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.
Recruitment & Eligibility
- Status
- NO_LONGER_AVAILABLE
- Sex
- All
- Target Recruitment
- Not specified
- 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
- 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
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (32)
Baptist Hospital of Miami
🇺🇸Miami, Florida, United States
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
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
Georgia Cancer Center at Augusta University
🇺🇸Augusta, Georgia, United States
Franciscan Health
🇺🇸Indianapolis, Indiana, 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 Commack
🇺🇸Commack, New York, United States
MSK Bergen
🇺🇸Montvale, New Jersey, United States
Memorial Sloan Kettering Cancer Center
🇺🇸New York, New York, United States
MSK Westchester
🇺🇸Harrison, New York, United States
Memorial Sloan Kettering Cancer Center - David H. Koch Center for Cancer Care (74th Street).
🇺🇸New York, New York, United States
MSK Nassau
🇺🇸Uniondale, New York, United States
OhioHealth Arthur G.H. Bing, MD Cancer Center
🇺🇸Columbus, Ohio, United States
OhioHealth Research Institute
🇺🇸Columbus, Ohio, United States
Baylor Scott & White Charles A. Sammons Cancer Center
🇺🇸Dallas, Texas, United States
Texas Oncology
🇺🇸Dallas, Texas, United States
Baylor University Medical Center, Investigational Drug Services, Department of Pharmacy
🇺🇸Dallas, Texas, United States
Baylor University Medical Center
🇺🇸Dallas, Texas, United States
Tom Baker Cancer Center
🇨🇦Calgary, Alberta, Canada
Princess Margaret Cancer Centre
🇨🇦Toronto, Ontario, Canada
Weill Cornell Medical College
🇺🇸New York, New York, United States
University of Mississippi Medical Center
🇺🇸Jackson, Mississippi, United States
McGill University Health Centre
🇨🇦Montréal, Quebec, Canada