Elranatamab Expanded Access Protocol in Adults With Relapsed/Refractory Multiple Myeloma (MAGNETISMM17) MAGNETISMM-17

What's the purpose of this trial?

This expanded access protocol will provide access to elranatamab until it becomes commercially available to patients who are refractory to at least one proteasome inhibitor, one immunomodulatory drug and one anti-CD38 antibody and have no access to other comparable/alternative therapy and for whom elranatamab could be a possible treatment option.

This trial is currently open and accepting patients.

What will happen during the trial?

Study C1071017 is a single-arm, open-label study in patient with relapsed /refractory multiple myeloma.

Each patient will receive study intervention until disease progression, unacceptable toxicity, withdrawal of consent, study termination or until elranatamab becomes commercially accessible.

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.

Inclusion Criteria:

  • Prior diagnosis of MM as defined according to IMWG criteria .
  • Patients who are ineligible for participation in any ongoing clinical trial of elranatamab, including lack of access due to geographical limitations, and who have exhausted all other treatment options or experience lack of access to commercially available therapies due to geographical, financial or socioeconomic limitations.
  • Measurable disease based on IMWG criteria as defined by at least 1 of the following:
  • Serum M-protein ≥0.5 g/dL (≥5 g/L)
  • Urinary M-protein excretion ≥200 mg/24 hours
  • Involved FLC ≥10 mg/dL (≥100 mg/L) AND abnormal serum immunoglobulin kappa to lambda FLC ratio (<0.26 or >1.65).
  • Refractory to at least one IMiD, one PI, and one anti-CD38 antibody.
  • Relapsed/refractory to last anti-MM regimen.
  • ECOG performance status 0-1.
  • Resolved acute effects of any prior therapy to baseline severity or CTCAE Grade ≤1.
  • Not pregnant, willing to use contraception

Exclusion Criteria:

  • Smoldering MM; plasma cell leukemia; POEMS syndrome; Waldenström's macroglobulinemia; amyloidosis; stem cell transplant within 12 weeks prior to enrollment or active GVHD
  • Previous treatment with BCMA directed therapy;
  • SARS-CoV2, HIV, HBV, HCV or any active, uncontrolled bacterial, fungal, or viral infection.
  • Active infections must be resolved at least 14 days prior to enrollment.
  • Any other active malignancy within 3 years prior to enrollment, except for adequately treated basal cell or squamous cell skin cancer, carcinoma in situ or Stage 0/1 with minimal risk of recurrence per treating physician.
  • Previous administration with an investigational drug or vaccine within 30 days (or as determined by the local requirement) or 5 half-lives preceding the first dose of study intervention used in this study (whichever is longer)
 

Additional Trial Information

Expanded Access

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Trial Locations

All Trial Locations

View all clinical trial locations sorted by state.

California

UCLA Jonsson Comprehensive Cancer Center University of California Los Angeles

Los Angeles, CA

Open and Accepting

Florida

Baptist Hospital of Miami

Miami, FL

Open and Accepting

Georgia

Northside Hospital (Atlanta)

Atlanta, GA

Open and Accepting

Augusta University Medical Center

Augusta, GA

Open and Accepting

Indiana

Franciscan Health Cancer Center Indianapolis

Indianapolis, IN

Not Yet Accepting

Mississippi

University of Mississippi Medical Center

Jackson, MS

Open and Accepting

New Jersey

Memorial Sloan Kettering Cancer Center

Basking Ridge, NJ

Open and Accepting

Memorial Sloan Kettering Cancer Center

Middletown, NJ

Open and Accepting

Memorial Sloan Kettering Bergen

Montvale, NJ

Open and Accepting

New York

Memorial Sloan Kettering Cancer Center

New York, NY

Open and Accepting

Memorial Sloan Kettering Cancer Center

Commack, NY

Open and Accepting

Weill Cornell

New York, NY

Open and Accepting

Memorial Sloan Kettering Cancer Center Nassau

Uniondale, NY

Open and Accepting

Memorial Sloan Kettering Cancer Center

West Harrison, NY

Open and Accepting

Texas

Baylor Charles A. Sammons Cancer Center Baylor Scott & White Health

Dallas, TX

Open and Accepting

Texas Oncology (Dallas)

Dallas, TX

Open and Accepting
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