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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 is a Phase 1 study that was terminated before completion, run by University of California, San Francisco. The registered enrollment target is 13 participants.
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).
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00985907
The ClinicalTrials.gov registry entry for NCT00985907 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 13 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of California, San Francisco, which has 1,713 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Doxil, melphalan, bortezomib is the first listed.
NCT00985907 reports 0 study locations.
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.
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