This is a Phase II, open-label, nonrandomized, single-arm study of elranatamab that will be administered in the outpatient setting in 2 sequential cohorts of participants with relapsed or refractory multiple myeloma (RRMM). The primary objective of this study is to evaluate the overall incidence of cytokine release syndrome (CRS) during Cycle 1 of elranatamab treatment following a single prophylactic dose of tocilizumab.
Written informed consent, according to institutional guidelines, signed and dated by the participant or by a legal guardian prior to the performance of any study-specific procedures, sampling, or analyses
At least 18 years-of-age at the time of signature of the ICF
Has documented diagnosis of MM according to IMWG diagnostic criteria
Serum M-protein level ≥0.5 g/dL
History of antitumor therapy as follows, before the first dose of study drug
Targeted therapy, epigenetic therapy, or treatment with an investigational drug or used an invasive investigational medical device within 21 days or at least 5 half-lives, whichever is shorter.
Monoclonal antibody treatment for MM within 21 days.
Cytotoxic therapy within 21 days.
SCRI Development Innovations, LLC
Lead sponsor
Pfizer
Collaborator