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.
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.
Drug: Elranatamab (PF-06863135)
BCMA-CD3 bispecific antibody
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)
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 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 St. Francis 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
Weill Cornell Medical College
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
Baylor University Medical Center, Investigational Drug Services, Department of Pharmacy
Dallas, Texas, United States
Baylor University Medical Center
Dallas, Texas, United States
Texas Oncology
Dallas, Texas, United States
Tom Baker Cancer Center
Calgary, Alberta, Canada
Princess Margaret Cancer Centre
Toronto, Ontario, Canada
McGill University Health Centre
Montréal, Quebec, Canada
Pfizer CT.gov Call Center
1-800-718-1021
ClinicalTrials.gov_Inquiries@pfizer.com
Pfizer CT.gov Call Center, Study Director
Pfizer