Phase I/II Study of Liposomal Doxorubicin (Doxil®)/Melphalan/Bortezomib (Velcade®) in Relapsed/Refractory Multiple Myeloma
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 zolendronic 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
Interventional
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To evaluate the safety and tolerability of four dose levels of liposomal doxorubicin, melphalan, and bortezomib in patients with relapsed/refractory MM
5 years
Yes
Thomas Martin, MD
Principal Investigator
University of California, San Francisco
United States: Institutional Review Board
2408
NCT00985907
June 2004
January 2010
Name | Location |
---|---|
UCSF | San Francisco, California 941430324 |
St. Vincent's Comprehensive Cancer Center | New York, New York 10011 |