Thalidomide and Prednisone Following Peripheral Stem Cell Transplantation in Treating Patients With Multiple Myeloma
- Conditions
- Multiple Myeloma and Plasma Cell Neoplasm
- Interventions
- Registration Number
- NCT00006890
- Lead Sponsor
- NCIC Clinical Trials Group
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 67
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Prednisone plus Thalidomide prednisone After Autologous Stem Cell Infusion Prednisone plus Thalidomide thalidomide After Autologous Stem Cell Infusion
- Primary Outcome Measures
Name Time Method incidence of drop-out or dose reduction 2 years incidence of drop-out or dose reduction due to toxicity within 6 months from the start of treatment.
- Secondary Outcome Measures
Name Time Method Response rate 2 years Time to progression 2 years Overall survival 8 years
Trial Locations
- Locations (64)
St. Mary's/Duluth Clinic Health System
🇺🇸Duluth, Minnesota, United States
Tom Baker Cancer Center - Calgary
🇨🇦Calgary, Alberta, Canada
Lethbridge Cancer Clinic
🇨🇦Lethbridge, Alberta, Canada
Burnaby Hospital Regional Cancer Centre
🇨🇦Burnaby, British Columbia, Canada
Nanaimo Cancer Clinic
🇨🇦Nanaimo, British Columbia, Canada
Penticton Regional Hospital
🇨🇦Penticton, British Columbia, Canada
British Columbia Cancer Agency - Fraser Valley Cancer Centre
🇨🇦Surrey, British Columbia, Canada
Prostate Centre at Vancouver General Hospital
🇨🇦Vancouver, British Columbia, Canada
British Columbia Cancer Agency
🇨🇦Vancouver, British Columbia, Canada
St. Paul's Hospital - Vancouver
🇨🇦Vancouver, British Columbia, Canada
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