A Randomized Phase II Dose Finding Study Of Thalidomide And Prednisone As Maintenance Therapy Following Autologous Stem Cell Transplant In Patients With 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
PROJECTED ACCRUAL: A total of 40-80 patients (20-40 per arm) will be accrued for this study
within 17-21 months.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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.
A. Keith Stewart, MD
Princess Margaret Hospital, Canada
United States: Federal Government
|St. Mary's/Duluth Clinic Health System||Duluth, Minnesota 55805|