RATIONALE: Thalidomide may stop the growth of multiple myeloma by stopping blood flow to the tumor. It is not yet known whether combining thalidomide with prednisone and giving them after autologous stem cell transplantation may be effective in treating multiple myeloma. PURPOSE: This randomized phase III trial is studying thalidomide and prednisone to see how well they work compared to observation in treating patients who have undergone stem cell transplantation for multiple myeloma.
OBJECTIVES: * Compare overall survival of patients with multiple myeloma treated with thalidomide and prednisone as maintenance therapy vs observation alone after autologous stem cell transplantation. * Compare progression-free survival of patients treated with these regimens. * Compare quality of life of patients treated with these regimens. * Compare toxic effects of these regimens in these patients. * Compare the objective venous thromboembolism rate in symptomatic patients treated with these regimens. OUTLINE: This is a randomized, non-blinded, multicenter study. Patients are stratified according to treatment center, age (under 60 vs 60 and over), and response to prior transplantation (complete vs incomplete). Patients are randomized to 1 of 2 treatment arms. * Arm I: Patients receive oral thalidomide daily and oral prednisone every other day for 4 years in the absence of disease progression or unacceptable toxicity. * Arm II: Patients undergo observation. For both arms, patients are assessed (including for quality of life) regularly throughout the treatment/observation period: at baseline, every 2 months for 6 months, every 3 months for up to 4 years, and then annually thereafter. After the treatment/observation period, patients are followed annually.. PROJECTED ACCRUAL: A total of 324 patients will be accrued for this study within 3.5 years.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
Given orally
Given orally
Tom Baker Cancer Centre
Calgary, Alberta, Canada
Cross Cancer Institute
Edmonton, Alberta, Canada
Overall Survival
Number of patients died from any cause during the study.
Time frame: 9 years
Disease Progression-free Survival
Number of patients with disease progression or death
Time frame: 9 years
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332
BCCA - Vancouver Cancer Centre
Vancouver, British Columbia, Canada
CancerCare Manitoba
Winnipeg, Manitoba, Canada
The Moncton Hospital
Moncton, New Brunswick, Canada
Atlantic Health Sciences Corporation
Saint John, New Brunswick, Canada
Dr. H. Bliss Murphy Cancer Centre
St. John's, Newfoundland and Labrador, Canada
QEII Health Sciences Center
Halifax, Nova Scotia, Canada
Juravinski Cancer Centre at Hamilton Health Sciences
Hamilton, Ontario, Canada
Cancer Centre of Southeastern Ontario at Kingston
Kingston, Ontario, Canada
...and 8 more locations