NCT05927571RecruitingPhase 1
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)
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
Source: ClinicalTrials.gov · Last updated 6 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 120 (estimated)
- First submitted
- 22 Jun 2023
- Start date
- 10 Aug 2023
- Primary completion date
- 31 Jul 2027
- Lead sponsor
- Genentech, Inc.
- Diseases
- Multiple myeloma
- NCT number
- NCT05927571
- EU CT number
- 2023-504657-13-00
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 120
- From 10 Aug 2023 to the primary completion date, 31 Jul 2027
- 14 sites in 3 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior treatment with cevostamab or another agent targeting fragment crystallizable receptor-like 5 (FcRH5)
- Prior treatment with elranatamab
- Prior allogeneic stem cell transplantation (SCT)
Other illness
- 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
Lab values
- Absolute plasma cell count exceeding 500 per milliliter (mL) or 5% of the peripheral blood white cells
Other
- Peripheral motor polyneuropathy of prespecified grade
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (14)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Royal Adelaide Hospital;Haematology Clinical Trials Unit Coordinator of this site? Confirm its status | Adelaide | Australia | Recruiting |
| Royal Prince Alfred Hospital Coordinator of this site? Confirm its status | Camperdown | Australia | Recruiting |
| St Vincent's Hospital Melbourne Coordinator of this site? Confirm its status | Melbourne | Australia | Recruiting |
| The Alfred Hospital Coordinator of this site? Confirm its status | Prahan | Australia | Recruiting |
| Calvary Mater Newcastle Coordinator of this site? Confirm its status | Waratah | Australia | Recruiting |
| Rambam Health Care Campus Coordinator of this site? Confirm its status | Haifa | Israel | Recruiting |
| Hadassah University Hospital - Ein Kerem Coordinator of this site? Confirm its status | Jerusalem | Israel | Recruiting |
| The Chaim Sheba Medical Center - PPDS Coordinator of this site? Confirm its status | Ramat Gan | Israel | Recruiting |
| Tel Aviv Sourasky Medical Center PPDS Coordinator of this site? Confirm its status | Tel Aviv | Israel | Recruiting |
| The Catholic University of Korea - Seoul St. Mary's Hospital (Kangnam St. Mary's Hospital) Coordinator of this site? Confirm its status | Seocho | South Korea | Recruiting |
| Samsung Medical Center - PPDS Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Severance Hospital, Yonsei University Health System Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Seoul National University Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Asan Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.