Phase 1 / 2 Study of Elranatamab in People with Relapsed/Refractory Multiple Myeloma MAGNETISMM-9
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What's the purpose of this trial?

The goal of this clinical trial is to evaluate the safety and effectiveness of different doses and dose intervals of Elranatamab in people with relapsed/refractory multiple myeloma.

This trial is open but patient recruitment is temporarily on hold.


What will happen during the trial?

This Phase 1 / 2 clinical trial is being conducted in two different parts. It is open-label, which means that both patient and researchers will know which group they are participating in and which doses they will receive. Patients enrolling in this trial will be allowed to continue to receive Elranatamab as long as their myeloma doesn’t get worse, and they don’t develop bad side effects.

Part 1
Part 1 of this study is organized into 28 day cycles. Researchers are seeking approximately 30 participants in this part of the study. All participants will be required to be hospitalized for a minimum of three days while receiving their first doses of Elranatamab in cycle 1. Patients participating in Part 1 of this study will receive Elranatamab weekly during their first 6 cycles, and every other week from cycle 7 onward if they respond well to Elranatamab. 

Part 2 
Part 2 is the dose exploration and expansion part of this trial, and also organized into 28 day cycles. Researchers are seeking approximately 46 participants in Part 2, in up to three different groups. All participants will be required to be hospitalized for a minimum of three days while receiving their first doses of Elranatamab in cycle 1. Some patients in part 2 will also be required to be hospitalized for one day while receiving the first dose in cycle 2. 

Patients in part 2 will receive one of two planned dose levels of Elranatamab weekly or every other week depending on when they join the study. After 4 and 7 cycles, some patients' dosing schedules may change to receive Elranatamab every other week and once a month respectively if they respond well to Elranatamab.

You may be able to join this trial if you:

The following criteria is a partial list of reasons why patients may be eligible to participate in this clinical trial. Further evaluation with a medical professional is required.

  • Have measurable disease as described in the trial protocol.
  • Are refractory to at least one immunomodulatory drug, one proteasome inhibitor, and one anti-CD38 antibody.
  • Are relapsed or refractory after your last treatment regimen.
  • Have not had a stem cell transplant in the 12 weeks before enrollment.
  • Have not had previous treatment with an anti-BCMA bispecific antibody.

Additional Trial Information

Phase 2

Enrollment: 76 patients (estimated)

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Trial Locations

All Trial Locations

View all clinical trial locations sorted by state.

Arizona

Mayo Clinic (Arizona)

Phoenix, AZ

Not Yet Accepting

Colorado

University of Colorado Health - Poudre Valley Hospital Poudre Valley Hospital

Fort Collins, CO

Recruitment on Hold

Florida

Shands Hospital University of Florida Health

Gainesville, FL

Recruitment on Hold

Illinois

Rush University Medical Center

Chicago, IL

Not Yet Accepting

Kentucky

Pikeville Medical Center

Pikeville, KY

Recruitment on Hold

Louisiana

Tulane Cancer Center Tulane University School of Medicine

New Orleans, LA

Recruitment on Hold

Michigan

University of Michigan Comprehensive Cancer Center

Ann Arbor, MI

Recruitment on Hold

Henry Ford Hospital

Detroit, MI

Recruitment on Hold

New York

Memorial Sloan Kettering Cancer Center

New York, NY

Not Yet Accepting

North Carolina

Novant Health Forsyth Medical Center - Silas Creek

Winston-Salem, NC

Not Yet Accepting

Novant Health Forsyth Cancer Institute - Bethesda Court

Winston-Salem, NC

Not Yet Accepting

Ohio

Cleveland Clinic Taussig Cancer Institute

Cleveland, OH

Recruitment on Hold

Pennsylvania

Fox Chase Cancer Center Temple Health

Philadelphia, PA

Not Yet Accepting

Texas

St. David's South Austin Medical Center

Austin, TX

Recruitment on Hold

Baylor Scott & White Hospital

Temple, TX

Not Yet Accepting

Utah

Huntsman Cancer Institute University of Utah

Salt Lake City, UT

Recruitment on Hold
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