Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

New hope for Hard-to-Treat myeloma: cevostamab trial underway

NCT ID NCT05535244

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Aug 07, 2026 · Updated 3 times

Summary

This study tests a drug called cevostamab in 90 people with multiple myeloma that has returned or not responded to prior treatments, including BCMA-targeted therapies. Participants receive cevostamab by IV every 3 weeks. The goal is to see if the drug can shrink tumors and how safe it is. Side effects like cytokine release syndrome will be managed with another drug, tocilizumab.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Cevostamab (a drug given by IV infusion)
What this could lead to
If successful, cevostamab could offer a new treatment option for people with multiple myeloma that has stopped responding to other BCMA-targeted therapies.
What could go wrong
This is an early-phase trial with only 90 participants, so results may not apply to everyone. Side effects like cytokine release syndrome are possible and will be managed with tocilizumab.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 90 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2022

Expected to finish

Feb 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 Exclusion Criteria: * 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) * 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 * Circulating plasma cell count exceeding 500/ microliter (µL) or 5% of the peripheral blood white cells * Prior solid organ transplantation * History of autoimmune disease * History of confirmed progressive multifocal leukoencephalopathy * History of severe allergic or anaphylactic reactions to mAb therapy * Known history of amyloidosis * Lesions in proximity of vital organs that may develop sudden decompensation/deterioration in the setting of a tumor flare * 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 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 or suspected chronic active EBV infection * Known history of Grade \>=3 CRS or immune effector cell-associated neurotoxicity syndrome (ICANS) with prior bispecific therapies * Known history of hemophagocytic lymphohistiocytosis (HLH) or macrophage activation syndrome (MAS) * Recent major surgery within 4 weeks prior to first study treatment * 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 * 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 * 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

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Multiple myeloma are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • A.O. Città della Salute e della Scienza D - Osp. S. Giov. Battista Molinette

    Turin, Piedmont, 10126, Italy

  • APHP - Hospital Saint Louis

    Paris, 75475, France

  • Asst Papa Giovanni Xxiii

    Bergamo, Lombardy, 24127, Italy

  • CHU NANTES - Hôtel Dieu

    Nantes, 44093, France

  • CHU de Poitiers - La Miletrie

    Poitiers, 86021, France

  • Calvary Mater Newcastle

    Waratah, New South Wales, 2298, Australia

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02215, United States

  • Fond. IRCCS Istituto Nazionale Tumori

    Milan, Lombardy, 20133, Italy

  • Hadassah Ein Karem Hospital

    Jerusalem, 9112001, Israel

  • Hospital Clínic i Provincial

    Barcelona, 08036, Spain

  • Hospital Univ. 12 de Octubre

    Madrid, 28041, Spain

  • Hunstman Cancer Institute

    Salt Lake City, Utah, 84112, United States

  • Icahn School of Medicine at Mount Sinai (ISMMS)

    New York, New York, 10029, United States

  • Klinik der Uni zu Köln

    Cologne, 50924, Germany

  • Mayo Clinic - Rochester

    Rochester, Minnesota, 55905, United States

  • Mayo Clinic-Jacksonville

    Jacksonville, Florida, 32224, United States

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065, United States

  • Policlinico S.Orsola-Malpighi

    Bologna, Emilia-Romagna, 40138, Italy

  • Sheba Medical Center

    Ramat Gan, 5262100, Israel

  • Sourasky Medical Centre

    Tel Aviv, 6423906, Israel

  • St Vincent's Hospital Melbourne

    Fitzroy, Victoria, 3065, Australia

  • Tennessee Oncology - Nashville

    Nashville, Tennessee, 37203, United States

  • UZ Leuven Gasthuisberg

    Leuven, 3000, Belgium

  • University of Colorado

    Aurora, Colorado, 80045-2517, United States

  • University of Maryland Greenebaum Cancer Center

    Baltimore, Maryland, 21201, United States

  • Universitätsklinikum Hamburg-Eppendorf Onkologisches Zentrum Medizinische Klinik II

    Hamburg, 20246, Germany

  • Universitätsklinikum Würzburg

    Würzburg, 97080, Germany

More trials for these conditions

Other studies related to the condition(s) this trial covers.