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)

  • Cancer
  • Multiple Myeloma
  • Relapsed or Refractory Multiple Myeloma
Please note that the recruitment status of the study at your site may differ from the overall study status because some study sites may recruit earlier than others.
Study Status:

Recruiting

This study runs in
Countries
  • Australia
  • Israel
  • Korea, Republic of
Study Identifier:

NCT05927571 2023-504657-13-00 GO43979

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      The source of the below information is public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc.. It has been summarised and edited into simpler language. For more information about this clinical study see the For Expert tab on the specific ForPatients page or follow these links to https://clinicaltrials.gov and/or https://euclinicaltrials.eu and/or https://www.isrctn.com.

      The below information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.

      Results Disclaimer

      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.

      Genentech, Inc. Sponsor
      Phase 1 Phase
      NCT05927571, GO43979, 2023-504657-13-00 Study Identifier
      Cevostamab, Elranatamab, Tocilizumab Treatments
      Relapsed or Refractory Multiple Myeloma Condition
      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

      Eligibility Criteria

      All Gender
      ≥18 Years Age
      No Healthy Volunteers
      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 or use contraception
      • For male participants: agreement to remain abstinent or use a condom
      Exclusion Criteria
      • Prior treatment with cevostamab or another agent targeting fragment crystallizable receptor-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 peripheral blood 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 activation syndrome (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

      For the latest version of this information please go to www.forpatients.roche.com

       

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