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

PHASE2RecruitingINTERVENTIONAL
Enrollment

100

Participants

Timeline

Start Date

August 8, 2025

Primary Completion Date

November 30, 2032

Study Completion Date

April 30, 2033

Conditions
Multiple Myeloma, Newly DiagnosedMultiple Myeloma (MM)
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.

Trial Locations (3)

23502

RECRUITING

Virginia Oncology Associates, Norfolk

45242

RECRUITING

Oncology Hematology Care, Cincinnati

80218

RECRUITING

Colorado Blood Cancer Institute, Denver

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Pfizer

INDUSTRY

collaborator

coMMit, Myeloma Trials, Innovated

UNKNOWN

lead

SCRI Development Innovations, LLC

OTHER

NCT06974786 - Frontline T-cell Engager vs Autologous Stem Cell Transplant (ASCT) and Measurable Residual Disease (MRD)-Guided Sequential Intensification thERapy in Multiple Myeloma | Biotech Hunter | Biotech Hunter