NCT05927571

A Study Evaluating the Safety, Pharmacokinetics, and Activity of the Combination of Cevostamab and Elranatamab in Participants With Relapsed or Refractory Multiple Myeloma (R/R MM)

An Open-Label, Multicenter, Phase Ib Trial Evaluating the Safety, Pharmacokinetics, and Activity of the Combination of Cevostamab and Elranatamab in Patients With Relapsed or Refractory Multiple Myeloma

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Genentech, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to evaluate safety and tolerability of the combination of cevostamab plus elranatamab and also determine the recommended Phase II regimen (RP2R) for the study treatment. The study consists of a safety lead-in stage, and an expansion stage.

Conditions

• Relapsed or Refractory Multiple Myeloma

Interventions

Type	Name	Description
DRUG	Cevostamab	Cevostamab solution for infusion will be administered as IV as specified in each treatment arm.
DRUG	Elranatamab	Elranatamab solution for injection will be administered SC as specified in each treatment arm.
DRUG	Tocilizumab	Tocilizumab will be used as rescue medication for participants who experience a cytokine release syndrome (CRS) event.

Timeline

• Start date: 2023-08-10
• Primary completion: 2027-07-31
• Completion: 2027-07-31
• First posted: 2023-07-03
• Last updated: 2026-04-02

Locations

14 sites across 3 countries: Australia, Israel, South Korea

Regulatory

• FDA-regulated drug study