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Aggressive Smoldering Curative Approach Evaluating Novel Therapies and Transplant (ASCENT): A Phase 2 Trial of Induction, Consolidation and Maintenance in Subjects with High Risk Smoldering Multiple Myeloma (SMM)
This study evaluates the use of carfilzomib, lenalidomide, daratumumab, and dexamethasone in patients with high-risk smoldering multiple myeloma (SMM).
Primary Objective 1.To determine the persistent MRD negativity rate at two years following the completion of intense induction, consolidation and maintenance treatment in subjects with high risk smoldering multiple myeloma. Secondary Objective 1. To determine the MRD negativity rate at the end of induction, end of consolidation, end of maintenance and at two years after the completion of treatment. 2. To determine the progression free survival and overall survival rate 3. To determine the toxicities associated with this treatment approach in subjects with high risk SMM Correlative Research 1. To determine the clonal architecture before treatment, after treatment in subjects with residual disease and in subjects who have disease progression after attaining MRD negativity. 2. To evaluate the bone marrow microenvironment before and after treatment and the time of MRD negative state
CC-5013 (Lenalidomide); Daratumumab (); Dexamethasone (); Lenalidomide (Revlimid); carfilzomib (Kyprolis)
> Between 18 and 80 years.