Een onderzoek waarin JNJ-79635322 en een anti-B-cel-rijpingsantigeen (BCMA)xCD3 bispecifiek antilichaam worden vergeleken bij deelnemers met recidiverend of refractair multipel myeloom (TRIlogy-4)
27 augustus 2026 bijgewerkt door: Janssen Research & Development, LLC
Een fase 3-gerandomiseerde studie die JNJ-79635322 vergelijkt met een anti-BCMAxCD3 bispecifiek antilichaam bij deelnemers met recidiverend of refractair multipel myeloom die ten minste 3 eerdere behandelingslijnen hebben ontvangen, waaronder een PI, een IMiD en een anti-CD38-antilichaam
Het doel van deze studie is te evalueren hoe goed JNJ-79635322 werkt in vergelijking met een anti-B-celrijpingsantigeen (BCMA)xCD3 bispecifiek antilichaam.
Studie Overzicht
Toestand
Werving
Conditie
Interventie / Behandeling
Studietype
Ingrijpend
Inschrijving (Geschat)
400
Fase
- Fase 3
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studiecontact
- Naam: Study Contact
- Telefoonnummer: 844-434-4210
- E-mail: Participate-In-This-Study1@its.jnj.com
Studie Locaties
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Box Hill, Australië, 3128
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- Box Hill Hospital
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Brisbane, Australië, 4101
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- Mater Misericordiae Ltd
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Clayton, Australië, 3168
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- Monash Medical Centre
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Fitzroy, Australië, 3065
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- St Vincents Hospital Melbourne
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Melbourne, Australië, 3004
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- The Alfred Hospital
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Murdoch, Australië, 6150
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- Fiona Stanley Hospital
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Nedlands, Australië, 6009
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- Sir Charles Gairdner Hospital
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Southport, Australië, 4215
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- Gold Coast University Hospital
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Campinas, Brazilië, 13083-888
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- Hospital das Clinicas da Universidade Estadual de Campinas UNICAMP
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Caxias do Sul, Brazilië, 95070 560
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- Fundacao Universidade de Caxias Do Sul
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Curitiba, Brazilië, 81520-060
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- Hospital Erasto Gaertner- Liga Paranaense de Combate ao Cancer
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Florianópolis, Brazilië, 88020 210
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- Grupo ELORA Centro de Pesquisa e Ensino em Saude de Santa Catarina
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Rio de Janeiro, Brazilië, 22775 001
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- Instituto de Educacao, Pesquisa e Gestao em Saude Instituto Americas (COI)
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Salvador, Brazilië, 41253-190
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- IDOR - Regional Bahia
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São José do Rio Preto, Brazilië, 15090-000
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- Funfarme Sjrp
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São Paulo, Brazilië, 01509 900
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- Fundacao Antonio Prudente A C Camargo Cancer Center
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São Paulo, Brazilië, 05652 900
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- Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein
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São Paulo, Brazilië, 04537 081
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- Clinica Medica Sao Germano LTDA
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São Paulo, Brazilië, 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
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- 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, China, 100034
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- Peking University First Hospital
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Beijing, China, 100044
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- Peking University People's Hospital
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Chengdu, China, 610032
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- Sichuan Provincial Peoples Hospital
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Guangzhou, China, 510060
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- Sun Yat Sen University Cancer Center
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Hangzhou, China, 310003
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- First affiliated Hospital of Zhejiang University
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Nanjing, China, 210008
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- Nanjing Drum Tower Hospital
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Nanning, China, 530021
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- The First Affiliated Hospital of Guangxi Medical University
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Shanghai, China, 200434
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- Shanghai Fourth People s Hospital
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Wenzhou, China, 325000
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- The First Affiliated Hospital of Wenzhou Medical University
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Xi'an, China, 710006
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- The Second Affiliated Hospital of Xi'an Jiaotong University
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Düsseldorf, Duitsland, 40479
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- Marien Hospital Düsseldorf
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Heidelberg, Duitsland, 69120
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- Universitaetsklinikum Heidelberg
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Jena, Duitsland, 07747
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- Universitatsklinikum Jena
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Würzburg, Duitsland, 97080
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- Universitaetsklinikum Wuerzburg
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Lille, Frankrijk, 59000
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- CHRU de Lille Hopital Claude Huriez
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Lyon, Frankrijk, 69002
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- Hospices Civils de Lyon HCL
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Nantes, Frankrijk, 44000
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- Hotel Dieu CHU de Nantes
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Paris, Frankrijk, 75010
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- Hopital Saint Louis APHP
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Paris, Frankrijk, 75012
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- APHP
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Pessac, Frankrijk, 33600
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- CHU de Bordeaux - Hospital Haut-Leveque
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Poitiers, Frankrijk, 86021
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- CHU De Poitiers
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Toulouse, Frankrijk, 31300
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- CHU Toulouse
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Tours, Frankrijk, 37000
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- CHRU de Tours
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Athens, Griekenland, 11528
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- Alexandra General Hospital of Athens
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Athens, Griekenland, 106 76
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- Evangelismos S A
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Thessaloniki, Griekenland, 570 10
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- Geniko Nosokomeio Thessalonikis George Papanikolaou
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Thessaloniki, Griekenland, 546 39
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- Theageneio Cancer Hospital
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Beersheba, Israël, 8457108
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- Soroka Medical Center
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Haifa, Israël, 3109601
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- Rambam Medical Center
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Haifa, Israël, 34362
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- Carmel Medical Center
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Haifa, Israël, 31048
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- Bnai Zion Medical Center
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Jerusalem, Israël, 9103102
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- Shaare Zedek Mc
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Ramat Gan, Israël, 52621
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- Sheba medical center
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Ramat Poriya, Israël, 1520800
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- Baruch Padeh MC
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Tel Aviv, Israël, 69710
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- Assuta MC
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Alessandria, Italië, 15121
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- A.O.U. SS. Antonio e Biagio e Cesare Arrigo
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Brescia, Italië, 25123
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- Spedali Civili di Brescia
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Milan, Italië, 20122
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- Fondazione IRCCS Ca Granda Ospedale Policlinico Di Milano
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Pisa, Italië, 56126
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- Ospedale Santa Chiara AO Universitaria Pisana
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Reggio Emilia, Italië, 42123
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- Arcispedale Santa Maria Nuova - IRCCS
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Roma, Italië, 00168
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- Fondazione Policlinico Universitario A Gemelli IRCCS
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Roma, Italië, 00128
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- Campus Bio Medico di Roma
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Rozzano, Italië, 20089
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- Humanitas Hospital
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San Giovanni Rotondo, Italië, 71013
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- Casa Sollievo Della Sofferenza IRCCS
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Vicenza, Italië, 36100
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- U.O. Ematologia Ospedale San Bortolo
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Bunkyō City, Japan, 113 8677
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- Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital
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Chiba, Japan, 260 0801
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- Chiba Cancer Center
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Kamakura-shi, Japan, 247-8533
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- Shonan Kamakura General Hospital
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Kamogawa, Japan, 296-8602
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- Kameda Medical Center
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Kofu, Japan, 400-0027
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- Yamanashi Prefectural Central Hospital
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Minato, Japan, 105-8471
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- The Jikei University Hospital
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Shibuya City, Japan, 150-8935
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- Japanese Red Cross Medical Center
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Yokohama, Japan, 241 8515
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- Kanagawa Cancer Center
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Amsterdam, Nederland, 1081 HV
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- VU Medisch Centrum
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Groningen, Nederland, 9713 GZ
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- Universitair Medisch Centrum Groningen
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Nieuwegein, Nederland, 3435 CM
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- St. Antonius Ziekenhuis Nieuwegein
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Nijmegen, Nederland, 6525 GA
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- Radboud Umcn
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Rotterdam, Nederland, 3015
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- Erasmus MC
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The Hague, Nederland, 2545 AA
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- Haga Ziekenhuis
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Lorenskog, Noorwegen, 1478
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- Akershus universitetssykehus
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Oslo, Noorwegen, 0450
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- Oslo University Hospital HF Ulleval sykehus
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Stavanger, Noorwegen, 4021
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- Stavanger University Hospital Ullandhaug
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Trondheim, Noorwegen, 7030
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- St. Olavs Hospital
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Badalona, Spanje, 08916
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- Hosp. Univ. Germans Trias I Pujol
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Barcelona, Spanje, 08036
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- Hosp. Clinic de Barcelona
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Barcelona, Spanje, 08035
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- H. Vall D'Hebron
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Granada, Spanje, 18014
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- Hosp. Univ. Virgen de Las Nieves
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Madrid, Spanje, 28041
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- Hosp. Univ. 12 de Octubre
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Pozuelo de Alarcón, Spanje, 28223
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- Hosp. Quiron Madrid Pozuelo
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Salamanca, Spanje, 37007
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- Hosp Clinico Univ de Salamanca
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Usansolo, Spanje, 48960
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- Hosp de Galdakao
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Valencia, Spanje, 46026
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- Hosp. Univ. I Politecni La Fe
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Canterbury, Verenigd Koninkrijk, CT1 3NG
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- Kent and Canterbury Hospital
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Cardiff, Verenigd Koninkrijk, CF14 4XW
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- Cardiff and Vale UHB - University Hospital of Wales
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Dundee, Verenigd Koninkrijk, DD1 9SY
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- Ninewells Hospital & Medical School
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London, Verenigd Koninkrijk, NW1 2PG
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- University College London Hospitals
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Nottingham, Verenigd Koninkrijk, NG5 1PB
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- Nottingham City Hospital
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Portsmouth, Verenigd Koninkrijk, PO6 3LY
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- Queen Alexandra Hospital
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Sutton, Verenigd Koninkrijk, SM2 5PT
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- Royal Marsden Hospital
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Arizona
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Phoenix, Arizona, Verenigde Staten, 85054
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- Mayo Clinic Phoenix
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Arkansas
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Little Rock, Arkansas, Verenigde Staten, 72205
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- UAMS
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California
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Duarte, California, Verenigde Staten, 91010
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- City of Hope Duarte
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Irvine, California, Verenigde Staten, 92618
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- City of Hope Orange County Lennar Foundation Cancer Center
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Los Angeles, California, Verenigde Staten, 90033
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- USC Norris Comprehensive Cancer Center
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San Francisco, California, Verenigde Staten, 94122
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- University of California San Francisco
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Colorado
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Denver, Colorado, Verenigde Staten, 80218
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- Colorado Blood Cancer Institute
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Connecticut
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Farmington, Connecticut, Verenigde Staten, 06030
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- University of Connecticut Health Center
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New Haven, Connecticut, Verenigde Staten, 06510
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- Yale Cancer Center
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Florida
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Fort Myers, Florida, Verenigde Staten, 33901
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- Florida Cancer Specialists & Research Institute
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Jacksonville, Florida, Verenigde Staten, 32224
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- Mayo Clinic Jacksonville
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Tampa, Florida, Verenigde Staten, 33612
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- Moffit Cancer Center
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Georgia
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Atlanta, Georgia, Verenigde Staten, 30322
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- Emory University
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Illinois
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Zion, Illinois, Verenigde Staten, 60099
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- City of Hope Chicago
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Iowa
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Iowa City, Iowa, Verenigde Staten, 52242
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- University of Iowa Hospital and Clinics
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Waukee, Iowa, Verenigde Staten, 50263
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- Mission Cancer Blood
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Kansas
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Kansas City, Kansas, Verenigde Staten, 66160
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- University of Kansas Cancer Center
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Kentucky
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Louisville, Kentucky, Verenigde Staten, 40207
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- Norton Cancer Institute
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Maryland
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Baltimore, Maryland, Verenigde Staten, 21201
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- University of Maryland School of Medicine
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Minnesota
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Rochester, Minnesota, Verenigde Staten, 55905
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- Mayo Clinic Rochester
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New York
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Brooklyn, New York, Verenigde Staten, 11234
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- Mount Sinai Brooklyn
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Mineola, New York, Verenigde Staten, 11501
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- NYU Winthrop
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New York, New York, Verenigde Staten, 10065
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- Memorial Sloan Kettering Cancer Center
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New York, New York, Verenigde Staten, 10011
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- Mount Sinai Chelsea
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New York, New York, Verenigde Staten, 10029
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- Icahn School of Medicine at Mount Sinai
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New York, New York, Verenigde Staten, 10016
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- Laura and Isaac Perlmutter Cancer Center NYU ACC
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North Carolina
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Chapel Hill, North Carolina, Verenigde Staten, 27514
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- University of North Carolina
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Durham, North Carolina, Verenigde Staten, 27705
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- Durham VAMC
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Oregon
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Portland, Oregon, Verenigde Staten, 97239
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- Oregon Health and Science University
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Pennsylvania
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Philadelphia, Pennsylvania, Verenigde Staten, 19107
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- Thomas Jefferson University Hospital
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Philadelphia, Pennsylvania, Verenigde Staten, 19111
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- Fox Chase Cancer Center
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Tennessee
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Nashville, Tennessee, Verenigde Staten, 37232
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- Vanderbilt University Medical Center
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Nashville, Tennessee, Verenigde Staten, 37203
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- SCRI Oncology Partners
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Texas
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Austin, Texas, Verenigde Staten, 78704
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- St. David's South Austin Medical Center
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Dallas, Texas, Verenigde Staten, 75390
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- UT Southwestern Medical Center
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Dallas, Texas, Verenigde Staten, 75246
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- Baylor University Medical Center
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San Antonio, Texas, Verenigde Staten, 78229
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- Texas Transplant Institute
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Utah
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Salt Lake City, Utah, Verenigde Staten, 84112
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- Huntsman Cancer Institute
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Wisconsin
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Milwaukee, Wisconsin, Verenigde Staten, 53226
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- Medical College of Wisconsin
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Nee
Beschrijving
Inclusie:
Gedocumenteerde diagnose van multipel myeloom (MM) zoals gedefinieerd door de onderstaande criteria:
- MM-diagnose volgens de diagnostische criteria van de internationale myeloma working group (IMWG)
- Meetbare ziekte bij screening zoals beoordeeld door het centrale laboratorium
- Ten minste 3 eerdere behandelingslijnen voor antimyeloomtherapie ontvangen, inclusief een proteasoomremmer (PI), een immunomodulerend geneesmiddel (IMiD) en een anti-cluster of differentiation (CD)38-antilichaam
- Gedocumenteerd bewijs van progressieve ziekte (PD) of het niet bereiken van een respons (dat wil zeggen partiële respons [PR] of beter) op de laatste behandelingslijn op basis van de beoordeling van de onderzoeker volgens IMWG-criteria
- Het gelijktijdig gebruik van andere antikankerbehandelingen (inclusief niet-palliatieve radiotherapie) of onderzoeksmiddelen is gestopt
- Een eastern cooperative oncology group (ECOG) prestatiestatus van 0 tot 2 hebben bij screening en onmiddellijk voor de start van de toediening van de studiebehandeling
Exclusie:
- Actieve hepatitis van infectieuze oorsprong
- Bekende actieve of eerdere betrokkenheid van het centrale zenuwstelsel (CZS) of vertoont klinische tekenen van meningeale betrokkenheid bij MM
- Vermoedde of bekende allergieën, overgevoeligheid of intolerantie voor de hulpstoffen van JNJ-79635322 en Teclistamab
- Grote chirurgie, (bijvoorbeeld onder algehele anesthesie) binnen 2 weken voor screening, of nog niet volledig hersteld van de operatie, of heeft een operatie gepland tijdens de periode dat de deelnemer naar verwachting deelneemt aan de studie
- Ontvangen of van plan om levend, verzwakt vaccin te ontvangen binnen 4 weken voor de eerste dosis van de studiebehandeling, tijdens, of binnen 90 dagen na de laatste dosis van de studiebehandeling
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: JNJ-79635322
Deelnemers krijgen een subcutane (SC) dosis JNJ-79635322 tot progressieve ziekte (PD) of onverdraaglijke toxiciteit.
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JNJ-79635322 zal worden toegediend als SC-injectie.
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Actieve vergelijker: Anti BCMAxCD3 Bispecifiek Antilichaam
Deelnemers zullen teclistamab (een anti-BCMAxCD3 bispecifiek antilichaam) ontvangen als een SC-injectie tot PD of onaanvaardbare toxiciteit.
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Teclistamab zal worden toegediend als SC-injectie.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Overall Response
Tijdsspanne: 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)
Tijdsspanne: 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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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Very Good Partial Response (VGPR) or Better
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: Up to 5 years and 7 months
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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)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
4 februari 2026
Primaire voltooiing (Geschat)
12 december 2028
Studie voltooiing (Geschat)
30 september 2031
Studieregistratiedata
Eerst ingediend
21 november 2025
Eerst ingediend dat voldeed aan de QC-criteria
21 november 2025
Eerst geplaatst (Werkelijk)
2 december 2025
Updates van studierecords
Laatste update geplaatst (Werkelijk)
28 augustus 2026
Laatste update ingediend die voldeed aan QC-criteria
27 augustus 2026
Laatst geverifieerd
1 augustus 2026
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
- Vaatziekten
- Hart-en vaatziekten
- Neoplasmata
- Ziekten van het immuunsysteem
- Neoplasmata per histologisch type
- Hematologische ziekten
- Lymfoproliferatieve aandoeningen
- Immunoproliferatieve aandoeningen
- Neoplasmata, plasmacel
- Hemostatische aandoeningen
- Paraproteïnemieën
- Bloed eiwit stoornissen
- Hemorragische aandoeningen
- Hemische en lymfatische ziekten
- Multipel myeloom
Andere studie-ID-nummers
- 79635322MMY3001 (Janssen Research & Development, LLC)
- 2025 (Subsidie/contract van de Amerikaanse NIH: Faculty of Social Sciences Scientific Grant at the University of Gdańsk)
- 2025-522007-18-00 (Register-ID: EUCT number)
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
JA
Beschrijving IPD-plan
Het datadelingbeleid van Johnson & Johnson Innovative Medicine is beschikbaar op innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency.
Zoals vermeld op deze site kunnen verzoeken om toegang tot de studiedata worden ingediend via de Yale Open Data Access (YODA) Project-site op yoda.yale.edu
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Ja
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .