EAA173: Daratumumab to Enhance Therapeutic Effectiveness of Revlimid in Smoldering Myeloma (DETER-SMM)

Eligibility: 

• Dx with asymptomatic high-risk smoldering multiple myeloma within the past 12 months
• High-risk is defined as 2 or more of the following:  1) abn serum free light chain ratio of involved to uninvolved ˃20 but less than 100 if the involved FLC is ≥10 mg/dL by serum FLC assay; 2) serum M-protein level ˃2 gm/dL; 3) presence of t(4;14) or del 17p, del 13q or 1q gain by conventional cytogenetics or FISH studies; 4) ˃20% plasma cells on bx or aspirate
• Measurable disease
• No lytic lesions, plasmacytoma, unexplained hypercalcemia
• No more than 1 focal marrow lesion on MRI of either pelvis or spine