A Randomized Phase III Study Of Thalidomide And Prednisone As Maintenance Therapy Following Autologous Stem Cell Transplant in Patients With Multiple Myeloma
- Compare overall survival of patients with multiple myeloma treated with thalidomide and
prednisone as maintenance therapy vs observation alone after autologous stem cell
- 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
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.
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
A. Keith Stewart, MD
Canada: Health Canada