NCT04910568

A Study Evaluating the Safety, Pharmacokinetics, and Activity of Cevostamab in Participants With Relapsed or Refractory Multiple Myeloma

An Open-Label, Multicenter, Phase Ib Trial Evaluating the Safety, Pharmacokinetics, and Activity of Cevostamab as Monotherapy and Cevostamab Plus Pomalidomide and Dexamethasone or Cevostamab Plus Daratumumab and Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 126 (actual)
• Sponsor: Genentech, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This Phase Ib, multicenter, open-label study will evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of cevostamab monotherapy, cevostamab plus pomalidomide and dexamethasone (Pd) or cevostamab plus daratumumab and dexamethasone (Dd) which will be administered to participants with relapsed or refractory multiple myeloma (R/R MM) via intravenous (IV) infusion.

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
DRUG	Cevostamab	Cevostamab will be administered intravenously on a 28-day cycle, up to a total of 13 cycles (Arm A), in 28-day cycles Q2W followed by Q4W (Arm B) and in 21 day cycles from C1-C8 Q3W and 28-day cycles from C9 onwards Q4W (Arm C). For Arm A, participants have the option to enter re-treatment after Cycle 13. For Arms B and C, participants can be treated until disease progression or unacceptable toxicity.
DRUG	Tocilizumab	Tocilizumab will be administered for the treatment of cytokine release syndrome (CRS) when necessary.
DRUG	Pomalidomide	Pomalidomide will be administered orally (PO) on a 28-day cycle.
DRUG	Daratumumab	Daratumumab will be administered subcutaneously (SC) on 21 day (C1-8) and 28-day cycles (C9 onwards).
DRUG	Dexamethasone	Arm A: Dexamethasone will be administered as a premedication. Arms B and C: Dexamethasone will be administered via IV or orally at 20 mg as study investigational medicinal product.

Timeline

• Start date: 2021-07-26
• Primary completion: 2029-12-10
• Completion: 2029-12-10
• First posted: 2021-06-02
• Last updated: 2026-03-19

Locations

26 sites across 13 countries: United States, Australia, Canada, Czechia, Denmark, France, Israel, Italy, Japan, Poland, South Korea, Spain, United Kingdom

Regulatory

• FDA-regulated drug study