Multiple Myeloma and Plasma Cell Neoplasm Clinical Trial
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
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.
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