Multiple Myeloma Clinical Trial
Official title:
Combination Post-transplant Consolidation Therapy With Isatuximab, Lenalidomide, Dexamethasone (IsaRD) in Multiple Myeloma Patients With Persistent Marrow Minimal Residual Disease (Elimination of MRD After Transplant; E-MAT)
This is a single-center, single-arm, phase II study that will enroll multiple myeloma (MM) patients with persistent bone marrow minimal residual disease (MRD) post autologous stem cell transplant (ASCT) irrespective of the International Myeloma Working Group (IMWG) response.
Thirty-one study subjects will be enrolled at Froedtert Hospital and the Medical College of Wisconsin Cancer Center. Enrolled subjects will receive a combination of isatuximab, lenalidomide, and dexamethasone (IsaRD) for 12 28-day cycles. The primary objective of this study is to determine bone marrow (BM) MRD ≤1x10^5 negativity rate, as measured by the clonoSEQ® next-generation sequencing (NGS) assay, at the end of 12 months of IsaRD treatment. Other objectives will further assess efficacy, tolerability, and molecular response to the IsaRD regimen. ;
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