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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.
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

Full criteria on ClinicalTrials.gov

Sites (14)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Royal Adelaide Hospital;Haematology Clinical Trials Unit
Coordinator of this site? Confirm its status
AdelaideAustraliaRecruiting
Royal Prince Alfred Hospital
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CamperdownAustraliaRecruiting
St Vincent's Hospital Melbourne
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MelbourneAustraliaRecruiting
The Alfred Hospital
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PrahanAustraliaRecruiting
Calvary Mater Newcastle
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WaratahAustraliaRecruiting
Rambam Health Care Campus
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HaifaIsraelRecruiting
Hadassah University Hospital - Ein Kerem
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JerusalemIsraelRecruiting
The Chaim Sheba Medical Center - PPDS
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Ramat GanIsraelRecruiting
Tel Aviv Sourasky Medical Center PPDS
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Tel AvivIsraelRecruiting
The Catholic University of Korea - Seoul St. Mary's Hospital (Kangnam St. Mary's Hospital)
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SeochoSouth KoreaRecruiting
Samsung Medical Center - PPDS
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SeoulSouth KoreaRecruiting
Severance Hospital, Yonsei University Health System
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SeoulSouth KoreaRecruiting
Seoul National University Hospital
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SeoulSouth KoreaRecruiting
Asan Medical Center
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SeoulSouth KoreaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.