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CAR-T therapy takes on standard drugs in Late-Stage myeloma trial

NCT ID NCT04181827

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 01, 2026 · Updated 4 times

Summary

This phase 3 trial tests whether a one-time infusion of cilta-cel, a CAR-T cell therapy, works better than standard drug combinations (PVd or DPd) for people with multiple myeloma that has come back and no longer responds to lenalidomide. About 419 participants will be randomly assigned to receive either the cell therapy or standard drugs. The main goal is to see how long the cancer stays under control.

What this could mean

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

Active substance
Cilta-cel (a CAR-T cell therapy)
What this could lead to
If successful, this could offer a more effective treatment option for people with multiple myeloma that has returned after previous therapies.
What could go wrong
This is an advanced trial, but CAR-T therapies can cause serious side effects like cytokine release syndrome. The long-term benefits and risks are still being studied.

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

419 people

The number who actually took part.

Started

Jun 2020

Expected to finish

Mar 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: * Measurable disease at screening as defined by any of the following: (a) Serum monoclonal paraprotein (M-protein) level greater than or equal to (\>=) 0.5 gram per deciliter (g/dL) or urine M-protein level \>=200 milligram (mg)/24 hours; or (b) Light chain multiple myeloma without measurable M-protein in the serum or the urine: Serum free light chain \>=10 mg/dL and abnormal serum free light chain ratio * Have received 1 to 3 prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory drug (IMiD) * Have documented evidence of PD by International Myeloma Working Group (IMWG) criteria based on investigator's determination on or within 6 months of their last regimen * Be refractory to lenalidomide per IMWG consensus guidelines (failure to achieve minimal response or progression on or within 60 days of completing lenalidomide therapy). Progression on or within 60 days of the last dose of lenalidomide given as maintenance will meet this criterion. For participants with more than 1 prior line of therapy, there is no requirement to be lenalidomide refractory to the most recent line of prior therapy. However, participants must be refractory to lenalidomide in at least one prior line * Have clinical laboratory values meeting the following criteria during the Screening Phase (re testing is allowed but the below criteria must be met in the latest test prior to randomization): 1. Hemoglobin \>=8 gram per deciliter (g/dL) (without prior RBC transfusion within 7 days before the laboratory test; recombinant human erythropoietin use is permitted); 2. Absolute neutrophil count (ANC) \>=1 \* 10\^9 per liter (L) (without recombinant human granulocyte colony-stimulating factor \[G-CSF\] within 7 days and without pegylated G-CSF within 14 days of the laboratory test); 3. Platelet count \>=75 \* 10\^9/L (without prior platelet transfusion within 7 days before the laboratory test) in participants in whom less than (\<) 50 percent (%) of bone marrow nucleated cells are plasma cells; platelet count \>=50 \* 10\^9/L (without prior platelet transfusion within 7 days before the laboratory test) in participants in whom \>=50% of bone marrow nucleated cells are plasma cells; 4. Lymphocyte count \>=0.3 \* 10\^9/L; 5. Aspartate aminotransferase (AST) less than or equal to (\<=)3 \* upper limit of normal (ULN); 6. Alanine aminotransferase (ALT) \<=3 \* ULN; 7. Total bilirubin \<=2.0 \* ULN; except in participants with congenital bilirubinemia, such as Gilbert syndrome (in which case direct bilirubin \<=1.5 \* ULN is required); 8. Estimated glomerular filtration rate \>=40 milliliter per minute (mL/min) per 1.73 meter square (m\^2) (to be calculated using the Modification of Diet in Renal Disease \[MDRD\] formula) Exclusion Criteria: * Prior treatment with chimeric antigen receptor T-cell (CAR-T) therapy directed at any target * Any previous therapy that is targeted to B-cell maturation antigen (BCMA) * Ongoing toxicity from previous anticancer therapy that has not resolved to baseline levels or to Grade 1 or less; except for alopecia * Participants with Grade 1 peripheral neuropathy with pain or Grade 2 or higher peripheral neuropathy will not be permitted to receive pomalidomide, bortezomib, and dexamethasone (PVd) as standard therapy or bridging therapy; however, participants may receive daratumumab, pomalidomide, and dexamethasone (DPd) as standard therapy or bridging therapy * Received a cumulative dose of corticosteroids equivalent to \>=70 mg of prednisone within the 7 days prior to randomization * Monoclonal antibody treatment within 21 days * Cytotoxic therapy within 14 days * Proteasome inhibitor therapy within 14 days * Immunomodulatory drug (IMiD) therapy within 7 days

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Conditions

The condition(s) this trial relates to.

plasma cell myeloma refractory plasma cell neoplasm

As listed by the trial registrant

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

Multiple myeloma

Contacts and locations

Locations

  • A.O.U. Citta della Salute e della Scienza di Torino - Presidio Molinette

    Turin, 10126, Italy

  • Akademiska Sjukhuset

    Uppsala, 751 85, Sweden

  • Alfred Health

    Melbourne, 3004, Australia

  • Attikon University General Hospital of Attica

    Athens, 12462, Greece

  • Azienda Opedaliero-Universitaria Policlinico Sant'orsola Malpighi di Bologna

    Bologna, 40138, Italy

  • Bristol Haematology and Oncology Centre

    Bristol, BS2 8ED, United Kingdom

  • C.H.U. Hotel Dieu - France

    Nantes, 44093, France

  • CHRU de Lille Hopital Claude Huriez

    Lille, 59037, France

  • CHU De Poitiers

    Poitiers, 86021, France

  • CHU de Montpellier Hopital Saint Eloi

    Montpellier, 34295, France

  • Centre Hospitalier Universitaire de Liege Domaine Universitaire du Sart Tilman

    Liège, B-4000, Belgium

  • Christie Hospital

    Manchester, M20 4BX, United Kingdom

  • Clinica Univ. de Navarra

    Pamplona, 31008, Spain

  • Colorado Blood Cancer Institute

    Denver, Colorado, 80218, United States

  • Duke University Medical Center

    Durham, North Carolina, 27710, United States

  • Erasmus MC

    Rotterdam, 3015 CN, Netherlands

  • Fiona Stanley Hospital

    Murdoch, 6150, Australia

  • Fondazione IRCCS Istituto Nazionale dei Tumori

    Milan, 20133, Italy

  • Freeman Hospital

    Newcastle upon Tyne, NE7 7DN, United Kingdom

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601, United States

  • Hadassah University Hospita Ein Kerem

    Jerusalem, P.O.B. 12000, Israel

  • Hokkaido University Hospital

    Sapporo, 060-8648, Japan

  • Hopital Saint Louis

    Paris, 75475, France

  • Hosp Clinic de Barcelona

    Barcelona, 08036, Spain

  • Hosp Clinico Univ de Salamanca

    Salamanca, 37007, Spain

  • Hosp. Gral. Univ. Gregorio Maranon

    Madrid, 28007, Spain

  • Hosp. Univ. 12 de Octubre

    Madrid, 28041, Spain

  • Hosp. Virgen Del Rocio

    Seville, 41013, Spain

  • Hospices Civils de Lyon HCL

    Lyon, 69002, France

  • Huntsman Cancer Institute

    Salt Lake City, Utah, 84112, United States

  • IRCCS Ospedale San Raffaele HSR

    Milan, 20132, Italy

  • Inst. Cat. D'Oncologia-Badalona

    Badalona, 08916, Spain

  • Institut Universitaire du cancer de Toulouse-Oncopole

    Toulouse, 31059, France

  • Instytut Hematologii i Transfuzjologii

    Warsaw, 02 776, Poland

  • Japanese Red Cross Medical Center

    Shibuya City, 150-8935, Japan

  • Kanazawa University Hospital

    Kanazawa, 920 8641, Japan

  • Karolinska Universitetssjukhuset Huddinge, Hematologiska Kliniken, Huddinge

    Stockholm, 141 86, Sweden

  • Kings College Hospital

    London, SE5 9RS, United Kingdom

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

    Tübingen, 72076, Germany

  • Kyushu University Hospital

    Fukuoka, 812 8582, Japan

  • Mayo Clinic - Rochester

    Rochester, Minnesota, 55905, United States

  • Mayo Clinic Cancer Center-Scottsdale

    Phoenix, Arizona, 85054, United States

  • Medical College Of Wisconsin

    Milwaukee, Wisconsin, 53226, United States

  • 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

  • Okayama University Hospital

    Okayama, 700 8558, Japan

  • Peter MacCallum Cancer Centre

    Melbourne, 3000, Australia

  • Policlinico Universitario Agostino Gemelli

    Roma, 00168, Italy

  • Queen Elizabeth Hospital

    Birmingham, B15 2TH, United Kingdom

  • Rigshospitalet

    Copenhagen, DK-2100, Denmark

  • Royal Adelaide Hospital

    Adelaide, 5000, Australia

  • Royal Brisbane and Womens Hospital

    Herston, 4029, Australia

  • Royal Prince Alfred Hospital

    Camperdown, 2050, Australia

  • Samsung Medical Center

    Seoul, 06351, South Korea

  • Seoul National University Hospital

    Seoul, 03080, South Korea

  • Sheba Medical Center

    Ramat Gan, 74047, Israel

  • Skane University Hospital

    Lund, 221 85, Sweden

  • Sourasky Medical Center

    Tel Aviv, 64239, Israel

  • Stanford University Medical Center

    Stanford, California, 94305-5623, United States

  • The Catholic University of Korea Seoul St Marys Hospital

    Seoul, 06591, South Korea

  • The Ohio State University

    Columbus, Ohio, 43210, United States

  • Tohoku University Hospital

    Sendai, 980 8574, Japan

  • UMC Utrecht

    Utrecht, 3584 CX, Netherlands

  • UZ Gent

    Ghent, 9000, Belgium

  • UZ Leuven

    Leuven, 3000, Belgium

  • Universitaetsklinikum Hamburg Eppendorf

    Hamburg, 20246, Germany

  • Universitaetsklinikum Koeln

    Cologne, 50924, Germany

  • Universitaetsklinikum Leipzig

    Leipzig, 04103, Germany

  • Universitair Ziekenhuis - Antwerpen

    Antwerp, 2650, Belgium

  • Universitatsklinikum Carl Gustvav Carus Dresden an der Technischen Universitat Dresden

    Dresden, 01307, Germany

  • Universitatsklinikum Wurzburg

    Würzburg, 97080, Germany

  • University College Hospital

    London, NW1 2BU, United Kingdom

  • University Hospital Kyoto Prefectural University of Medicine

    Kyoto, 602-8566, Japan

  • University Hospital Wales

    Cardiff, CF14 4XW, United Kingdom

  • University Medical Center Groningen

    Groningen, 9713 GZ, Netherlands

  • University Of Maryland Medical Center

    Baltimore, Maryland, 21201, United States

  • University Of Miami Leonard M Mille School Of Medicine SCCC

    Miami, Florida, 33136, United States

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294, United States

  • University of Iowa Hospitals and Clinics

    Iowa City, Iowa, 52242, United States

  • University of Kansas

    Westwood, Kansas, 66205, United States

  • University of Rochester Medical Center

    Rochester, New York, 14642, United States

  • Uniwersytecki Szpital Kliniczny w Poznaniu

    Poznan, 60-569, Poland

  • Uniwersyteckie Centrum Kliniczne

    Gdansk, 80 214, Poland

  • VU Medisch Centrum

    Amsterdam, 1081 HV, Netherlands

  • Washington University School Of Medicine

    St Louis, Missouri, 63110, United States

  • Wisconsin Institutes for Medical Research

    Madison, Wisconsin, 53705, United States

  • Yale New Haven Hospital

    New Haven, Connecticut, 06520, United States

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