A Study of Elranatamab Outpatient Administration in Patients With Relapsed/Refractory Multiple Myeloma
A Phase II, Nonrandomized, Single-Arm Study of Elranatamab Outpatient Administration in Patients With Relapsed/Refractory Multiple Myeloma (CORE-MM)
SCRI Development Innovations, LLC
46 participants
Sep 1, 2026
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Plain Language Summary
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Interventions
Elranatamab 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.
A 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.
Locations(6)
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NCT07637578