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CAR-T therapy takes on multiple myeloma in major new trial

NCT ID NCT04923893

Disease control Sponsor: Janssen Research & Development, LLC 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Aug 28, 2026 · Updated 3 times

Summary

This phase 3 trial compares a new CAR-T cell therapy (cilta-cel) plus standard drugs against standard drugs alone for people newly diagnosed with multiple myeloma who cannot have a stem cell transplant. About 743 participants will receive either the CAR-T combination or standard maintenance therapy. The main goal is to see which approach better delays cancer progression.

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 (cilta-cel), a CAR-T cell therapy targeting BCMA, plus bortezomib, lenalidomide, and dexamethasone
What this could lead to
If successful, this could offer a more effective initial treatment for multiple myeloma patients who cannot have a stem cell transplant, potentially delaying disease progression.
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 work better than standard therapy for all patients.

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

743 people

The number who actually took part.

Started

Aug 2021

Expected to finish

Sep 2036

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 multiple myeloma (MM) according to International Myeloma Working Group (IMWG) diagnostic criteria * Measurable disease at screening as defined by any of the following: Serum monoclonal paraprotein (M-protein) level greater than or equal to (\>=)1.0 gram per deciliter (g/dL) or urine M-protein level \>=200 milligram (mg)/24 hours; or Light chain MM in whom only measurable disease is by serum free light chain (FLC) levels: Serum immunoglobin (Ig) free light chain \>=10 milligrams per deciliter (mg/dL) and abnormal serum Ig kappa/lambda FLC ratio * Eastern Cooperative Oncology Group Performance Status grade of 0 or 1 * Not considered for high-dose chemotherapy with Autologous Stem Cell Transplant (ASCT) due to: Ineligible due to advanced age; or Ineligible due to presence of comorbid condition(s) likely to have a negative impact on tolerability of high-dose chemotherapy with ASCT; or Deferral of high-dose chemotherapy with ASCT as initial treatment * A woman of childbearing potential (WOCBP) must have 2 negative highly sensitive serum or urine pregnancy tests (beta-human chorionic gonadotropin) prior to starting Bortezomib, Lenalidomide and Dexamethasone (VRd) and must agree to further testing during the study. * Clinical laboratory values meeting the following criteria during the screening phase: hemoglobin greater than or equal to (\>=) 8.0 g/dL (\>=5 millimoles per liter \[mmol/L\]), recombinant human erythropoietin use is permitted; platelets \>=75 \*10\^9/L; absolute lymphocyte count \>=0.3 \*10\^9/L; absolute neutrophil count (ANC) \>=1.0 ×10\^9/L (prior growth factor support is permitted but must be without support in the 7 days prior to the laboratory test); aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than or equal to (\<=) 3.0 \* upper limit of normal (ULN); estimated glomerular filtration rate \>=40 milliliter per minute/1.73 meter square (mL/min/1.73 m\^2) based upon modified diet in renal disease formula (MDRD-4) calculation or a 24-hour urine collection; total bilirubin \<=2.0 \* ULN; except in participants with congenital hyperbilirubinemia, such as Gilbert syndrome (in which case direct bilirubin \<=2.0 \* ULN is required) Exclusion Criteria: * Frailty index of \>=2 according to Myeloma Geriatric Assessment score * Peripheral neuropathy or neuropathic pain Grade 2 or higher, as defined by the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5 * 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) * Seropositive for human immunodeficiency virus (HIV) * Vaccinated with live, attenuated vaccine within 4 weeks prior to first dose of VRd * Participant must not require continuous supplemental oxygen * Hepatitis B infection * Hepatitis C infection * Prior treatment with chimeric antigen receptor T (CAR-T) therapy directed at any target * Any therapy that is targeted to B-cell maturation antigen (BCMA)

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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

  • AZ St.-Jan Brugge-Oostende AV

    Bruges, 8000, Belgium

  • Aarhus University Hospital

    Aarhus N, 8200, Denmark

  • AdventHealth Cancer Institute

    Orlando, Florida, 32832, United States

  • Alexandra General Hospital of Athens

    Athens, 11528, Greece

  • Alfred Health

    Melbourne, 3004, Australia

  • Arthur J E Child Comprehensive Cancer Centre

    Calgary, Alberta, T2N 5G2, Canada

  • Asan Medical Center

    Seoul, 05505, South Korea

  • Attikon University General Hospital of Attica

    Athens, 12462, Greece

  • Austin Health

    Heidelberg, 3084, Australia

  • Barbara Ann Karmanos Cancer Institute

    Detroit, Michigan, 48201, United States

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215, United States

  • Bristol Royal Infirmary

    Bristol, BS2 8BJ, United Kingdom

  • C.H.U. Hotel Dieu - France

    Nantes, 44093, France

  • CHU Poitiers - Hopital la Miletrie

    Poitiers, 86021, France

  • Calvary Mater Newcastle Hospital

    Waratah, 2298, Australia

  • Centre Hospitalier Régional Universitaire de Lille, Hôpital Claude Huriez

    Lille, 59000, France

  • Centre Hospitalier Universitaire de Liege Domaine Universitaire du Sart Tilman

    Liège, B-4000, Belgium

  • Centrum Onkologii Ziemi Lubelskiej im sw Jana z Dukli

    Lublin, 20 090, Poland

  • Charité - Universitätsmedizin Berlin, Campus Benjamin Franklin

    Berlin, 12203, Germany

  • Chonnam National University Hwasun Hospital

    Jeollanam-do, 58128, South Korea

  • Clinica Univ. de Navarra

    Pamplona, 31008, Spain

  • Columbia University Medical Center

    New York, New York, 10032, United States

  • Debreceni Egyetem Klinikai Kozpont

    Debrecen, 4032, Hungary

  • Del Pesti Centrumkorhaz Orszagos Hematologiai es Infektologiai Intezet Szent Laszlo Telephely

    Budapest, 1097, Hungary

  • Erasmus MC

    Rotterdam, 3075 EA, Netherlands

  • Fakultni Nemocnice Ostrava

    Ostrava - Poruba, 708 52, Czechia

  • Fakultni nemocnice Brno

    Brno, 625 00, Czechia

  • Fakultni nemocnice Hradec Kralove

    Hradec Králové, 500 05, Czechia

  • Fiona Stanley Hospital

    Murdoch, 6150, Australia

  • Fundacao Antonio Prudente A C Camargo Cancer Center

    São Paulo, 01509 900, Brazil

  • G.Papanikolaou

    Thessaloniki, 57010, Greece

  • Hadassah University Hospita Ein Kerem

    Jerusalem, P.O.B. 12000, Israel

  • Helsinki University Hospital

    Helsinki, 00290, Finland

  • Henry Ford Cancer Institute

    Detroit, Michigan, 48202-2608, United States

  • Hokkaido University Hospital

    Sapporo, 060-8648, Japan

  • Hopital Maisonneuve Rosemont

    Montreal, Quebec, H1T 2M4, Canada

  • Hopital Saint Louis

    Paris, 75475, France

  • Hosp Clinico Univ de Salamanca

    Salamanca, 37007, Spain

  • Hosp Univ Vall D Hebron

    Barcelona, 8035, Spain

  • Hosp. Gral. Univ. Gregorio Maranon

    Madrid, 28007, Spain

  • Hosp. Univ. 12 de Octubre

    Madrid, 28041, Spain

  • Hosp. Univ. I Politecni La Fe

    Valencia, 46026, Spain

  • Hosp. Univ. Marques de Valdecilla

    Santander, 39008, Spain

  • Hosp. Univ. Virgen de La Arrixaca

    Murcia, 30120, Spain

  • Hosp. Virgen Del Rocio

    Seville, 41013, Spain

  • Hosp. de La Santa Creu I Sant Pau

    Barcelona, 08041, Spain

  • Hospital Aleman

    Buenos Aires, C1118AAT, Argentina

  • Hospital Italiano de Buenos Aires

    Buenos Aires, C1199ABD, Argentina

  • Hospital Privado Universitario De Cordoba

    Córdoba, 5016, Argentina

  • Hyogo Medical University Hospital

    Hyôgo, 663-8501, Japan

  • IDOR - Regional Bahia

    Salvador, 41253-190, Brazil

  • Inselspital Universitatsspital Bern

    Bern, 3010, Switzerland

  • Institut Universitaire du cancer de Toulouse-Oncopole

    Toulouse, 31059, France

  • Instituto Catalan Deoncologia Hospital Duran I Reynals

    L'Hospitalet de Llobregat, 08908, Spain

  • Instituto Portugues de Oncologia de Lisboa Francisco Gentil, E.P.E. 1

    Lisbon, 1099-023, Portugal

  • Instituto Portugues de Oncologia do Porto Francisco Gentil, E.P.E.

    Porto, 4200072, Portugal

  • Instytut Hematologii i Transfuzjologii

    Warsaw, 02 776, Poland

  • Japanese Red Cross Medical Center

    Shibuya City, 150-8935, Japan

  • Juntendo University Hospital

    Bunkyō City, 113 8431, Japan

  • Juravinski Cancer Centre

    Hamilton, Ontario, L8V5C2, Canada

  • Kanazawa University Hospital

    Kanazawa, 920 8641, Japan

  • Kantonsspital St Gallen

    Sankt Gallen, 9007, Switzerland

  • Kings College Hospital

    London, SE5 9RS, United Kingdom

  • Klinikum Grosshadern Der Ludwig-Maximilians-Universitat

    München, 81377, Germany

  • Klinikum der Eberhard Karls Universitaet Abt fur innere Med II Haematologie Onkologie Germany

    Tübingen, 72076, Germany

  • Krankenhaus der Elisabethinen Linz

    Linz, 4020, Austria

  • Kyushu University Hospital

    Fukuoka, 812 8582, Japan

  • LKH - Universitätsklinikum der PMU Salzburg

    Salzburg, 5020, Austria

  • Leeds Teaching Hospitals NHS Trust

    Leeds, LS9 7TF, United Kingdom

  • Levine Cancer Institute

    Charlotte, North Carolina, 28204, United States

  • Manchester Royal Infirmary

    Manchester, M13 9WL, United Kingdom

  • Medical College Of Wisconsin

    Milwaukee, Wisconsin, 53226, United States

  • Medical University of Vienna Universitatsklinik fur Innere Medizin I

    Vienna, 1090, Austria

  • Medizinische Universitat Graz, LKH-Univ.Klinikum Graz, Klinische Abteilung für Hämatologie

    Graz, 8036, Austria

  • Memorial Sloan-Kettering Cancer Center

    New York, New York, 10065, United States

  • Nagoya City University Hospital

    Nagoya, 467 8602, Japan

  • Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut BadawczyOddz w Gliwicach

    Gliwice, 44102, Poland

  • New York Presbyterian-Weill Cornell Medical College

    New York, New York, 10065, United States

  • Norton Cancer Institute

    Louisville, Kentucky, 40207, United States

  • Odense Universitetshospital

    Odense C, 5000, Denmark

  • Okayama University Hospital

    Okayama, 700 8558, Japan

  • Oslo universitetssykehus HF, Rikshospitalet

    Oslo, 0372, Norway

  • Oulu University Hospital

    Oulu, 90220, Finland

  • Peter MacCallum Cancer Centre

    Melbourne, 8006, Australia

  • Princess Margaret Cancer Centre University Health Network

    Toronto, Ontario, M5G2M9, Canada

  • Rigshospitalet

    Copenhagen, 2100, Denmark

  • Royal Brisbane and Womens Hospital

    Herston, 4029, Australia

  • Royal Prince Alfred Hospital

    Camperdown, 2050, Australia

  • Sahlgrenska University Hospital

    Gothenburg, 413 45, Sweden

  • Samsung Medical Center

    Seoul, 06351, South Korea

  • Seoul National University Hospital

    Seoul, 03080, South Korea

  • Severance Hospital Yonsei University Health System

    Seoul, 03722, South Korea

  • Sheba Medical Center Tel Hashomer

    Ramat Gan, 52621, Israel

  • Skane University Hospital

    Lund, 221 85, Sweden

  • Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein

    São Paulo, 05651-901, Brazil

  • St James Hospital

    Dublin, D08 NHY1, Ireland

  • St Vincents Hospital Melbourne

    Fitzroy, 3065, Australia

  • Tel Aviv Sourasky Medical Center

    Tel Aviv, 64239, Israel

  • The Catholic University of Korea Seoul St Marys Hospital

    Seoul, 06591, South Korea

  • The Royal Marsden NHS Trust Sutton

    Surrey, SM2 5PT, United Kingdom

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107, United States

  • Tohoku University Hospital

    Sendai, 980 8574, Japan

  • Turku University Hospital

    Turku, 20520, Finland

  • UCSF

    San Francisco, California, 94143, United States

  • UMC Radboud

    Nijmegen, 6500 HB, Netherlands

  • UZ Gent

    Ghent, 9000, Belgium

  • UZ Leuven

    Leuven, 3000, Belgium

  • Universitaetsklinikum Carl Gustav Carus TU Dresden

    Dresden, 01307, Germany

  • Universitaetsklinikum Hamburg Eppendorf

    Hamburg, 20246, Germany

  • Universitaetsklinikum Heidelberg

    Heidelberg, 69120, Germany

  • Universitaetsklinikum Leipzig

    Leipzig, 04103, Germany

  • Universitaetsklinikum Regensburg

    Regensburg, 93053, Germany

  • Universitair Ziekenhuis - Antwerpen

    Antwerp, 2650, Belgium

  • Universitatsklinikum Freiburg

    Freiburg im Breisgau, 79106, Germany

  • Universitatsklinikum Wurzburg

    Würzburg, 97080, Germany

  • Universitatsmedizin der Johannes Gutenberg Universitat Mainz

    Mainz, 55131, Germany

  • Universitatsspital Basel

    Basel, 4031, Switzerland

  • Universitetssjukhuset

    Linköping, 58185, Sweden

  • University College Hospital

    London, NW1 2BU, United Kingdom

  • University Hospital Kyoto Prefectural University of Medicine

    Kyoto, 602-8566, Japan

  • University Hospitals Birmingham NHS Trust,

    Birmingham, B15 2TH, United Kingdom

  • University Medical Center Groningen

    Groningen, 9713 GZ, Netherlands

  • University Of Maryland Medical Center

    Baltimore, Maryland, 21201-1595, United States

  • University of Iowa Hospitals and Clinics

    Iowa City, Iowa, 52242, United States

  • University of Kentucky

    Lexington, Kentucky, 40536-0293, United States

  • University of Miami Health System

    Miami, Florida, 33136, United States

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15232, United States

  • University of Virginia

    Charlottesville, Virginia, 22903, United States

  • Uniwersytecki Szpital Kliniczny im Jana Mikulicza Radeckiego we Wroclawiu

    Wroclaw, 50 367, Poland

  • Uniwersytecki Szpital Kliniczny w Poznaniu

    Poznan, 60 569, Poland

  • Uniwersyteckie Centrum Kliniczne

    Gdansk, 80 214, Poland

  • VU Medisch Centrum

    Amsterdam, 1081 HV, Netherlands

  • Vancouver General Hospital

    Vancouver, British Columbia, V5Z 1M9, Canada

  • Vseobecna fakultni nemocnice v Praze

    Prague, 128 08, Czechia

  • Western Sydney Local Health District

    Westmead, 2145, Australia

  • Yale Cancer Center

    New Haven, Connecticut, 06510, United States

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