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NCT05535244Active, not recruitingPhase 1/2

A Study Evaluating the Efficacy and Safety of Cevostamab in Prior B Cell Maturation Antigen (BCMA)-Exposed Participants With Relapsed/Refractory Multiple Myeloma

A Phase I/II, Open-Label, Multi-Cohort Study to Evaluate the Efficacy and Safety of Cevostamab in Prior B Cell Maturation Antigen-Exposed Patients With Relapsed/Refractory Multiple Myeloma

Source: ClinicalTrials.gov · Last updated 3 Nov 2026

Brief summary (registry, in English)

This study will evaluate the efficacy, safety, and pharmacokinetics of cevostamab in participants with relapsed or refractory multiple myeloma (R/R MM) via intravenous (IV) infusion.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 1/2
Study type
Interventional
Enrollment
90 (estimated)
First submitted
24 Aug 2022
Start date
17 Oct 2022
Primary completion date
26 Feb 2027
Lead sponsor
Hoffmann-La Roche
NCT number
NCT05535244
EU CT number
2023-505865-94-00
EudraCT number
2021-006816-10

What you commit to

  • Study type: Interventional · Phase 1/2
  • Planned participants: 90
  • From 17 Oct 2022 to the primary completion date, 26 Feb 2027
  • 32 sites in 8 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 with the same target
  • Prior BCMA ADC or CAR-T Cohort: prior treatment with any T cell dependent bi-specific antibody (TDB) antibody including non BCMA targeting TDB
  • Prior use of any monoclonal antibody (mAb), radioimmunoconjugate, or ADC as anti-cancer therapy within 4 weeks before first study treatment, except for the use of non-myeloma therapy
  • Prior treatment with systemic immunotherapeutic agents
  • Prior treatment with CAR-T cell therapy within 12 weeks before first cevostamab infusion
  • Known treatment-related, immune-mediated adverse events associated with prior checkpoint inhibitors
  • Treatment with radiotherapy, any chemotherapeutic agent, or treatment with any other anti-cancer agent within 4 weeks or 5 half-lives of the drug, whichever is shorter, prior to first study treatment
  • Autologous stem cell transplantation (SCT) within 100 days prior to first study treatment
  • Prior allogeneic SCT
  • Prior solid organ transplantation
  • Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection at study enrollment, or any major episode of infection requiring treatment with IV (intravenous) antimicrobials where the last dose of IV antimicrobial was given within 14 days prior to first study treatment
  • Active symptomatic COVID-19 infection at study enrollment or requiring treatment with IV antiviral where the last dose of IV antiviral treatment was given within 14 days prior to first study treatment. Participants with active COVID-19 infection must have clinical recovery and two negative antigen tests at least 24 hours apart prior to first study treatment
  • Positive and quantifiable Epstein-Barr virus (EBV) polymerase chain reaction (PCR) or cytomegalovirus (CMV) PCR prior to first study treatment
  • Known history of Grade \>=3 CRS or immune effector cell-associated neurotoxicity syndrome (ICANS) with prior bispecific therapies
  • Recent major surgery within 4 weeks prior to first study treatment
  • Administration of a live, attenuated vaccine within 4 weeks before first study treatment or anticipation that such a live attenuated vaccine will be required during the study
  • Treatment with systemic immunosuppressive medications, with the exception of corticosteroid treatment \<= 10 mg/day prednisone or equivalent, within 2 weeks prior to first study treatment
  • History of illicit drug or alcohol abuse within 12 months prior to screening, in the investigator's judgment

Other illness

  • History of autoimmune disease
  • History of confirmed progressive multifocal leukoencephalopathy
  • History of severe allergic or anaphylactic reactions to mAb therapy
  • Known history of amyloidosis
  • History of other malignancy within 2 years prior to screening, except those with negligible risk of metastasis or death, such as ductal carcinoma in situ not requiring chemotherapy, appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, low-grade, localized prostate cancer not requiring treatment or appropriately treated Stage I uterine cancer
  • Current or past history of central nervous system (CNS) disease, such as stroke, epilepsy, CNS vasculitis, neurodegenerative disease, or CNS involvement by MM
  • Significant cardiovascular disease that may limit a potential participant's ability to adequately respond to a cytokine release syndrome (CRS) event
  • Symptomatic active pulmonary disease or requiring supplemental oxygen
  • Known or suspected chronic active EBV infection
  • Known history of hemophagocytic lymphohistiocytosis (HLH) or macrophage activation syndrome (MAS)
  • Positive serologic or PCR test results for acute or chronic hepatitis B virus (HBV) infection
  • Acute or chronic hepatitis C virus (HCV) infection
  • Known history of human immunodeficiency virus (HIV) seropositivity

Lab values

  • Circulating plasma cell count exceeding 500/ microliter (µL) or 5% of the peripheral blood white cells
  • Any medical condition or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes the participant's safe participation in and completion of the study, or which could affect compliance with the protocol or interpretation of results

Other

  • Inability to comply with protocol-mandated hospitalization
  • Pregnancy or breastfeeding, or intention of becoming pregnant during the study or within 5 months after the final dose of cevostamab or tocilizumab or within 3 months after the last dose of tocilizumab (if applicable)
  • Lesions in proximity of vital organs that may develop sudden decompensation/deterioration in the setting of a tumor flare

Who the study is looking for

  • Documented diagnosis of MM based on standard International Myeloma Working Group (IMWG) criteria
  • Evidence of progressive disease based on investigators determination of response by IMWG criteria on or after their last dosing regimen
  • Prior BCMA ADC or CAR-T Cohort: participants who have received a BCMA-targeted CAR-T or ADC therapy and are triple-class relapsed or refractory
  • Prior BCMA Bispecific Cohort: participants who have received a BCMA-targeting T-cell-dependent bispecific (TDB) antibody and are triple-class relapsed or refractory
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
  • Life expectancy is at least 12 weeks
  • Agreement to protocol-specified assessments, including bone marrow biopsy and aspirate samples as detailed in the protocol
  • Resolution of AEs from prior anti-cancer therapy to Grade =\< 1
  • For female participants of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception during the treatment period and for at least 5 months after the final dose of cevostamab and for 3 months after the last dose of tocilizumab was administered
  • For male participants: agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agree to refrain from donating sperm during the treatment period and for at least 2 months after the final dose of tocilizumab (if applicable) to avoid exposing the embryo

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (32)

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

SiteCityCountrySite status
St Vincent's Hospital Melbourne
Coordinator of this site? Confirm its status
FitzroyAustraliaUnknown status
Calvary Mater Newcastle
Coordinator of this site? Confirm its status
WaratahAustraliaUnknown status
UZ Leuven
Coordinator of this site? Confirm its status
LeuvenBelgiumActive, not recruiting
Charite Universitaetsmedizin Berlin KöR
Coordinator of this site? Confirm its status
BerlinGermanyActive, not recruiting
University Hospital Cologne AöR
Coordinator of this site? Confirm its status
CologneGermanyActive, not recruiting
University Medical Center Hamburg-Eppendorf
Coordinator of this site? Confirm its status
HamburgGermanyActive, not recruiting
Universitaetsklinikum Tuebingen AöR
Coordinator of this site? Confirm its status
TuebingenGermanyActive, not recruiting
Universitätsklinikum Würzburg
Coordinator of this site? Confirm its status
WürzburgGermanyActive, not recruiting
Hospital Clinic de Barcelona
Coordinator of this site? Confirm its status
BarcelonaSpainActive, not recruiting
Clinica Universidad de Navarra
Coordinator of this site? Confirm its status
MadridSpainActive, not recruiting
Hospital Universitario 12 de Octubre
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MadridSpainActive, not recruiting
Clínica Universidad de navarra
Coordinator of this site? Confirm its status
PamplonaSpainActive, not recruiting
Hospital Universitario Y Politecnico La Fe
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ValenciaSpainActive, not recruiting
Centre Hospitalier Universitaire de Nantes
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NantesFranceActive, not recruiting
Assistance Publique Hopitaux de Paris
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ParisFranceActive, not recruiting
Centre Hospitalier Universitaire de Poitiers
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PoitiersFranceActive, not recruiting
Hadassah Ein Karem Hospital
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JerusalemIsraelUnknown status
Sheba medical center
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Ramat GanIsraelUnknown status
Sourasky Medical Centre
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Tel AvivIsraelUnknown status
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII
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BergamoItalyActive, not recruiting
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
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BolognaItalyActive, not recruiting
Fondazione IRCCS - Istituto Nazionale dei Tumori
Coordinator of this site? Confirm its status
MilanItalyActive, not recruiting
Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
Coordinator of this site? Confirm its status
TurinItalyActive, not recruiting
University of Colorado
Coordinator of this site? Confirm its status
AuroraUnited StatesUnknown status
University of Maryland/Greenebaum Cancer Center
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BaltimoreUnited StatesUnknown status
Dana-Farber Cancer Institute
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BostonUnited StatesUnknown status
Mayo Clinic- Jacksonville
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JacksonvilleUnited StatesUnknown status
Tennessee Oncology - Nashville
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NashvilleUnited StatesUnknown status
Memorial Sloan-Kettering Cancer Center
Coordinator of this site? Confirm its status
New YorkUnited StatesUnknown status
Icahn School of Medicine at Mount Sinai (ISMMS)
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New YorkUnited StatesUnknown status
Mayo Clinic - Rochester
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RochesterUnited StatesUnknown status
Hunstman Cancer Institute
Coordinator of this site? Confirm its status
Salt Lake CityUnited StatesUnknown status

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