Tests two drugs together in adults with relapsed or refractory multiple myeloma
Tests cevostamab with elranatamab in adults with returning or resistant multiple myeloma.
Plain-language title generated from the registry record
Registry 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)
Key facts
- Where
- Adelaide, Camperdown, Melbourne, Prahan, and Waratah, AustraliaSee the 5 sites
- Phase
- Phase 1
Where in Australia
- Royal Adelaide Hospital;Haematology Clinical Trials UnitAdelaide, AustraliaTaking people
- Royal Prince Alfred HospitalCamperdown, AustraliaTaking people
- St Vincent's Hospital MelbourneMelbourne, AustraliaTaking people
- The Alfred HospitalPrahan, AustraliaTaking people
- Calvary Mater NewcastleWaratah, AustraliaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Genentech, Inc.
- Trial code
- NCT05927571EU 2023-504657-13-00
- Record updated
- 5 November 2026
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: 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: Prior treatment with cevostamab or another agent targeting fragment crystallizable receptor-like 5 (FcRH5); Prior treatment with elranatamab; Prior allogeneic stem cell transplantation (SCT); 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; 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; Absolute plasma cell count exceeding 500 per milliliter (mL) or 5% of the peripheral blood white cells; Peripheral motor polyneuropathy of prespecified grade.