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
- Diseases
- Multiple myeloma
- 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
Sites (32)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| St Vincent's Hospital Melbourne Coordinator of this site? Confirm its status | Fitzroy | Australia | Unknown status |
| Calvary Mater Newcastle Coordinator of this site? Confirm its status | Waratah | Australia | Unknown status |
| UZ Leuven Coordinator of this site? Confirm its status | Leuven | Belgium | Active, not recruiting |
| Charite Universitaetsmedizin Berlin KöR Coordinator of this site? Confirm its status | Berlin | Germany | Active, not recruiting |
| University Hospital Cologne AöR Coordinator of this site? Confirm its status | Cologne | Germany | Active, not recruiting |
| University Medical Center Hamburg-Eppendorf Coordinator of this site? Confirm its status | Hamburg | Germany | Active, not recruiting |
| Universitaetsklinikum Tuebingen AöR Coordinator of this site? Confirm its status | Tuebingen | Germany | Active, not recruiting |
| Universitätsklinikum Würzburg Coordinator of this site? Confirm its status | Würzburg | Germany | Active, not recruiting |
| Hospital Clinic de Barcelona Coordinator of this site? Confirm its status | Barcelona | Spain | Active, not recruiting |
| Clinica Universidad de Navarra Coordinator of this site? Confirm its status | Madrid | Spain | Active, not recruiting |
| Hospital Universitario 12 de Octubre Coordinator of this site? Confirm its status | Madrid | Spain | Active, not recruiting |
| Clínica Universidad de navarra Coordinator of this site? Confirm its status | Pamplona | Spain | Active, not recruiting |
| Hospital Universitario Y Politecnico La Fe Coordinator of this site? Confirm its status | Valencia | Spain | Active, not recruiting |
| Centre Hospitalier Universitaire de Nantes Coordinator of this site? Confirm its status | Nantes | France | Active, not recruiting |
| Assistance Publique Hopitaux de Paris Coordinator of this site? Confirm its status | Paris | France | Active, not recruiting |
| Centre Hospitalier Universitaire de Poitiers Coordinator of this site? Confirm its status | Poitiers | France | Active, not recruiting |
| Hadassah Ein Karem Hospital Coordinator of this site? Confirm its status | Jerusalem | Israel | Unknown status |
| Sheba medical center Coordinator of this site? Confirm its status | Ramat Gan | Israel | Unknown status |
| Sourasky Medical Centre Coordinator of this site? Confirm its status | Tel Aviv | Israel | Unknown status |
| Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII Coordinator of this site? Confirm its status | Bergamo | Italy | Active, not recruiting |
| Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico Coordinator of this site? Confirm its status | Bologna | Italy | Active, not recruiting |
| Fondazione IRCCS - Istituto Nazionale dei Tumori Coordinator of this site? Confirm its status | Milan | Italy | Active, not recruiting |
| Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino Coordinator of this site? Confirm its status | Turin | Italy | Active, not recruiting |
| University of Colorado Coordinator of this site? Confirm its status | Aurora | United States | Unknown status |
| University of Maryland/Greenebaum Cancer Center Coordinator of this site? Confirm its status | Baltimore | United States | Unknown status |
| Dana-Farber Cancer Institute Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| Mayo Clinic- Jacksonville Coordinator of this site? Confirm its status | Jacksonville | United States | Unknown status |
| Tennessee Oncology - Nashville Coordinator of this site? Confirm its status | Nashville | United States | Unknown status |
| Memorial Sloan-Kettering Cancer Center Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Icahn School of Medicine at Mount Sinai (ISMMS) Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Mayo Clinic - Rochester Coordinator of this site? Confirm its status | Rochester | United States | Unknown status |
| Hunstman Cancer Institute Coordinator of this site? Confirm its status | Salt Lake City | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.