Une étude comparant le JNJ-79635322 et un anticorps bispécifique anti-antigène de maturation des lymphocytes B (BCMA)xCD3 chez des participants atteints de myélome multiple en rechute ou réfractaire (TRIlogy-4)
27 août 2026 mis à jour par: Janssen Research & Development, LLC
Étude randomisée de phase 3 comparant le JNJ-79635322 et un anticorps bispécifique anti-BCMAxCD3 chez des participants atteints de myélome multiple en rechute ou réfractaire ayant reçu au moins 3 lignes de traitement antérieures comprenant un inhibiteur du protéasome, un immunomodulateur et un anticorps anti-CD38
L'objectif de cette étude est d'évaluer l'efficacité du JNJ-79635322 par rapport à un anticorps bispécifique anti-BCMA×CD3.
Aperçu de l'étude
Statut
Recrutement
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Estimé)
400
Phase
- Phase 3
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Study Contact
- Numéro de téléphone: 844-434-4210
- E-mail: Participate-In-This-Study1@its.jnj.com
Lieux d'étude
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Düsseldorf, Allemagne, 40479
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- Marien Hospital Düsseldorf
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Heidelberg, Allemagne, 69120
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- Universitaetsklinikum Heidelberg
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Jena, Allemagne, 07747
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- Universitatsklinikum Jena
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Würzburg, Allemagne, 97080
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- Universitaetsklinikum Wuerzburg
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Box Hill, Australie, 3128
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- Box Hill Hospital
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Brisbane, Australie, 4101
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- Mater Misericordiae Ltd
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Clayton, Australie, 3168
- Recrutement
- Monash Medical Centre
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Fitzroy, Australie, 3065
- Recrutement
- St Vincents Hospital Melbourne
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Melbourne, Australie, 3004
- Recrutement
- The Alfred Hospital
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Murdoch, Australie, 6150
- Recrutement
- Fiona Stanley Hospital
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Nedlands, Australie, 6009
- Recrutement
- Sir Charles Gairdner Hospital
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Southport, Australie, 4215
- Recrutement
- Gold Coast University Hospital
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Campinas, Brésil, 13083-888
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- Hospital das Clinicas da Universidade Estadual de Campinas UNICAMP
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Caxias do Sul, Brésil, 95070 560
- Recrutement
- Fundacao Universidade de Caxias Do Sul
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Curitiba, Brésil, 81520-060
- Recrutement
- Hospital Erasto Gaertner- Liga Paranaense de Combate ao Cancer
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Florianópolis, Brésil, 88020 210
- Recrutement
- Grupo ELORA Centro de Pesquisa e Ensino em Saude de Santa Catarina
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Rio de Janeiro, Brésil, 22775 001
- Recrutement
- Instituto de Educacao, Pesquisa e Gestao em Saude Instituto Americas (COI)
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Salvador, Brésil, 41253-190
- Recrutement
- IDOR - Regional Bahia
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São José do Rio Preto, Brésil, 15090-000
- Recrutement
- Funfarme Sjrp
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São Paulo, Brésil, 01509 900
- Recrutement
- Fundacao Antonio Prudente A C Camargo Cancer Center
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São Paulo, Brésil, 05652 900
- Recrutement
- Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein
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São Paulo, Brésil, 04537 081
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- Clinica Medica Sao Germano LTDA
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São Paulo, Brésil, 01401 002
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- IDOR - Regional Sao Paulo
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Alberta
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Calgary, Alberta, Canada, T2N 4N1
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- Arthur J E Child Comprehensive Cancer Centre
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British Columbia
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Vancouver, British Columbia, Canada, V5Z4E6
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- British Columbia Cancer Agency
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Nova Scotia
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Halifax, Nova Scotia, Canada, B3H 3A7
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- Queen Elizabeth Ii Health Sciences Centre
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Ontario
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Hamilton, Ontario, Canada, L8V5C2
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- Juravinski Cancer Centre
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London, Ontario, Canada, N6A 5W9
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- London Health Sciences Centre
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Toronto, Ontario, Canada, M5G 2M9
- Recrutement
- University Health Network UHN Princess Margaret Cancer Centre
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Quebec
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Montreal, Quebec, Canada, H1T 2M4
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- CIUSSS de l Est de l Ile de Montreal Installation Hopital Maisonneuve Rosemont
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Beijing, Chine, 100034
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- Peking University First Hospital
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Beijing, Chine, 100044
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- Peking University People's Hospital
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Chengdu, Chine, 610032
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- Sichuan Provincial Peoples Hospital
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Guangzhou, Chine, 510060
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- Sun Yat Sen University Cancer Center
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Hangzhou, Chine, 310003
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- First affiliated Hospital of Zhejiang University
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Nanjing, Chine, 210008
- Recrutement
- Nanjing Drum Tower Hospital
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Nanning, Chine, 530021
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- The First Affiliated Hospital of Guangxi Medical University
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Shanghai, Chine, 200434
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- Shanghai Fourth People s Hospital
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Wenzhou, Chine, 325000
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- The First Affiliated Hospital of Wenzhou Medical University
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Xi'an, Chine, 710006
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- The Second Affiliated Hospital of Xi'an Jiaotong University
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Badalona, Espagne, 08916
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- Hosp. Univ. Germans Trias I Pujol
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Barcelona, Espagne, 08036
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- Hosp. Clinic de Barcelona
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Barcelona, Espagne, 08035
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- H. Vall D'Hebron
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Granada, Espagne, 18014
- Recrutement
- Hosp. Univ. Virgen de Las Nieves
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Madrid, Espagne, 28041
- Recrutement
- Hosp. Univ. 12 de Octubre
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Pozuelo de Alarcón, Espagne, 28223
- Recrutement
- Hosp. Quiron Madrid Pozuelo
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Salamanca, Espagne, 37007
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- Hosp Clinico Univ de Salamanca
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Usansolo, Espagne, 48960
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- Hosp de Galdakao
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Valencia, Espagne, 46026
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- Hosp. Univ. I Politecni La Fe
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Lille, France, 59000
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- CHRU de Lille Hopital Claude Huriez
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Lyon, France, 69002
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- Hospices Civils de Lyon HCL
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Nantes, France, 44000
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- Hotel Dieu CHU de Nantes
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Paris, France, 75010
- Recrutement
- Hopital Saint Louis APHP
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Paris, France, 75012
- Recrutement
- APHP
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Pessac, France, 33600
- Recrutement
- CHU de Bordeaux - Hospital Haut-Leveque
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Poitiers, France, 86021
- Recrutement
- CHU De Poitiers
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Toulouse, France, 31300
- Recrutement
- CHU Toulouse
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Tours, France, 37000
- Recrutement
- CHRU de Tours
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Athens, Grèce, 11528
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- Alexandra General Hospital of Athens
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Athens, Grèce, 106 76
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- Evangelismos S A
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Thessaloniki, Grèce, 570 10
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- Geniko Nosokomeio Thessalonikis George Papanikolaou
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Thessaloniki, Grèce, 546 39
- Recrutement
- Theageneio Cancer Hospital
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Beersheba, Israël, 8457108
- Recrutement
- Soroka Medical Center
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Haifa, Israël, 3109601
- Recrutement
- Rambam Medical Center
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Haifa, Israël, 34362
- Recrutement
- Carmel Medical Center
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Haifa, Israël, 31048
- Recrutement
- Bnai Zion Medical Center
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Jerusalem, Israël, 9103102
- Recrutement
- Shaare Zedek Mc
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Ramat Gan, Israël, 52621
- Recrutement
- Sheba medical center
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Ramat Poriya, Israël, 1520800
- Recrutement
- Baruch Padeh MC
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Tel Aviv, Israël, 69710
- Recrutement
- Assuta MC
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Alessandria, Italie, 15121
- Recrutement
- A.O.U. SS. Antonio e Biagio e Cesare Arrigo
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Brescia, Italie, 25123
- Recrutement
- Spedali Civili di Brescia
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Milan, Italie, 20122
- Recrutement
- Fondazione IRCCS Ca Granda Ospedale Policlinico Di Milano
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Pisa, Italie, 56126
- Recrutement
- Ospedale Santa Chiara AO Universitaria Pisana
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Reggio Emilia, Italie, 42123
- Recrutement
- Arcispedale Santa Maria Nuova - IRCCS
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Roma, Italie, 00168
- Recrutement
- Fondazione Policlinico Universitario A Gemelli IRCCS
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Roma, Italie, 00128
- Recrutement
- Campus Bio Medico di Roma
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Rozzano, Italie, 20089
- Recrutement
- Humanitas Hospital
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San Giovanni Rotondo, Italie, 71013
- Recrutement
- Casa Sollievo Della Sofferenza IRCCS
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Vicenza, Italie, 36100
- Recrutement
- U.O. Ematologia Ospedale San Bortolo
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Bunkyō City, Japon, 113 8677
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- Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital
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Chiba, Japon, 260 0801
- Recrutement
- Chiba Cancer Center
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Kamakura-shi, Japon, 247-8533
- Recrutement
- Shonan Kamakura General Hospital
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Kamogawa, Japon, 296-8602
- Recrutement
- Kameda Medical Center
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Kofu, Japon, 400-0027
- Recrutement
- Yamanashi Prefectural Central Hospital
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Minato, Japon, 105-8471
- Recrutement
- The Jikei University Hospital
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Shibuya City, Japon, 150-8935
- Recrutement
- Japanese Red Cross Medical Center
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Yokohama, Japon, 241 8515
- Recrutement
- Kanagawa Cancer Center
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Lorenskog, Norvège, 1478
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- Akershus universitetssykehus
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Oslo, Norvège, 0450
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- Oslo University Hospital HF Ulleval sykehus
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Stavanger, Norvège, 4021
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- Stavanger University Hospital Ullandhaug
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Trondheim, Norvège, 7030
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- St. Olavs Hospital
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Amsterdam, Pays-Bas, 1081 HV
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- VU Medisch Centrum
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Groningen, Pays-Bas, 9713 GZ
- Recrutement
- Universitair Medisch Centrum Groningen
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Nieuwegein, Pays-Bas, 3435 CM
- Recrutement
- St. Antonius Ziekenhuis Nieuwegein
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Nijmegen, Pays-Bas, 6525 GA
- Recrutement
- Radboud Umcn
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Rotterdam, Pays-Bas, 3015
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- Erasmus MC
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The Hague, Pays-Bas, 2545 AA
- Recrutement
- Haga Ziekenhuis
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Canterbury, Royaume-Uni, CT1 3NG
- Recrutement
- Kent and Canterbury Hospital
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Cardiff, Royaume-Uni, CF14 4XW
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- Cardiff and Vale UHB - University Hospital of Wales
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Dundee, Royaume-Uni, DD1 9SY
- Recrutement
- Ninewells Hospital & Medical School
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London, Royaume-Uni, NW1 2PG
- Recrutement
- University College London Hospitals
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Nottingham, Royaume-Uni, NG5 1PB
- Recrutement
- Nottingham City Hospital
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Portsmouth, Royaume-Uni, PO6 3LY
- Recrutement
- Queen Alexandra Hospital
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Sutton, Royaume-Uni, SM2 5PT
- Recrutement
- Royal Marsden Hospital
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Arizona
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Phoenix, Arizona, États-Unis, 85054
- Recrutement
- Mayo Clinic Phoenix
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Arkansas
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Little Rock, Arkansas, États-Unis, 72205
- Recrutement
- UAMS
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California
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Duarte, California, États-Unis, 91010
- Recrutement
- City of Hope Duarte
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Irvine, California, États-Unis, 92618
- Recrutement
- City of Hope Orange County Lennar Foundation Cancer Center
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Los Angeles, California, États-Unis, 90033
- Recrutement
- USC Norris Comprehensive Cancer Center
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San Francisco, California, États-Unis, 94122
- Recrutement
- University of California San Francisco
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Colorado
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Denver, Colorado, États-Unis, 80218
- Recrutement
- Colorado Blood Cancer Institute
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Connecticut
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Farmington, Connecticut, États-Unis, 06030
- Recrutement
- University of Connecticut Health Center
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New Haven, Connecticut, États-Unis, 06510
- Recrutement
- Yale Cancer Center
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Florida
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Fort Myers, Florida, États-Unis, 33901
- Recrutement
- Florida Cancer Specialists & Research Institute
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Jacksonville, Florida, États-Unis, 32224
- Recrutement
- Mayo Clinic Jacksonville
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Tampa, Florida, États-Unis, 33612
- Recrutement
- Moffit Cancer Center
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Georgia
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Atlanta, Georgia, États-Unis, 30322
- Recrutement
- Emory University
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Illinois
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Zion, Illinois, États-Unis, 60099
- Recrutement
- City of Hope Chicago
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Iowa
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Iowa City, Iowa, États-Unis, 52242
- Recrutement
- University of Iowa Hospital and Clinics
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Waukee, Iowa, États-Unis, 50263
- Recrutement
- Mission Cancer Blood
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Kansas
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Kansas City, Kansas, États-Unis, 66160
- Recrutement
- University of Kansas Cancer Center
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Kentucky
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Louisville, Kentucky, États-Unis, 40207
- Recrutement
- Norton Cancer Institute
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Maryland
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Baltimore, Maryland, États-Unis, 21201
- Recrutement
- University of Maryland School of Medicine
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Minnesota
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Rochester, Minnesota, États-Unis, 55905
- Recrutement
- Mayo Clinic Rochester
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New York
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Brooklyn, New York, États-Unis, 11234
- Recrutement
- Mount Sinai Brooklyn
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Mineola, New York, États-Unis, 11501
- Recrutement
- NYU Winthrop
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New York, New York, États-Unis, 10065
- Recrutement
- Memorial Sloan Kettering Cancer Center
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New York, New York, États-Unis, 10011
- Recrutement
- Mount Sinai Chelsea
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New York, New York, États-Unis, 10029
- Recrutement
- Icahn School of Medicine at Mount Sinai
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New York, New York, États-Unis, 10016
- Recrutement
- Laura and Isaac Perlmutter Cancer Center NYU ACC
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North Carolina
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Chapel Hill, North Carolina, États-Unis, 27514
- Recrutement
- University of North Carolina
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Durham, North Carolina, États-Unis, 27705
- Recrutement
- Durham VAMC
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Oregon
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Portland, Oregon, États-Unis, 97239
- Recrutement
- Oregon Health and Science University
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Pennsylvania
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Philadelphia, Pennsylvania, États-Unis, 19107
- Recrutement
- Thomas Jefferson University Hospital
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Philadelphia, Pennsylvania, États-Unis, 19111
- Recrutement
- Fox Chase Cancer Center
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Tennessee
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Nashville, Tennessee, États-Unis, 37232
- Recrutement
- Vanderbilt University Medical Center
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Nashville, Tennessee, États-Unis, 37203
- Recrutement
- SCRI Oncology Partners
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Texas
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Austin, Texas, États-Unis, 78704
- Recrutement
- St. David's South Austin Medical Center
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Dallas, Texas, États-Unis, 75390
- Recrutement
- UT Southwestern Medical Center
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Dallas, Texas, États-Unis, 75246
- Recrutement
- Baylor University Medical Center
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San Antonio, Texas, États-Unis, 78229
- Recrutement
- Texas Transplant Institute
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Utah
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Salt Lake City, Utah, États-Unis, 84112
- Recrutement
- Huntsman Cancer Institute
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Wisconsin
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Milwaukee, Wisconsin, États-Unis, 53226
- Recrutement
- Medical College of Wisconsin
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Non
La description
Inclusion :
Diagnostic documenté de myélome multiple (MM) tel que défini par les critères ci-dessous :
- Diagnostic de MM selon les critères diagnostiques du groupe de travail international sur le myélome (IMWG)
- Maladie mesurable au dépistage telle qu'évaluée par le laboratoire central
- A reçu au moins 3 lignes antérieures de traitement antimyélome, incluant un inhibiteur du protéasome (IP), un agent immunomodulateur (IMiD) et un anticorps anti-cluster de différenciation (CD)38
- Preuve documentée de maladie progressive (MP) ou d'échec à obtenir une réponse (c'est-à-dire une réponse partielle [RP] ou mieux) à la dernière ligne de traitement, basée sur la détermination de la réponse par l'investigateur selon les critères IMWG
- A cessé l'utilisation concomitante de tout autre traitement anticancéreux (y compris la radiothérapie non palliative) ou agent expérimental
- A un indice de performance de l'Eastern Cooperative Oncology Group (ECOG) de 0 à 2 au dépistage et immédiatement avant le début de l'administration du traitement de l'étude
Exclusion :
- Hépatite active d'origine infectieuse
- Atteinte active ou antérieure connue du système nerveux central (SNC) ou présente des signes cliniques d'atteinte méningée du MM
- Allergies, hypersensibilité ou intolérance suspectées ou connues aux excipients du JNJ-79635322 et du Teclistamab
- Chirurgie majeure (exemple, nécessitant une anesthésie générale) dans les 2 semaines précédant le dépistage, ou ne s'étant pas complètement remis de la chirurgie, ou a une chirurgie prévue pendant la période où le participant est censé participer à l'étude
- A reçu ou prévoit de recevoir un vaccin vivant atténué dans les 4 semaines avant la première dose du traitement de l'étude, pendant, ou dans les 90 jours après la dernière dose du traitement de l'étude
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: JNJ-79635322
Les participants recevront une dose sous-cutanée (SC) de JNJ-79635322 jusqu'à progression de la maladie (PD) ou toxicité intolérable.
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JNJ-79635322 sera administré sous forme d'injection SC.
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Comparateur actif: Anticorps bispécifique Anti-BCMA×CD3
Les participants recevront du teclistamab (un anticorps bispécifique Anti BCMAxCD3) en injection sous-cutanée jusqu'à progression de la maladie ou toxicité intolérable.
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Le teclistamab sera administré en injection SC.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Overall Response
Délai: Up to 5 years and 7 months
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Overall response is defined as having achieved partial response (PR) or better, according to the international myeloma working group (IMWG) response criteria, as assessed any time after first administration of study treatment, but prior to progression of disease (PD) or subsequent antimyeloma therapy.
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Up to 5 years and 7 months
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Progression-Free Survival (PFS)
Délai: Up to 5 years and 7 months
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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.
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Up to 5 years and 7 months
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Very Good Partial Response (VGPR) or Better
Délai: Up to 5 years and 7 months
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VGPR or better is defined as achieving VGPR, complete response (CR), or stringent complete response (sCR) in accordance with the IMWG criteria during or after the study treatment but prior to subsequent antimyeloma therapy.
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Up to 5 years and 7 months
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Complete Response (CR) or Better
Délai: Up to 5 years and 7 months
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CR or better is defined as achieving CR or sCR in accordance with the IMWG criteria during or after the study treatment but prior to subsequent antimyeloma therapy.
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Up to 5 years and 7 months
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Duration of Response (DoR)
Délai: Up to 5 years and 7 months
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DoR is defined as the time interval between the date of initial documentation of a response (partial 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.
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Up to 5 years and 7 months
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Minimal Residual Disease (MRD)-negative CR
Délai: Up to 5 years and 7 months
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MRD-negative CR is defined as the participants who achieve MRD-negative status, as determined by next-generation flow cytometry (NGF), at any time point after the date of randomization and prior to PD or subsequent antimyeloma therapy.
Additionally, participants must achieve CR or better, according to IMWG response criteria at any time from the date of randomization and within 3 months after achieving MRD negative status, prior to PD or subsequent antimyeloma therapy.
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Up to 5 years and 7 months
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MRD-Negative CR at 12 months
Délai: 12 months
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MRD-negative CR at 12 months is defined as the participants who achieve MRD-negative status at the analysis time window of 12 months (+/-3 months) from the date of randomization, as determined by NGF prior to PD or subsequent anti-myeloma therapy.
Additionally, participants must also achieve CR or better, according to IMWG criteria at any time from the date of randomization up to and including 12 months (+/-3 months), prior to PD or subsequent antimyeloma therapy.
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12 months
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Sustained MRD-negative CR
Délai: Up to 5 years and 7 months
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Sustained MRD-negative CR is defined as participants who achieve MRD-negative CR status, as determined by NGF, for at least 12 months without any examination showing MRD-positive status and prior to PD or subsequent anti-myeloma therapy.
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Up to 5 years and 7 months
|
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Progression-Free Survival on the First Subsequent Line of Antimyeloma Therapy (PFS2)
Délai: Up to 5 years and 7 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.
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Up to 5 years and 7 months
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Overall Survival (OS)
Délai: Up to 5 years and 7 months
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OS is defined as the time from the date of randomization to the date of the participant's death due to any cause.
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Up to 5 years and 7 months
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Time to Subsequent Anti-Myeloma Therapy
Délai: Up to 5 years and 7 months
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Time to subsequent anti-myeloma therapy 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.
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Up to 5 years and 7 months
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Number of Participants With Treatment-Emergent Adverse Events (TEAE) by Severity
Délai: Up to 5 years and 7 months
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An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non investigational) product.
An AE does not necessarily have a causal relationship with the treatment.
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, whichever is earlier, or any follow-up AE with onset date and time beyond 30 days after the last dose of study treatment but prior to the start of subsequent therapy or any AE that is considered treatment-related regardless of the start date of the event is considered to be treatment-emergent.
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, to Grade 5= death related to adverse event.
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Up to 5 years and 7 months
|
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Number of Participants with Abnormalities in Clinical Laboratories Results
Délai: Up to 5 years and 7 months
|
Number of participants with abnormalities in clinical laboratories results (serum chemistry and hematology) will be reported.
|
Up to 5 years and 7 months
|
|
Change from Baseline in Symptoms, Functioning, and Health-related Quality of Life (HRQoL) as Assessed by Multiple Myeloma Symptom and Impact Questionnaire (MySIm-Q) Score
Délai: Baseline up to 5 years and 7 months
|
Change from baseline in symptoms, functioning, and health-related quality of life (HRQoL) as assessed by multiple myeloma symptom and impact questionnaire (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.
|
Baseline up to 5 years and 7 months
|
|
Change from Baseline in Symptoms, Functioning, and HRQoL as Assessed by European Organization for Research and Treatment of Cancer Quality of life Questionnaire Core 30 (EORTC-QLQ-C30) Score
Délai: Baseline up to 5 years and 7 months
|
Change from baseline in symptoms, functioning, and HRQoL as assessed by european organization for research and treatment of cancer quality of life questionnaire core 30 (EORTC-QLQ-C30) score will be reported.
|
Baseline up to 5 years and 7 months
|
|
Change from Baseline in Symptoms, Functioning, and HRQoL as Assessed by European Quality of Life 5-Dimensions 5-Level Version (EQ-5D-5L) Score
Délai: Baseline up to 5 years and 7 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.
|
Baseline up to 5 years and 7 months
|
|
Time to Worsening in Symptoms, Functioning, and HRQoL as Assessed by MySIm-Q Score
Délai: Up to 5 years and 7 months
|
Time to worsening in symptoms, functioning, and HRQoL as assessed by MySIm-Q score will be reported.
The MySIm-Q is a disease-specific PRO assessment with established content validity for participants with RRMM and newly diagnosed MM.
|
Up to 5 years and 7 months
|
|
Time to Worsening in Symptoms, Functioning, and HRQoL as Assessed by EORTC-QLQ-C30 Score
Délai: Up to 5 years and 7 months
|
Time to worsening in symptoms, functioning, and HRQoL as assessed by EORTC-QLQ-C30 score will be reported.
|
Up to 5 years and 7 months
|
|
Time to Worsening in Symptoms, Functioning, and HRQoL as Assessed by EQ-5D-5L Score
Délai: Up to 5 years and 7 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 5 years and 7 months
|
|
Percentage of Participants With Meaningful Improvement in Symptoms, Functioning, and HRQoL as Assessed by MySIm-Q Score
Délai: Up to 5 years and 7 months
|
The MySIm-Q is a disease-specific PRO assessment with established content validity for participants with RRMM and newly diagnosed MM.
It is included to be complementary to the EORTC-QLQ-C30.
It includes 17 items resulting in a symptom subscale and an impact subscale.
The recall period is the "past 7 days" and responses are reported on a 5-point verbal rating scale.
|
Up to 5 years and 7 months
|
|
Percentage of Participants With Meaningful Improvement in Symptoms, Functioning, and HRQoL as Assessed by EORTC-QLQ-C30 Score
Délai: Up to 5 years and 7 months
|
Percentage of participants with meaningful improvement in symptoms, functioning, and HRQoL as assessed by EORTC-QLQ-C30 score will be reported.
|
Up to 5 years and 7 months
|
|
Percentage of Participants With Meaningful Improvement in Symptoms, Functioning, and HRQoL as Assessed by EQ-5D-5L Score
Délai: Up to 5 years and 7 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 5 years and 7 months
|
|
Percentage of Participants With Side Effects Burden on the European Organization for Research and Treatment of Cancer Item List 46 (EORTC IL46)
Délai: Up to 5 years and 7 months
|
Percentage of participants with side effects burden on the EORTC IL46 will be reported.
The EORTC IL46 measures the global impression of burden due to treatment-related symptoms.
|
Up to 5 years and 7 months
|
|
Serum Concentrations for JNJ-79635322
Délai: Up to 5 years and 7 months
|
Serum concentrations of JNJ-79635322 will be reported.
|
Up to 5 years and 7 months
|
|
Number of Participants With Anti-drug Antibodies (ADA) to JNJ-79635322
Délai: Up to 5 years and 7 months
|
Serum samples will be analyzed for the detection of ADA to JNJ-79635322 using a validated assay method.
|
Up to 5 years and 7 months
|
|
Number of Participants With Neutralizing Antibodies (NAb) to JNJ-79635322
Délai: Up to 5 years and 7 months
|
Number of participants who are ADA-positive will be assessed for the presence of NAbs.
|
Up to 5 years and 7 months
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
4 février 2026
Achèvement primaire (Estimé)
12 décembre 2028
Achèvement de l'étude (Estimé)
30 septembre 2031
Dates d'inscription aux études
Première soumission
21 novembre 2025
Première soumission répondant aux critères de contrôle qualité
21 novembre 2025
Première publication (Réel)
2 décembre 2025
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
28 août 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
27 août 2026
Dernière vérification
1 août 2026
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- Maladies vasculaires
- Maladies cardiovasculaires
- Tumeurs
- Maladies du système immunitaire
- Tumeurs par type histologique
- Maladies hématologiques
- Troubles lymphoprolifératifs
- Troubles immunoprolifératifs
- Tumeurs, plasmocyte
- Troubles hémostatiques
- Paraprotéinémies
- Troubles des protéines sanguines
- Troubles hémorragiques
- Maladies hémiques et lymphatiques
- Myélome multiple
Autres numéros d'identification d'étude
- 79635322MMY3001 (Janssen Research & Development, LLC)
- 2025 (Subvention/contrat des NIH des États-Unis: Faculty of Social Sciences Scientific Grant at the University of Gdańsk)
- 2025-522007-18-00 (Identificateur de registre: EUCT number)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
OUI
Description du régime IPD
La politique de partage de données de Johnson & Johnson Innovative Medicine est disponible sur innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency.
Comme indiqué sur ce site, les demandes d'accès aux données de l'étude peuvent être soumises via le site du projet Yale Open Data Access (YODA) à yoda.yale.edu
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Oui
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .