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NCT01023308 · ClinicalTrials.gov registry record · Phase 3
Panobinostat or Placebo With Bortezomib and Dexamethasone in Patients With Relapsed Multiple Myeloma
A Phase 3 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 767
- Enrollment target
NCT01023308: Completed Phase 3 study, sponsored by Novartis Pharmaceuticals.
NCT01023308 is a Phase 3 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 767 participants, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01023308, a Phase 3 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 767 participants
- Enrollment target
Study 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
- DRUG Placebo
- DRUG Dexamethasone
- DRUG Bortezomib
- DRUG Panobinostat
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 767 participants |
| Start Date | 2009-12-21 |
| Est. Completion | 2015-07-30 |
| Phase | Phase 3 |
What the finished NCT01023308 record still lists
NCT01023308 is an interventional study that assigns participants to a tested intervention. The registered 767 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target.
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT01023308 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01023308 about?
NCT01023308 is a clinical study titled "Panobinostat or Placebo With Bortezomib and Dexamethasone in Patients With Relapsed Multiple Myeloma". 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 p...
What is the current status of trial NCT01023308?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 767 participants. The study started on 2009-12-21. Estimated completion is 2015-07-30.
What interventions are being tested in trial NCT01023308?
The interventions under investigation include: Placebo (DRUG), Dexamethasone (DRUG), Bortezomib (DRUG), Panobinostat (DRUG).
Who is sponsoring clinical trial NCT01023308?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01023308's enrollment target sits among peer trials
767 445th of 2000 higher than 1,556 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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