Um estudo de bortezomibe, lenalidomida e dexametasona (VRd) seguido de Cilta-cel, uma terapia CAR-T direcionada contra BCMA versus VRd seguida de terapia com lenalidomida e dexametasona (Rd) em participantes com mieloma múltiplo recém-diagnosticado para os quais ASCT não está planejado como Terapia Inicial (CARTITUDE-5)
Um estudo randomizado de fase 3 comparando bortezomibe, lenalidomida e dexametasona (VRd) seguido por ciltacabtagene autoleucel, uma terapia quimérica de célula T receptora de antígeno (CAR-T) direcionada contra BCMA versus bortezomibe, lenalidomida e dexametasona (VRd) seguida de lenalidomida e dexametasona ( Rd) Terapia em participantes com mieloma múltiplo recém-diagnosticado para os quais o transplante de células-tronco hematopoiéticas não está planejado como terapia inicial
The purpose of this study is to compare the efficacy of Bortezomib, Lenalidomide and Dexamethasone (VRd) induction followed by a single administration of ciltacabtagene autoleucel (cilta-cel) versus VRd induction followed by Lenalidomide and Dexamethasone (Rd) maintenance in newly diagnosed multiple myeloma participants for whom ASCT is not planned as initial therapy in terms of Progression Free Survival (PFS).
Visão geral do estudo
Status
Condições
Descrição detalhada
Multiple myeloma (MM) is a malignant plasma cell disorder characterized by the production of monoclonal immunoglobulin (Ig) proteins or protein fragments (M proteins) that have lost their function. JNJ-68284528 (ciltacabtagene autoleucel [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 of this study is that in participants with newly diagnosed MM, treatment with VRd induction followed by a single administration of cilta-cel will significantly improve progression free survival compared to Bortezomib, Lenalidomide and Dexamethasone (VRd) induction followed by Rd maintenance. The study will screen participants with newly diagnosed MM who are not planned to receive autologous stem cell transplant (ASCT) as initial therapy. This study will be conducted in 4 phases: Screening (up to 28 days), Pre-randomization Treatment, Treatment, and Follow-up. Assessments like patient-reported outcome(s) (PROs), electrocardiogram (ECG), vital signs and pharmacokinetics will be performed during the study. Safety evaluations will include review of adverse events, laboratory test results, vital sign measurements, physical examination findings, assessment of cardiac function, Immune-Effector Cell-Associated Encephalopathy (ICE) and handwriting assessments (only for Arm B) and Eastern Cooperative Oncology Group (ECOG) performance status. Safety data will be periodically reviewed by an Independent Data Monitoring Committee (IDMC). The duration of the study is approximately 12 years 5 months.
Tipo de estudo
Inscrição (Real)
Estágio
- Fase 3
Acesso expandido
Contactos e Locais
Locais de estudo
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Berlin, Alemanha, 12203
- Charité - Universitätsmedizin Berlin, Campus Benjamin Franklin
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Dresden, Alemanha, 01307
- Universitaetsklinikum Carl Gustav Carus TU Dresden
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Freiburg im Breisgau, Alemanha, 79106
- Universitatsklinikum Freiburg
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Hamburg, Alemanha, 20246
- Universitaetsklinikum Hamburg Eppendorf
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Heidelberg, Alemanha, 69120
- Universitaetsklinikum Heidelberg
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Leipzig, Alemanha, 04103
- Universitaetsklinikum Leipzig
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Mainz, Alemanha, 55131
- Universitatsmedizin der Johannes Gutenberg Universitat Mainz
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München, Alemanha, 81377
- Klinikum Grosshadern Der Ludwig-Maximilians-Universitat
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Regensburg, Alemanha, 93053
- Universitaetsklinikum Regensburg
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Tübingen, Alemanha, 72076
- Klinikum der Eberhard Karls Universitaet Abt fur innere Med II Haematologie Onkologie Germany
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Würzburg, Alemanha, 97080
- Universitatsklinikum Wurzburg
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Buenos Aires, Argentina, C1118AAT
- Hospital Aleman
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Buenos Aires, Argentina, C1199ABD
- Hospital Italiano de Buenos Aires
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Córdoba, Argentina, 5016
- Hospital Privado Universitario De Cordoba
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Camperdown, Austrália, 2050
- Royal Prince Alfred Hospital
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Fitzroy, Austrália, 3065
- St Vincents Hospital Melbourne
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Heidelberg, Austrália, 3084
- Austin Health
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Herston, Austrália, 4029
- Royal Brisbane and Womens Hospital
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Melbourne, Austrália, 3004
- Alfred Health
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Melbourne, Austrália, 8006
- Peter MacCallum Cancer Centre
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Murdoch, Austrália, 6150
- Fiona Stanley Hospital
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Waratah, Austrália, 2298
- Calvary Mater Newcastle Hospital
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Westmead, Austrália, 2145
- Western Sydney Local Health District
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Salvador, Brasil, 41253-190
- IDOR - Regional Bahia
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São Paulo, Brasil, 01509 900
- Fundacao Antonio Prudente A C Camargo Cancer Center
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São Paulo, Brasil, 05651-901
- Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein
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Antwerp, Bélgica, 2650
- Universitair Ziekenhuis - Antwerpen
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Bruges, Bélgica, 8000
- AZ St.-Jan Brugge-Oostende AV
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Ghent, Bélgica, 9000
- UZ Gent
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Leuven, Bélgica, 3000
- UZ Leuven
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Liège, Bélgica, B-4000
- Centre Hospitalier Universitaire de Liege Domaine Universitaire du Sart Tilman
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Alberta
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Calgary, Alberta, Canadá, T2N 5G2
- Arthur J E Child Comprehensive Cancer Centre
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British Columbia
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Vancouver, British Columbia, Canadá, V5Z 1M9
- Vancouver General Hospital
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Ontario
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Hamilton, Ontario, Canadá, L8V5C2
- Juravinski Cancer Centre
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Toronto, Ontario, Canadá, M5G2M9
- Princess Margaret Cancer Centre University Health Network
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Quebec
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Montreal, Quebec, Canadá, H1T 2M4
- Hopital Maisonneuve Rosemont
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Jeollanam-do, Coréia do Sul, 58128
- Chonnam National University Hwasun Hospital
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Seoul, Coréia do Sul, 03080
- Seoul National University Hospital
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Seoul, Coréia do Sul, 05505
- Asan Medical Center
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Seoul, Coréia do Sul, 03722
- Severance Hospital Yonsei University Health System
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Seoul, Coréia do Sul, 06351
- Samsung Medical Center
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Seoul, Coréia do Sul, 06591
- The Catholic University of Korea Seoul St Marys Hospital
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Aarhus N, Dinamarca, 8200
- Aarhus University Hospital
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Copenhagen, Dinamarca, 2100
- Rigshospitalet
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Odense C, Dinamarca, 5000
- Odense Universitetshospital
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Barcelona, Espanha, 08041
- Hosp. de La Santa Creu I Sant Pau
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Barcelona, Espanha, 8035
- Hosp Univ Vall D Hebron
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L'Hospitalet de Llobregat, Espanha, 08908
- Instituto Catalan Deoncologia Hospital Duran I Reynals
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Madrid, Espanha, 28041
- Hosp. Univ. 12 de Octubre
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Madrid, Espanha, 28007
- Hosp. Gral. Univ. Gregorio Maranon
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Murcia, Espanha, 30120
- Hosp. Univ. Virgen de La Arrixaca
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Pamplona, Espanha, 31008
- Clinica Univ. de Navarra
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Salamanca, Espanha, 37007
- Hosp Clinico Univ de Salamanca
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Santander, Espanha, 39008
- Hosp. Univ. Marques de Valdecilla
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Seville, Espanha, 41013
- Hosp. Virgen Del Rocio
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Valencia, Espanha, 46026
- Hosp. Univ. I Politecni La Fe
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California
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San Francisco, California, Estados Unidos, 94143
- UCSF
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Connecticut
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New Haven, Connecticut, Estados Unidos, 06510
- Yale Cancer Center
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Florida
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Miami, Florida, Estados Unidos, 33136
- University of Miami Health System
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Orlando, Florida, Estados Unidos, 32832
- AdventHealth Cancer Institute
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Iowa
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Iowa City, Iowa, Estados Unidos, 52242
- University of Iowa Hospitals and Clinics
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Kentucky
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Lexington, Kentucky, Estados Unidos, 40536-0293
- University of Kentucky
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Louisville, Kentucky, Estados Unidos, 40207
- Norton Cancer Institute
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Maryland
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Baltimore, Maryland, Estados Unidos, 21201-1595
- University Of Maryland Medical Center
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Massachusetts
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Boston, Massachusetts, Estados Unidos, 02215
- Beth Israel Deaconess Medical Center
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Michigan
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Detroit, Michigan, Estados Unidos, 48201
- Barbara Ann Karmanos Cancer Institute
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Detroit, Michigan, Estados Unidos, 48202-2608
- Henry Ford Cancer Institute
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New York
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New York, New York, Estados Unidos, 10032
- Columbia University Medical Center
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New York, New York, Estados Unidos, 10065
- Memorial Sloan-Kettering Cancer Center
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New York, New York, Estados Unidos, 10065
- New York Presbyterian-Weill Cornell Medical College
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North Carolina
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Charlotte, North Carolina, Estados Unidos, 28204
- Levine Cancer Institute
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Pennsylvania
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Philadelphia, Pennsylvania, Estados Unidos, 19107
- Thomas Jefferson University
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Pittsburgh, Pennsylvania, Estados Unidos, 15232
- University of Pittsburgh Medical Center
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Virginia
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Charlottesville, Virginia, Estados Unidos, 22903
- University of Virginia
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Wisconsin
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Milwaukee, Wisconsin, Estados Unidos, 53226
- Medical College Of Wisconsin
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Helsinki, Finlândia, 00290
- Helsinki University Hospital
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Oulu, Finlândia, 90220
- Oulu University Hospital
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Turku, Finlândia, 20520
- Turku University Hospital
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Lille, França, 59000
- Centre Hospitalier Régional Universitaire de Lille, Hôpital Claude Huriez
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Nantes, França, 44093
- C.H.U. Hotel Dieu - France
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Paris, França, 75475
- Hopital Saint Louis
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Poitiers, França, 86021
- CHU Poitiers - Hopital la Miletrie
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Toulouse, França, 31059
- Institut Universitaire du cancer de Toulouse-Oncopole
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Athens, Grécia, 11528
- Alexandra General Hospital of Athens
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Athens, Grécia, 12462
- Attikon University General Hospital of Attica
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Thessaloniki, Grécia, 57010
- G.Papanikolaou
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Amsterdam, Holanda, 1081 HV
- VU Medisch Centrum
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Groningen, Holanda, 9713 GZ
- University Medical Center Groningen
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Nijmegen, Holanda, 6500 HB
- UMC Radboud
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Rotterdam, Holanda, 3075 EA
- Erasmus MC
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Budapest, Hungria, 1097
- Del Pesti Centrumkorhaz Orszagos Hematologiai es Infektologiai Intezet Szent Laszlo Telephely
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Debrecen, Hungria, 4032
- Debreceni Egyetem Klinikai Kozpont
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Dublin, Irlanda, D08 NHY1
- St James Hospital
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Jerusalem, Israel, P.O.B. 120
- Hadassah University Hospita Ein Kerem
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Ramat Gan, Israel, 52621
- Sheba Medical Center Tel Hashomer
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Tel Aviv, Israel, 64239
- Tel Aviv Sourasky Medical Center
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Bunkyō City, Japão, 113 8431
- Juntendo University Hospital
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Fukuoka, Japão, 812 8582
- Kyushu University Hospital
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Hyôgo, Japão, 663-8501
- Hyogo Medical University Hospital
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Kanazawa, Japão, 920 8641
- Kanazawa University Hospital
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Kyoto, Japão, 602-8566
- University Hospital Kyoto Prefectural University of Medicine
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Nagoya, Japão, 467 8602
- Nagoya City University Hospital
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Okayama, Japão, 700 8558
- Okayama University Hospital
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Sapporo, Japão, 060-8648
- Hokkaido University Hospital
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Sendai, Japão, 980 8574
- Tohoku University Hospital
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Shibuya City, Japão, 150-8935
- Japanese Red Cross Medical Center
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Oslo, Noruega, 0372
- Oslo universitetssykehus HF, Rikshospitalet
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Gdansk, Polônia, 80 214
- Uniwersyteckie Centrum Kliniczne
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Gliwice, Polônia, 44102
- Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut BadawczyOddz w Gliwicach
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Lublin, Polônia, 20 090
- Centrum Onkologii Ziemi Lubelskiej im sw Jana z Dukli
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Poznan, Polônia, 60 569
- Uniwersytecki Szpital Kliniczny w Poznaniu
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Warsaw, Polônia, 02 776
- Instytut Hematologii i Transfuzjologii
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Wroclaw, Polônia, 50 367
- Uniwersytecki Szpital Kliniczny im Jana Mikulicza Radeckiego we Wroclawiu
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Lisbon, Portugal, 1099-023
- Instituto Portugues de Oncologia de Lisboa Francisco Gentil, E.P.E. 1
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Porto, Portugal, 4200072
- Instituto Portugues de Oncologia do Porto Francisco Gentil, E.P.E.
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Birmingham, Reino Unido, B15 2TH
- University Hospitals Birmingham NHS Trust,
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Bristol, Reino Unido, BS2 8BJ
- Bristol Royal Infirmary
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Leeds, Reino Unido, LS9 7TF
- Leeds Teaching Hospitals NHS Trust
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London, Reino Unido, SE5 9RS
- Kings College Hospital
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London, Reino Unido, NW1 2BU
- University College Hospital
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Manchester, Reino Unido, M13 9WL
- Manchester Royal Infirmary
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Surrey, Reino Unido, SM2 5PT
- The Royal Marsden NHS Trust Sutton
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Gothenburg, Suécia, 413 45
- Sahlgrenska University Hospital
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Linköping, Suécia, 58185
- Universitetssjukhuset
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Lund, Suécia, 221 85
- Skane University Hospital
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Basel, Suíça, 4031
- Universitatsspital Basel
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Bern, Suíça, 3010
- Inselspital Universitatsspital Bern
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Sankt Gallen, Suíça, 9007
- Kantonsspital St Gallen
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Brno, Tcheca, 625 00
- Fakultni nemocnice Brno
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Hradec Králové, Tcheca, 500 05
- Fakultni nemocnice Hradec Kralove
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Ostrava - Poruba, Tcheca, 708 52
- Fakultni Nemocnice Ostrava
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Prague, Tcheca, 128 08
- Vseobecna fakultni nemocnice v Praze
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Graz, Áustria, 8036
- Medizinische Universitat Graz, LKH-Univ.Klinikum Graz, Klinische Abteilung für Hämatologie
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Linz, Áustria, 4020
- Krankenhaus der Elisabethinen Linz
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Salzburg, Áustria, 5020
- LKH - Universitätsklinikum der PMU Salzburg
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Vienna, Áustria, 1090
- Medical University of Vienna Universitatsklinik fur Innere Medizin I
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- Documented diagnosis of multiple myeloma (MM) according to International Myeloma Working Group (IMWG) diagnostic criteria
- Measurable disease at screening as defined by any of the following: Serum monoclonal paraprotein (M-protein) level greater than or equal to (>=)1.0 gram per deciliter (g/dL) or urine M-protein level >=200 milligram (mg)/24 hours; or Light chain MM in whom only measurable disease is by serum free light chain (FLC) levels: Serum immunoglobin (Ig) free light chain >=10 milligrams per deciliter (mg/dL) and abnormal serum Ig kappa/lambda FLC ratio
- Eastern Cooperative Oncology Group Performance Status grade of 0 or 1
- Not considered for high-dose chemotherapy with Autologous Stem Cell Transplant (ASCT) due to: Ineligible due to advanced age; or Ineligible due to presence of comorbid condition(s) likely to have a negative impact on tolerability of high-dose chemotherapy with ASCT; or Deferral of high-dose chemotherapy with ASCT as initial treatment
- A woman of childbearing potential (WOCBP) must have 2 negative highly sensitive serum or urine pregnancy tests (beta-human chorionic gonadotropin) prior to starting Bortezomib, Lenalidomide and Dexamethasone (VRd) and must agree to further testing during the study.
- Clinical laboratory values meeting the following criteria during the screening phase: hemoglobin greater than or equal to (>=) 8.0 g/dL (>=5 millimoles per liter [mmol/L]), recombinant human erythropoietin use is permitted; platelets >=75 *10^9/L; absolute lymphocyte count >=0.3 *10^9/L; absolute neutrophil count (ANC) >=1.0 ×10^9/L (prior growth factor support is permitted but must be without support in the 7 days prior to the laboratory test); aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than or equal to (<=) 3.0 * upper limit of normal (ULN); estimated glomerular filtration rate >=40 milliliter per minute/1.73 meter square (mL/min/1.73 m^2) based upon modified diet in renal disease formula (MDRD-4) calculation or a 24-hour urine collection; total bilirubin <=2.0 * ULN; except in participants with congenital hyperbilirubinemia, such as Gilbert syndrome (in which case direct bilirubin <=2.0 * ULN is required)
Exclusion Criteria:
- Frailty index of >=2 according to Myeloma Geriatric Assessment score
- Peripheral neuropathy or neuropathic pain Grade 2 or higher, as defined by the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5
- Known active, or prior history of central nervous system (CNS) involvement or clinical signs of meningeal involvement of MM
- Stroke or seizure within 6 months of signing Informed Consent Form (ICF)
- Seropositive for human immunodeficiency virus (HIV)
- Vaccinated with live, attenuated vaccine within 4 weeks prior to first dose of VRd
- Participant must not require continuous supplemental oxygen
- Hepatitis B infection
- Hepatitis C infection
- Prior treatment with chimeric antigen receptor T (CAR-T) therapy directed at any target
- Any therapy that is targeted to B-cell maturation antigen (BCMA)
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: Arm A: VRd+Rd (Standard Therapy)
Participants will receive bortezomib, lenalidomide, and dexamethasone (VRd) regimen for 6 cycles before randomization. Following randomization, participants in Arm A will receive 2 more cycles of VRd. In VRd treatment, participants will receive bortezomib 1.3 milligram per meter square (mg/m^2) subcutaneously (SC) on Days 1, 4, 8 and 11 of each cycle (Cycles 1 to 8), oral lenalidomide 25 mg on Days 1 to 14 of each cycle (Cycles 1 to 8) and oral dexamethasone 20 mg on Days 1, 2, 4, 5, 8, 9, 11, and 12 of each cycle (Cycles 1 to 8). Each cycle will consist of 21 days. After 8 cycles of VRd, treatment will continue with lenalidomide and dexamethasone (Rd) maintenance therapy. In Rd treatment, participants will receive oral lenalidomide 25 mg on Days 1 to 21 of each cycle and oral dexamethasone 40 mg on Days 1, 8, 15, and 22 of each cycle. Each cycle will consist of 28 days. Participants will continue to receive Rd until confirmed progressive disease or unacceptable toxicity. |
Bortezomib will be administered SC. Dexamethasone will be administered orally. Lenalidomide will be administered orally. |
|
Experimental: Arm B: VRd+Ciltacabtagene Autoleucel (Cilta-cel)
Participants will receive VRd regimen for 6 cycles before randomization. Following randomization, participants in Arm B will undergo apheresis and receive two more cycles of VRd as bridging therapy. In VRd treatment, participants will receive bortezomib 1.3 mg/m^2 SC on Days 1, 4, 8 and 11 of each cycle for Cycles 1 to 8; oral lenalidomide 25 mg on days 1 to 14 of each cycle for Cycles 1 to 8 and oral dexamethasone 20 mg on days 1, 2, 4, 5, 8, 9, 11 and 12 of each cycle for Cycles 1 to 8. Each cycle will consist of 21 days. After 8 cycles of VRd, participants will receive a conditioning regimen (cyclophosphamide 300 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). |
Bortezomib will be administered SC. Dexamethasone will be administered orally. Lenalidomide will be administered orally. Cilta-cel infusion will be administered.
Outros nomes:
Cyclophosphamide will be administered intravenously. Fludarabine will be administered intravenously. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Progression Free Survival (PFS)
Prazo: Up to 4 years and 5 months
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Progression-free survival is defined as the time from the date of randomization to the date of first documented Progressive Disease (PD), as defined in the International Myeloma Working Group (IMWG) criteria, or death due to any cause, whichever occurs first. |
Up to 4 years and 5 months
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Sustained Minimal Residual Disease (MRD) Negative CR
Prazo: Up to 12 years and 5 months
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Sustained MRD negative complete response (CR) as determined by next generation sequencing (NGS) with sensitivity of 10^-5, and defined by MRD negative CR plus at least 12 months durability of the MRD negative CR status. |
Up to 12 years and 5 months
|
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MRD Negative CR at 9 Months
Prazo: 9 months
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MRD negative CR rate at 9 months is defined as the percentage of participants who achieve MRD negative CR status at 9±3 months after the randomization date. |
9 months
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Overall MRD Negative CR
Prazo: Up to 12 years and 5 months
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Overall MRD negative is defined as the percentage of participants who achieve MRD negativity at any time after the date of randomization before initiation of subsequent therapy. |
Up to 12 years and 5 months
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Overall Survival (OS)
Prazo: Up to 12 years and 5 months
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Overall survival is measured from the date of randomization to the date of the participant's death. |
Up to 12 years and 5 months
|
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Complete Response or Better
Prazo: Up to 12 years and 5 months
|
CR or better is defined as percentage of participants who achieve a CR response or Stringent Complete Response (sCR) response according to the IMWG criteria. |
Up to 12 years and 5 months
|
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Time to Subsequent Anti-myeloma Therapy
Prazo: Up to 12 years and 5 months
|
Time to subsequent anti-myeloma therapy is defined as the time from randomization to the start of subsequent anti-myeloma therapy. |
Up to 12 years and 5 months
|
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Progression Free Survival on Next-line Therapy (PFS2)
Prazo: Up to 12 years and 5 months
|
PFS2 is defined as the time interval between the date of randomization and date of event, which is defined as PD as assessed by investigator that starts after the next line of subsequent therapy, or death from any cause, whichever occurs first. |
Up to 12 years and 5 months
|
|
Number of Participants with Adverse Events (AEs), Abnormalities in Laboratory Parameters, 12-Lead Electrocardiogram (ECG), Physical Examination, and Vital Signs
Prazo: Up to 12 years and 5 months
|
Number of participants with AEs, abnormalities in laboratory parameters (complete blood count [CBC] with differential, coagulation, chimeric antigen receptor T cell [CAR-T] chemistry, full metabolic panel etc.), 12-lead ECG, physical examination, and vital signs will be reported. |
Up to 12 years and 5 months
|
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Arm B: Systemic Cytokine Concentrations
Prazo: Up to Day 112
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Serum or plasma proteomic profiling of cytokines (such as interleukin [IL] 6, IL-15, and IL 10) concentrations will be measured for biomarker assessment. |
Up to Day 112
|
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Arm B: Levels of Chimeric Antigen Receptor T cell (CAR-T) Cell Activation Markers
Prazo: Up to 12 years and 5 months
|
CAR-T cell activation markers including, but not limited to, CD4+, CD8+, CD25+, central memory, effector memory cells will be reported. An evaluation of cell populations may be performed by flow cytometry, cytometry by time of flight (CyTOF), single cell RNA sequencing (scRNAseq) or similar technologies and be correlated with response. |
Up to 12 years and 5 months
|
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Arm B: Levels of Soluble B-cell Maturation Antigen (BCMA)
Prazo: Up to 1 year
|
Levels of soluble BCMA will be reported. |
Up to 1 year
|
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Arm B: Levels of Cilta-cel Expansion (proliferation), and Persistence
Prazo: Up to 12 years and 5 months
|
Levels of cilta-cel expansion (proliferation), and persistence via monitoring CAR-T positive cell counts and CAR transgene level will be reported. |
Up to 12 years and 5 months
|
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Arm B: Number of Participants with Anti-cilta-cel Antibodies
Prazo: Up to 12 years and 5 months
|
Number of participants with anti-cilta-cel antibodies will be reported. |
Up to 12 years and 5 months
|
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Arm B: Number of Participants with Presence of Replication Competent Lentivirus
Prazo: Up to 12 years and 5 months
|
Number of participants with presence of replication competent lentivirus will be reported. |
Up to 12 years and 5 months
|
|
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 (EORTC-QLQ-C30) Scale Score
Prazo: Baseline up to 12 years and 5 months
|
The EORTC QLQ-C30 includes 30 items in 5 functional scales (physical, role, emotional, cognitive, and social), 1 global health status scale, 3 symptom scales (pain, fatigue, nausea/vomiting), and 6 single symptom items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). The responses are reported using a verbal rating scale. The item and scale scores are transformed to a 0 to 100 scale. A higher score represents greater HRQoL, better functioning, and more (worse) symptoms. |
Baseline up to 12 years and 5 months
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Change from Baseline in Health-Related Quality of Life as Assessed by MySIm-Q Scale Score
Prazo: Baseline up to 12 years and 5 months
|
The MySIm-Q is a disease-specific PRO assessment complementary to the EORTC-QLQ-C30. It includes 17 items with recall period of "7 days" and responses are reported on a 5-point verbal rating scale. Item responses are scored from 0 to 4. Higher scores indicate greater severity/impact. |
Baseline up to 12 years and 5 months
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Change from Baseline in Health-Related Quality of Life as Assessed by European Quality of Life - 5 Dimensions-5 Levels (EQ-5D-5L) Scale Score
Prazo: Baseline up to 12 years and 5 months
|
The EQ-5D-5L is a generic measure of health status. The EQ-5D-5L is a 5-item questionnaire that assesses 5 domains including mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each of the 5 dimensions is divided into 5 levels of perceived problems, where Level 1: no problem, Level 2: slight problems, Level 3: moderate problems, Level 4: severe problems and Level 5: extreme problems, plus a visual analog scale rating "health today" with anchors ranging from 0 (worst imaginable health state) to 100 (best imaginable health state). |
Baseline up to 12 years and 5 months
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Change from Baseline in Health-Related Quality of Life as Assessed by Patient Global Impression of Symptom Severity (PGIS) Scale Score
Prazo: Baseline up to 12 years and 5 months
|
The PGIS uses 2 items to assess the participant's perception of the severity of their disease symptoms and impact using a 5-point verbal rating scale. Score ranges from 1 (None) to 5 (Very Severe). |
Baseline up to 12 years and 5 months
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Patient-reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Items
Prazo: Up to 161 days
|
The National Cancer Institute's PRO-CTCAE is an item library of common adverse events experienced by people with cancer that are appropriate for self-reporting. Each symptom selected for inclusion can be rated by up to 3 attributes characterizing the presence/frequency, severity, and/or interference that ranges from 0 to 4 with higher scores indicating higher frequency or greater severity/impact. |
Up to 161 days
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Time to Worsening of Symptoms, Functioning and Overall Well-being
Prazo: Up to 12 year and 5 months
|
Time to worsening is measured as the interval from the date of randomization to the start date of worsening in MySIm-Q symptom, impact, or total scores. |
Up to 12 year and 5 months
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Diretor de estudo: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC
Publicações e links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
- Doenças Vasculares
- Doenças cardiovasculares
- Neoplasias
- Doenças do sistema imunológico
- Neoplasias por Tipo Histológico
- Doenças Hematológicas
- Distúrbios Linfoproliferativos
- Distúrbios imunoproliferativos
- Neoplasias de Células Plasmáticas
- Distúrbios hemostáticos
- Paraproteinemias
- Distúrbios das Proteínas Sanguíneas
- Distúrbios hemorrágicos
- Doenças hemic e linfáticas
- Mieloma múltiplo
- Produtos químicos orgânicos
- Compostos heterocíclicos, 1 anel
- Compostos heterocíclicos
- Compostos heterocíclicos, 2 anel
- Compostos heterocíclicos, anel fundido
- Hidrocarbonetos
- Ácidos carboxílicos
- Compostos policíclicos
- Piperidinas
- Produtos químicos inorgânicos
- Pregada
- Pregnas
- Esteróides
- Compostos de anel fundido
- Esteróides, fluorados
- Mustarazas de fosforamida
- Compostos de mostarda de nitrogênio
- Compostos de mostarda
- Hidrocarbonetos, halogenados
- Fosforamidas
- Compostos organofosforos
- Pregadienetriols
- Ácidos borônicos
- Ácidos, não carboxílico
- Ácidos
- Compostos de boro
- Pirazinas
- Ftalimidas
- Ácidos ftaléticos
- Ácidos, carbocíclicos
- Piperidones
- Isoindoles
- Lenalidomida
- Bortezomibe
- Dexametasona
- Ciclofosfamida
- fludarabina
Outros números de identificação do estudo
- CR109015
- 2021-001242-35 (Número EudraCT)
- 68284528MMY3004 (Outro identificador: Janssen Research & Development, LLC)
- 2023-505850-16-00 (Identificador de registro: EUCT number)
- 2023 (Concessão/Contrato do NIH dos EUA)
Plano para dados de participantes individuais (IPD)
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Descrição do plano IPD
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/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
Informações sobre medicamentos e dispositivos, documentos de estudo
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