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NCT00765102 · ClinicalTrials.gov registry record · Phase 2
Trial of Romidepsin and Bortezomib for Multiple Myeloma
A Phase 2 study, sponsored by Celgene.
- Terminated
- Registry status
- Phase 2
- Development phase
- 32
- Enrollment target
NCT00765102: Clinical Trial Phase 2 study, sponsored by Celgene.
NCT00765102 is a Phase 2 study that was terminated before completion, run by Celgene. The registered enrollment target is 32 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (76% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00765102, a Phase 2 study, was terminated before completion, sponsored by Celgene.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 32 participants
- Enrollment target
Study Summary
This is a phase II, open-label, multicenter, dual-strata study designed to evaluate the efficacy and safety of IV romidepsin given in combination with IV bortezomib for multiple myeloma (MM) patients with refractory or relapsed disease. Patients will be enrolled into one of two strata, bortezomib-resistant or bortezomib non-resistant.
Primary Outcome
Complete Response: disappearance of monoclonal protein from blood and urine, and disappearance of soft tissue plasmacytomas, \<5% plasmas cells in marrow and no increase of lytic bone lesions. Very Good Partial Response: disappearance of plasmacytomas, no increase of lytic bone lesions, serum and urine M-protein not detectable by immunofixation, other. Partial Response: \>=50% decrease in serum monoclonal protein, and in soft tissue plasmacytomas, no increase of lytic bone lesions, other. Min
Interventions
- DRUG Bortezomib
- DRUG Romidepsin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2008-09-01 |
| Est. Completion | 2010-03-01 |
| Phase | Phase 2 |
Why NCT00765102 stopped before completion
NCT00765102 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (76% lower).
The record links to 0 conditions, and to 2 interventions - of which Bortezomib is the first listed.
NCT00765102 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00765102 about?
NCT00765102 is a clinical study titled "Trial of Romidepsin and Bortezomib for Multiple Myeloma". This is a phase II, open-label, multicenter, dual-strata study designed to evaluate the efficacy and safety of IV romidepsin given in combination with IV bortezomib for multiple myeloma (MM) patients with refractory or relapsed disease. Patients will be enrolled into one of two strata, bortezomib-re...
What is the current status of trial NCT00765102?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 32 participants. The study started on 2008-09-01. Estimated completion is 2010-03-01.
What interventions are being tested in trial NCT00765102?
The interventions under investigation include: Bortezomib (DRUG), Romidepsin (DRUG).
Who is sponsoring clinical trial NCT00765102?
This trial is sponsored by Celgene, which has 308 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00765102's enrollment target sits among peer trials
32 1563rd of 2000 higher than 423 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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