Randomized Phase III Study of Thalidomide and Prednisone as Maintenance Therapy Following Autologous Stem Cell Transplant in Patients with Multiple Myeloma

III

To determine whether treatment with Thalidomide and Prednisone prolongs overall survival compared to observation alone when used as long term maintenance therapy following autologous stem cell transplant.

Measurable serum M-component of IgG, IgA, IgD or IgE at initial diagnosis or if only light chain disease was present (urine M-protein only), the urinary excretion of light chain (Bence Jones) protein must have been > 1.0 gm/24 hrs (at the time of initial diagnosis)
A confirmed diagnosis of Multiple Myeloma must have been made histologically prior to initial treatment.
ASCT < 1 yr from the beginning of initial chemotherapy treatment of MM
Patient must be randomized between 60 and 100 days after autologous stem cell infusion, and must not demonstrate evidence of progressive disease

Toronto, Canada
Princess Margaret Hospital
Giovanni Piza
416-946-4627