Multiple Myeloma Clinical Trial

Elranatamab Expanded Access Protocol in Adults With Relapsed/Refractory Multiple Myeloma

Summary

Elranatamab is a bispecific antibody: binding of elranatamab to CD3- expressing T-cell and BCMA- expressing multiple myeloma cells causes targeted T-cell mediated cytotoxicity.

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.

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Full Description

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 available.

View Eligibility Criteria

Eligibility Criteria

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.
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)

Study is for people with:

Multiple Myeloma

Study ID:

NCT05462639

Recruitment Status:

Available

Sponsor:

Pfizer

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There are 5 Locations for this study

See Locations Near You

Baptist Hospital of Miami
Miami Florida, 33176, United States
Miami Cancer Institute
Miami Florida, 33176, United States
Blood and Marrow Transplant Group of Georgia
Atlanta Georgia, 30342, United States
Northside Hospital
Atlanta Georgia, 30342, United States
Franciscan St. Francis Health
Indianapolis Indiana, 46237, United States
Weill Cornell Medical College
New York New York, 10065, United States
Baylor Scott & White Charles A. Sammons Cancer Center
Dallas Texas, 75246, United States
Baylor University Medical Center, Investigational Drug Services, Department of Pharmacy
Dallas Texas, 75246, United States
Baylor University Medical Center
Dallas Texas, 75246, United States
Texas Oncology
Dallas Texas, 75246, United States

How clear is this clinincal trial information?

Study is for people with:

Multiple Myeloma

Study ID:

NCT05462639

Recruitment Status:

Available

Sponsor:


Pfizer

How clear is this clinincal trial information?

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