Trial · NCT01023308
Panobinostat or Placebo With Bortezomib and Dexamethasone in Patients With Relapsed Multiple Myeloma
NCT01023308, Phase 3, Completed, Novartis Pharmaceuticals; results first posted 2015-10-23
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Panobinostat or Placebo With Bortezomib and Dexamethasone in Patients With Relapsed Multiple Myeloma. Trials, record NCT01023308. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01023308
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Panobinostat or Placebo With Bortezomib and Dexamethasone in Patients With Relapsed Multiple Myeloma
- NCT number
- NCT01023308
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 767 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Multiple Myeloma
- Interventions
- Panobinostat, Bortezomib, Dexamethasone, Placebo
- First posted
- 2009-12-02
- Last updated
- 2020-03-17
- Other registries' IDs
- eudract:2009-015507-52
- Results first posted
- 2015-10-23
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| 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. | 45 months | |
| 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. | 45 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 | 45 months | Number of OS events |
| 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 | 45 months | survival time in months |
| 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. | 45 months | Best overall response based on mEBMT criteria per investigator assessment |
| 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. | 45 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. | 45 months | |
| 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. | 45 months | |
| Secondary | 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. |
| Secondary | 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. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| 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. | 45 months | number of events | NUMBER | |
| 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. | 45 months | Full Analysis Set | months | MEDIAN |
| 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 | 45 months | Number of OS events | NUMBER | |
| 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 | 45 months | FAS | months | MEDIAN |
| 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. | 45 months | % participants with response | NUMBER | |
| 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. | 45 months | time to response in months | MEDIAN | |
| 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. | 45 months | duration of response in months | MEDIAN | |
| 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. | 45 months | months | MEDIAN | |
| SECONDARY | 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 | Full Analysis Set | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | European Organization for Research and Treatment of Cancer Multiple Myeloma Module (EORTC ) QLQ-C30 - Summary Statistics by Treatment Group | 12, 24 and 48 weeks | Full Analysis Set | score on a scale | LEAST_SQUARES_MEAN |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group136
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
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. | Panobinostat + Bortezomib | 207 | number of events | ||
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. | Placebo + Bortezomib | 260 | number of events | ||
| 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. | Panobinostat + Bortezomib | 11.99 | 95% Confidence Interval 10.32 to 12.94 | 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. | Placebo + Bortezomib | 8.80 | 95% Confidence Interval 7.56 to 9.23 | 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 | Panobinostat + Bortezomib | 134 | Number of OS events | ||
| Overall Survival in Patients Treated With Panobinostat in Combination With Bortezomib and Dexamethasone vs. Patients Treated by Placebo in Combination With Bortezomib and Dexamethasone | Placebo + Bortezomib | 152 | Number of OS events | ||
| Overall Survival in Patients Treated With Panobinostat in Combination With Bortezomib and Dexamethasone vs. Patients Treated by Placebo in Combination With Bortezomib and Dexamethasone | Panobinostat + Bortezomib | 40.28 | 95% Confidence Interval 35.02 to 44.81 | 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 | Placebo + Bortezomib | 35.78 | 95% Confidence Interval 28.98 to 40.64 | months | |
| 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. | Panobinostat + Bortezomib | 60.7 | % participants with response | ||
| 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. | Placebo + Bortezomib | 54.6 | % participants with response |
1 to 10 of 136Source ClinicalTrials.gov
See all 136 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Panobinostat + Bortezomib | 387 | |
| Overall Study | STARTED | Placebo + Bortezomib | 381 | |
| Overall Study | COMPLETED | Panobinostat + Bortezomib | 102 | |
| Overall Study | COMPLETED | Placebo + Bortezomib | 102 | |
| Overall Study | NOT COMPLETED | Panobinostat + Bortezomib | 285 | |
| Overall Study | NOT COMPLETED | Placebo + Bortezomib | 279 |
Source ClinicalTrials.gov
Adverse events690
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | PAN+BTZ | 154 | 381 | |
| other | Anaemia | Blood and lymphatic system disorders | PBO+BTZ | 125 | 377 | |
| other | Leukopenia | Blood and lymphatic system disorders | PAN+BTZ | 61 | 381 | |
| other | Leukopenia | Blood and lymphatic system disorders | PBO+BTZ | 31 | 377 | |
| other | Lymphopenia | Blood and lymphatic system disorders | PAN+BTZ | 52 | 381 | |
| other | Lymphopenia | Blood and lymphatic system disorders | PBO+BTZ | 35 | 377 | |
| other | Neutropenia | Blood and lymphatic system disorders | PAN+BTZ | 112 | 381 | |
| other | Neutropenia | Blood and lymphatic system disorders | PBO+BTZ | 40 | 377 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | PAN+BTZ | 238 | 381 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | PBO+BTZ | 150 | 377 |
1 to 10 of 690Source ClinicalTrials.gov
See all 690 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | PAN+BTZ | ||
| Total, all-cause mortality | PBO+BTZ | ||
| Total, other adverse events | PAN+BTZ | 379 | 381 |
| Total, other adverse events | PBO+BTZ | 366 | 377 |
| Total, serious adverse events | PAN+BTZ | 228 | 381 |
| Total, serious adverse events | PBO+BTZ | 157 | 377 |
Source ClinicalTrials.gov
Papers4
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| PAN+BTZ vs PBO+BTZ: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01023308
GET https://conductscience.org/api/trials/v1/NCT01023308/results?page=2