RecruitingPhase 2NCT06974786

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)


Sponsor

SCRI Development Innovations, LLC

Enrollment

100 participants

Start Date

Aug 8, 2025

Study Type

INTERVENTIONAL

Conditions

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).


Eligibility

Min Age: 19 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing a new immune therapy approach (a T-cell engager drug called teclistamab) against a standard stem cell transplant to see which is better for newly diagnosed multiple myeloma patients who have responded well to initial treatment. **You may be eligible if...** - You are over 18 with newly diagnosed multiple myeloma - You are eligible for a stem cell transplant - You completed induction therapy (16–24 weeks) with a combination including a proteasome inhibitor, lenalidomide, and an anti-CD38 antibody, and achieved at least a partial response - Your disease was measurable at diagnosis - Your physical performance score is ECOG 0–1 **You may NOT be eligible if...** - You have significant organ dysfunction (kidneys, liver, heart, lungs) - You have active infections or other cancers - You are pregnant or breastfeeding - You have already received more than one line of treatment before this study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGElranatamab

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.

DRUGDaratumumab

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

DRUGLenalidomide

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.

PROCEDUREautologous stem cell transplantation

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


Locations(11)

University of Alabama at Birmingham

Birmingham, Alabama, United States

Colorado Blood Cancer Institute

Denver, Colorado, United States

University of Iowa

Iowa City, Iowa, United States

University of North Carolina

Chapel Hill, North Carolina, United States

Oncology Hematology Care

Cincinnati, Ohio, United States

The Ohio State University- The James Cancer Hospital and Solove Research Institute

Columbus, Ohio, United States

SCRI Oncology Partners

Nashville, Tennessee, United States

University of Texas Southwestern

Dallas, Texas, United States

Virginia Oncology Associates

Norfolk, Virginia, United States

University of Wisconsin Clinical Science Center

Madison, Wisconsin, United States

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

View Full Details on ClinicalTrials.gov

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NCT06974786


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