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| ID | Type | Description | Link |
|---|---|---|---|
| 68284528MMY3002 | Other Identifier | Janssen Research & Development, LLC | |
| 2019-001413-16 | EudraCT Number | ||
| 2023-506588-32-00 | Registry Identifier | EUCT number |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A: PVd or DPd (Standard Therapy) | Experimental | 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. |
|
| Arm B: (Ciltacabtagene Autoleucel [Cilta-cel]) | Experimental | 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cilta-cel | Drug | Cilta-cel infusion will be administered at a target dose of 0.75 * 10^6 CAR-positive viable T cells/kilogram (kg). |
|
| 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) |
| Measure | Description | 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 |
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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):
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | United States | ||
| Mayo Clinic Cancer Center-Scottsdale |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41824255 | Derived | 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. | |
| 41627370 |
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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
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Currently results are reported until the primary completion date (01-May-2024). Results of remaining duration of the study will be reported after study completion.
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm A: Standard Therapy: PVd or DPd | Participants received either PVd or DPd as standard therapy. In pomalidomide, bortezomib and dexamethasone (PVd) treatment, participants received pomalidomide 4 milligrams (mg) orally (PO) on Days 1 to 14 in each treatment cycle; bortezomib 1.3 mg/meter square (m^2) subcutaneous (SC) injection on Days 1, 4, 8 and 11 (Cycles 1 to 8) and on Days 1 and 8 (Cycle 9 onwards); and dexamethasone 20 mg (or 10 mg for participants aged greater than [>] 75 years) PO 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 treatment cycle of 21 days. In daratumumab, pomalidomide and dexamethasone (DPd) treatment, participants received daratumumab 1800 mg SC injection weekly on Days 1, 8, 15 and 22 (Cycle 1 and 2), every 2 weeks on Days 1 and 15 (Cycle 3 to 6) and every 4 weeks on Day 1 (Cycle 7 onwards); pomalidomide 4 mg PO on Days 1 to 21 (Cycle 1 onwards); dexamethasone 40 mg (or 20 mg for participants aged >75 years) PO or intravenous(IV) weekly during Cycle 1-2 on Days 1, 8, 15, and 22 or split with 20 mg on Days 1, 2, 8, 9, 15, 16, 22, and 23. Each treatment cycle of 28 days. Participants continued to receive PVd or DPd until confirmed progressive disease (PD), death, intolerable toxicity, withdrawal of consent, or end of study, whichever occurred earlier. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 18, 2022 | May 1, 2025 |
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| Pomalidomide | Drug | Pomalidomide 4 mg will be administered orally. |
|
| Bortezomib | Drug | Bortezomib 1.3 milligram per meter square (mg/m^2) will be administered subcutaneously (SC). |
|
| Dexamethasone | Drug | 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. |
|
| Daratumumab | Drug | Daratumumab 1800 mg will be administered SC. |
|
| 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 |
| Phoenix |
| Arizona |
| 85054 |
| United States |
| Stanford University Medical Center | Stanford | California | 94305-5623 | United States |
| Colorado Blood Cancer Institute | Denver | Colorado | 80218 | United States |
| Yale New Haven Hospital | New Haven | Connecticut | 06520 | United States |
| University Of Miami Leonard M Mille School Of Medicine SCCC | Miami | Florida | 33136 | United States |
| University of Iowa Hospitals and Clinics | Iowa City | Iowa | 52242 | United States |
| University of Kansas | Westwood | Kansas | 66205 | United States |
| University Of Maryland Medical Center | Baltimore | Maryland | 21201 | United States |
| Mayo Clinic - Rochester | Rochester | Minnesota | 55905 | United States |
| Washington University School Of Medicine | St Louis | Missouri | 63110 | United States |
| Hackensack University Medical Center | Hackensack | New Jersey | 07601 | United States |
| Memorial Sloan-Kettering Cancer Center | New York | New York | 10065 | United States |
| University of Rochester Medical Center | Rochester | New York | 14642 | United States |
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| The Ohio State University | Columbus | Ohio | 43210 | United States |
| Huntsman Cancer Institute | Salt Lake City | Utah | 84112 | United States |
| Wisconsin Institutes for Medical Research | Madison | Wisconsin | 53705 | United States |
| Medical College Of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
| Royal Adelaide Hospital | Adelaide | 5000 | Australia |
| Royal Prince Alfred Hospital | Camperdown | 2050 | Australia |
| Royal Brisbane and Womens Hospital | Herston | 4029 | Australia |
| Peter MacCallum Cancer Centre | Melbourne | 3000 | Australia |
| Alfred Health | Melbourne | 3004 | Australia |
| Fiona Stanley Hospital | Murdoch | 6150 | Australia |
| Universitair Ziekenhuis - Antwerpen | Antwerp | 2650 | Belgium |
| UZ Gent | Ghent | 9000 | Belgium |
| UZ Leuven | Leuven | 3000 | Belgium |
| Centre Hospitalier Universitaire de Liege Domaine Universitaire du Sart Tilman | Liège | B-4000 | Belgium |
| Rigshospitalet | Copenhagen | DK-2100 | Denmark |
| CHRU de Lille Hopital Claude Huriez | Lille | 59037 | France |
| Hospices Civils de Lyon HCL | Lyon | 69002 | France |
| CHU de Montpellier Hopital Saint Eloi | Montpellier | 34295 | France |
| C.H.U. Hotel Dieu - France | Nantes | 44093 | France |
| Hopital Saint Louis | Paris | 75475 | France |
| CHU De Poitiers | Poitiers | 86021 | France |
| Institut Universitaire du cancer de Toulouse-Oncopole | Toulouse | 31059 | France |
| Universitaetsklinikum Koeln | Cologne | 50924 | Germany |
| Universitatsklinikum Carl Gustvav Carus Dresden an der Technischen Universitat Dresden | Dresden | 01307 | Germany |
| Universitaetsklinikum Hamburg Eppendorf | Hamburg | 20246 | Germany |
| Universitaetsklinikum Leipzig | Leipzig | 04103 | Germany |
| Klinikum der Eberhard Karls Universitaet Abt fur innere Med II Haematologie Onkologie Germany | Tübingen | 72076 | Germany |
| Universitatsklinikum Wurzburg | Würzburg | 97080 | Germany |
| Attikon University General Hospital of Attica | Athens | 12462 | Greece |
| Hadassah University Hospita Ein Kerem | Jerusalem | P.O.B. 12000 | Israel |
| Sheba Medical Center | Ramat Gan | 74047 | Israel |
| Sourasky Medical Center | Tel Aviv | 64239 | Israel |
| Azienda Opedaliero-Universitaria Policlinico Sant'orsola Malpighi di Bologna | Bologna | 40138 | Italy |
| IRCCS Ospedale San Raffaele HSR | Milan | 20132 | Italy |
| Fondazione IRCCS Istituto Nazionale dei Tumori | Milan | 20133 | Italy |
| Policlinico Universitario Agostino Gemelli | Roma | 00168 | Italy |
| A.O.U. Citta della Salute e della Scienza di Torino - Presidio Molinette | Turin | 10126 | Italy |
| Kyushu University Hospital | Fukuoka | 812 8582 | Japan |
| Kanazawa University Hospital | Kanazawa | 920 8641 | Japan |
| University Hospital Kyoto Prefectural University of Medicine | Kyoto | 602-8566 | Japan |
| Nagoya City University Hospital | Nagoya | 467 8602 | Japan |
| Okayama University Hospital | Okayama | 700 8558 | Japan |
| Hokkaido University Hospital | Sapporo | 060-8648 | Japan |
| Tohoku University Hospital | Sendai | 980 8574 | Japan |
| Japanese Red Cross Medical Center | Shibuya City | 150-8935 | Japan |
| VU Medisch Centrum | Amsterdam | 1081 HV | Netherlands |
| University Medical Center Groningen | Groningen | 9713 GZ | Netherlands |
| Erasmus MC | Rotterdam | 3015 CN | Netherlands |
| UMC Utrecht | Utrecht | 3584 CX | Netherlands |
| Uniwersyteckie Centrum Kliniczne | Gdansk | 80 214 | Poland |
| Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut BadawczyOddz w Gliwicach | Gliwice | 44102 | Poland |
| Uniwersytecki Szpital Kliniczny w Poznaniu | Poznan | 60-569 | Poland |
| Instytut Hematologii i Transfuzjologii | Warsaw | 02 776 | Poland |
| Seoul National University Hospital | Seoul | 03080 | South Korea |
| Samsung Medical Center | Seoul | 06351 | South Korea |
| The Catholic University of Korea Seoul St Marys Hospital | Seoul | 06591 | South Korea |
| Inst. Cat. D'Oncologia-Badalona | Badalona | 08916 | Spain |
| Hosp Clinic de Barcelona | Barcelona | 08036 | Spain |
| Hosp. Gral. Univ. Gregorio Maranon | Madrid | 28007 | Spain |
| Hosp. Univ. 12 de Octubre | Madrid | 28041 | Spain |
| Clinica Univ. de Navarra | Pamplona | 31008 | Spain |
| Hosp Clinico Univ de Salamanca | Salamanca | 37007 | Spain |
| Hosp. Virgen Del Rocio | Seville | 41013 | Spain |
| Skane University Hospital | Lund | 221 85 | Sweden |
| Karolinska Universitetssjukhuset Huddinge, Hematologiska Kliniken, Huddinge | Stockholm | 141 86 | Sweden |
| Akademiska Sjukhuset | Uppsala | 751 85 | Sweden |
| Queen Elizabeth Hospital | Birmingham | B15 2TH | United Kingdom |
| Bristol Haematology and Oncology Centre | Bristol | BS2 8ED | United Kingdom |
| University Hospital Wales | Cardiff | CF14 4XW | United Kingdom |
| University College Hospital | London | NW1 2BU | United Kingdom |
| Kings College Hospital | London | SE5 9RS | United Kingdom |
| Christie Hospital | Manchester | M20 4BX | United Kingdom |
| Freeman Hospital | Newcastle upon Tyne | NE7 7DN | United Kingdom |
| Derived |
| 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. |
| 41519141 | Derived | 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. |
| 40768190 | Derived | 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. |
| 40613875 | Derived | 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. |
| 39938094 | Derived | 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. |
| 39756844 | Derived | 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. |
| 39110421 | Derived | 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. |
| 37272512 | Derived | 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. |
| FG001 | Arm B: JNJ-68284528 (Ciltacabtagene Autoleucel [Cilta-cel]) | Participants received at least one cycle of bridging therapy, that is PVd: pomalidomide 4 mg PO on Days 1 to 14, bortezomib 1.3 mg/m^2 SC injection on Days 1, 4, 8, and 11, and dexamethasone 20 mg (or 10 mg for participants aged >75 years) PO on Days 1, 2, 4, 5, 8, 9, 11, and 12; each treatment cycle of 21 days. DPd: daratumumab SC 1800 mg (co-formulated with rHuPH20) weekly on Days 1, 8, 15, and 22, pomalidomide 4 mg PO on Days 1 to 21, and dexamethasone PO or IV 40 mg (or 20 mg for participants aged >75 years) weekly during Cycle 1-2 on Days 1, 8, 15, and 22 or split with 20 mg on Days 1, 2, 8, 9, 15, 16, 22, and 23. Each treatment cycle of 28 days. Additional cycles of bridging therapy was considered based on participant's clinical status and timing of availability of JNJ-68284528 (cilta-cel). Followed by bridging therapy, participants received conditioning regimen: cyclophosphamide 300 mg/m^2 IV and fludarabine 30 mg/m^2 IV daily, for 3 days on chimeric antigen receptor T cells (CAR-T) Day -5, -4, -3 (prior to JNJ-68284528 infusion), followed by JNJ-68284528 (cilta-cel) infusion 0.75*10^6 chimeric antigen receptor (CAR)-positive viable T cells per kilogram (kg) 5 to 7 days after the start of conditioning regimen. |
| Treated (Safety Analysis Set) |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm A: Standard Therapy: PVd or DPd | Participants received either PVd or DPd as standard therapy. In pomalidomide, bortezomib and dexamethasone (PVd) treatment, participants received pomalidomide 4 milligrams (mg) orally (PO) on Days 1 to 14 in each treatment cycle; bortezomib 1.3 mg/meter square (m^2) subcutaneous (SC) injection on Days 1, 4, 8 and 11 (Cycles 1 to 8) and on Days 1 and 8 (Cycle 9 onwards); and dexamethasone 20 mg (or 10 mg for participants aged greater than [>] 75 years) PO 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 treatment cycle of 21 days. In daratumumab, pomalidomide and dexamethasone (DPd) treatment, participants received daratumumab 1800 mg SC injection weekly on Days 1, 8, 15 and 22 (Cycle 1 and 2), every 2 weeks on Days 1 and 15 (Cycle 3 to 6) and every 4 weeks on Day 1 (Cycle 7 onwards); pomalidomide 4 mg PO on Days 1 to 21 (Cycle 1 onwards); dexamethasone 40 mg (or 20 mg for participants aged >75 years) PO or intravenous(IV) weekly during Cycle 1-2 on Days 1, 8, 15, and 22 or split with 20 mg on Days 1, 2, 8, 9, 15, 16, 22, and 23. Each treatment cycle of 28 days. Participants continued to receive PVd or DPd until confirmed progressive disease (PD), death, intolerable toxicity, withdrawal of consent, or end of study, whichever occurred earlier. |
| BG001 | Arm B: JNJ-68284528 (Ciltacabtagene Autoleucel [Cilta-cel]) | Participants received at least one cycle of bridging therapy, that is PVd: pomalidomide 4 mg PO on Days 1 to 14, bortezomib 1.3 mg/m^2 SC injection on Days 1, 4, 8, and 11, and dexamethasone 20 mg (or 10 mg for participants aged >75 years) PO on Days 1, 2, 4, 5, 8, 9, 11, and 12; each treatment cycle of 21 days. DPd: daratumumab SC 1800 mg (co-formulated with rHuPH20) weekly on Days 1, 8, 15, and 22, pomalidomide 4 mg PO on Days 1 to 21, and dexamethasone PO or IV 40 mg (or 20 mg for participants aged >75 years) weekly during Cycle 1-2 on Days 1, 8, 15, and 22 or split with 20 mg on Days 1, 2, 8, 9, 15, 16, 22, and 23. Each treatment cycle of 28 days. Additional cycles of bridging therapy was considered based on participant's clinical status and timing of availability of JNJ-68284528 (cilta-cel). Followed by bridging therapy, participants received conditioning regimen: cyclophosphamide 300 mg/m^2 IV and fludarabine 30 mg/m^2 IV daily, for 3 days on chimeric antigen receptor T cells (CAR-T) Day -5, -4, -3 (prior to JNJ-68284528 infusion), followed by JNJ-68284528 (cilta-cel) infusion 0.75*10^6 chimeric antigen receptor (CAR)-positive viable T cells per kilogram (kg) 5 to 7 days after the start of conditioning regimen. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | The intent-to-treat (ITT) analysis set included all participants who were randomized in the study. | Posted | Median | 95% Confidence Interval | months | From randomization (Day 1) to either progressive disease or death, whichever occurred first (up to 3.9 years) |
|
|
| ||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Achieved Complete Response (CR) or Stringent Complete Response (sCR) | Not Posted | Jun 2028 | From randomization (Day 1) up to 7 years | Participants | ||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Achieved Overall Minimal Residual Disease (MRD) Negative Status (at 10^-5) | Not Posted | Jun 2028 | From randomization (Day 1) up to 7 years | Participants | ||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Were in CR or sCR and Achieved MRD-negative Status at 12 Months +/-3 Months | Not Posted | Jun 2028 | From randomization (Day 1) up to 12 months +/- 3 months | Participants | ||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Achieved Sustained MRD-negative Status | Not Posted | Jun 2028 | From randomization (Day 1) up to 7 years | Participants | ||||||||||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) | Not Posted | Jun 2028 | From randomization (Day 1) up to 7 years | Participants | ||||||||||||||||||||||||||||||||||
| Secondary | Time to Worsening of Symptoms Using the Multiple Myeloma Symptom and Impact Questionnaire (MySIm-Q) Total Symptom Score | Not Posted | Jun 2028 | From randomization (Day 1) up to 7 years | Participants | ||||||||||||||||||||||||||||||||||
| Secondary | Overall Response Rate (ORR) | Not Posted | Jun 2028 | From randomization (Day 1) up to 7 years | Participants | ||||||||||||||||||||||||||||||||||
| Secondary | Progression Free Survival on Next-line Therapy (PFS2) | Not Posted | Jun 2028 | From randomization (Day 1) up to 7 years | Participants | ||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Treatment-emergent Adverse Events (AEs) | Not Posted | Jun 2028 | From Cycle 1 Day 1 up to 7 years | Participants | ||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Treatment-emergent Adverse Events (AEs) by Severity | Not Posted | Jun 2028 | From Cycle 1 Day 1 up to 7 years | Participants | ||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Systemic Cytokine Concentrations on Participants Who Received Cilta-cel as Study Treatment (Arm B) | Not Posted | Jun 2028 | From baseline (Cycle 1 Day 1) up to 7 years | Participants | ||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Levels of CAR-T Cell Activation Markers on Participants Who Received Cilta-cel as Study Treatment (Arm B) | Not Posted | Jun 2028 | From baseline (Cycle 1 Day 1) up to 7 years (each cycle of 28 days) | Participants | ||||||||||||||||||||||||||||||||||
| Secondary | 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) | Not Posted | Jun 2028 | From baseline (Cycle 1 Day 1) up to 7 years (each cycle of 28 days) | Participants | ||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Anti-JNJ-68284528 Antibodies on Participants Who Received Cilta-cel as Study Treatment (Arm B) | Not Posted | Jun 2028 | From Cycle 1 Day 1 up to 7 years | Participants | ||||||||||||||||||||||||||||||||||
| Secondary | 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 | Not Posted | Jun 2028 | From baseline (Cycle 1 Day 1) up to 7 years (each cycle of 28 days) | Participants | ||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Health-Related Quality of Life as Assessed by MySIm-Q Scale Sore | Not Posted | Jun 2028 | From baseline (Cycle 1 Day 1) up to 7 years (each cycle of 28 days) | Participants | ||||||||||||||||||||||||||||||||||
| Secondary | 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 | Not Posted | Jun 2028 | From baseline (Cycle 1 Day 1) up to 7 years (each cycle of 28 days) | Participants | ||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Health-Related Quality of Life as Assessed by Patient Global Impression of Symptom Severity (PGIS) Scale Score | Not Posted | Jun 2028 | From baseline (Cycle 1 Day 1) up to 7 years (each cycle of 28 days) | Participants | ||||||||||||||||||||||||||||||||||
| Secondary | 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 | Not Posted | Jun 2028 | From randomization (Day 1) up to 7 years | Participants |
All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm A: Standard Therapy: PVd or DPd | Participants received either PVd or DPd as standard therapy. In pomalidomide, bortezomib and dexamethasone (PVd) treatment, participants received pomalidomide 4 milligrams (mg) orally (PO) on Days 1 to 14 in each treatment cycle; bortezomib 1.3 mg/meter square (m^2) subcutaneous (SC) injection on Days 1, 4, 8 and 11 (Cycles 1 to 8) and on Days 1 and 8 (Cycle 9 onwards); and dexamethasone 20 mg (or 10 mg for participants aged greater than [>] 75 years) PO 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 treatment cycle of 21 days. In daratumumab, pomalidomide and dexamethasone (DPd) treatment, participants received daratumumab 1800 mg SC injection weekly on Days 1, 8, 15 and 22 (Cycle 1 and 2), every 2 weeks on Days 1 and 15 (Cycle 3 to 6) and every 4 weeks on Day 1 (Cycle 7 onwards); pomalidomide 4 mg PO on Days 1 to 21 (Cycle 1 onwards); dexamethasone 40 mg (or 20 mg for participants aged >75 years) PO or intravenous(IV) weekly during Cycle 1-2 on Days 1, 8, 15, and 22 or split with 20 mg on Days 1, 2, 8, 9, 15, 16, 22, and 23. Each treatment cycle of 28 days. Participants continued to receive PVd or DPd until confirmed progressive disease (PD), death, intolerable toxicity, withdrawal of consent, or end of study, whichever occurred earlier. | 83 | 211 | 98 | 208 | 207 | 208 |
| EG001 | Arm B: JNJ-68284528 (Ciltacabtagene Autoleucel [Cilta-cel]) | Participants received at least one cycle of bridging therapy, that is PVd: pomalidomide 4 mg PO on Days 1 to 14, bortezomib 1.3 mg/m^2 SC injection on Days 1, 4, 8, and 11, and dexamethasone 20 mg (or 10 mg for participants aged >75 years) PO on Days 1, 2, 4, 5, 8, 9, 11, and 12; each treatment cycle of 21 days. DPd: daratumumab SC 1800 mg (co-formulated with rHuPH20) weekly on Days 1, 8, 15, and 22, pomalidomide 4 mg PO on Days 1 to 21, and dexamethasone PO or IV 40 mg (or 20 mg for participants aged >75 years) weekly during Cycle 1-2 on Days 1, 8, 15, and 22 or split with 20 mg on Days 1, 2, 8, 9, 15, 16, 22, and 23. Each treatment cycle of 28 days. Additional cycles of bridging therapy was considered based on participant's clinical status and timing of availability of JNJ-68284528 (cilta-cel). Followed by bridging therapy, participants received conditioning regimen: cyclophosphamide 300 mg/m^2 IV and fludarabine 30 mg/m^2 IV daily, for 3 days on chimeric antigen receptor T cells (CAR-T) Day -5, -4, -3 (prior to JNJ-68284528 infusion), followed by JNJ-68284528 (cilta-cel) infusion 0.75*10^6 chimeric antigen receptor (CAR)-positive viable T cells per kilogram (kg) 5 to 7 days after the start of conditioning regimen. | 50 | 208 | 98 | 208 | 208 | 208 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Cytopenia | Blood and lymphatic system disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Febrile Neutropenia | Blood and lymphatic system disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Hyperviscosity Syndrome | Blood and lymphatic system disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Immune Thrombocytopenia | Blood and lymphatic system disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Lymphocytosis | Blood and lymphatic system disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Pancytopenia | Blood and lymphatic system disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Acute Coronary Syndrome | Cardiac disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Acute Myocardial Infarction | Cardiac disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Angina Pectoris | Cardiac disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Atrial Fibrillation | Cardiac disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Atrial Flutter | Cardiac disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Atrioventricular Block Second Degree | Cardiac disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Cardiac Failure | Cardiac disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Left Ventricular Dysfunction | Cardiac disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Myocardial Infarction | Cardiac disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Pericarditis | Cardiac disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Supraventricular Tachycardia | Cardiac disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Diplopia | Eye disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Gastric Haemorrhage | Gastrointestinal disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Chest Discomfort | General disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Chills | General disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| General Physical Health Deterioration | General disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Cholestasis | Hepatobiliary disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Cytokine Release Syndrome | Immune system disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Anal Abscess | Infections and infestations | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Bacterial Pericarditis | Infections and infestations | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Covid-19 | Infections and infestations | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Covid-19 Pneumonia | Infections and infestations | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Cytomegalovirus Chorioretinitis | Infections and infestations | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Cytomegalovirus Colitis | Infections and infestations | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Cytomegalovirus Infection | Infections and infestations | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Cytomegalovirus Infection Reactivation | Infections and infestations | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Device Related Sepsis | Infections and infestations | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Endophthalmitis | Infections and infestations | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Enterocolitis Viral | Infections and infestations | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Epiglottitis | Infections and infestations | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Escherichia Urinary Tract Infection | Infections and infestations | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Gastroenteritis Bacterial | Infections and infestations | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Gastroenteritis Escherichia Coli | Infections and infestations | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Gastroenteritis Salmonella | Infections and infestations | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Gastrointestinal Infection | Infections and infestations | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Haemophilus Sepsis | Infections and infestations | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Herpes Zoster | Infections and infestations | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Jc Virus Infection | Infections and infestations | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Large Intestine Infection | Infections and infestations | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Leishmaniasis | Infections and infestations | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Lower Respiratory Tract Infection | Infections and infestations | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Metapneumovirus Infection | Infections and infestations | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Metapneumovirus Pneumonia | Infections and infestations | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Neutropenic Sepsis | Infections and infestations | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Parainfluenzae Virus Infection | Infections and infestations | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Parvovirus B19 Infection | Infections and infestations | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Pneumocystis Jirovecii Pneumonia | Infections and infestations | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Pneumonia Haemophilus | Infections and infestations | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Pneumonia Klebsiella | Infections and infestations | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Pneumonia Legionella | Infections and infestations | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Pneumonia Parainfluenzae Viral | Infections and infestations | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Pneumonia Pneumococcal | Infections and infestations | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Pneumonia Pseudomonal | Infections and infestations | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Pneumonia Respiratory Syncytial Viral | Infections and infestations | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Pneumonia Staphylococcal | Infections and infestations | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Pneumonia Streptococcal | Infections and infestations | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Post Procedural Infection | Infections and infestations | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Progressive Multifocal Leukoencephalopathy | Infections and infestations | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Pseudomonal Sepsis | Infections and infestations | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Pyelonephritis Acute | Infections and infestations | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Respiratory Syncytial Virus Infection | Infections and infestations | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Respiratory Tract Infection | Infections and infestations | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Respiratory Tract Infection Viral | Infections and infestations | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Rhinovirus Infection | Infections and infestations | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Rotavirus Infection | Infections and infestations | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Septic Shock | Infections and infestations | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Sinusitis Bacterial | Infections and infestations | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Soft Tissue Infection | Infections and infestations | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Staphylococcal Bacteraemia | Infections and infestations | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Staphylococcal Infection | Infections and infestations | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Staphylococcal Skin Infection | Infections and infestations | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Upper Respiratory Tract Infection Bacterial | Infections and infestations | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Viral Uveitis | Infections and infestations | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Hip Fracture | Injury, poisoning and procedural complications | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Humerus Fracture | Injury, poisoning and procedural complications | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Spinal Compression Fracture | Injury, poisoning and procedural complications | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Subdural Haemorrhage | Injury, poisoning and procedural complications | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Tracheal Obstruction | Injury, poisoning and procedural complications | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Alanine Aminotransferase Increased | Investigations | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Aspartate Aminotransferase Increased | Investigations | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Procalcitonin Increased | Investigations | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Troponin I Increased | Investigations | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Hyperferritinaemia | Metabolism and nutrition disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Bone Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Pain in Extremity | Musculoskeletal and connective tissue disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Pathological Fracture | Musculoskeletal and connective tissue disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Acute Myeloid Leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Basal Cell Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Epstein-Barr Virus Associated Lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Invasive Lobular Breast Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Lip Squamous Cell Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Lung Adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Malignant Pleural Effusion | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Myelodysplastic Syndrome | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Myelodysplastic Syndrome with Multilineage Dysplasia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Neoplasm of Appendix | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Paraneoplastic Syndrome | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Peripheral T-Cell Lymphoma Unspecified | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Renal Cell Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Serous Cystadenocarcinoma Ovary | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Squamous Cell Carcinoma of Skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Tonsil Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Facial Paralysis | Nervous system disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Facial Paresis | Nervous system disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Iiird Nerve Paralysis | Nervous system disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Immune Effector Cell-Associated Neurotoxicity Syndrome | Nervous system disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Ischaemic Stroke | Nervous system disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Parkinsonism | Nervous system disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Polyneuropathy | Nervous system disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Spinal Cord Compression | Nervous system disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Subdural Hygroma | Nervous system disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Trigeminal Palsy | Nervous system disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Confusional State | Psychiatric disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Disorientation | Psychiatric disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Mental Disorder | Psychiatric disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Suicidal Ideation | Psychiatric disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Acute Kidney Injury | Renal and urinary disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Pelvic Pain | Reproductive system and breast disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Acute Respiratory Distress Syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Acute Respiratory Failure | Respiratory, thoracic and mediastinal disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Interstitial Lung Disease | Respiratory, thoracic and mediastinal disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Lung Disorder | Respiratory, thoracic and mediastinal disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Pulmonary Oedema | Respiratory, thoracic and mediastinal disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Deep Vein Thrombosis | Vascular disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Thrombophlebitis | Vascular disorders | MedDRA Version 26.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Vision Blurred | Eye disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Chills | General disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Oedema Peripheral | General disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Cytokine Release Syndrome | Immune system disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Hypogammaglobulinaemia | Immune system disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Covid-19 | Infections and infestations | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Respiratory Tract Infection | Infections and infestations | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Alanine Aminotransferase Increased | Investigations | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Aspartate Aminotransferase Increased | Investigations | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Blood Alkaline Phosphatase Increased | Investigations | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Gamma-Glutamyltransferase Increased | Investigations | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Decreased Appetite | Metabolism and nutrition disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Bone Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Muscle Spasms | Musculoskeletal and connective tissue disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Muscular Weakness | Musculoskeletal and connective tissue disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Musculoskeletal Chest Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Pain in Extremity | Musculoskeletal and connective tissue disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Peripheral Sensory Neuropathy | Nervous system disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Nasal Congestion | Respiratory, thoracic and mediastinal disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Productive Cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA Version 26.1 | Non-systematic Assessment |
|
If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days to allow for filing of a patent application.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Executive Medical Director Oncology | Janssen Research & Development, LLC | 844-434-4210 | ClinicalTrialDisclosure@its.jnj.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 8, 2022 | May 1, 2025 | SAP_001.pdf |
| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C467566 | pomalidomide |
| D000069286 | Bortezomib |
| D003907 | Dexamethasone |
| C556306 | daratumumab |
| ID | Term |
|---|---|
| D001897 | Boronic Acids |
| D000148 | Acids, Noncarboxylic |
| D000143 | Acids |
| D007287 | Inorganic Chemicals |
| D001896 | Boron Compounds |
| D009930 | Organic Chemicals |
| D011719 | Pyrazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|