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Keep this study
Lead
Pfizer
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.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible 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 be 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)
Clareo Health | Elranatamab Expanded Access Protocol in Adults With Relapsed/Refractory Multiple Myeloma
