Study Name: EAA173

Recruiting

Smoldering Myeloma

EAA173 This phase III trial studies how well lenalidomide and dexamethasone works with or without daratumumab in treating patients with high-risk smoldering myeloma.

NCT#NCT03937635

clinicaltrials.gov/show/NCTNCT03937635

This phase III trial studies how well lenalidomide and dexamethasone works with or without daratumumab in treating patients with high-risk smoldering myeloma. Drugs used in chemotherapy, such as lenalidomide and dexamethasone, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as daratumumab, may induce changes in the body’s immune system and may interfere with the ability of tumor cells to grow and spread. Giving lenalidomide and dexamethasone with daratumumab may work better in treating patients with smoldering myeloma.

Male and Female – 18 years and older

• Patients must be diagnosed with asymptomatic high-risk smoldering multiple myeloma (SMM) within the past 12 months. High-risk is defined by the presence of 2 or more of the following factors: Abnormal serum free light chain ratio of involved to uninvolved >20, but less than 100 if the involved FLC is >= 10 mg/dL by serum free light chain (FLC) assay; Serum M-protein level >= 2 gm/dL; Presence of t(4;14) or del 17p, del 13q or 1q gain by conventional cytogenetics or fluorescence in situ hybridization (FISH) studies; >20% plasma cells on biopsy or aspirate
• Bone marrow aspirate and/or biopsy is required to be performed within 42 days prior to randomization and must demonstrate 10-59% clonal plasma cells.
• >= 1 g/dL on serum protein electrophoresis (within 28 days prior to randomization)
• >= 200 mg of monoclonal protein on a 24 hour urine protein electrophoresis (within 28 days prior to randomization). NOTE: In the rare situation where the serum protein electrophoresis (SPEP) is felt to be unreliable, then quantitative immunoglobulin levels on nephelometry or turbidometry can be accepted
• SPEP, urine protein electrophoresis (UPEP), and serum FLC are required to be performed within 28 days prior to randomization. NOTE: UPEP (on a 24-hour collection) is required; no substitute method is acceptable. Urine must be followed monthly if the baseline urine M-spike is >= 200 mg/24 hour (hr), and urine in addition to serum must be followed in order to confirm a very good partial response (VGPR) or higher response
• Patients must have no lytic lesions, no known plasmacytoma, and no unexplained hypercalcemia (i.e., >11 mg/dL or 1mg/dL above upper limit of normal [ULN])
• Hemoglobin >= 11 g/dL (within 28 days prior to randomization)
• Platelet count >= 100,000 cells/mm^3 (within 28 days prior to randomization)
• Absolute neutrophil count >= 1500 cells/mm^3 (within 28 days prior to randomization)
• Calculated creatinine clearance >= 30 mL/min (within 28 days prior to randomization)
• Bilirubin =< 1.5 mg/dL (within 28 days prior to randomization)
• Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) and serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) =< 2.5 times the upper limit of normal (within 28 days prior to randomization)
• Patients must not have any prior or concurrent systemic or radiation therapy for the treatment of myeloma. Patients must also not have contraindication to deep vein thrombosis (DVT) prophylaxis/aspirin