Frontline T-cell Engager vs Autologous Stem Cell Transplant (ASCT) and Measurable Residual Disease (MRD)-Guided Sequential Intensification thERapy in Multiple Myeloma

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).

Trial Details

NCT ID
NCT06974786
Phase
PHASE2
Sponsor
SCRI Development Innovations, LLC
Status
RECRUITING
Cancer Type
Newly Diagnosed Multiple Myeloma
Interventions
  • Elranatamab
  • Daratumumab
  • Lenalidomide
  • autologous stem cell transplantation
Locations (sample)
  • Birmingham, Alabama, United States|33.52066,-86.80249
  • Denver, Colorado, United States|39.73915,-104.9847
  • Iowa City, Iowa, United States|41.66113,-91.53017
  • Chapel Hill, North Carolina, United States|35.9132,-79.05584
  • Cincinnati, Ohio, United States|39.12711,-84.51439

Key Eligibility Criteria

  • 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 d…
  • Eligible for ASCT according to institutional policy as evaluated by investigator.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-1 (Appendix A).

For full eligibility, visit ClinicalTrials.gov.

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