CARTITUDE-4

Podcasts, YouTube videos and X posts in our index that name this trial. A report screens them, searches for more and cites what clinicians said when it is built.

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

Phase

Phase 3

Status

Active not recruiting

Conditions

Multiple Myeloma

Interventions

Cilta-cel; Pomalidomide; Bortezomib; Dexamethasone; Daratumumab

Arms

• Arm A: PVd or DPd (Standard Therapy) · Experimental
• Arm B: (Ciltacabtagene Autoleucel [Cilta-cel]) · Experimental

Enrollment

419

Primary outcomes

• Progression Free Survival (PFS)

Sponsor

Janssen Research & Development, LLC

Start

Jun 12, 2020

Primary completion

May 1, 2024

Results posted

Yes

Registry record

NCT04181827 · updated Sep 28, 2026

• 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