Un estudio que compara JNJ-79635322 y teclistamab en participantes con mieloma múltiple recidivante o refractario (TRIlogy-5)
Un estudio aleatorizado de fase 3 que compara JNJ-79635322 frente a teclistamab en participantes con mieloma múltiple recidivante o refractario tras 1 a 3 líneas de tratamiento previas, incluido un anticuerpo anti-CD38 y lenalidomida
The purpose of this study is to evaluate how well JNJ-79635322 works when compared with teclistamab.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Fase
- Fase 3
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Study Contact
- Número de teléfono: 844-434-4210
- Correo electrónico: Participate-In-This-Study1@its.jnj.com
Ubicaciones de estudio
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Freiburg im Breisgau, Alemania, 79106
- Reclutamiento
- Universitaetsklinikum Freiburg
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Hamburg, Alemania, 22763
- Reclutamiento
- Asklepios Klinik Altona
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Hamburg, Alemania, 20251
- Reclutamiento
- Universitaetsklinikum Hamburg Eppendorf
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Tübingen, Alemania, 72076
- Reclutamiento
- Universitaetsklinik Tuebingen
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Darlinghurst, Australia, 2010
- Reclutamiento
- St Vincent s Hospital Sydney
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Garran, Australia, 2605
- Reclutamiento
- Canberra Hospital
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Heidelberg, Australia, 3084
- Reclutamiento
- Austin Hospital
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Macquarie University, Australia, 2109
- Reclutamiento
- Macquarie University Hospital
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Melbourne, Australia, 3128
- Reclutamiento
- Box Hill Hospital
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Perth, Australia, 6000
- Reclutamiento
- Royal Perth Hospital
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Port Macquarie, Australia, 2444
- Reclutamiento
- Port Macquarie Base Hospital
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Brasília, Brasil, 70200 730
- Reclutamiento
- Sociedade Beneficente de Senhoras - Hospital Sirio Libanes HSL Unidade Brasilia
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Curitiba, Brasil, 81520-060
- Reclutamiento
- Hospital Erasto Gaertner- Liga Paranaense de Combate ao Cancer
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Florianópolis, Brasil, 88020 210
- Reclutamiento
- Grupo ELORA Centro de Pesquisa e Ensino em Saude de Santa Catarina
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Joinville, Brasil, 89201-260
- Reclutamiento
- Instituto Joinvilense de Hematologia e Oncologia Ltda Centro de Hematologia e Oncologia
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Porto Alegre, Brasil, 90050 170
- Reclutamiento
- Irmandade Santa Casa de Misericordia de Porto Alegre
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Rio de Janeiro, Brasil, 22775-002
- Reclutamiento
- Instituto de Educacao, Pesquisa e Gestao em Saude Instituto Americas (COI)
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São José do Rio Preto, Brasil, 15090-000
- Reclutamiento
- Funfarme Sjrp
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São Paulo, Brasil, 01323 001
- Reclutamiento
- Real e Benemerita Associacao Portuguesa de Beneficencia
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São Paulo, Brasil, 05651 901
- Reclutamiento
- Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein
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São Paulo, Brasil, 04537 081
- Reclutamiento
- Clinica Medica Sao Germano LTDA
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Alberta
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Calgary, Alberta, Canadá, T2N 5G2
- Reclutamiento
- Arthur J E Child Comprehensive Cancer Centre
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Edmonton, Alberta, Canadá, T6G 1Z2
- Reclutamiento
- Cross Cancer Institute
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Ontario
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Oshawa, Ontario, Canadá, L1G-2B9
- Reclutamiento
- Lakeridge Health Oshawa
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Toronto, Ontario, Canadá, M5G 2M9
- Reclutamiento
- Princess Margaret Hospital
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Brno, Chequia, 625 00
- Reclutamiento
- Fakultni nemocnice Brno
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Hradec Králové, Chequia, 500 05
- Reclutamiento
- FN Hradec Kralove
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Ostrava, Chequia, 708 52
- Reclutamiento
- Fakultni Nemocnice Ostrava
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Plzen-Lochotin, Chequia, 323 00
- Reclutamiento
- FN Plzen
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Prague, Chequia, 128 08
- Reclutamiento
- VFN Praha
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Goyang-si, Corea del Sur, 10408
- Reclutamiento
- National Cancer Center
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Gyeonggi-do, Corea del Sur, 13620
- Reclutamiento
- Seoul National University Bundang Hospital
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Hwasun, Corea del Sur, 58128
- Reclutamiento
- Chonnam National University Hwasun Hospital
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Seoul, Corea del Sur, 05505
- Reclutamiento
- Asan Medical Center
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Seoul, Corea del Sur, 03080
- Reclutamiento
- Seoul National University Hospital
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Seoul, Corea del Sur, 06351
- Reclutamiento
- Samsung Medical Center
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Seoul, Corea del Sur, 06591
- Reclutamiento
- The Catholic University of Korea Seoul St Marys Hospital
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Barcelona, España, 08036
- Reclutamiento
- Hosp. Clinic de Barcelona
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Barcelona, España, 08035
- Reclutamiento
- Hosp Univ Vall D Hebron
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Cáceres, España, 10003
- Reclutamiento
- Hosp. San Pedro de Alcantara
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Córdoba, España, 14004
- Reclutamiento
- Hosp Reina Sofia
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Jerez de la Frontera, España, 11407
- Reclutamiento
- Hosp. de Jerez de La Frontera
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Madrid, España, 28041
- Reclutamiento
- Hosp. Univ. 12 de Octubre
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Pamplona, España, 31008
- Reclutamiento
- Clinica Univ. de Navarra
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Salamanca, España, 37007
- Reclutamiento
- Hosp Clinico Univ de Salamanca
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Santander, España, 39008
- Reclutamiento
- Hosp. Univ. Marques de Valdecilla
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Santiago de Compostela, España, 15706
- Reclutamiento
- Hosp. Clinico Univ. de Santiago
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Seville, España, 41013
- Reclutamiento
- Hosp. Virgen Del Rocio
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Alabama
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Birmingham, Alabama, Estados Unidos, 35211
- Reclutamiento
- Alabama Oncology
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Arizona
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Phoenix, Arizona, Estados Unidos, 85054
- Reclutamiento
- Mayo Clinic 1
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Arkansas
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Springdale, Arkansas, Estados Unidos, 72762
- Reclutamiento
- Highlands Oncology Group
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California
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Beverly Hills, California, Estados Unidos, 90211
- Reclutamiento
- Beverly Hills Cancer Center Clinical Research Advisors LLC
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Irvine, California, Estados Unidos, 92612
- Reclutamiento
- UC Irvine Health Chao Family Comprehensive Cancer Center and Ambulatory Care
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Los Angeles, California, Estados Unidos, 90067
- Reclutamiento
- Valkyrie Clinical Trials
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Orange, California, Estados Unidos, 92868
- Reclutamiento
- University of California Irvine Medical Center
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Colorado
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Denver, Colorado, Estados Unidos, 80218
- Reclutamiento
- Colorado Blood Cancer Institute
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Connecticut
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Farmington, Connecticut, Estados Unidos, 06030
- Reclutamiento
- University of Connecticut Health Center
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Florida
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Jacksonville, Florida, Estados Unidos, 32224
- Reclutamiento
- Mayo Clinic Jacksonville
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Pembroke Pines, Florida, Estados Unidos, 33026
- Reclutamiento
- Memorial Cancer Institute
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Georgia
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Atlanta, Georgia, Estados Unidos, 30322
- Reclutamiento
- Emory University
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Illinois
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Chicago, Illinois, Estados Unidos, 60607
- Reclutamiento
- Rush University System for Health
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Indiana
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Indianapolis, Indiana, Estados Unidos, 46237-8601
- Reclutamiento
- Franciscan Health
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Iowa
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Iowa City, Iowa, Estados Unidos, 52242
- Reclutamiento
- University of Iowa Hospitals and Clinics
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Waukee, Iowa, Estados Unidos, 50263
- Reclutamiento
- Mission Cancer Blood University of Iowa Health Care
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Kentucky
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Louisville, Kentucky, Estados Unidos, 40207
- Reclutamiento
- Norton Cancer Institute
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Louisiana
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Shreveport, Louisiana, Estados Unidos, 71103
- Reclutamiento
- LSU Health Feist Weiller Cancer Center
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Maryland
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Baltimore, Maryland, Estados Unidos, 21287
- Reclutamiento
- Johns Hopkins Hospital
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Massachusetts
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Boston, Massachusetts, Estados Unidos, 02111
- Reclutamiento
- Tufts Medical Center
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Michigan
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Detroit, Michigan, Estados Unidos, 48201
- Reclutamiento
- Karmanos Cancer Institute
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Minnesota
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Minneapolis, Minnesota, Estados Unidos, 55455
- Reclutamiento
- University Of Minnesota Medical Center
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Rochester, Minnesota, Estados Unidos, 55905
- Reclutamiento
- Mayo Clinic
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Nebraska
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Omaha, Nebraska, Estados Unidos, 68130
- Reclutamiento
- Nebraska Cancer Specialists
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New Jersey
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East Brunswick, New Jersey, Estados Unidos, 08816
- Reclutamiento
- Astera Cancer Care
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New Mexico
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Santa Fe, New Mexico, Estados Unidos, 87505
- Reclutamiento
- Christus St. Vincent Regional Cancer Center
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New York
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Albany, New York, Estados Unidos, 12208
- Reclutamiento
- New York Oncology Hematology
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Mineola, New York, Estados Unidos, 11501
- Reclutamiento
- Laura & Isaac Perlmutter Cancer Center at NYU Langone Hospital - Long Island
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New York, New York, Estados Unidos, 10016
- Reclutamiento
- NYU Langone Health Manhattan
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Shirley, New York, Estados Unidos, 11967
- Reclutamiento
- New York Cancer and Blood Specialists
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North Carolina
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Durham, North Carolina, Estados Unidos, 27705
- Reclutamiento
- Duke University Medical Center
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Ohio
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Canton, Ohio, Estados Unidos, 44718
- Reclutamiento
- Gabrail Cancer Center
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Cincinnati, Ohio, Estados Unidos, 45069
- Reclutamiento
- The Christ Hospital
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Dayton, Ohio, Estados Unidos, 45415
- Reclutamiento
- Dayton Physicians Network Urology
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Oregon
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Eugene, Oregon, Estados Unidos, 97401
- Reclutamiento
- Willamette Valley Cancer Institute and Research Center
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South Carolina
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Greenville, South Carolina, Estados Unidos, 29607
- Reclutamiento
- Bon Secours Saint Francis Cancer Center
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Tennessee
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Nashville, Tennessee, Estados Unidos, 37203
- Reclutamiento
- Tennessee Oncology, PLLC
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Texas
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Dallas, Texas, Estados Unidos, 75246
- Reclutamiento
- Baylor University Medical Center
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Lubbock, Texas, Estados Unidos, 79410
- Reclutamiento
- Joe Arrington Cancer Research Treatment Center
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Utah
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Salt Lake City, Utah, Estados Unidos, 84102
- Reclutamiento
- Utah Cancer Specialists
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Washington
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Tacoma, Washington, Estados Unidos, 98405
- Reclutamiento
- NorthWest Medical Specialties, PLLC
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Amiens, Francia, 80000
- Reclutamiento
- CHU Amiens
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Lyon, Francia, 69002
- Reclutamiento
- Hospices Civils de Lyon HCL
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Montpellier, Francia, 34295
- Reclutamiento
- CHRU Montpellier - Hopital Saint-Eloi
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Nantes, Francia, 44000
- Reclutamiento
- CHU Nantes - Hotel Dieu
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Poitiers, Francia, 86021
- Reclutamiento
- CHU Poitiers - Hopital la Miletrie
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Talence, Francia, 33400
- Reclutamiento
- CHU Bordeaux
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Toulouse, Francia, 31300
- Reclutamiento
- CHU Toulouse
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Tours, Francia, 37000
- Reclutamiento
- CHRU de Tours
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Athens, Grecia, 11528
- Reclutamiento
- Alexandra General Hospital of Athens
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Athens, Grecia, 106 76
- Reclutamiento
- Evangelismos S A
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Athens, Grecia, 124 62
- Reclutamiento
- University General Hospital Attikon General Hospital Of West Attica H Agia Varvara
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Ioannina, Grecia, 455 00Q
- Reclutamiento
- University General Hospital of Ioannina
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Bengaluru, India, 560054
- Reclutamiento
- M S Ramaiah Medical College and Hospital
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Gūrgaon, India, 122002
- Reclutamiento
- Fortis Memorial Research Institute
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Jaipur, India, 302017
- Reclutamiento
- Bhagwan Mahaveer Cancer Hospital & Research Centre
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Kolkata, India, 700156
- Reclutamiento
- Tata Medical Center
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Kolkata, India, 700014
- Reclutamiento
- Nil Ratan Sircar Medical College and Hospital
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New Delhi, India, 110085
- Reclutamiento
- Rajiv Gandhi Cancer Institute and Research Centre
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Pune, India, 411004
- Reclutamiento
- Deenanath Mangeshkar Hospital and Research Centre
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Ashdod, Israel, 7747629
- Reclutamiento
- Samson Assuta Ashdod University Hospital
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Haifa, Israel, 3436212
- Reclutamiento
- Carmel Medical Center
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Haifa, Israel, 3109601
- Reclutamiento
- Rambam Med.Center - Hematology Institute
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Petah Tikva, Israel, 4941492
- Reclutamiento
- Rabin Medical Center
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Ramat Gan, Israel, 5266202
- Reclutamiento
- Sheba Medical Center
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Tel Aviv, Israel, 6423906
- Reclutamiento
- Tel Aviv Sourasky Medical Center
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Bari, Italia, 70124
- Reclutamiento
- IRCCS Istituto Tumori Giovanni Paolo II
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Bologna, Italia, 40138
- Reclutamiento
- A O U Sant Orsola Malpighi
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Bolzano, Italia, 39100
- Reclutamiento
- Azienda Sanitaria dell'Alto Adige - Ospedale di Bolzano
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Milan, Italia, 20132
- Reclutamiento
- Ospedale San Raffaele di Milano
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Milan, Italia, 20153
- Reclutamiento
- ASST Santi Paolo e Carlo
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Novara, Italia, 28100
- Reclutamiento
- Azienda Ospedaliero Universitaria Maggiore della Carita di Novara
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Palermo, Italia, 90146
- Reclutamiento
- Casa di Cura La Maddalena
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Pescara, Italia, 65124
- Reclutamiento
- Ospedale S. Spirito, Azienda Sanitaria Pescara
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Rimini, Italia, 47900
- Reclutamiento
- Ospedale Infermi Rimini
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Varese, Italia, 21100
- Reclutamiento
- ASST dei Sette Laghi, Ospedale di Circolo e Fonazione Macchi
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Chiba, Japón, 260-8717
- Reclutamiento
- Chiba Cancer Center
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Fukuoka, Japón, 810 8563
- Reclutamiento
- National Hospital Organization Kyushu Medical Center
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Gunma, Japón, 371-0034
- Reclutamiento
- Gunma University Hospital
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Kamakura-shi, Japón, 247-8533
- Reclutamiento
- Shonan Kamakura General Hospital
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Kyoto, Japón, 602-8566
- Reclutamiento
- University Hospital Kyoto Prefectural University of Medicine
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Matsuyama, Japón, 790-8524
- Reclutamiento
- Matsuyama Red Cross Hospital
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Okayama, Japón, 701-1192
- Reclutamiento
- National Hospital Organization Okayama Medical Center
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Sapporo, Japón, 060-8604
- Reclutamiento
- Sapporo City General Hospital
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Tokyo, Japón, 135-8550
- Reclutamiento
- The Cancer Institute Hospital of JFCR
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Yokohama, Japón, 241 8515
- Reclutamiento
- Kanagawa Cancer Center
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Bydgoszcz, Polonia, 85 168
- Reclutamiento
- Szpital Uniwersytecki nr 2 im dr Jana Biziela w Bydgoszczy
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Gdansk, Polonia, 80 214
- Reclutamiento
- Uniwersyteckie Centrum Kliniczne
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Katowice, Polonia, 40 519
- Reclutamiento
- Pratia Onkologia Katowice
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Lublin, Polonia, 20 090
- Reclutamiento
- Centrum Onkologii Ziemi Lubelskiej im sw Jana z Dukli
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Warsaw, Polonia, 02-172
- Reclutamiento
- MTZ Clinical Research Powered by Pratia
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Wałbrzych, Polonia, 58 309
- Reclutamiento
- Specjalistyczny Szpital im dra Alfreda Sokolowskiego w Walbrzychu
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Beijing, Porcelana, 100034
- Reclutamiento
- Peking University First Hospital
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Beijing, Porcelana, 100006
- Reclutamiento
- Peking Union Medical College Hospital
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Changchun, Porcelana, 130061
- Reclutamiento
- The First Hospital of Jilin University
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Chaoyang District, Porcelana, 100020
- Reclutamiento
- Beijing Chaoyang Hospital
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Chengdu, Porcelana, 610072
- Reclutamiento
- Sichuan Academy of Medical Science Sichuan Provincial Peoples Hospital
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Guangzhou, Porcelana, 510710
- Reclutamiento
- Sun Yat Sen University Cancer Center
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Hangzhou, Porcelana, 310003
- Reclutamiento
- The First Affiliated Hospital Zhejiang University College of Medicine
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Nanchang, Porcelana, 330006
- Reclutamiento
- The First Affiliated Hospital of NanChang University
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Nanjing, Porcelana, 210008
- Reclutamiento
- Nanjing Drum Tower Hospital
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Shanghai, Porcelana, 200434
- Reclutamiento
- Shanghai Fourth People s Hospital
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Shenzhen, Porcelana, 518036
- Reclutamiento
- Peking University Shenzhen Hospital
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Tianjin, Porcelana, 300060
- Reclutamiento
- Tianjin Medical University Cancer Institute and Hospital
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Tijian, Porcelana, 300020
- Reclutamiento
- Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences
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Wenzhou, Porcelana, 325000
- Reclutamiento
- The First Affiliated Hospital of Wenzhou Medical University
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Wuhan, Porcelana, 430032
- Reclutamiento
- Wuhan Tongji Hospital Tongji Medical College
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Xi'an, Porcelana, 710004
- Reclutamiento
- The Second Affiliated Hospital of Xi'an Jiaotong University
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Kaohsiung City, Taiwán, 833
- Reclutamiento
- Chang Kung Memorial Hospital
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Taichung, Taiwán, 40705
- Reclutamiento
- Taichung Veterans General Hospital
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Taichung, Taiwán, 40447
- Reclutamiento
- China Medical University Hospital
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Tainan, Taiwán, 70403
- Reclutamiento
- National Cheng Kung University Hospital
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Taipei, Taiwán, 100
- Reclutamiento
- National Taiwan University Hospital
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Taipei, Taiwán, 112
- Reclutamiento
- Taipei Veterans General Hospital
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Ankara, Turquía (Türkiye), 06680
- Reclutamiento
- Liv Hospital Ankara
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Ankara, Turquía (Türkiye), 06010
- Reclutamiento
- Gulhane Egitim ve Arastirma Hastanesi
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Ankara, Turquía (Türkiye), 06200
- Reclutamiento
- Dr Abdurrahman Yurtaslan Oncology Training and Research Hospital
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Ankara, Turquía (Türkiye), 06620
- Reclutamiento
- Ankara University Medical Faculty
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Ankara, Turquía (Türkiye), 6170
- Reclutamiento
- Ankara Etlik Sehir Hastanesi
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Antalya, Turquía (Türkiye), 07025
- Reclutamiento
- Memorial Antalya Hospital
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Istanbul, Turquía (Türkiye), 34214
- Reclutamiento
- Medipol Mega University Hospital
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Istanbul, Turquía (Türkiye), 34381
- Reclutamiento
- Istanbul Florance Nightingale Hospital
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Izmir, Turquía (Türkiye), 35001
- Reclutamiento
- Izmir Tinaztepe University Galen Hospital
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Mersin, Turquía (Türkiye), 33110
- Reclutamiento
- Mersin University Medical Faculty
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Samsun, Turquía (Türkiye), 55420
- Reclutamiento
- Ondokuz Mayis University
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion criteria:
- Documented diagnosis of multiple myeloma (MM) as defined by the criteria below: a. MM diagnosis according to the international myeloma working group (IMWG) diagnostic criteria, b. Measurable disease at screening as assessed by central laboratory
- Received 1 to 3 prior lines of antimyeloma therapy, including an anti-cluster of differentiation (CD) 38 antibody and lenalidomide
- Have an eastern cooperative oncology group (ECOG) performance status of 0 to 2 at screening and immediately before the first dose of study medication
- Have clinical laboratory values meeting the criteria specified in the protocol during the screening and within 1 day of the start of administration of study treatment
Exclusion criteria:
- Major surgery, (for example, requiring general anesthesia) or significant traumatic injury within 2 weeks prior to first dose, or will not have fully recovered from surgery, or has surgery planned during the time the participant is expected to participate in the study
- Suspected or known allergies, hypersensitivity, intolerance or other contraindications to the use of JNJ-79635322 or teclistamab or their excipients
- Presence of any of the following: i. Any ongoing myelodysplastic syndrome or B-cell malignancy (other than MM); ii. Any history of malignancy, other than MM, that is considered at high risk of recurrence requiring systemic therapy; iii. Any active malignancy (that is, progressing or requiring treatment change in the last 24 months) other than MM
- Known active or prior central nervous system (CNS) involvement or exhibits clinical signs of meningeal involvement of MM. If either is suspected, negative whole brain magnetic resonance imaging (MRI) and lumbar cytology are required
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Arm A: JNJ-79635322
Participants will receive subcutaneous (SC) dose of JNJ-79635322 treatment of a finite duration or intolerable toxicity (whichever is first). |
JNJ-79635322 will be administered as SC injection. |
|
Comparador activo: Arm B: Teclistamab
Participants will receive teclistamab as a SC injection until PD or intolerable toxicity. |
Teclistamab will be administered as SC injection. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Complete Response (CR) or Better
Periodo de tiempo: Up to approximately 41 months
|
CR or better is defined as the percentage of participants achieving CR or stringent complete response (sCR) prior to subsequent antimyeloma therapy in accordance with the international myeloma working group (IMWG) criteria during or after the study treatment. |
Up to approximately 41 months
|
|
Progression-Free Survival (PFS)
Periodo de tiempo: Up to approximately 41 months
|
PFS is defined as the duration from the date of randomization to either progressive disease (PD) or death, whichever comes first. Disease progression will be determined according to the IMWG response criteria. |
Up to approximately 41 months
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Overall Response Rate (ORR)
Periodo de tiempo: Up to approximately 41 months
|
ORR is defined as the percentage of participants who achieve partial response (PR) or better prior to subsequent antimyeloma therapy in accordance with the IMWG criteria. |
Up to approximately 41 months
|
|
Very Good Partial Response (VGPR) or Better
Periodo de tiempo: Up to approximately 41 months
|
VGPR or better is defined as the percentage of participants achieving VGPR, CR, or sCR prior to subsequent antimyeloma therapy in accordance with the IMWG criteria during or after the study treatment. |
Up to approximately 41 months
|
|
Duration of Response (DoR)
Periodo de tiempo: Up to approximately 41 months
|
DoR is defined as the time interval between the date of initial documentation of a response (PR or better) to the date of first documented evidence of progressive disease according to the IMWG response criteria or death due to any cause, whichever occurs first. |
Up to approximately 41 months
|
|
Minimal Residual Disease (MRD)-negative CR
Periodo de tiempo: Up to approximately 41 months
|
MRD-negative CR is defined as the percentage of participants with CR or better who achieve MRD-negative status, as determined by next-generation flow cytometry (NGF), at any time point after randomization and prior to PD or subsequent antimyeloma therapy. |
Up to approximately 41 months
|
|
MRD-negative CR at 1 Year
Periodo de tiempo: At 1 Year
|
MRD-negative CR at 1 year is defined as the percentage of participants who achieve MRD-negative status at 12 months as determined by NGF, prior to PD or subsequent antimyeloma therapy and who also achieve CR or better according to IMWG criteria. |
At 1 Year
|
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MRD-negative CR at 5 Years
Periodo de tiempo: At 5 Years
|
MRD-negative CR at 5 years is defined as the percentage of participants who achieve MRD-negative status at 5 years as determined by NGF, prior to PD or subsequent antimyeloma therapy and who also achieve CR or better according to IMWG criteria. |
At 5 Years
|
|
Progression-Free Survival on the First Subsequent Line of Antimyeloma Therapy (PFS2)
Periodo de tiempo: Up to approximately 41 months
|
PFS2 is defined as the time interval between the date of randomization and date of event, which is defined as progressive disease as assessed by investigator on the first subsequent line of antimyeloma therapy, or death from any cause, whichever occurs first. Those who are alive and for whom a second disease progression has not been observed are censored at the last date of follow-up. |
Up to approximately 41 months
|
|
Overall Survival (OS)
Periodo de tiempo: Up to approximately 41 months
|
OS is defined as the time from the date of randomization to the date of the participant's death due to any cause. |
Up to approximately 41 months
|
|
Time To Next Line of Therapy (TTNT)
Periodo de tiempo: Up to approximately 41 months
|
TTNT is defined as the time from randomization to the start of subsequent antimyeloma treatment. Death due to progressive disease without the start of any subsequent antimyeloma therapy will be considered as an event. |
Up to approximately 41 months
|
|
Number of Participants With Treatment-Emergent Adverse Event (TEAE) by Severity
Periodo de tiempo: Up to approximately 41 months
|
An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non investigational) product. Any new or worsening AE occurring at or after the initial administration of study treatment through the day of last dose plus 30 days or prior to the start of subsequent anticancer therapy will be considered treatment-related regardless of the start date of the event. TEAEs will be graded according to the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 6.0. Severity scale ranges from Grade 1= mild, Grade 2= moderate, Grade 3= severe, Grade 4= life-threatening, Grade 5= death related to adverse event. |
Up to approximately 41 months
|
|
Number of Participants with Abnormalities in Laboratory Parameters
Periodo de tiempo: Up to approximately 41 months
|
Number of participants with abnormalities in laboratory parameters (serum chemistry, hematology, and urinalysis) will be reported. |
Up to approximately 41 months
|
|
Change from Baseline in Health-related Quality of Life (HRQoL), Symptoms and Functioning using the Multiple Myeloma Symptom and Impact Questionnaire (MySIm-Q) Scale Scores
Periodo de tiempo: From Baseline up to approximately 41 months
|
Change from baseline in HRQoL, symptoms and functioning as assessed by MySIm-Q score will be reported. The MySIm-Q is a disease-specific patient-reported outcome (PRO) assessment with established content validity for participants with relapsed or refractory multiple myeloma (RRMM) and newly diagnosed MM. |
From Baseline up to approximately 41 months
|
|
Change from Baseline in HRQoL, Symptoms and Functioning Using the European Organization for Research and Treatment of Cancer Quality of life Questionnaire Core 30 (EORTC-QLQ-C30) Scale Scores
Periodo de tiempo: From Baseline up to approximately 41 months
|
Change from baseline in symptoms, functioning, and HRQoL as assessed by EORTC-QLQ-C30 score will be reported. |
From Baseline up to approximately 41 months
|
|
Change from Baseline in HRQoL, Symptoms and Functioning Using the European Quality of Life 5-Dimensions 5-Level Version (EQ-5D-5L) Scale Scores
Periodo de tiempo: From Baseline up to approximately 41 months
|
The EQ-5D-5L is a generic measure of health status that contains 5-item questionnaire that assesses 5 domains (mobility, self-care, usual activities, pain or discomfort, and anxiety or depression) plus a visual analog scale rating "health today" with anchors ranging from 0 (worst imaginable health state) to 100 (best imaginable health state). The scores for the 5 dimensions are used to compute a single utility score, ranging from zero (0.0) to 1 (1.0), representing the general health status of the individual. |
From Baseline up to approximately 41 months
|
|
Time to Worsening in HRQoL, Symptoms and Functioning Using the MySIm-Q Scale Scores
Periodo de tiempo: Up to approximately 41 months
|
Time to worsening in HRQoL, symptoms and functioning using the MySIm-Q scale scores will be reported. The MySIm-Q is a disease-specific patient-reported outcome (PRO) assessment with established content validity for participants with RRMM and newly diagnosed MM. |
Up to approximately 41 months
|
|
Time to Worsening in HRQoL, Symptoms and Functioning Using the EORTC-QLQ-C30 Scale Scores
Periodo de tiempo: Up to approximately 41 months
|
Time to worsening in HRQoL, symptoms and functioning using the EORTC-QLQ-C30 score will be reported. |
Up to approximately 41 months
|
|
Time to Worsening in HRQoL, Symptoms and Functioning using the EQ-5D-5L Scale Scores
Periodo de tiempo: Up to approximately 41 months
|
The EQ-5D-5L is a generic measure of health status that contains 5-item questionnaire that assesses 5 domains (mobility, self-care, usual activities, pain or discomfort, and anxiety or depression) plus a visual analog scale rating "health today" with anchors ranging from 0 (worst imaginable health state) to 100 (best imaginable health state). The scores for the 5 dimensions are used to compute a single utility score, ranging from zero (0.0) to 1 (1.0), representing the general health status of the individual. |
Up to approximately 41 months
|
|
Percentage of Participants With Meaningful Improvement in HRQoL, Symptoms and Functioning Using the MySIm-Q Scale Scores
Periodo de tiempo: Up to approximately 41 months
|
The MySIm-Q is a disease-specific PRO assessment with established content validity for participants with RRMM and newly diagnosed MM. |
Up to approximately 41 months
|
|
Percentage of Participants With Meaningful Improvement in HRQoL, Symptoms and Functioning Using the EORTC-QLQ-C30 Scale Scores
Periodo de tiempo: Up to approximately 41 months
|
Percentage of participants with meaningful improvement in symptoms, functioning, and HRQoL as assessed by EORTC-QLQ-C30 score will be reported. |
Up to approximately 41 months
|
|
Percentage of Participants With Meaningful Improvement in HRQoL, Symptoms and Functioning Using the EQ-5D-5L Scale Scores
Periodo de tiempo: Up to approximately 41 months
|
The EQ-5D-5L is a generic measure of health status that contains 5-item questionnaire that assesses 5 domains (mobility, self-care, usual activities, pain or discomfort, and anxiety or depression) plus a visual analog scale rating "health today" with anchors ranging from 0 (worst imaginable health state) to 100 (best imaginable health state). The scores for the 5 dimensions are used to compute a single utility score, ranging from zero (0.0) to 1 (1.0), representing the general health status of the individual. |
Up to approximately 41 months
|
|
Percentage of Participants who Report Side Effects Burden on the European Organization for Research and Treatment of Cancer Item List (EORTC IL) 46
Periodo de tiempo: Up to approximately 41 months
|
The EORTC IL46 consists of one single question that measures global impression of burden due to treatment-related symptoms. The response options range from "not at all" to "very much" on a 4-point scale. |
Up to approximately 41 months
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Director de estudio: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Enfermedades Vasculares
- Enfermedades cardiovasculares
- Neoplasias
- Enfermedades del sistema inmunológico
- Neoplasias por tipo histológico
- Enfermedades hematológicas
- Trastornos linfoproliferativos
- Trastornos inmunoproliferativos
- Neoplasias De Células Plasmáticas
- Trastornos hemostáticos
- Paraproteinemias
- Trastornos de proteínas en sangre
- Trastornos hemorrágicos
- Enfermedades hemic y linfáticas
- Mieloma múltiple
Otros números de identificación del estudio
- 79635322MMY3002
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
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
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
producto fabricado y exportado desde los EE. UU.
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