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 (CARTITUDE-4)

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).

Study Overview

• Status: Active, not recruiting
• Conditions: Multiple Myeloma
• Intervention / Treatment: Drug: Pomalidomide; Drug: Bortezomib; Drug: Dexamethasone; Drug: Daratumumab; Drug: Cilta-cel

Detailed Description

Multiple myeloma is a malignant plasma cell disorder diagnosed annually in approximately 86,000 participants worldwide. JNJ-68284528 (cilta-cel) is an autologous chimeric antigen receptor T-cell (CAR-T) therapy that targets B-cell maturation antigen (BCMA), a molecule expressed on the surface of mature B lymphocytes and malignant plasma cells. The primary hypothesis for this study is that JNJ-68284528 (cilta-cel) will significantly improve progression free survival (PFS) compared with standard therapy (PVd or DPd), in participants who have previously received 1 to 3 prior line(s) of therapy, that included a proteasome inhibitor (PI) and an immunomodulatory drug (IMiD) and who are refractory to lenalidomide. This study will be conducted in 3 phases: Screening (up to 28 days before randomization), Treatment, and Follow-Up. Assessment like patient-reported outcome(s) (PROs) assessments, electrocardiogram (ECG), vital signs, pharmacokinetic will be performed during the study. Safety evaluations will include review of adverse events, laboratory test results, vital sign measurements, physical examination findings, and assessments of cardiac function, Immune Effector Cell-associated Encephalopathy (only for Arm B) and Eastern Cooperative Oncology Group performance status. Safety data will be periodically reviewed by an Independent Data Monitoring Committee (IDMC). The duration of the study is approximately 6 years.

• Study Type: Interventional
• Enrollment (Actual): 419
• Phase: Phase 3

Expanded Access

Available outside the clinical trial. See expanded access record.

Contacts and Locations

Study Locations

• Australia
  • Adelaide, Australia, 5000
    • Royal Adelaide Hospital
  • Camperdown, Australia, 2050
    • Royal Prince Alfred Hospital
  • Herston, Australia, 4029
    • Royal Brisbane and Womens Hospital
  • Melbourne, Australia, 3004
    • Alfred Health
  • Melbourne, Australia, 3000
    • Peter MacCallum Cancer Centre
  • Murdoch, Australia, 6150
    • Fiona Stanley Hospital
• Belgium
  • Antwerp, Belgium, 2650
    • Universitair Ziekenhuis - Antwerpen
  • Ghent, Belgium, 9000
    • UZ Gent
  • Leuven, Belgium, 3000
    • UZ Leuven
  • Liège, Belgium, B-4000
    • Centre Hospitalier Universitaire de Liege Domaine Universitaire du Sart Tilman
• Denmark
  • Copenhagen, Denmark, DK-2100
    • Rigshospitalet
• France
  • Lille, France, 59037
    • CHRU de Lille Hopital Claude Huriez
  • Lyon, France, 69002
    • Hospices Civils de Lyon HCL
  • Montpellier, France, 34295
    • CHU de Montpellier Hopital Saint Eloi
  • Nantes, France, 44093
    • C.H.U. Hotel Dieu - France
  • Paris, France, 75475
    • Hôpital Saint Louis
  • Poitiers, France, 86021
    • CHU de Poitiers
  • Toulouse, France, 31059
    • Institut Universitaire du cancer de Toulouse-Oncopole
• Germany
  • Cologne, Germany, 50924
    • Universitaetsklinikum Koeln
  • Dresden, Germany, 01307
    • Universitatsklinikum Carl Gustvav Carus Dresden an der Technischen Universitat Dresden
  • Hamburg, Germany, 20246
    • Universitaetsklinikum Hamburg Eppendorf
  • Leipzig, Germany, 04103
    • Universitaetsklinikum Leipzig
  • Tübingen, Germany, 72076
    • Klinikum der Eberhard Karls Universitaet Abt fur innere Med II Haematologie Onkologie Germany
  • Würzburg, Germany, 97080
    • Universitätsklinikum Würzburg
• Greece
  • Athens, Greece, 12462
    • Attikon University General Hospital of Attica
• Israel
  • Jerusalem, Israel, P.O.B. 12000
    • Hadassah University Hospita Ein Kerem
  • Ramat Gan, Israel, 74047
    • Sheba Medical Center
  • Tel Aviv, Israel, 64239
    • Sourasky Medical Center
• Italy
  • Bologna, Italy, 40138
    • Azienda Opedaliero-Universitaria Policlinico Sant'orsola Malpighi di Bologna
  • Milan, Italy, 20133
    • Fondazione IRCCS Istituto Nazionale dei Tumori
  • Milan, Italy, 20132
    • IRCCS Ospedale San Raffaele HSR
  • Roma, Italy, 00168
    • Policlinico Universitario Agostino Gemelli
  • Turin, Italy, 10126
    • A.O.U. Citta della Salute e della Scienza di Torino - Presidio Molinette
• Japan
  • Fukuoka, Japan, 812 8582
    • Kyushu University Hospital
  • Kanazawa, Japan, 920 8641
    • Kanazawa University Hospital
  • Kyoto, Japan, 602-8566
    • University Hospital Kyoto Prefectural University of Medicine
  • Nagoya, Japan, 467 8602
    • Nagoya City University Hospital
  • Okayama, Japan, 700 8558
    • Okayama University Hospital
  • Sapporo, Japan, 060-8648
    • Hokkaido University Hospital
  • Sendai, Japan, 980 8574
    • Tohoku University Hospital
  • Shibuya City, Japan, 150-8935
    • Japanese Red Cross Medical Center
• Netherlands
  • Amsterdam, Netherlands, 1081 HV
    • VU Medisch Centrum
  • Groningen, Netherlands, 9713 GZ
    • University Medical Center Groningen
  • Rotterdam, Netherlands, 3015 CN
    • Erasmus MC
  • Utrecht, Netherlands, 3584 CX
    • UMC Utrecht
• Poland
  • Gdansk, Poland, 80 214
    • Uniwersyteckie Centrum Kliniczne
  • Gliwice, Poland, 44102
    • Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut BadawczyOddz w Gliwicach
  • Poznan, Poland, 60-569
    • Uniwersytecki Szpital Kliniczny W Poznaniu
  • Warsaw, Poland, 02 776
    • Instytut Hematologii i Transfuzjologii
• South Korea
  • Seoul, South Korea, 03080
    • Seoul National University Hospital
  • Seoul, South Korea, 06351
    • Samsung Medical Center
  • Seoul, South Korea, 06591
    • The Catholic University of Korea Seoul St Marys Hospital
• Spain
  • Badalona, Spain, 08916
    • Inst. Cat. D'Oncologia-Badalona
  • Barcelona, Spain, 08036
    • Hosp Clinic de Barcelona
  • Madrid, Spain, 28041
    • Hosp. Univ. 12 de Octubre
  • Madrid, Spain, 28007
    • Hosp. Gral. Univ. Gregorio Maranon
  • Pamplona, Spain, 31008
    • Clinica Univ. de Navarra
  • Salamanca, Spain, 37007
    • Hosp Clinico Univ de Salamanca
  • Seville, Spain, 41013
    • Hosp. Virgen Del Rocio
• Sweden
  • Lund, Sweden, 221 85
    • Skåne University Hospital
  • Stockholm, Sweden, 141 86
    • Karolinska Universitetssjukhuset Huddinge, Hematologiska Kliniken, Huddinge
  • Uppsala, Sweden, 751 85
    • Akademiska sjukhuset
• United Kingdom
  • Birmingham, United Kingdom, B15 2TH
    • Queen Elizabeth Hospital
  • Bristol, United Kingdom, BS2 8ED
    • Bristol Haematology and Oncology Centre
  • Cardiff, United Kingdom, CF14 4XW
    • University Hospital Wales
  • London, United Kingdom, SE5 9RS
    • Kings College Hospital
  • London, United Kingdom, NW1 2BU
    • University College Hospital
  • Manchester, United Kingdom, M20 4BX
    • Christie Hospital
  • Newcastle upon Tyne, United Kingdom, NE7 7DN
    • Freeman Hospital
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • University of Alabama at Birmingham
  • Arizona
    • Phoenix, Arizona, United States, 85054
      • Mayo Clinic Cancer Center-Scottsdale
  • California
    • Stanford, California, United States, 94305-5623
      • Stanford University Medical Center
  • Colorado
    • Denver, Colorado, United States, 80218
      • Colorado Blood Cancer Institute
  • Connecticut
    • New Haven, Connecticut, United States, 06520
      • Yale New Haven Hospital
  • Florida
    • Miami, Florida, United States, 33136
      • University Of Miami Leonard M Mille School Of Medicine SCCC
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • University of Iowa Hospitals and Clinics
  • Kansas
    • Westwood, Kansas, United States, 66205
      • University of Kansas
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • University of Maryland Medical Center
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic - Rochester
  • Missouri
    • St Louis, Missouri, United States, 63110
      • Washington University School of Medicine
  • New Jersey
    • Hackensack, New Jersey, United States, 07601
      • Hackensack University Medical Center
  • New York
    • New York, New York, United States, 10065
      • Memorial Sloan-Kettering Cancer Center
    • Rochester, New York, United States, 14642
      • University of Rochester Medical Center
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center
  • Ohio
    • Columbus, Ohio, United States, 43210
      • The Ohio State University
  • Utah
    • Salt Lake City, Utah, United States, 84112
      • Huntsman Cancer Institute
  • Wisconsin
    • Madison, Wisconsin, United States, 53705
      • Wisconsin Institutes for Medical Research
    • Milwaukee, Wisconsin, United States, 53226
      • Medical College of Wisconsin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm A: PVd or DPd (Standard Therapy); Participants 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.	Drug: Pomalidomide; Pomalidomide 4 mg will be administered orally.; Drug: Bortezomib; Bortezomib 1.3 milligram per meter square (mg/m^2) will be administered subcutaneously (SC).; Drug: Dexamethasone; 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.; Drug: Daratumumab; Daratumumab 1800 mg will be administered SC.
Experimental: Arm B: (Ciltacabtagene Autoleucel [Cilta-cel]); Participants 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).	Drug: Cilta-cel; Cilta-cel infusion will be administered at a target dose of 0.75 * 10^6 CAR-positive viable T cells/kilogram (kg).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From randomization (Day 1) to either progressive disease or death, whichever occurred first (up to 3.9 years)

Secondary Outcome Measures

Outcome Measure	Time Frame
Percentage of Participants Who Achieved Complete Response (CR) or Stringent Complete Response (sCR)	From randomization (Day 1) up to 7 years
Percentage of Participants Who Achieved Overall Minimal Residual Disease (MRD) Negative Status (at 10^-5)	From randomization (Day 1) up to 7 years
Percentage of Participants Who Were in CR or sCR and Achieved MRD-negative Status at 12 Months +/-3 Months	From randomization (Day 1) up to 12 months +/- 3 months
Percentage of Participants Who Achieved Sustained MRD-negative Status	From randomization (Day 1) up to 7 years
Overall Survival (OS)	From randomization (Day 1) up to 7 years
Time to Worsening of Symptoms Using the Multiple Myeloma Symptom and Impact Questionnaire (MySIm-Q) Total Symptom Score	From randomization (Day 1) up to 7 years
Overall Response Rate (ORR)	From randomization (Day 1) up to 7 years
Progression Free Survival on Next-line Therapy (PFS2)	From randomization (Day 1) up to 7 years
Number of Participants With Treatment-emergent Adverse Events (AEs)	From Cycle 1 Day 1 up to 7 years
Number of Participants With Treatment-emergent Adverse Events (AEs) by Severity	From Cycle 1 Day 1 up to 7 years
Change From Baseline in Systemic Cytokine Concentrations on Participants Who Received Cilta-cel as Study Treatment (Arm B)	From baseline (Cycle 1 Day 1) up to 7 years
Change From Baseline in Levels of CAR-T Cell Activation Markers on Participants Who Received Cilta-cel as Study Treatment (Arm B)	From baseline (Cycle 1 Day 1) up to 7 years (each cycle of 28 days)
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)	From baseline (Cycle 1 Day 1) up to 7 years (each cycle of 28 days)
Number of Participants With Anti-JNJ-68284528 Antibodies on Participants Who Received Cilta-cel as Study Treatment (Arm B)	From Cycle 1 Day 1 up to 7 years
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	From baseline (Cycle 1 Day 1) up to 7 years (each cycle of 28 days)
Change From Baseline in Health-Related Quality of Life as Assessed by MySIm-Q Scale Sore	From baseline (Cycle 1 Day 1) up to 7 years (each cycle of 28 days)
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	From baseline (Cycle 1 Day 1) up to 7 years (each cycle of 28 days)
Change From Baseline in Health-Related Quality of Life as Assessed by Patient Global Impression of Symptom Severity (PGIS) Scale Score	From baseline (Cycle 1 Day 1) up to 7 years (each cycle of 28 days)
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	From randomization (Day 1) up to 7 years

Collaborators and Investigators

• Sponsor: Janssen Research & Development, LLC
• Investigators: Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 12, 2020
• Primary Completion (Actual): May 1, 2024
• Study Completion (Estimated): April 9, 2029

Study Registration Dates

• First Submitted: November 27, 2019
• First Submitted That Met QC Criteria: November 27, 2019
• First Posted (Actual): December 2, 2019

Study Record Updates

• Last Update Posted (Actual): May 11, 2026
• Last Update Submitted That Met QC Criteria: May 7, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Neoplasms; Immune System Diseases; Neoplasms by Histologic Type; Hematologic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Neoplasms, Plasma Cell; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Hemorrhagic Disorders; Hemic and Lymphatic Diseases; Multiple Myeloma; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Polycyclic Compounds; Inorganic Chemicals; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Steroids, Fluorinated; Pregnadienetriols; Boronic Acids; Acids, Noncarboxylic; Acids; Boron Compounds; Pyrazines; Bortezomib; Dexamethasone; pomalidomide; daratumumab
• Other Study ID Numbers: CR108695; 2019-001413-16 (EudraCT Number); 68284528MMY3002 (Other Identifier: Janssen Research & Development, LLC); 2023-506588-32-00 (Registry Identifier: EUCT number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No