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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 is a Phase 2 study that has completed, run by pharmaand. The registered enrollment target is 248 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02654990
The ClinicalTrials.gov registry entry for NCT02654990 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 248 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is pharmaand, which has 15 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Bortezomib Injection is the first listed.
NCT02654990 reports 0 study locations.
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.
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