Thalidomide and Prednisone Following Peripheral Stem Cell Transplantation in Treating Patients With Multiple Myeloma
RATIONALE: Thalidomide may stop the growth of multiple myeloma by stopping blood flow to the tumor. Prednisone may be effective in preventing relapse of multiple myeloma.
PURPOSE: Randomized phase II trial to compare the effectiveness of two doses of thalidomide combined with prednisone following peripheral stem cell transplantation in treating patients who have multiple myeloma.
Multiple Myeloma and Plasma Cell Neoplasm
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Randomized Phase II Dose Finding Study Of Thalidomide And Prednisone As Maintenance Therapy Following Autologous Stem Cell Transplant In Patients With Multiple Myeloma|
- incidence of drop-out or dose reduction [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]incidence of drop-out or dose reduction due to toxicity within 6 months from the start of treatment.
- Response rate [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Time to progression [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Overall survival [ Time Frame: 8 years ] [ Designated as safety issue: No ]
|Study Start Date:||July 2000|
|Study Completion Date:||December 2008|
|Primary Completion Date:||May 2002 (Final data collection date for primary outcome measure)|
Experimental: Prednisone plus Thalidomide
After Autologous Stem Cell Infusion
Prednisone 50mg on alternate daysDrug: thalidomide
THALIDOMIDE 200 mg qhs
OBJECTIVES: I. Determine which dose of thalidomide (200 mg vs 400 mg) combined with prednisone is the optimally tolerated dose when used as maintenance therapy following autologous stem cell transplantation in patients with multiple myeloma. II. Compare the response rate in patients treated with these regimens. III. Compare the progression-free and overall survival in patients treated with these regimens.
OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to age (60 and over vs under 60). Within 60-100 days after autologous stem cell transplantation, patients are randomized to 1 of 2 treatment arms. Arm I: Patients receive lower dose oral thalidomide daily and oral prednisone every other day. Arm II: Patients receive higher dose thalidomide daily and oral prednisone every other day. Treatment continues for 2 years in the absence of disease progression or unacceptable toxicity. Patients are followed monthly for 6 months, every 3 months, and then at time of disease progression.
PROJECTED ACCRUAL: A total of 40-80 patients (20-40 per arm) will be accrued for this study within 17-21 months.
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|Study Chair:||A. Keith Stewart, MD||Princess Margaret Hospital, Canada|