Doxil® + Melphalan + Velcade (DMV) in Relapsed/Refractory Multiple Myeloma
Status:
Terminated
Trial end date:
2010-01-12
Target enrollment:
Participant gender:
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).