Multiple Myeloma Clinical Trial
Official title:
Phase I/II Study of Liposomal Doxorubicin (Doxil®)/Melphalan/Bortezomib (Velcade®) 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 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).
Dose Level 1: Doxil 10 mg/m2, Melphalan 5 mg/m2, Velcade 0.7 mg/m2
Dose Level 2: Doxil 10 mg/m2, Melphalan 10 mg/m2, Velcade 0.7 mg/m2
Dose Level 3: Doxil 20 mg/m2, Melphalan 10 mg/m2, Velcade 0.7 mg/m2
Dose Level 4: Doxil 20 mg/m2, Melphalan 10 mg/m2, Velcade 1.0 mg/m2
Adjunctive therapy with a bisphosphonate, either pamidronate or zoledronic acid, will be
given monthly.
Dose Escalation Schedule: Dose escalation will occur only after patients have completed at
least two cycles at a given dose level.
1. If 0/3 experience DLT (as defined in attachment Section 6.0), the next three patients
will be escalated by one dose level.
2. If 1/3 experience DLT, 3 additional patients enrolled at this dose level.
- If 0, 1, or 2 of these additional patients experience DLT (i.e. total 3/6), the
dose will be escalated.
- If 3/3 experience DLT (i.e. total 4/6) then the next lower dose will be considered
the MTD..
3. If 2/3 experience DLT, 3 additional patients enrolled at this dose level.
- If 0 or 1 of these additional patients experience DLT (i.e. total 3/6), the dose
will be escalated.
- If 2 or more/3 experience DLT (i.e. total more than 3/6) then the next lower dose
level is MTD
;
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