Actively Recruiting

Phase 1
Age: 18Years +
All Genders
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)

Led by Genentech, Inc. · Updated on 2026-05-04

120

Participants Needed

14

Research Sites

207 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official 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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
  • Diagnosis of relapsed or refractory multiple myeloma according to IMWG criteria
  • Female participants of childbearing potential must agree to remain abstinent or use contraception
  • Male participants must agree to remain abstinent or use a condom
Not Eligible

You will not qualify if you...

  • Prior treatment with cevostamab or another agent targeting 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
  • Known history of hemophagocytic lymphohistiocytosis or macrophage activation syndrome
  • Acute or chronic hepatitis B or hepatitis 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

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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

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Research Team

G

GO43979 https://forpatients.roche.com/

CONTACT

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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