortezomib | European Organization for Research and Treatment of Cancer Multiple Myeloma Module (EORTC) QLQ-MY20-Change From Baseline by Treatment Group | Side effects of treatment wk 24 chge (n=148,175) | 7.731 score on a scale |
Secondary
Functional Assessment of Chronic Illness Therapy (FACIT) Measurement System : FACT/GOG-NTX-Change From Baseline by Treatment Group
Chronic Illness Therapy (FACIT) Measurement System and focuses on four general quality of life domains for physical well being, functional well-being, social/family well-being, and emotional well-being, and includes additional items to characterize treatment-related neurotoxicity. Higher subscales/total scores represent higher QOL. In the case of the neurotoxicity subscale, lower scores correspond to higher neurotoxicity. The recall period referenced in the questionnaire is the past 7 days.Ranges for FACT-G subscales are as follows:.PWB, scale 0 -28, , NtxS scale 0-44, FACT/GOG-Ntx trial outcome index scale is 0-100 and FACT-G scale is also scaled 0-100. An increase from baseline in these scores indicate improvement.
Time frame: 12, 24 and 48 weeks
Population: Full Analysis Set
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Panobinostat + Bortezomib | Functional Assessment of Chronic Illness Therapy (FACIT) Measurement System : FACT/GOG-NTX-Change From Baseline by Treatment Group | Physical wellbeing wk 12 chge (n=215,240) | -3.29 score on a scale |
| Panobinostat + Bortezomib | Functional Assessment of Chronic Illness Therapy (FACIT) Measurement System : FACT/GOG-NTX-Change From Baseline by Treatment Group | Trial Outcomes wk 24 chge (n=148,173) | -9.84 score on a scale |
| Panobinostat + Bortezomib | Functional Assessment of Chronic Illness Therapy (FACIT) Measurement System : FACT/GOG-NTX-Change From Baseline by Treatment Group | Neurotoxicity wk 12 change baseline (n=212,240) | -4.481 score on a scale |
| Panobinostat + Bortezomib | Functional Assessment of Chronic Illness Therapy (FACIT) Measurement System : FACT/GOG-NTX-Change From Baseline by Treatment Group | Trial Outcomes wk 48 chge (n=35,26) | -6.633 score on a scale |
| Panobinostat + Bortezomib | Functional Assessment of Chronic Illness Therapy (FACIT) Measurement System : FACT/GOG-NTX-Change From Baseline by Treatment Group | Physical wellbeingwk 24 chge (n=150,176) | -3.044 score on a scale |
| Panobinostat + Bortezomib | Functional Assessment of Chronic Illness Therapy (FACIT) Measurement System : FACT/GOG-NTX-Change From Baseline by Treatment Group | FACT-G Total wk 12 chge (n=213,240) | -6.658 score on a scale |
| Panobinostat + Bortezomib | Functional Assessment of Chronic Illness Therapy (FACIT) Measurement System : FACT/GOG-NTX-Change From Baseline by Treatment Group | Neurotoxicity wk 48 change baseline (n=35,26) | -3.158 score on a scale |
| Panobinostat + Bortezomib | Functional Assessment of Chronic Illness Therapy (FACIT) Measurement System : FACT/GOG-NTX-Change From Baseline by Treatment Group | FACT-G Totalwk 24 chge (n=147,175) | -6.076 score on a scale |
| Panobinostat + Bortezomib | Functional Assessment of Chronic Illness Therapy (FACIT) Measurement System : FACT/GOG-NTX-Change From Baseline by Treatment Group | Physical wellbeing wk 48 chge (n=38,26) | -2.037 score on a scale |
| Panobinostat + Bortezomib | Functional Assessment of Chronic Illness Therapy (FACIT) Measurement System : FACT/GOG-NTX-Change From Baseline by Treatment Group | FACT-G Total wk 48 chge (n=37,26) | -2.704 score on a scale |
| Panobinostat + Bortezomib | Functional Assessment of Chronic Illness Therapy (FACIT) Measurement System : FACT/GOG-NTX-Change From Baseline by Treatment Group | Neurotoxicity wk 24 change baseline (n=148,174) | -4.564 score on a scale |
| Panobinostat + Bortezomib | Functional Assessment of Chronic Illness Therapy (FACIT) Measurement System : FACT/GOG-NTX-Change From Baseline by Treatment Group | FACT/GOGNTX Total wk 12 chge (n=206,230) | -11.176 score on a scale |
| Panobinostat + Bortezomib | Functional Assessment of Chronic Illness Therapy (FACIT) Measurement System : FACT/GOG-NTX-Change From Baseline by Treatment Group | Trial Outcomes wk 12 chge (n=209,236) | -10.573 score on a scale |
| Panobinostat + Bortezomib | Functional Assessment of Chronic Illness Therapy (FACIT) Measurement System : FACT/GOG-NTX-Change From Baseline by Treatment Group | FACT/GOGNTX Total wk 24 chge (n=146,172) | -10.581 score on a scale |
| Panobinostat + Bortezomib | Functional Assessment of Chronic Illness Therapy (FACIT) Measurement System : FACT/GOG-NTX-Change From Baseline by Treatment Group | FACT/GOGNTX Total wk 48 chge (n=35,26) | -5.871 score on a scale |
| Placebo + Bortezomib | Functional Assessment of Chronic Illness Therapy (FACIT) Measurement System : FACT/GOG-NTX-Change From Baseline by Treatment Group | FACT/GOGNTX Total wk 24 chge (n=146,172) | -9.179 score on a scale |
| Placebo + Bortezomib | Functional Assessment of Chronic Illness Therapy (FACIT) Measurement System : FACT/GOG-NTX-Change From Baseline by Treatment Group | FACT/GOGNTX Total wk 48 chge (n=35,26) | -3.151 score on a scale |
| Placebo + Bortezomib | Functional Assessment of Chronic Illness Therapy (FACIT) Measurement System : FACT/GOG-NTX-Change From Baseline by Treatment Group | Neurotoxicity wk 12 change baseline (n=212,240) | -3.337 score on a scale |
| Placebo + Bortezomib | Functional Assessment of Chronic Illness Therapy (FACIT) Measurement System : FACT/GOG-NTX-Change From Baseline by Treatment Group | Neurotoxicity wk 24 change baseline (n=148,174) | -4.739 score on a scale |
| Placebo + Bortezomib | Functional Assessment of Chronic Illness Therapy (FACIT) Measurement System : FACT/GOG-NTX-Change From Baseline by Treatment Group | Neurotoxicity wk 48 change baseline (n=35,26) | -2.133 score on a scale |
| Placebo + Bortezomib | Functional Assessment of Chronic Illness Therapy (FACIT) Measurement System : FACT/GOG-NTX-Change From Baseline by Treatment Group | Physical wellbeing wk 12 chge (n=215,240) | -1.952 score on a scale |
| Placebo + Bortezomib | Functional Assessment of Chronic Illness Therapy (FACIT) Measurement System : FACT/GOG-NTX-Change From Baseline by Treatment Group | Physical wellbeingwk 24 chge (n=150,176) | -2.259 score on a scale |
| Placebo + Bortezomib | Functional Assessment of Chronic Illness Therapy (FACIT) Measurement System : FACT/GOG-NTX-Change From Baseline by Treatment Group | Physical wellbeing wk 48 chge (n=38,26) | 0.203 score on a scale |
| Placebo + Bortezomib | Functional Assessment of Chronic Illness Therapy (FACIT) Measurement System : FACT/GOG-NTX-Change From Baseline by Treatment Group | Trial Outcomes wk 12 chge (n=209,236) | -6.874 score on a scale |
| Placebo + Bortezomib | Functional Assessment of Chronic Illness Therapy (FACIT) Measurement System : FACT/GOG-NTX-Change From Baseline by Treatment Group | Trial Outcomes wk 24 chge (n=148,173) | -8.894 score on a scale |
| Placebo + Bortezomib | Functional Assessment of Chronic Illness Therapy (FACIT) Measurement System : FACT/GOG-NTX-Change From Baseline by Treatment Group | Trial Outcomes wk 48 chge (n=35,26) | -2.821 score on a scale |
| Placebo + Bortezomib | Functional Assessment of Chronic Illness Therapy (FACIT) Measurement System : FACT/GOG-NTX-Change From Baseline by Treatment Group | FACT-G Total wk 12 chge (n=213,240) | -4.106 score on a scale |
| Placebo + Bortezomib | Functional Assessment of Chronic Illness Therapy (FACIT) Measurement System : FACT/GOG-NTX-Change From Baseline by Treatment Group | FACT-G Totalwk 24 chge (n=147,175) | -4.609 score on a scale |
| Placebo + Bortezomib | Functional Assessment of Chronic Illness Therapy (FACIT) Measurement System : FACT/GOG-NTX-Change From Baseline by Treatment Group | FACT-G Total wk 48 chge (n=37,26) | -1.435 score on a scale |
| Placebo + Bortezomib | Functional Assessment of Chronic Illness Therapy (FACIT) Measurement System : FACT/GOG-NTX-Change From Baseline by Treatment Group | FACT/GOGNTX Total wk 12 chge (n=206,230) | -7.524 score on a scale |
Secondary
Overall Response Rate in Patients Treated With Panobinostat in Combination With Bortezomib and Dexamethasone vs. Patients Treated by Placebo in Combination With Bortezomib and Dexamethasone.
Best overall response based on mEBMT criteria per investigator assessment
Time frame: 45 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Panobinostat + Bortezomib | Overall Response Rate in Patients Treated With Panobinostat in Combination With Bortezomib and Dexamethasone vs. Patients Treated by Placebo in Combination With Bortezomib and Dexamethasone. | 60.7 % participants with response |
| Placebo + Bortezomib | Overall Response Rate in Patients Treated With Panobinostat in Combination With Bortezomib and Dexamethasone vs. Patients Treated by Placebo in Combination With Bortezomib and Dexamethasone. | 54.6 % participants with response |
Secondary
Overall Survival in Patients Treated With Panobinostat in Combination With Bortezomib and Dexamethasone vs. Patients Treated by Placebo in Combination With Bortezomib and Dexamethasone
survival time in months
Time frame: 45 months
Population: FAS
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Panobinostat + Bortezomib | Overall Survival in Patients Treated With Panobinostat in Combination With Bortezomib and Dexamethasone vs. Patients Treated by Placebo in Combination With Bortezomib and Dexamethasone | 40.28 months |
| Placebo + Bortezomib | Overall Survival in Patients Treated With Panobinostat in Combination With Bortezomib and Dexamethasone vs. Patients Treated by Placebo in Combination With Bortezomib and Dexamethasone | 35.78 months |
Secondary
Overall Survival in Patients Treated With Panobinostat in Combination With Bortezomib and Dexamethasone vs. Patients Treated by Placebo in Combination With Bortezomib and Dexamethasone
Number of OS events
Time frame: 45 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Panobinostat + Bortezomib | Overall Survival in Patients Treated With Panobinostat in Combination With Bortezomib and Dexamethasone vs. Patients Treated by Placebo in Combination With Bortezomib and Dexamethasone | 134 Number of OS events |
| Placebo + Bortezomib | Overall Survival in Patients Treated With Panobinostat in Combination With Bortezomib and Dexamethasone vs. Patients Treated by Placebo in Combination With Bortezomib and Dexamethasone | 152 Number of OS events |
Secondary
Time to Progression/Relapse Per Investigator Assessment (mEBMT Criteria) Patients Treated With Panobinostat in Combination With Bortezomib and Dexamethasone vs. Patients Treated by Placebo in Combination With Bortezomib and Dexamethasone.
Time frame: 45 months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Panobinostat + Bortezomib | Time to Progression/Relapse Per Investigator Assessment (mEBMT Criteria) Patients Treated With Panobinostat in Combination With Bortezomib and Dexamethasone vs. Patients Treated by Placebo in Combination With Bortezomib and Dexamethasone. | 12.71 months |
| Placebo + Bortezomib | Time to Progression/Relapse Per Investigator Assessment (mEBMT Criteria) Patients Treated With Panobinostat in Combination With Bortezomib and Dexamethasone vs. Patients Treated by Placebo in Combination With Bortezomib and Dexamethasone. | 8.54 months |
Secondary
Time to Response Per Investigator Assessment (mEBMT Criteria) of Response Patients Treated With Panobinostat in Combination With Bortezomib and Dexamethasone vs. Patients Treated by Placebo in Combination With Bortezomib and Dexamethasone.
Time frame: 45 months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Panobinostat + Bortezomib | Time to Response Per Investigator Assessment (mEBMT Criteria) of Response Patients Treated With Panobinostat in Combination With Bortezomib and Dexamethasone vs. Patients Treated by Placebo in Combination With Bortezomib and Dexamethasone. | 1.51 time to response in months |
| Placebo + Bortezomib | Time to Response Per Investigator Assessment (mEBMT Criteria) of Response Patients Treated With Panobinostat in Combination With Bortezomib and Dexamethasone vs. Patients Treated by Placebo in Combination With Bortezomib and Dexamethasone. | 2.00 time to response in months |