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

NO_LONGER_AVAILABLE

Conditions studied: Multiple Myeloma

In brief

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 accessible 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.

Key facts

Study ID

NCT05462639

Run by

Pfizer

Last updated by the study team

2024-08-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 at screening 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

You may not qualify if…

• 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;
• Active HBV, HCV, SARS- CoV-2, HIV 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)

Where it is running

• Ronald Reagan UCLA Medical Center — Los Angeles, California, United States
• UCLA Hematology/Oncology - Westwood (Building 200 Suite 120) — Los Angeles, California, United States
• UC Irvine Health — Orange, California, United States
• UC Irvine Medical Center — Orange, California, United States
• Baptist Hospital of Miami — Miami, Florida, United States
• Miami Cancer Institute — Miami, Florida, United States
• Memorial Cancer Institute at Memorial Hospital West — Pembroke Pines, Florida, United States
• Memorial Cancer Institute at Memorial Hospital West — Pembroke Pines, Florida, United States
• Memorial Cancer Institute at Memorial Hospital West — Pembroke Pines, Florida, United States
• Memorial Hospital West Laboratory Services — Pembroke Pines, Florida, United States
• Blood and Marrow Transplant Group of Georgia — Atlanta, Georgia, United States
• Northside Hospital — Atlanta, Georgia, United States
• Georgia Cancer Center at Augusta University — Augusta, Georgia, United States
• Franciscan Health — Indianapolis, Indiana, United States
• University of Mississippi Medical Center — Jackson, Mississippi, United States
• University of Mississippi Medical Center — Jackson, Mississippi, United States
• MSK Basking Ridge — Basking Ridge, New Jersey, United States
• John Theurer Cancer Center at Hackensack University Medical Center — Hackensack, New Jersey, United States
• MSK Monmouth — Middletown, New Jersey, United States
• MSK Bergen — Montvale, New Jersey, United States
• MSK Commack — Commack, New York, United States
• MSK Westchester — Harrison, New York, United States
• Memorial Sloan Kettering Cancer Center — Long Island City, New York, United States
• Memorial Sloan Kettering Cancer Center - David H. Koch Center for Cancer Care (74th Street). — New York, New York, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States

Full record on ClinicalTrials.gov

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