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Doxil® + Melphalan + Velcade (DMV) in Relapsed/Refractory Multiple Myeloma
Phase 1, PHASE2 trial testing Doxil, melphalan, bortezomib in Multiple Myeloma in 13 participants. Terminated before completion.
| Lead sponsor | University of California, San Francisco |
|---|---|
| Phase | Phase 1, PHASE2 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 13 |
| Start date | 28 October 2004 |
| Primary completion | 7 October 2008 |
| Estimated completion | 12 January 2010 |
| Sites | 2 locations across United States |
University of California, San Francisco
18 and older, any sex, with Multiple Myeloma or Patient Participation. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
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.
| Group | Value | 95% CI |
|---|---|---|
| Doxil® + Melphalan + Velcade (DMV) | 0 |
Time frame: Up to 5 years. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Phase 1 Doxil® + Melphalan… |
|---|---|---|
| Hyperbilirubinemia | Investigations | — |
| Infection | Infections and infestations | — |
| Neurological disorder NOS | Nervous system disorders | — |
| Cholecystitis | Hepatobiliary disorders | — |
| Bone Fracture | Musculoskeletal and connective tissue disorders | — |
| Hypotension | Vascular disorders | — |
| Thrombosis | Vascular disorders | — |
| Lung Infection | Infections and infestations | — |
Most-reported serious reactions: Hyperbilirubinemia, Infection, Neurological disorder NOS, Cholecystitis, Bone Fracture, Hypotension, Thrombosis, Lung Infection.
Data from ClinicalTrials.gov NCT00985907 adverse events section.
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).
1 peer-reviewed publication reference this trial (live from Europe PMC):
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