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NCT02654990 · ClinicalTrials.gov registry record · Phase 2
Panobinostat/Bortezomib/Dexamethasone in Relapsed or Relapsed-and-refractory Multiple Myeloma
A Phase 2 study, sponsored by pharmaand.
- Completed
- Registry status
- Phase 2
- Development phase
- 248
- Enrollment target
NCT02654990: Completed Phase 2 study, sponsored by pharmaand.
NCT02654990 is a Phase 2 study that has completed, run by pharmaand. The registered enrollment target is 248 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (86% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02654990, a Phase 2 study, has completed, sponsored by pharmaand.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 248 participants
- Enrollment target
Study Summary
Note: The study data was transferred to zr pharma\& following the divestment of panobinostat to pharma\&. Prior to study completion under the sponsorship of Secura Bio, the study was initiated and conducted in part under the sponsorship of Novartis. The purpose of this study is to investigate the safety and efficacy of 3 different regimens of panobinostat (20 milligrams \[mg\] thrice a week \[TIW\], 20 mg twice a week \[BIW\], and 10 mg TIW) in combination with subcutaneous bortezomib and dexamethasone and to provide exposure, safety and efficacy data to identify the optimal regimen of panobinostat in a randomized, 3-arm parallel design. This study will also assess the impact of administering subcutaneous bortezomib (in combination with panobinostat and dexamethasone) twice weekly for 4 cycles, and then weekly starting from Cycle 5 until disease progression in participants ≤ 75 years of age. Participants \> 75 years of age will receive subcutaneous bortezomib weekly for the entire treatment period (in combination with panobinostat and dexamethasone) until disease progression. Participants will be treated until disease progression or until they discontinue earlier due to unacceptable toxicity or for other reasons. Participants who discontinued study treatment for reasons other than disease progression will be followed for efficacy every 6 weeks. All participants will be followed for survival until the last participant entering long-term follow-up has completed a 3-year survival follow-up or discontinued earlier.
Primary Outcome
ORR is defined as the percentage of participants with a confirmed partial response (PR) or better (immunophenotypic complete response \[iCR\] or stringent complete response \[sCR\] or complete response \[CR\] or very good partial response \[VGPR\]) as their best overall response after completion of up to 8 cycles of assigned study regimen. Each cycle was 21 days long. Best overall response was the best post-baseline confirmed overall response observed in a given participant and was determined ba
Interventions
- DRUG Bortezomib Injection
- DRUG Panobinostat Capsules
- DRUG Dexamethasone tablets
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 248 participants |
| Start Date | 2016-04-27 |
| Est. Completion | 2022-08-15 |
| Phase | Phase 2 |
What the finished NCT02654990 record still lists
NCT02654990 is an interventional study that assigns participants to a tested intervention. The registered 248 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (86% higher).
The record links to 0 conditions, and to 3 interventions - of which Bortezomib Injection is the first listed.
NCT02654990 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02654990 about?
NCT02654990 is a clinical study titled "Panobinostat/Bortezomib/Dexamethasone in Relapsed or Relapsed-and-refractory Multiple Myeloma". Note: The study data was transferred to zr pharma\& following the divestment of panobinostat to pharma\&. Prior to study completion under the sponsorship of Secura Bio, the study was initiated and conducted in part under the sponsorship of Novartis. The purpose of this study is to investigate the s...
What is the current status of trial NCT02654990?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 248 participants. The study started on 2016-04-27. Estimated completion is 2022-08-15.
What interventions are being tested in trial NCT02654990?
The interventions under investigation include: Bortezomib Injection (DRUG), Panobinostat Capsules (DRUG), Dexamethasone tablets (DRUG).
Who is sponsoring clinical trial NCT02654990?
This trial is sponsored by pharmaand, which has 15 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02654990's enrollment target sits among peer trials
248 234th of 2000 higher than 1,767 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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