Actively Recruiting
An Open-Label, Multicenter Phase Ib Trial Evaluating Safety and Activity of Cevostamab Plus Elranatamab in Relapsed or Refractory Multiple Myeloma
Led by Genentech, Inc. · Updated on 2026-06-03
120
Participants Needed
14
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and tolerability of combining two drugs, cevostamab and elranatamab, in people with relapsed or refractory multiple myeloma. This phase 1b trial aims to find the recommended dose regimen for further study. The study includes a safety lead-in stage and an expansion stage to assess these treatments in participants who have previously received treatment for this condition. Participants will receive cevostamab intravenously and elranatamab as a subcutaneous injection, starting with step-up dosing in a pre-phase to gradually increase doses. Depending on the study group, participants may receive the combination of cevostamab and elranatamab or elranatamab alone. Treatment continues until disease progression, unacceptable side effects, or for up to one year for cevostamab. During the study, participants will have regular assessments to monitor adverse events, drug levels in the blood, and responses to treatment based on standard myeloma criteria. Researchers will track how well participants respond, how long responses last, and overall survival for up to about 36 months. Safety and tolerability will be closely monitored throughout the study period.
CONDITIONS
Brief Title
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)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- Diagnosed with relapsed or refractory multiple myeloma according to International Myeloma Working Group criteria
- Female participants of childbearing potential must agree to abstain or use contraception
- Male participants must agree to abstain or use a condom
- Aged 18 years or older
You will not qualify if you...
- Prior treatment with cevostamab or another agent targeting fragment crystallizable receptor-like 5 (FcRH5)
- Prior treatment with elranatamab
- Prior allogeneic stem cell transplantation
- Absolute plasma cell count exceeding 500 per milliliter or 5% of peripheral blood white cells
- Diagnosis of Waldenström macroglobulinemia or POEMS syndrome
- Known history of amyloidosis
- History of autoimmune disease
- History of confirmed progressive multifocal leukoencephalopathy
- Peripheral motor polyneuropathy of prespecified grade
- Known or suspected chronic cytomegalovirus or Epstein-Barr virus infection
- History of hemophagocytic lymphohistiocytosis or macrophage activation syndrome
- Acute or chronic hepatitis B or C infection
- HIV seropositivity
- History of central nervous system myeloma disease
- Significant cardiovascular disease
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Not specified
Participants receive step-up dosing of cevostamab (IV) and/or elranatamab (SC) in a pre-phase before starting assigned treatment doses.
Multiple visits during pre-phase dosing
Duration - Until disease progression, unacceptable toxicity, or up to 1 year on treatment
Participants receive assigned doses of cevostamab intravenously and/or elranatamab subcutaneously until disease progression, unacceptable toxicity, or up to 1 year on treatment.
Regular visits for treatment administration and monitoring
Duration - Up to approximately 36 months
Participants are monitored for safety, response, and survival for up to approximately 36 months after treatment starts.
Periodic visits for assessments
Trial Site Locations
Total: 14 locations
1
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia, 2050
Actively Recruiting
2
Calvary Mater Newcastle
Waratah, New South Wales, Australia, 2298
Actively Recruiting
3
Royal Adelaide Hospital;Haematology Clinical Trials Unit
Adelaide, South Australia, Australia, 5000
Actively Recruiting
4
St. Vincent's Hospital Melbourne
Melbourne, Victoria, Australia, 3065
Actively Recruiting
5
The Alfred Hospital
Prahan, Victoria, Australia, 3181
Actively Recruiting
6
The Chaim Sheba Medical Center - PPDS
Ramat Gan, Central District, Israel, 5262100
Actively Recruiting
7
Rambam Health Care Campus
Haifa, Israel, 3109600
Actively Recruiting
8
Hadassah University Hospital - Ein Kerem
Jerusalem, Israel, 9112001
Actively Recruiting
9
Tel Aviv Sourasky Medical Center PPDS
Tel Aviv, Israel, 6423906
Actively Recruiting
10
The Catholic University of Korea - Seoul St. Mary's Hospital (Kangnam St. Mary's Hospital)
Seocho, South Korea, 06591
Actively Recruiting
11
Seoul National University Hospital
Seoul, South Korea, 03080
Actively Recruiting
12
Severance Hospital, Yonsei University Health System
Seoul, South Korea, 03722
Actively Recruiting
13
Asan Medical Center.
Seoul, South Korea, 05505
Actively Recruiting
14
Samsung Medical Center - PPDS
Seoul, South Korea, 06351
Actively Recruiting
Research Team
G
GO43979 https://forpatients.roche.com/
F
Fastest response: use the inquiry form. No email attachments. https://www.gene.com/contact-us/submit-medical-inquiry
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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