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.
Sequential
Elranatamab
DrugElranatamab will be administered subcutaneously (SC) in step-up doses on Day 1 (12 mg) and Day 4 (32 mg) followed by dosing of 76 mg on Day 8, Day 15, and Day 22 during Cycle 1, then 76 mg every other week for Cycle 2 and 3. For Cycles 4- 12, elranatamab 76 mg dose will be given once a cycle. Participants will receive a maximum of 12 cycles of elranatamab. Cycles will be 28 days.
Tocilizumab
DrugA single (one time) intravenous (IV) dose of tocilizumab 8 mg/kg will be administered 1-4 hours prior to the first step-up dose (SUD) of elranatamab in Cycle 1. Cycles will be 28 days.
Incidence of Cytokine Release Syndrome (CRS) in Cycle 1
Evaluate the number of participants with events of CRS during Cycle 1 of study treatment. CRS events will be graded per the American Society for Transplantation and Cellular Therapy grading (ASTCT 2019).
Incidence of ≥ Grade 2 CRS during Cycle 1
Evaluate the number of participants with Grade 2 or greater events of CRS during Cycle 1 of study treatment. CRS events will be graded per the American Society for Transplantation and Cellular Therapy grading (ASTCT 2019).
Incidence of all-grade CRS
Evaluate the number of participants with any grade of events of CRS during any time on study treatment. CRS events will be graded per the American Society for Transplantation and Cellular Therapy grading (ASTCT 2019).
Incidence of recurrent CRS
Evaluate the number of participants with multiple events of CRS during any time on study treatment. CRS events will be graded per the American Society for Transplantation and Cellular Therapy grading (ASTCT 2019).
Timing of CRS relative to the first dose of elranatamab
Evaluate the the frequency of any events of CRS occurring at different intervals of time following administration of the first dose of elranatamab. CRS events will be graded per the American Society for Transplantation and Cellular Therapy grading (ASTCT 2019).
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SCRI Development Innovations, LLC
Lead sponsor
Pfizer
Collaborator
