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).
Age >18 years with no upper age limit.
Newly diagnosed multiple myeloma with indication for initiation of therapy diagnosed within last 12 months. Pretreatment parameters necessary for disease characterization and response assessment must be available.
Eligible for ASCT according to institutional policy as evaluated by investigator.
Eastern Cooperative Oncology Group (ECOG) performance status 0-1 (Appendix A).
Diagnosis of primary light chain amyloidosis, POEMS, Waldenstrom's macroglobulinemia, plasma cell leukemia, or central nervous system (CNS) involvement by MM.
Contraindications or life-threatening allergies, hypersensitivity, or intolerance to any study drug or its excipients (refer to the elranatamab Investigator's Brochure [IB] and appropriate package inserts).
PI therapy - 14 days.
IMiD agent therapy -14 days.
SCRI Development Innovations, LLC
Lead sponsor
Pfizer
Collaborator
coMMit, Myeloma Trials, Innovated
Collaborator