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

• Conditions: Multiple Myeloma

• Registration Number: NCT05462639
• Lead Sponsor: Pfizer

Brief 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 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.

Detailed 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 accessible.

Study Timeline

• Study First Submitted: 2022-06-20
• Study First Submitted QC: 2022-07-15
• Study First Posted: 2022-07-18
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-06
• Last Update Posted: 2024-08-09

Recruitment & Eligibility

• Status: NO_LONGER_AVAILABLE
• Sex: All
• Target Recruitment: Not specified

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 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

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;
• 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)

Study & Design

• Study Type: EXPANDED_ACCESS
• Study Design: Not specified

Trial Locations

Locations (32)

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 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

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