NCT06974786

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

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: SCRI Development Innovations, LLC · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

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).

Detailed 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 treatment (Arm B). Patients who have residual detectable disease by MRD assessment after one year of consolidation and maintenance will undergo "late intensification" and receive the alternative therapy. Patients who achieve sustained "MRD-negativity" on 2 consecutive assessments will discontinue treatment with observation for disease progression or MRD resurgence. Elranatamab is a humanized bispecific antibody which binds to BCMA on MM cells and CD3 on T cells. Elranatamab activates and directs T cells to induce a cytotoxic T-cell response against myeloma cells. Daratumumab is a CD-38 directed therapy.

Conditions

• Multiple Myeloma, Newly Diagnosed
• Multiple Myeloma (MM)

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-08-08
• Primary completion: 2032-11-01
• Completion: 2033-04-01
• First posted: 2025-05-16
• Last updated: 2026-01-23

Locations

9 sites across 1 country: United States

Regulatory

• FDA-regulated drug study