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AzTrials

Multiple MyelomaPhase 3CARTITUDE-4NCT04181827

A Study Comparing JNJ-68284528, a CAR-T Therapy Directed Against B-cell Maturation Antigen (BCMA), Versus Pomalidomide, Bortezomib and Dexamethasone (PVd) or Daratumumab, Pomalidomide and Dexamethasone (DPd) in Participants With Relapsed and Lenalidomide-Refractory Multiple Myeloma

A Phase 3 study testing Cilta-cel, Pomalidomide and Bortezomib in people with Multiple Myeloma, run by Janssen Research & Development, LLC at 88 sites in 16 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

The purpose of this study is to compare the efficacy of ciltacabtagene autoleucel (cilta-cel) with standard therapy, either Pomalidomide, Bortezomib and Dexamethasone (PVd) or Daratumumab, Pomalidomide and Dexamethasone (DPd). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Multiple Myeloma
What is being tested?
Cilta-cel, Pomalidomide and Bortezomib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
419 participants
Where
88 sitesin 16 countries
Study dates
12 Jun 2020to 31 Mar 2027
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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):
  • Hemoglobin >=8 gram per deciliter (g/dL) (without prior RBC transfusion within 7 days before the laboratory test; recombinant human erythropoietin use is permitted);
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  • 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);
  • 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;
  • Lymphocyte count >=0.3 * 10^9/L;
  • Aspartate aminotransferase (AST) less than or equal to (<=)3 * upper limit of normal (ULN);
  • Alanine aminotransferase (ALT) <=3 * ULN;
  • 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);
  • 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)

Who cannot join

  • 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
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  • Cytotoxic therapy within 14 days
  • Proteasome inhibitor therapy within 14 days
  • Immunomodulatory drug (IMiD) therapy within 7 days

Trial locations and contacts

88 sites in 16 countries.

88 sites in 16 countries

United States19 sites

  • University Of Maryland Medical Center

    Baltimore, Maryland, 21201

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294

  • The Ohio State University

    Columbus, Ohio, 43210

  • Colorado Blood Cancer Institute

    Denver, Colorado, 80218

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601

  • University of Iowa Hospitals and Clinics

    Iowa City, Iowa, 52242

  • Wisconsin Institutes for Medical Research

    Madison, Wisconsin, 53705

  • University Of Miami Leonard M Mille School Of Medicine SCCC

    Miami, Florida, 33136

  • Medical College Of Wisconsin

    Milwaukee, Wisconsin, 53226

  • Yale New Haven Hospital

    New Haven, Connecticut, 06520

  • Memorial Sloan-Kettering Cancer Center

    New York, New York, 10065

  • Mayo Clinic Cancer Center-Scottsdale

    Phoenix, Arizona, 85054

  • Mayo Clinic - Rochester

    Rochester, Minnesota, 55905

  • University of Rochester Medical Center

    Rochester, New York, 14642

  • Huntsman Cancer Institute

    Salt Lake City, Utah, 84112

  • Washington University School Of Medicine

    St Louis, Missouri, 63110

  • Stanford University Medical Center

    Stanford, California, 94305-5623

  • University of Kansas

    Westwood, Kansas, 66205

Other trials in United States

Japan8 sites

  • Kyushu University Hospital

    Fukuoka, 812 8582

  • Kanazawa University Hospital

    Kanazawa, 920 8641

  • University Hospital Kyoto Prefectural University of Medicine

    Kyoto, 602-8566

  • Nagoya City University Hospital

    Nagoya, 467 8602

  • Okayama University Hospital

    Okayama, 700 8558

  • Hokkaido University Hospital

    Sapporo, 060-8648

  • Tohoku University Hospital

    Sendai, 980 8574

  • Japanese Red Cross Medical Center

    Shibuya City, 150-8935

Other trials in Japan

France7 sites

  • CHRU de Lille Hopital Claude Huriez

    Lille, 59037

  • Hospices Civils de Lyon HCL

    Lyon, 69002

  • CHU de Montpellier Hopital Saint Eloi

    Montpellier, 34295

  • C.H.U. Hotel Dieu - France

    Nantes, 44093

  • Hopital Saint Louis

    Paris, 75475

  • CHU De Poitiers

    Poitiers, 86021

  • Institut Universitaire du cancer de Toulouse-Oncopole

    Toulouse, 31059

Other trials in France

Spain7 sites

  • Inst. Cat. D'Oncologia-Badalona

    Badalona, 08916

  • Hosp Clinic de Barcelona

    Barcelona, 08036

  • Hosp. Gral. Univ. Gregorio Maranon

    Madrid, 28007

  • Hosp. Univ. 12 de Octubre

    Madrid, 28041

  • Clinica Univ. de Navarra

    Pamplona, 31008

  • Hosp Clinico Univ de Salamanca

    Salamanca, 37007

  • Hosp. Virgen Del Rocio

    Seville, 41013

Other trials in Spain

United Kingdom7 sites

  • Queen Elizabeth Hospital

    Birmingham, B15 2TH

  • Bristol Haematology and Oncology Centre

    Bristol, BS2 8ED

  • University Hospital Wales

    Cardiff, CF14 4XW

  • University College Hospital

    London, NW1 2BU

  • Kings College Hospital

    London, SE5 9RS

  • Christie Hospital

    Manchester, M20 4BX

  • Freeman Hospital

    Newcastle upon Tyne, NE7 7DN

Other trials in United Kingdom

Australia6 sites

  • Royal Adelaide Hospital

    Adelaide, 5000

  • Royal Prince Alfred Hospital

    Camperdown, 2050

  • Royal Brisbane and Womens Hospital

    Herston, 4029

  • Peter MacCallum Cancer Centre

    Melbourne, 3000

  • Alfred Health

    Melbourne, 3004

  • Fiona Stanley Hospital

    Murdoch, 6150

Other trials in Australia

Germany6 sites

  • Universitaetsklinikum Koeln

    Cologne, 50924

  • Universitatsklinikum Carl Gustvav Carus Dresden an der Technischen Universitat Dresden

    Dresden, 01307

  • Universitaetsklinikum Hamburg Eppendorf

    Hamburg, 20246

  • Universitaetsklinikum Leipzig

    Leipzig, 04103

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

    Tübingen, 72076

  • Universitatsklinikum Wurzburg

    Würzburg, 97080

Other trials in Germany

Italy5 sites

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

    Bologna, 40138

  • IRCCS Ospedale San Raffaele HSR

    Milan, 20132

  • Fondazione IRCCS Istituto Nazionale dei Tumori

    Milan, 20133

  • Policlinico Universitario Agostino Gemelli

    Roma, 00168

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

    Turin, 10126

Other trials in Italy

Belgium4 sites

  • Universitair Ziekenhuis - Antwerpen

    Antwerp, 2650

  • UZ Gent

    Ghent, 9000

  • UZ Leuven

    Leuven, 3000

  • Centre Hospitalier Universitaire de Liege Domaine Universitaire du Sart Tilman

    Liège, B-4000

Other trials in Belgium

Netherlands4 sites

  • VU Medisch Centrum

    Amsterdam, 1081 HV

  • University Medical Center Groningen

    Groningen, 9713 GZ

  • Erasmus MC

    Rotterdam, 3015 CN

  • UMC Utrecht

    Utrecht, 3584 CX

Other trials in Netherlands

Poland4 sites

  • Uniwersyteckie Centrum Kliniczne

    Gdansk, 80 214

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

    Gliwice, 44102

  • Uniwersytecki Szpital Kliniczny w Poznaniu

    Poznan, 60-569

  • Instytut Hematologii i Transfuzjologii

    Warsaw, 02 776

Other trials in Poland

Israel3 sites

  • Hadassah University Hospita Ein Kerem

    Jerusalem, P.O.B. 12000

  • Sheba Medical Center

    Ramat Gan, 74047

  • Sourasky Medical Center

    Tel Aviv, 64239

Other trials in Israel

South Korea3 sites

  • Seoul National University Hospital

    Seoul, 03080

  • Samsung Medical Center

    Seoul, 06351

  • The Catholic University of Korea Seoul St Marys Hospital

    Seoul, 06591

Other trials in South Korea

Sweden3 sites

  • Skane University Hospital

    Lund, 221 85

  • Karolinska Universitetssjukhuset Huddinge, Hematologiska Kliniken, Huddinge

    Stockholm, 141 86

  • Akademiska Sjukhuset

    Uppsala, 751 85

Other trials in Sweden

Denmark1 site

  • Rigshospitalet

    Copenhagen, DK-2100

Other trials in Denmark

Greece1 site

  • Attikon University General Hospital of Attica

    Athens, 12462

Other trials in Greece

About this study

Official title: A Phase 3 Randomized Study Comparing JNJ-68284528, a Chimeric Antigen Receptor T Cell (CAR-T) Therapy Directed Against BCMA, Versus Pomalidomide, Bortezomib and Dexamethasone (PVd) or Daratumumab, Pomalidomide and Dexamethasone (DPd) in Subjects With Relapsed and Lenalidomide-Refractory Multiple Myeloma

The purpose of this study is to compare the efficacy of ciltacabtagene autoleucel (cilta-cel) with standard therapy, either Pomalidomide, Bortezomib and Dexamethasone (PVd) or Daratumumab, Pomalidomide and Dexamethasone (DPd).

Medical subject headings
Multiple Myeloma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cilta-celDrug

    Cilta-cel infusion will be administered at a target dose of 0.75 * 10^6 CAR-positive viable T cells/kilogram (kg).

  • PomalidomideDrug

    Pomalidomide 4 mg will be administered orally.

  • BortezomibDrug

    Bortezomib 1.3 milligram per meter square (mg/m^2) will be administered subcutaneously (SC).

  • DexamethasoneDrug

    Dexamethasone 20 mg/day (10mg/day for participants >75 years of age) (on bortezomib treatment days and the days following bortezomib treatment) will be administered orally in PVd treatment; and orally or intravenous (IV) at 40 mg weekly (20mg weekly for participants >75 years of age) in DPd treatment.

  • DaratumumabDrug

    Daratumumab 1800 mg will be administered SC.

Study groups in NCT04181827
Study groupRoleWhat they receive
Arm A: PVd or DPd (Standard Therapy)ExperimentalParticipants will receive either PVd or DPd as a standard therapy. In PVd treatment, participants will receive oral pomalidomide 4 mg on Days 1 to 14 in each cycle; bortezomib 1.3 mg/meter square (m^2) SC on Days 1, 4, 8 and 11 (Cycles 1 to 8) and on Days 1 and 8 (Cycle 9 onwards) and oral dexamethasone 20 mg on Days 1, 2, 4, 5, 8, 9, 11 and 12 (Cycles 1 to 8) and Days 1, 2, 8 and 9 (Cycle 9 onwards). Each cycle will consist of 21 days. In DPd treatment, participants will receive daratumumab SC 1800 mg weekly on Days 1, 8, 15, and 22 (Cycles 1 and 2), every 2 weeks on Days 1 and 15 (Cycles 3 to 6) and every 4 weeks on Day 1 (Cycle 7 onwards); oral pomalidomide 4 mg on Days 1 to 21 (Cycle 1 onwards); dexamethasone 40 mg oral or IV weekly on Days 1, 8, 15, and 22 (Cycle 1 onwards). Each cycle will consist of 28 days. Participants will continue to receive PVd or DPd until confirmed PD, death, intolerable toxicity, withdrawal of consent, or end of the study, whichever occurs earlier.
Receives: Drug: Pomalidomide; Drug: Bortezomib; Drug: Dexamethasone; Drug: Daratumumab
Arm B: (Ciltacabtagene Autoleucel [Cilta-cel])ExperimentalParticipants will receive at least one cycle of bridging therapy (PVd or DPd) and additional cycles of bridging therapy may be considered based on participant's clinical status and timing of availability of cilta-cel along with conditioning regimen (cyclophosphamide 300 milligram [mg]/m^2 intravenous [IV] and fludarabine 30 mg/m^2 IV daily, for 3 days), and cilta-cel infusion 0.75 * 10^6 chimeric antigen receptor (CAR)-positive viable T cells/ kilogram (kg).
Receives: Drug: Cilta-cel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression Free Survival (PFS)

    PFS: defined as time from date of randomization to date of first documented progressed disease (PD) as per International Myeloma Working Group (IMWG) criteria, or death due to any cause, whichever occurred first. PD: increase of 25% from lowest response value: serum and urine M-component (absolute increase must be >=0.5 grams per deciliter [g/dL] and >=200 milligrams [mg] per 24 hours, respectively); only in participants without measurable serum and urine M-protein levels, difference between involved and uninvolved free light chain (FLC) levels (absolute increase of >10 mg/dL); only in participants without measurable serum and urine M-protein levels and without measurable disease by FLC levels, bone marrow plasma cell (PC)% (absolute increase of >=10%), appearance of new lesion; definite development of new bone lesions or definite increase in size of existing bone lesions, >=50% increase in circulating PCs (minimum of 200 cells per microliter [uL]) if this was only measure of disease.

    Measured: From randomization (Day 1) to either progressive disease or death, whichever occurred first (up to 3.9 years)

Secondary outcomes (19)

  1. Percentage of Participants Who Achieved Complete Response (CR) or Stringent Complete Response (sCR)

    Measured: From randomization (Day 1) up to 7 years

  2. Percentage of Participants Who Achieved Overall Minimal Residual Disease (MRD) Negative Status (at 10^-5)

    Measured: From randomization (Day 1) up to 7 years

  3. Percentage of Participants Who Were in CR or sCR and Achieved MRD-negative Status at 12 Months +/-3 Months

    Measured: From randomization (Day 1) up to 12 months +/- 3 months

  4. Percentage of Participants Who Achieved Sustained MRD-negative Status

    Measured: From randomization (Day 1) up to 7 years

  5. Overall Survival (OS)

    Measured: From randomization (Day 1) up to 7 years

  6. Time to Worsening of Symptoms Using the Multiple Myeloma Symptom and Impact Questionnaire (MySIm-Q) Total Symptom Score

    Measured: From randomization (Day 1) up to 7 years

  7. Overall Response Rate (ORR)

    Measured: From randomization (Day 1) up to 7 years

  8. Progression Free Survival on Next-line Therapy (PFS2)

    Measured: From randomization (Day 1) up to 7 years

  9. Number of Participants With Treatment-emergent Adverse Events (AEs)

    Measured: From Cycle 1 Day 1 up to 7 years

  10. Number of Participants With Treatment-emergent Adverse Events (AEs) by Severity

    Measured: From Cycle 1 Day 1 up to 7 years

  11. Change From Baseline in Systemic Cytokine Concentrations on Participants Who Received Cilta-cel as Study Treatment (Arm B)

    Measured: From baseline (Cycle 1 Day 1) up to 7 years

  12. Change From Baseline in Levels of CAR-T Cell Activation Markers on Participants Who Received Cilta-cel as Study Treatment (Arm B)

    Measured: From baseline (Cycle 1 Day 1) up to 7 years (each cycle of 28 days)

  13. Change From Baseline in Levels of JNJ-68284528 T Cell Expansion (Proliferation), and Persistence on Participants Who Received Cilta-cel as Study Treatment (Arm B)

    Measured: From baseline (Cycle 1 Day 1) up to 7 years (each cycle of 28 days)

  14. Number of Participants With Anti-JNJ-68284528 Antibodies on Participants Who Received Cilta-cel as Study Treatment (Arm B)

    Measured: From Cycle 1 Day 1 up to 7 years

  15. Change From Baseline in Health-Related Quality of Life (HRQoL) as Assessed by European Organization for Research and Treatment of Cancer Quality-of-life Questionnaire Core 30 Item (EORTC-QLQ-C30) Scale Score

    Measured: From baseline (Cycle 1 Day 1) up to 7 years (each cycle of 28 days)

  16. Change From Baseline in Health-Related Quality of Life as Assessed by MySIm-Q Scale Sore

    Measured: From baseline (Cycle 1 Day 1) up to 7 years (each cycle of 28 days)

  17. Change From Baseline in Health-Related Quality of Life as Assessed by European Quality of Life - 5 Dimensions-5 Levels (EQ-5D-5L) Questionnaire Scale Score

    Measured: From baseline (Cycle 1 Day 1) up to 7 years (each cycle of 28 days)

  18. Change From Baseline in Health-Related Quality of Life as Assessed by Patient Global Impression of Symptom Severity (PGIS) Scale Score

    Measured: From baseline (Cycle 1 Day 1) up to 7 years (each cycle of 28 days)

  19. Number of Participants in Health-Related Quality of Life as Assessed by The Patient-reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Item

    Measured: From randomization (Day 1) up to 7 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Dec 2019
  2. Study start12 Jun 2020
  3. Primary completion1 May 2024
  4. Study completion31 Mar 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
419 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04181827
Sponsor's protocol ID
CR108695
Other IDs
68284528MMY3002, 2019-001413-16, 2023-506588-32-00, 2023, 2019
Acronym
CARTITUDE-4
Status last verified
Sep 2026
First submitted
27 Nov 2019
Last updated
28 Sep 2026
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: The data sharing policy of Johnson \& Johnson Innovative Medicine is available at innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
Expanded access
Available

Publications

  • Mina R, Mylin AK, Yokoyama H, Magen H, Alsdorf W, Shune L, Isufi I, Harrison SJ, Shah UA, De Champlain A, Katz EG, Gries KS, Schecter JM, Lendvai N, Slaughter A, Lonardi C, Deraedt W, Costa Filho O, Patel N, Florendo E, Ho KF, Karlin L, Weisel K. Validation of the Multiple Myeloma Symptom and Impact Questionnaire (MySIm-Q) in patients with multiple myeloma who were enrolled in the CARTITUDE-4 trial. J Patient Rep Outcomes. 2026 Mar 13;10(1):64. doi: 10.1186/s41687-026-01034-z.

    PubMed 41824255

  • Lopez-Munoz N, Bar N, Diels J, van Sanden S, Mendes J, Lee S, Hernando T, Lendvai N, Patel N, Ishida T, Er J, Harrison SJ. Ciltacabtagene Autoleucel Versus Idecabtagene Vicleucel in Triple-Class-Exposed Relapsed/Refractory Multiple Myeloma with 2-4 Prior Lines of Therapy: Updated Matching-Adjusted Indirect Comparison. Adv Ther. 2026 Mar;43(3):1327-1340. doi: 10.1007/s12325-025-03479-y. Epub 2026 Feb 2.

    PubMed 41627370

  • Einsele H, San-Miguel J, Dhakal B, Touzeau C, Leleu X, van de Donk NW, Sidana S, Oriol A, Cohen YC, Harrison SJ, Mateos MV, Martinez-Lopez J, Corradini P, Karlin L, Chen D, Li Q, Yeh TM, Li K, Plaks V, Slaughter A, Lonardi C, Benachour N, Ghosh A, Vogel M, Schecter JM, Lendvai N, Koneru M, Patel N, Florendo E, Ho PJ, Popat R. Cilta-cel in lenalidomide-refractory multiple myeloma (CARTITUDE-4): an updated analysis including overall survival from an open-label, multicentre, randomised, phase 3 trial. Lancet Oncol. 2026 Feb;27(2):254-268. doi: 10.1016/S1470-2045(25)00653-9. Epub 2026 Jan 7.

    PubMed 41519141

  • Touzeau C, Lipe B, Khan AM, Dhakal B, Nair S, He J, Mendes J, Lee S, Lonardi C, Slaughter A, Lendvai N, Schecter JM, Chen D, Zhao M, Yeh TM, Leleu X, Puig N, Dytfeld D, Zamagni E, Weisel K, Karlin L, Delforge M, Corradini P, Mina R, Roeloffzen W, Sidana S. Comparative Effectiveness of Ciltacabtagene Autoleucel in CARTITUDE-4 Versus Real-World Physician's Choice of Therapy from the Flatiron Registry in Lenalidomide-Refractory Multiple Myeloma. Adv Ther. 2025 Oct;42(10):5023-5041. doi: 10.1007/s12325-025-03308-2. Epub 2025 Aug 6.

    PubMed 40768190

  • Fonseca R, Diels J, Ghilotti F, Mendes J, Van Hoorenbeeck S, Lee S, Schecter JM, Lendvai N, Patel N, Triguero A, Alsdorf W, van de Donk NWCJ, Ursi M. Survival Outcomes with Cilta-cel Versus Conventional Treatment Regimens for Patients with Lenalidomide-Refractory Multiple Myeloma Using Inverse Probability of Treatment Weighting. Adv Ther. 2025 Sep;42(9):4418-4431. doi: 10.1007/s12325-025-03278-5. Epub 2025 Jul 4.

    PubMed 40613875

  • Harrison SJ, Touzeau C, Kint N, Li K, Nguyen T, Mayeur-Rousse C, Rahman M, Le Bris Y, Er J, Eugene-Lamer J, Haynes NM, Li J, Abbott RC, Bodet-Milin C, Moreau A, Letouze E, Lendvai N, Schecter JM, Deraedt W, Banerjee A, Lengil T, Vogel M, Foulk B, Zhao H, Smirnov D, Slaughter A, Lonardi C, Lee E, Marquez L, Sankari A, Plaks V, Filho JOC, Patel N, Geng D, Gastinne T, Kelly H, Tiong IS, Eveillard M, Chevallier P, Lade S, Moreau P, Grimmond S, Oliaro J, Tessoulin B, Blombery P. CAR+ T-Cell Lymphoma after Cilta-cel Therapy for Relapsed or Refractory Myeloma. N Engl J Med. 2025 Feb 13;392(7):677-685. doi: 10.1056/NEJMoa2309728.

    PubMed 39938094

  • Mina R, Mylin AK, Yokoyama H, Magen H, Alsdorf W, Minnema MC, Shune L, Isufi I, Harrison SJ, Shah UA, Schecter JM, Vogel M, Lendvai N, Gries KS, Katz EG, Slaughter A, Lonardi C, Gilbert J, Li Q, Deraedt W, Filho OC, Patel N, Florendo E, Karlin L, Weisel K. Patient-reported outcomes following ciltacabtagene autoleucel or standard of care in patients with lenalidomide-refractory multiple myeloma (CARTITUDE-4): results from a randomised, open-label, phase 3 trial. Lancet Haematol. 2025 Jan;12(1):e45-e56. doi: 10.1016/S2352-3026(24)00320-X.

    PubMed 39756844

  • Hansen DK, Lu X, Puglianini OC, Sorensen S, Usmani SZ, Zhang E, Huo S, Zhang Y, Qureshi ZP, Jagannath S. Cost-per-responder analysis of patients with lenalidomide-refractory multiple myeloma receiving ciltacabtagene autoleucel in CARTITUDE-4. Front Immunol. 2024 Aug 21;15:1408892. doi: 10.3389/fimmu.2024.1408892. eCollection 2024.

    PubMed 39234256

  • San-Miguel J, Dhakal B, Patel N, Schecter JM, Lendvai N, Einsele H. Plain language summary of the CARTITUDE-4 study of ciltacabtagene autoleucel for the treatment of people with relapsed or refractory multiple myeloma. Future Oncol. 2024;20(33):2509-2520. doi: 10.1080/14796694.2024.2376973. Epub 2024 Aug 7.

    PubMed 39110421

  • San-Miguel J, Dhakal B, Yong K, Spencer A, Anguille S, Mateos MV, Fernandez de Larrea C, Martinez-Lopez J, Moreau P, Touzeau C, Leleu X, Avivi I, Cavo M, Ishida T, Kim SJ, Roeloffzen W, van de Donk NWCJ, Dytfeld D, Sidana S, Costa LJ, Oriol A, Popat R, Khan AM, Cohen YC, Ho PJ, Griffin J, Lendvai N, Lonardi C, Slaughter A, Schecter JM, Jackson CC, Connors K, Li K, Zudaire E, Chen D, Gilbert J, Yeh TM, Nagle S, Florendo E, Pacaud L, Patel N, Harrison SJ, Einsele H. Cilta-cel or Standard Care in Lenalidomide-Refractory Multiple Myeloma. N Engl J Med. 2023 Jul 27;389(4):335-347. doi: 10.1056/NEJMoa2303379. Epub 2023 Jun 5.

    PubMed 37272512

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Cilta-cel, Pomalidomide and Bortezomib in people with Multiple Myeloma, run by Janssen Research & Development, LLC at 88 sites in 16 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 88 sites in United States, Japan, France, Spain, United Kingdom and 11 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression Free Survival (PFS) (time frame: From randomization (Day 1) to either progressive disease or death, whichever occurred first (up to 3.9 years)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04181827, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2026.

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