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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
67
Prednisone 50mg on alternate days
THALIDOMIDE 200 mg qhs
incidence of drop-out or dose reduction
incidence of drop-out or dose reduction due to toxicity within 6 months from the start of treatment.
Time frame: 2 years
Response rate
Time frame: 2 years
Time to progression
Time frame: 2 years
Overall survival
Time frame: 8 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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
...and 54 more locations