First Analysis of the Australasian Leukaemia and Lymphoma Group (ALLG) Trial of Thalidomide and Alternate Day Prednisolone Following Autologous Stem Cell Transplantation (ASCT) for Patients with Multiple Myeloma (ALLG MM6).

The therapeutic intervention with the greatest impact on survival prolongation for patients with multiple myeloma (MM) is high-dose chemotherapy with ASCT. Unfortunately, relapse is inevitable, thus the identification of strategies that prolong response duration is required. Glucocorticoids are a major component of MM therapy and randomized data suggest that they also have a role in response maintenance following conventional chemotherapy. Thalidomide (T) is effective in both de novo and relapsed MM and synergizes with glucocorticoids at low doses without relevant myelotoxicity. Based on these observations a randomized trial of T combined with maintenance alternate day prednisolone (AP) (ARM 1) vs AP (ARM 2) following ASCT was conducted. Inclusion criteria included age >18 years, non-progressive MM with a maximum of 12 months prior therapy, ECOG