Frontline T-cell Engager vs Autologous Stem Cell Transplant and Measurable Residual Disease (MRD)-Guided Sequential Intensification thERapy in Multiple Myeloma (FASTER)
SCRI Development Innovations, LLC
Summary
This is an open-label, multi-site, Phase II randomized trial with response-adaptive design for newly diagnosed multiple myeloma (NDMM) participants who have had prior induction therapy. The primary objective of this study is to compare the rates of achieving undetectable measurable residual disease (MRD) in the bone marrow with elranatamab and daratumumab employed as post-induction consolidation and maintenance treatment (Arm A) versus autologous stem cell transplant (ASCT) followed by lenalidomide and daratumumab treatment (Arm B).
Description
This is an open-label, multi-site, Phase II randomized trial with response-adaptive design for newly diagnosed multiple myeloma (NDMM) participants who had prior induction therapy with one proteasome inhibitor, lenalidomide, and an anti-CD38 Monoclonal antibody (mAb) for 16-24 weeks and obtained at least partial response (PR). Eligible participants will be randomized in equal allocation to receive either elranatamab and daratumumab as consolidation and maintenance treatment (Arm A) or to undergo autologous stem cell transplant (ASCT) followed by lenalidomide and daratumumab maintenance treatme…