EAA173 Daratumumab to Enhance Therapeutic Effectiveness of Revlimid in Smoldering Myeloma (DETER-SMM)
Objective
Primary Objective: To compare overall survival in patients with high-risk smoldering multiple myeloma randomized to daratumumab-hyaluronidase subcutaneous (SC)-revlimid-dexamethasone or revlimid-dexamethasone.
Secondary Clinical Objectives: To compare progression-free survival and response rates between arms. To evaluate safety and compare toxicity rates between arms. To monitor incidence of infusion-related reactions over the first cycle of daratumumab. To evaluate stem cell mobilization failure and early stem cell mobilization feasibility