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CAR-T therapy challenges stem cell transplant as First-Line treatment for multiple myeloma

NCT ID NCT05257083

Disease control Sponsor: Stichting European Myeloma Network Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 3 trial tests whether a new CAR-T cell therapy (cilta-cel) works better than the standard stem cell transplant for people newly diagnosed with multiple myeloma. About 759 participants will receive either CAR-T or a transplant after initial drug treatment. The main goal is to see who lives longer without the cancer getting worse.

What this could mean

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

Active substance
Ciltacabtagene autoleucel (CAR-T cell therapy)
What this could lead to
If successful, this could offer a more effective first-line treatment option for newly diagnosed multiple myeloma, potentially replacing the need for a stem cell transplant.
What could go wrong
This is a large phase 3 trial, but CAR-T therapy carries risks like severe immune reactions and long-term side effects. It may not prove superior to the current standard of care.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

759 people

The number who actually took part.

Started

Oct 2023

Expected to finish

Aug 2040

An estimate. End dates often move.

Lead sponsor

A research network

The lead sponsor is a research network or cooperative group.

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: * Participants with documented NDMM according to IMWG diagnostic criteria, for whom high-dose therapy and ASCT are part of the intended initial treatment plan. * Measurable disease, as assessed by central laboratory, at screening as defined by any of the following: 1. Serum monoclonal paraprotein (M-protein) level ≥1.0 g/dL or urine M-protein level ≥200 mg/24 hours; or 2. Light chain MM without measurable disease in serum or urine: serum Ig free-light chain (FLC) ≥10 mg/dL and abnormal serum Ig kappa lambda FLC ratio. * ECOG performance status of grade 0 or 1 * Clinical laboratory values within prespecified range. Exclusion Criteria: * Prior treatment with CAR-T therapy directed at any target. * Any prior BCMA target therapy. * Any prior therapy for MM or smoldering myeloma other than a short course of corticosteroids * Received a strong cytochrome P450 (CYP)3A4 inducer within 5 half-lives prior to randomization * Received or plans to receive any live, attenuated vaccine (except for COVID-19 vaccines) within 4 weeks prior to randomization. * Known active, or prior history of central nervous system (CNS) involvement or clinical signs of meningeal involvement of MM * Stroke or seizure within 6 months of signing Informed Consent Form (ICF)

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Conditions

The condition(s) this trial relates to.

plasma cell myeloma

As listed by the trial registrant

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

Multiple myeloma

Contacts and locations

Locations

  • 'G. Papanikolaou' Hospital of Thessaloniki

    Thessaloniki, Greece

  • (CHU) Centre Hospitalier Universitaire de Quebec Laval

    Québec, Canada

  • Akademiska Sjukhuset

    Uppsala, Sweden

  • Alfred Health

    Melbourne, Australia

  • Attikon University General Hospital of Attica

    Athens, Greece

  • Austin Hospital

    Melbourne, Australia

  • Boston Medical Center

    Boston, Massachusetts, 02118, United States

  • CHRU de Lille - Hopital Claude Huriez

    Lille, France

  • CHU De Nantes - Hématologie Clinique

    Nantes, France

  • CHU Poitiers - Pôle régional de Cancérologie

    Poitiers, France

  • CHU de Toulouse

    Toulouse, France

  • CLINICA UNIV. DE NAVARRA, Pamplona

    Pamplona, Spain

  • Calvary Mater Newcastle Hospital

    Waratah, Australia

  • Centre Hospitalier Universitaire Vaudois (CHUV)Département d'oncologie

    Lausanne, Switzerland

  • City of Hope

    Duarte, California, 91010, United States

  • Cleveland Clinic

    Cleveland, Ohio, 44195, United States

  • Cross Cancer Institute

    Edmonton, Canada

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215, United States

  • Duke University Medical Center

    Durham, North Carolina, 27705, United States

  • Emory University Hospital

    Atlanta, Georgia, 30322, United States

  • Erasmus MC

    Rotterdam, Netherlands

  • Fakultni nemocnice Brno

    Brno, Czechia

  • Fakultni nemocnice Hradec Kralove

    Králová, Czechia

  • Fakultni nemocnice Plzen

    Pilsen, Czechia

  • Fakutni nemocnice Ostrava

    Ostrava, Czechia

  • Fiona Stanley Hospital

    Murdoch, Australia

  • Hadassah Medical Center

    Jerusalem, Israel

  • Hokkaido University Hospital-Department of Hematology

    Hokkaido, Japan

  • Hopital Maisonneuve-Rosemont

    Montreal, Canada

  • Hopital Saint Louis - Aphp Hôpitaux Universitaires Saint-Louis

    Saint-Louis, France

  • Hospices Civils De Lyon

    Lyon, France

  • Hospital Clinic de Barcelona

    Barcelona, Spain

  • Hospital General Universitario Gregorio Marañón

    Madrid, Spain

  • Hospital Universitario 12 de Octubre

    Madrid, Spain

  • Hospital Universitario Germans Trias i Pujol

    Badalona, Spain

  • Hospital Universitario Ramón y Cajal

    Madrid, 28034, Spain

  • Hospital Universitario Virgen del Rocío

    Seville, Spain

  • Hospital Universitario de Salamanca

    Salamanca, Spain

  • Hospital Universitario la Fe, Valencia

    Valencia, Spain

  • Hospital de Santiago de Compostela

    Santiago de Compostela, Spain

  • Hyogo College of Medicine

    Hyōgo, Japan

  • Instituto Catalán de Oncología

    Barcelona, Spain

  • Japanese Red Cross Medical Center - Hematology

    Shibuya City, Japan

  • Jules Bordet Instituut

    Anderlecht, Belgium

  • Juntendo University Hospital

    Bunkyō City, Japan

  • Kanazawa University Hospital

    Kanazawa, Japan

  • Karmanos Cancer Center

    Detroit, Michigan, 48201, United States

  • Keio University Hospital - Hematology

    Shinjuku-Ku, Japan

  • Kyushu University Hospital - Hematology/Oncology

    Fukuoka, Japan

  • Landstinget i Ostergotland-Universitetssjukhuset i Linkoping

    Linköping, Sweden

  • Levine Cancer Institute

    Charlotte, North Carolina, 28204, United States

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • McMaster University

    Hamilton, Canada

  • Mcgill University Health Centre

    Montreal, Canada

  • Medical College Wisconsin

    Milwaukee, Wisconsin, 53226, United States

  • Memorial Sloan-Kettering Cancer Center

    New York, New York, 10065, United States

  • Moffit Cancer Center

    Tampa, Florida, 33612, United States

  • Montefiore M-E Center

    The Bronx, New York, 10467, United States

  • Mount Sinai Medical Center

    New York, New York, 10029, United States

  • Nagoya City University Hospital - Department of Hematology & Oncology

    Nagoya, Japan

  • Okayama University Hospital - Hematology/Oncology

    Okayama, Japan

  • Osaka metropolitan university hospital

    Osaka, Japan

  • Oslo University Hospital Ullevål - Oncology

    Oslo, Norway

  • Ottawa Hospital Research Institute

    Ottawa, Canada

  • Peter MacCallum Cancer Centre

    Melbourne, Australia

  • Princess Alexandra Hospital

    Brisbane, Australia

  • Princess Margaret Cancer Centre

    Toronto, Canada

  • Queen Elizabeth Medical Centre

    Birmingham, United Kingdom

  • Radboud UMC

    Nijmegen, Netherlands

  • Royal Brisbane and Womens Hospital

    Herston, Australia

  • Royal Prince Alfred Hospital

    Camperdown, Australia

  • Sahlgrenska Universitetssjukhuset

    Gothenburg, Sweden

  • Sheba medical center

    Ramat Gan, Israel

  • Skånes University Hospital Lund

    Lund, Sweden

  • Stanford University

    Stanford, California, 94305, United States

  • Tel Aviv Sourasky Medical Center

    Tel Aviv, Israel

  • The Ohio State University

    Columbus, Ohio, 43210, United States

  • Thomas Jefferson University Hospital

    Philadelphia, Pennsylvania, 19107, United States

  • Tohoku University Hospital - Hematology

    Tōhoku, Japan

  • Tübingen

    Tübingen, Germany

  • UC San Diego Health Moores Cancer Center

    San Diego, California, 92093, United States

  • UMC Utrecht

    Utrecht, Netherlands

  • UZ Gent

    Ghent, Belgium

  • UZ Leuven

    Leuven, Belgium

  • UZA

    Antwerp, Belgium

  • Universitaetsspital Basel - Zentrum fur Hamato-Onkologie

    Basel, Switzerland

  • Universitaetsspital Bern, Inselspital

    Bern, Switzerland

  • Universitaetsspital Zuerich -Universitaeren Herzzentrum Zuerich

    Zurich, Switzerland

  • University Hospital of Cologne

    Cologne, Germany

  • University Hospital of Leipzig

    Leipzig, Germany

  • University Hospital of Wales

    Cardiff, United Kingdom

  • University Hospital of Würzburg

    Würzburg, Germany

  • University Medical Center Groningen

    Groningen, Netherlands

  • University Of Maryland Medical Center

    Baltimore, Maryland, 21201, United States

  • University of Arkansas

    Little Rock, Arkansas, 72205, United States

  • University of California San Francisco (UCSF)

    San Francisco, California, 94117, United States

  • University of Chicago

    Chicago, Illinois, 60637, United States

  • University of Iowa

    Iowa City, Iowa, 52242, United States

  • University of Rochester

    Rochester, New York, 14642, United States

  • University of Texas Southwestern Medical Center

    Dallas, Texas, 75390, United States

  • University of Virginia

    Charlottesville, Virginia, 22903, United States

  • University of Washington Medical

    Seattle, Washington, 98195, United States

  • Universitätsklinikum Hamburg - Eppendorf

    Hamburg, Germany

  • VU Medisch Centrum

    Amsterdam, Netherlands

  • Vancouver General Hospital

    Vancouver, Canada

  • Westmead Hospital

    Westmead, Australia

More trials for these conditions

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