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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)
Participants are enrolled to screening (Reg Step 1) prior to or after ASCT but prior to Reg Step 2. Patients are followed until they will begin Maintenance and then registered to Reg Step 2 (first randomization). Patients are randomized between Lenalidomide for 2 years and Lenalidomide + Daratumumab/rHuPH20. After 2 years of Maintenance, MRD is assessed to guide further therapy. MRD-positive patients will continue with the assigned treatment. MRD-negative patients will be further randomized (Reg Step 3) to either continue or discontinue the assigned treatment. Participants are treated for up to 7 years from Step 2 reg and followed for up to 15 years.
Primary 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. Secondary Objectives of First Randomization: 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. Objectives of Second Randomization: To compare overall survival (OS) between MRD negative patients randomized to continued lenalidomide vs. discontinued lenalidomide from the time of second randomization in this patient population. To compare overall survival (OS) between MRD negative patients randomized to continued lenalidomide + daratumumab/rHuPH20 vs. discontinued lenalidomide + daratumumab/rHuPH20 from time of second randomization in this patient population.
CC-5013 (Lenalidomide); Daratumumab/rHuPH20 (); Lenalidomide (Revlimid)