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)

Last updated: March 27, 2025
Sponsor: Genentech, Inc.
Overall Status: Active - Recruiting

Phase

1

Condition

Bone Neoplasm

Platelet Disorders

Bone Diseases

Treatment

Elranatamab

Cevostamab

Tocilizumab

Clinical Study ID

NCT05927571
GO43979
2023-504657-13-00
2022-501724-15-00
  • Ages > 18
  • All Genders

Study 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 dose (RP2D) for the study treatment. The study consists of a safety lead-in stage, and an expansion stage.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1

  • Diagnosis of R/R MM per IMWG criteria

  • For female participants of childbearing potential: agreement to remain abstinent oruse contraception

  • For male participants: agreement to remain abstinent or use a condom

Exclusion

Exclusion Criteria:

  • Prior treatment with cevostamab or another agent targeting fragment crystallizablereceptor-like 5 (FcRH5)

  • Prior treatment with elranatamab

  • Prior allogeneic stem cell transplantation (SCT)

  • Absolute plasma cell count exceeding 500 per milliliter (mL) or 5% of the peripheralblood white cells

  • Diagnosis of Waldenström macroglobulinemia or polyneuropathy, organomegaly,endocrinopathy, monoclonal gammopathy, skin changes (POEMS) syndrome

  • Participants with 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 (CMV) and/or Epstein-Barr virus (EBV)infection

  • Known history of hemophagocytic lymphohistiocytosis (HLH) or macrophage activationsyndrome (MAS)

  • Acute or chronic hepatitis B virus (HBV) or hepatitis C virus (HCV) infection

  • Human immunodeficiency virus (HIV) seropositivity

  • History of central nervous system (CNS) myeloma disease

  • Significant cardiovascular disease

Study Design

Total Participants: 120
Treatment Group(s): 3
Primary Treatment: Elranatamab
Phase: 1
Study Start date:
August 10, 2023
Estimated Completion Date:
July 31, 2026

Connect with a study center

  • Royal Prince Alfred Hospital

    Camperdown, New South Wales 2050
    Australia

    Active - Recruiting

  • Calvary Mater Newcastle

    Waratah, New South Wales 2298
    Australia

    Active - Recruiting

  • The Alfred Hospital

    Prahan, Victoria 3181
    Australia

    Active - Recruiting

  • Rambam Health Care Campus

    Haifa, 3109600
    Israel

    Active - Recruiting

  • Sheba Medical Center - PPDS

    Ramat Gan, 5266202
    Israel

    Site Not Available

  • Sheba Medical Center - PPDS

    Ramat-Gan, 5262000
    Israel

    Active - Recruiting

  • Tel Aviv Sourasky Medical Center PPDS

    Tel Aviv-Yafo, 6423906
    Israel

    Active - Recruiting

  • The Catholic University of Korea - Seoul St. Mary's Hospital (Kangnam St. Mary's Hospital)

    Seocho, 06591
    Korea, Republic of

    Active - Recruiting

  • Samsung Medical Center - PPDS

    Seoul, 06351
    Korea, Republic of

    Active - Recruiting

  • Seoul National University Hospital

    Seoul, 03080
    Korea, Republic of

    Active - Recruiting

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