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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)
Sponsor: Genentech, Inc.
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
120
Start Date
2023-08-10
Completion Date
2027-07-31
Last Updated
2026-04-02
Healthy Volunteers
No
Conditions
Interventions
Cevostamab
Cevostamab solution for infusion will be administered as IV as specified in each treatment arm.
Elranatamab
Elranatamab solution for injection will be administered SC as specified in each treatment arm.
Tocilizumab
Tocilizumab will be used as rescue medication for participants who experience a cytokine release syndrome (CRS) event.
Locations (14)
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia
Calvary Mater Newcastle
Waratah, New South Wales, Australia
Royal Adelaide Hospital;Haematology Clinical Trials Unit
Adelaide, South Australia, Australia
St. Vincent's Hospital Melbourne
Melbourne, Victoria, Australia
The Alfred Hospital
Prahan, Victoria, Australia
Rambam Health Care Campus
Haifa, Israel
Hadassah University Hospital - Ein Kerem
Jerusalem, Israel
Sheba Medical Center - PPDS
Ramat Gan, Israel
Tel Aviv Sourasky Medical Center PPDS
Tel Aviv, Israel
The Catholic University of Korea - Seoul St. Mary's Hospital (Kangnam St. Mary's Hospital)
Seocho, South Korea
Seoul National University Hospital
Seoul, South Korea
Severance Hospital, Yonsei University Health System
Seoul, South Korea
Asan Medical Center.
Seoul, South Korea
Samsung Medical Center - PPDS
Seoul, South Korea