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)

NCT05927571 · tracked via the Priya Life Science Israel tracker

Sponsor

Genentech, Inc

Phase

Phase 1

Started

2023-08-10

Last updated

2026-09-03

Condition(s) studied

Relapsed or Refractory Multiple Myeloma

Investigational drug(s) / intervention(s)

Cevostamab →Elranatamab →Tocilizumab →

Cevostamab: Cevostamab solution for infusion will be administered as IV as specified in each treatment arm.

Elranatamab: Elranatamab solution for injection will be administered SC as specified in each treatment arm.

Tocilizumab: Tocilizumab will be used as rescue medication for participants who experience a cytokine release syndrome (CRS) event.

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 regimen (RP2R) for the study treatment. The study consists of a safety lead-in stage, and an expansion stage.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

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

Primary outcome measure(s)

Number of Participants With Adverse Events (AEs) — From signing of informed consent up to end of study (EOS) (approximately 36 months)
Adverse events will be reported according to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5.0). The severity of CRS, immune effector cell-associated neurotoxicity syndrome (ICANS) and hemophagocytic lymphohistiocytosis (HLH) will be graded based on the American Society for Transplantation and Cellular Therapy (ASTCT) Grading Scales.
Recommended Phase II Regimen (RP2R) — Up to approximately 36 months

Trial sites (14)

Facility	City	Region	Status
Royal Prince Alfred Hospital	Camperdown	New South Wales	Recruiting
Calvary Mater Newcastle	Waratah	New South Wales	Recruiting
Royal Adelaide Hospital;Haematology Clinical Trials Unit	Adelaide	South Australia	Recruiting
St. Vincent's Hospital Melbourne	Melbourne	Victoria	Recruiting
The Alfred Hospital	Prahan	Victoria	Recruiting
The Chaim Sheba Medical Center - PPDS	Ramat Gan	Central District	Recruiting
Rambam Health Care Campus	Haifa	Israel	Recruiting
Hadassah University Hospital - Ein Kerem	Jerusalem	Israel	Recruiting
Tel Aviv Sourasky Medical Center PPDS	Tel Aviv	Israel	Recruiting
The Catholic University of Korea - Seoul St. Mary's Hospital (Kangnam St. Mary's Hospital)	Seocho	South Korea	Recruiting
Seoul National University Hospital	Seoul	South Korea	Recruiting
Severance Hospital, Yonsei University Health System	Seoul	South Korea	Recruiting
Asan Medical Center.	Seoul	South Korea	Recruiting
Samsung Medical Center - PPDS	Seoul	South Korea	Recruiting

On this site

📄 Actemra (tocilizumab) drug profile →

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05927571 on ClinicalTrials.gov ↗ ← All trials in Israel