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NCT00985907 · ClinicalTrials.gov registry record · Phase 1
Doxil® + Melphalan + Velcade (DMV) in Relapsed/Refractory Multiple Myeloma
A Phase 1 study, sponsored by University of California, San Francisco.
- Terminated
- Registry status
- Phase 1
- Development phase
- 13
- Enrollment target
NCT00985907: Clinical Trial Phase 1 study, sponsored by University of California, San Francisco.
NCT00985907 is a Phase 1 study that was terminated before completion, run by University of California, San Francisco. The registered enrollment target is 13 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (78% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00985907, a Phase 1 study, was terminated before completion, sponsored by University of California, San Francisco.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 13 participants
- Enrollment target
Study Summary
The median overall survival (OS) of relapsed/refractory multiple myeloma (MM) is less than nine months. However, phase II data with the proteasome inhibitor bortezomib (Velcade®) has been heartening, with 35% overall response rates and median survival of 16 months. In-vitro data has shown that this agent dramatically increases the sensitivity to chemotherapeutic agents. Liposomal doxorubicin (Doxil), melphalan, and bortezomib all have different mechanisms of action and toxicity profiles. Clinical studies employing two drug combinations with these agents in patients with refractory MM have found favorable efficacy (nearly no progression of disease) and tolerance data. Thus, the investigators are initiating a phase I/II study to examine the safety and efficacy of combining all three agents into the regimen DMV (Doxil® + melphalan + Velcade).
Primary Outcome
Safety assessments will be evaluated as the proportion of patients experiencing the following: treatment-related grade 3 or higher toxicity (hematologic and nonhematologic) and treatment-related death.
Interventions
- DRUG Doxil, melphalan, bortezomib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2004-10-28 |
| Est. Completion | 2010-01-12 |
| Phase | Phase 1 |
Why NCT00985907 stopped before completion
NCT00985907 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 13 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (78% lower).
The record links to 0 conditions, and to 1 intervention - of which Doxil, melphalan, bortezomib is the first listed.
NCT00985907 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00985907 about?
NCT00985907 is a clinical study titled "Doxil® + Melphalan + Velcade (DMV) in Relapsed/Refractory Multiple Myeloma". The median overall survival (OS) of relapsed/refractory multiple myeloma (MM) is less than nine months. However, phase II data with the proteasome inhibitor bortezomib (Velcade®) has been heartening, with 35% overall response rates and median survival of 16 months. In-vitro data has shown that this ...
What is the current status of trial NCT00985907?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 13 participants. The study started on 2004-10-28. Estimated completion is 2010-01-12.
What interventions are being tested in trial NCT00985907?
The interventions under investigation include: Doxil, melphalan, bortezomib (DRUG).
Who is sponsoring clinical trial NCT00985907?
This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00985907's enrollment target sits among peer trials
13 1847th of 2000 higher than 149 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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