Doxorubicin Hydrochloride Liposome, Melphalan, and Bortezomib in Treating Patients With Relapsed or Refractory Stage I, Stage II, or Stage III Multiple Myeloma
Recruitment status was: Recruiting
RATIONALE: Drugs used in chemotherapy, such as doxorubicin hydrochloride liposome and melphalan, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving doxorubicin hydrochloride liposome and melphalan together with bortezomib may kill more cancer cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of doxorubicin hydrochloride liposome , melphalan, and bortezomib and to see how well they work in treating patients with relapsed or refractory stage I, stage II, or stage III multiple myeloma.
Multiple Myeloma and Plasma Cell Neoplasm
Drug: pegylated liposomal doxorubicin hydrochloride
|Study Design:||Primary Purpose: Treatment|
|Official Title:||Phase I/II Study of Liposomal Doxorubicin (Doxil®)/ Melphalan/Bortezomib (Velcade®) in Relapsed/Refractory Multiple Myeloma|
- Proportion of patients experiencing treatment-related ≥ grade 3 hematologic or nonhematologic toxicity or treatment-related death (phase I) [ Designated as safety issue: Yes ]
- Time to response (phase II) [ Designated as safety issue: No ]
- Progression-free survival (phase II) [ Designated as safety issue: No ]
- Overall survival (phase II) [ Designated as safety issue: No ]
- Toxicities by NCI criteria (phase II) [ Designated as safety issue: Yes ]
|Study Start Date:||February 2006|
|Estimated Primary Completion Date:||January 2010 (Final data collection date for primary outcome measure)|
- Determine the safety and tolerability of doxorubicin HCl liposome, melphalan, and bortezomib in patients with relapsed or refractory stage I-III multiple myeloma.
- Determine the maximum tolerated dose (MTD) of this regimen in these patients.
- Determine the overall response rate, including complete, near-complete, partial, and minimal response rate, in patients treated with this regimen.
- Determine the time to response, progression-free survival, and overall survival of patients treated with this regimen.
- Determine the toxic effects of this regimen at the MTD in these patients.
OUTLINE: This is a multicenter, phase I, dose-escalation study followed by a phase II study.
- Phase I: Patients receive doxorubicin HCl liposome IV over 30-60 minutes and melphalan IV over 30 minutes on day 1 and bortezomib IV on days 1, 4, 8, and 11. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of doxorubicin HCl liposome, melphalan, and bortezomib until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 4 of 6 patients experience dose-limiting toxicity after 2 courses of therapy.
- Phase II: Patients receive doxorubicin HCl liposome, melphalan, and bortezomib at the MTD as in phase I.
After completion of study treatment, patients are followed every 3 months.
PROJECTED ACCRUAL: Approximately 32 patients will be accrued for this study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00334932
|United States, California|
|UCSF Helen Diller Family Comprehensive Cancer Center|
|San Francisco, California, United States, 94115|
|United States, New York|
|Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center|
|New York, New York, United States, 10032|
|Principal Investigator:||Ajai Chari, MD||Herbert Irving Comprehensive Cancer Center|