drugset / Trial / NCT07637578

A Study of Elranatamab Outpatient Administration in Patients With Relapsed/Refractory Multiple Myeloma

NCT07637578

Phase 2 Not yet recruiting 46 enrolled SCRI Development Innovations, LLC Pfizer · collab
Non-randomizedSequentialOpen-labelTreatment

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.

Timeline

Start
2026-08
Primary completion
2029-10
Completion
2030-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Elranatamab Monoclonal antibody 76 mg Subcutaneous
Background Tocilizumab Monoclonal antibody 8 mg/kg Intravenous

Indications