Amrita Krishnan, MD
George Somlo, MD
Edward Stadtmauer, MD
The study is designed as a Phase III, multicenter trial of tandem autologous transplants plus maintenance therapy versus the strategy of single autologous transplant plus consolidation therapy with lenalidomide, bortezomib and dexamethasone (RVD) followed by maintenance therapy or single autologous transplant plus maintenance therapy as part of upfront treatment of multiple myeloma (MM). Lenalidomide will be used as maintenance therapy for three years in all arms.
The primary objective of the randomized trial is to compare three‐year progression free survival (PFS) between the three treatment arms as a pairwise comparison.
Secondary objectives are to:
compare disease response with rates of complete remission and very good partial remission (CR + VGPR);
compare the rate of CR conversion for patients not in CR at initiation of maintenance;
compare overall survival (OS);
compare the rate of Grade ≥ 3 toxicity according to the Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0;
compare the incidence of infections;
compare the rate of treatment‐related mortality;
assess the rate of discontinuation of therapy; and
describe and compare quality of life in all three arms of the study.