Phase III study of daratumumab/rHuPH20 (NSC- 810307) + lenalidomide or lenalidomide as post-autologous stem cell transplant maintenance therapy in patients with multiple myeloma (MM) using minimal residual disease to direct therapy duration (DRAMMATIC Study)
Objective
To compare overall survival (OS) between the two treatment arms with lenalidomide as the comparator arm and lenalidomide + daratumumab/rHuPH20 as the experimental arm in post-autologous transplant multiple myeloma (MM) patients.
To compare the best overall response rate (ORR), including partial remission (PR),very good partial remission (VGPR), and complete remission (CR, sCR) in the subset of patients not in PR at randomization to lenalidomide versus lenalidomide + daratumumab/rHuPH20 in this patient population. To compare progression-free survival (PFS) between the study arms in this patient population
To evaluate MRD-negativity on the two treatment arms at randomization (Registration Step 2), and to compare MRD-negativity rate at 12, 24 (second randomization), 36, and 48 months after first randomization between lenalidomide and lenalidomide + daratumumab/rHuPH20 in this patient population. To compare toxicities and tolerability of long term therapy between the study arms
