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

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Basic Details

Sponsor Genentech, Inc.

Phase Phase 1

Study Identifier NCT05927571, GO43979, 2023-504657-13-00

Condition Relapsed or Refractory Multiple Myeloma

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

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

Gender

All

Age

≥18 Years

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

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

Results Disclaimer

What is Clinical Research?

In clinical research, volunteers, researchers, and medical professionals work together toward a shared goal: better treatment outcomes for patients. Clinical trials are vital to their process. They are carefully designed and follow approved protocols.

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)

Basic Details

Study Summary

Eligibility Criteria

What is Clinical Research?

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

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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)

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