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

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

Eligibility

Age range

19+ years

Sex

All

Healthy volunteers

No

Interventions

• Drug
  Elranatamab

  Participants will receive step up dosing of Elranatamab subcutaneously in first cycle of consolidation followed by fixed dosing for 2 additional cycles and for 12 cycles in maintenance. Arm A participants will receive additional 12 cycles of Elranatamab monotherapy if they are MRD negative after Maintenance 1 for a total of 27 cycles. Cycles will be 28 days.

• Drug
  Daratumumab

  Participants will be given 1800 mg of Daratumumab subcutaneously every 4 weeks for up a maximum of 26 cycles.

• Drug
  Lenalidomide

  Participants will receive 10 mg of Lenalidomide daily by mouth for 21 days of each 28-day cycle for up to a maximum of 24 cycles.

• Procedure
  autologous stem cell transplantation

  Participants will undergo ASCT as standard treatment following individual site's processes and practices.

Locations (11)