En undersøgelse, der sammenligner JNJ-79635322 og en anti-B-cellemodningsantigen (BCMA)xCD3 bispecifikt antistof hos deltagere med tilbagevendende eller refraktær myelomatose (TRIlogy-4)
27. august 2026 opdateret af: Janssen Research & Development, LLC
En fase 3-randomiseret undersøgelse, der sammenligner JNJ-79635322 og en anti-BCMAxCD3-bispecifik antistof hos deltagere med tilbagevendende eller refraktær myelomatose, som har modtaget mindst 3 tidligere behandlingslinjer, herunder en PI, en IMiD og en anti-CD38-antistof
Formålet med dette studie er at evaluere, hvor godt JNJ-79635322 virker, når det sammenlignes med en anti-B-cellemodningsantigen (BCMA)xCD3 bispecifikt antistof.
Studieoversigt
Status
Rekruttering
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
400
Fase
- Fase 3
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Study Contact
- Telefonnummer: 844-434-4210
- E-mail: Participate-In-This-Study1@its.jnj.com
Studiesteder
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Box Hill, Australien, 3128
- Rekruttering
- Box Hill Hospital
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Brisbane, Australien, 4101
- Rekruttering
- Mater Misericordiae Ltd
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Clayton, Australien, 3168
- Rekruttering
- Monash Medical Centre
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Fitzroy, Australien, 3065
- Rekruttering
- St Vincents Hospital Melbourne
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Melbourne, Australien, 3004
- Rekruttering
- The Alfred Hospital
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Murdoch, Australien, 6150
- Rekruttering
- Fiona Stanley Hospital
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Nedlands, Australien, 6009
- Rekruttering
- Sir Charles Gairdner Hospital
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Southport, Australien, 4215
- Rekruttering
- Gold Coast University Hospital
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Campinas, Brasilien, 13083-888
- Rekruttering
- Hospital das Clinicas da Universidade Estadual de Campinas UNICAMP
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Caxias do Sul, Brasilien, 95070 560
- Rekruttering
- Fundacao Universidade de Caxias Do Sul
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Curitiba, Brasilien, 81520-060
- Rekruttering
- Hospital Erasto Gaertner- Liga Paranaense de Combate ao Cancer
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Florianópolis, Brasilien, 88020 210
- Rekruttering
- Grupo ELORA Centro de Pesquisa e Ensino em Saude de Santa Catarina
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Rio de Janeiro, Brasilien, 22775 001
- Rekruttering
- Instituto de Educacao, Pesquisa e Gestao em Saude Instituto Americas (COI)
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Salvador, Brasilien, 41253-190
- Rekruttering
- IDOR - Regional Bahia
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São José do Rio Preto, Brasilien, 15090-000
- Rekruttering
- Funfarme Sjrp
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São Paulo, Brasilien, 01509 900
- Rekruttering
- Fundacao Antonio Prudente A C Camargo Cancer Center
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São Paulo, Brasilien, 05652 900
- Rekruttering
- Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein
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São Paulo, Brasilien, 04537 081
- Rekruttering
- Clinica Medica Sao Germano LTDA
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São Paulo, Brasilien, 01401 002
- Rekruttering
- IDOR - Regional Sao Paulo
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Alberta
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Calgary, Alberta, Canada, T2N 4N1
- Rekruttering
- Arthur J E Child Comprehensive Cancer Centre
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British Columbia
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Vancouver, British Columbia, Canada, V5Z4E6
- Rekruttering
- British Columbia Cancer Agency
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Nova Scotia
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Halifax, Nova Scotia, Canada, B3H 3A7
- Rekruttering
- Queen Elizabeth Ii Health Sciences Centre
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Ontario
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Hamilton, Ontario, Canada, L8V5C2
- Rekruttering
- Juravinski Cancer Centre
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London, Ontario, Canada, N6A 5W9
- Rekruttering
- London Health Sciences Centre
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Toronto, Ontario, Canada, M5G 2M9
- Rekruttering
- University Health Network UHN Princess Margaret Cancer Centre
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Quebec
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Montreal, Quebec, Canada, H1T 2M4
- Rekruttering
- CIUSSS de l Est de l Ile de Montreal Installation Hopital Maisonneuve Rosemont
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Canterbury, Det Forenede Kongerige, CT1 3NG
- Rekruttering
- Kent and Canterbury Hospital
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Cardiff, Det Forenede Kongerige, CF14 4XW
- Rekruttering
- Cardiff and Vale UHB - University Hospital of Wales
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Dundee, Det Forenede Kongerige, DD1 9SY
- Rekruttering
- Ninewells Hospital & Medical School
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London, Det Forenede Kongerige, NW1 2PG
- Rekruttering
- University College London Hospitals
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Nottingham, Det Forenede Kongerige, NG5 1PB
- Rekruttering
- Nottingham City Hospital
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Portsmouth, Det Forenede Kongerige, PO6 3LY
- Rekruttering
- Queen Alexandra Hospital
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Sutton, Det Forenede Kongerige, SM2 5PT
- Rekruttering
- Royal Marsden Hospital
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Arizona
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Phoenix, Arizona, Forenede Stater, 85054
- Rekruttering
- Mayo Clinic Phoenix
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Arkansas
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Little Rock, Arkansas, Forenede Stater, 72205
- Rekruttering
- UAMS
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California
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Duarte, California, Forenede Stater, 91010
- Rekruttering
- City of Hope Duarte
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Irvine, California, Forenede Stater, 92618
- Rekruttering
- City of Hope Orange County Lennar Foundation Cancer Center
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Los Angeles, California, Forenede Stater, 90033
- Rekruttering
- USC Norris Comprehensive Cancer Center
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San Francisco, California, Forenede Stater, 94122
- Rekruttering
- University of California San Francisco
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Colorado
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Denver, Colorado, Forenede Stater, 80218
- Rekruttering
- Colorado Blood Cancer Institute
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Connecticut
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Farmington, Connecticut, Forenede Stater, 06030
- Rekruttering
- University of Connecticut Health Center
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New Haven, Connecticut, Forenede Stater, 06510
- Rekruttering
- Yale Cancer Center
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Florida
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Fort Myers, Florida, Forenede Stater, 33901
- Rekruttering
- Florida Cancer Specialists & Research Institute
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Jacksonville, Florida, Forenede Stater, 32224
- Rekruttering
- Mayo Clinic Jacksonville
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Tampa, Florida, Forenede Stater, 33612
- Rekruttering
- Moffit Cancer Center
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Georgia
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Atlanta, Georgia, Forenede Stater, 30322
- Rekruttering
- Emory University
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Illinois
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Zion, Illinois, Forenede Stater, 60099
- Rekruttering
- City of Hope Chicago
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Iowa
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Iowa City, Iowa, Forenede Stater, 52242
- Rekruttering
- University of Iowa Hospital and Clinics
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Waukee, Iowa, Forenede Stater, 50263
- Rekruttering
- Mission Cancer Blood
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Kansas
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Kansas City, Kansas, Forenede Stater, 66160
- Rekruttering
- University of Kansas Cancer Center
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Kentucky
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Louisville, Kentucky, Forenede Stater, 40207
- Rekruttering
- Norton Cancer Institute
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Maryland
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Baltimore, Maryland, Forenede Stater, 21201
- Rekruttering
- University of Maryland School of Medicine
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Minnesota
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Rochester, Minnesota, Forenede Stater, 55905
- Rekruttering
- Mayo Clinic Rochester
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New York
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Brooklyn, New York, Forenede Stater, 11234
- Rekruttering
- Mount Sinai Brooklyn
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Mineola, New York, Forenede Stater, 11501
- Rekruttering
- NYU Winthrop
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New York, New York, Forenede Stater, 10065
- Rekruttering
- Memorial Sloan Kettering Cancer Center
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New York, New York, Forenede Stater, 10011
- Rekruttering
- Mount Sinai Chelsea
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New York, New York, Forenede Stater, 10029
- Rekruttering
- Icahn School of Medicine at Mount Sinai
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New York, New York, Forenede Stater, 10016
- Rekruttering
- Laura and Isaac Perlmutter Cancer Center NYU ACC
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North Carolina
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Chapel Hill, North Carolina, Forenede Stater, 27514
- Rekruttering
- University of North Carolina
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Durham, North Carolina, Forenede Stater, 27705
- Rekruttering
- Durham VAMC
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Oregon
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Portland, Oregon, Forenede Stater, 97239
- Rekruttering
- Oregon Health and Science University
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Pennsylvania
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Philadelphia, Pennsylvania, Forenede Stater, 19107
- Rekruttering
- Thomas Jefferson University Hospital
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Philadelphia, Pennsylvania, Forenede Stater, 19111
- Rekruttering
- Fox Chase Cancer Center
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Tennessee
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Nashville, Tennessee, Forenede Stater, 37232
- Rekruttering
- Vanderbilt University Medical Center
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Nashville, Tennessee, Forenede Stater, 37203
- Rekruttering
- SCRI Oncology Partners
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Texas
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Austin, Texas, Forenede Stater, 78704
- Rekruttering
- St. David's South Austin Medical Center
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Dallas, Texas, Forenede Stater, 75390
- Rekruttering
- UT Southwestern Medical Center
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Dallas, Texas, Forenede Stater, 75246
- Rekruttering
- Baylor University Medical Center
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San Antonio, Texas, Forenede Stater, 78229
- Rekruttering
- Texas Transplant Institute
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Utah
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Salt Lake City, Utah, Forenede Stater, 84112
- Rekruttering
- Huntsman Cancer Institute
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Wisconsin
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Milwaukee, Wisconsin, Forenede Stater, 53226
- Rekruttering
- Medical College of Wisconsin
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Lille, Frankrig, 59000
- Rekruttering
- CHRU de Lille Hopital Claude Huriez
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Lyon, Frankrig, 69002
- Rekruttering
- Hospices Civils de Lyon HCL
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Nantes, Frankrig, 44000
- Rekruttering
- Hotel Dieu CHU de Nantes
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Paris, Frankrig, 75010
- Rekruttering
- Hopital Saint Louis APHP
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Paris, Frankrig, 75012
- Rekruttering
- APHP
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Pessac, Frankrig, 33600
- Rekruttering
- CHU de Bordeaux - Hospital Haut-Leveque
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Poitiers, Frankrig, 86021
- Rekruttering
- CHU De Poitiers
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Toulouse, Frankrig, 31300
- Rekruttering
- CHU Toulouse
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Tours, Frankrig, 37000
- Rekruttering
- CHRU de Tours
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Athens, Grækenland, 11528
- Rekruttering
- Alexandra General Hospital of Athens
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Athens, Grækenland, 106 76
- Rekruttering
- Evangelismos S A
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Thessaloniki, Grækenland, 570 10
- Rekruttering
- Geniko Nosokomeio Thessalonikis George Papanikolaou
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Thessaloniki, Grækenland, 546 39
- Rekruttering
- Theageneio Cancer Hospital
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Amsterdam, Holland, 1081 HV
- Rekruttering
- VU Medisch Centrum
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Groningen, Holland, 9713 GZ
- Rekruttering
- Universitair Medisch Centrum Groningen
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Nieuwegein, Holland, 3435 CM
- Rekruttering
- St. Antonius Ziekenhuis Nieuwegein
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Nijmegen, Holland, 6525 GA
- Rekruttering
- Radboud Umcn
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Rotterdam, Holland, 3015
- Rekruttering
- Erasmus MC
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The Hague, Holland, 2545 AA
- Rekruttering
- Haga Ziekenhuis
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Beersheba, Israel, 8457108
- Rekruttering
- Soroka Medical Center
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Haifa, Israel, 3109601
- Rekruttering
- Rambam Medical Center
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Haifa, Israel, 34362
- Rekruttering
- Carmel Medical Center
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Haifa, Israel, 31048
- Rekruttering
- Bnai Zion Medical Center
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Jerusalem, Israel, 9103102
- Rekruttering
- Shaare Zedek Mc
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Ramat Gan, Israel, 52621
- Rekruttering
- Sheba medical center
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Ramat Poriya, Israel, 1520800
- Rekruttering
- Baruch Padeh MC
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Tel Aviv, Israel, 69710
- Rekruttering
- Assuta MC
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Alessandria, Italien, 15121
- Rekruttering
- A.O.U. SS. Antonio e Biagio e Cesare Arrigo
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Brescia, Italien, 25123
- Rekruttering
- Spedali Civili di Brescia
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Milan, Italien, 20122
- Rekruttering
- Fondazione IRCCS Ca Granda Ospedale Policlinico Di Milano
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Pisa, Italien, 56126
- Rekruttering
- Ospedale Santa Chiara AO Universitaria Pisana
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Reggio Emilia, Italien, 42123
- Rekruttering
- Arcispedale Santa Maria Nuova - IRCCS
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Roma, Italien, 00168
- Rekruttering
- Fondazione Policlinico Universitario A Gemelli IRCCS
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Roma, Italien, 00128
- Rekruttering
- Campus Bio Medico di Roma
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Rozzano, Italien, 20089
- Rekruttering
- Humanitas Hospital
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San Giovanni Rotondo, Italien, 71013
- Rekruttering
- Casa Sollievo Della Sofferenza IRCCS
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Vicenza, Italien, 36100
- Rekruttering
- U.O. Ematologia Ospedale San Bortolo
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Bunkyō City, Japan, 113 8677
- Rekruttering
- Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital
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Chiba, Japan, 260 0801
- Rekruttering
- Chiba Cancer Center
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Kamakura-shi, Japan, 247-8533
- Rekruttering
- Shonan Kamakura General Hospital
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Kamogawa, Japan, 296-8602
- Rekruttering
- Kameda Medical Center
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Kofu, Japan, 400-0027
- Rekruttering
- Yamanashi Prefectural Central Hospital
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Minato, Japan, 105-8471
- Rekruttering
- The Jikei University Hospital
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Shibuya City, Japan, 150-8935
- Rekruttering
- Japanese Red Cross Medical Center
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Yokohama, Japan, 241 8515
- Rekruttering
- Kanagawa Cancer Center
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Beijing, Kina, 100034
- Rekruttering
- Peking University First Hospital
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Beijing, Kina, 100044
- Rekruttering
- Peking University People's Hospital
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Chengdu, Kina, 610032
- Rekruttering
- Sichuan Provincial Peoples Hospital
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Guangzhou, Kina, 510060
- Rekruttering
- Sun Yat Sen University Cancer Center
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Hangzhou, Kina, 310003
- Rekruttering
- First affiliated Hospital of Zhejiang University
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Nanjing, Kina, 210008
- Rekruttering
- Nanjing Drum Tower Hospital
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Nanning, Kina, 530021
- Rekruttering
- The First Affiliated Hospital of Guangxi Medical University
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Shanghai, Kina, 200434
- Rekruttering
- Shanghai Fourth People s Hospital
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Wenzhou, Kina, 325000
- Rekruttering
- The First Affiliated Hospital of Wenzhou Medical University
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Xi'an, Kina, 710006
- Rekruttering
- The Second Affiliated Hospital of Xi'an Jiaotong University
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Lorenskog, Norge, 1478
- Rekruttering
- Akershus universitetssykehus
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Oslo, Norge, 0450
- Rekruttering
- Oslo University Hospital HF Ulleval sykehus
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Stavanger, Norge, 4021
- Rekruttering
- Stavanger University Hospital Ullandhaug
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Trondheim, Norge, 7030
- Rekruttering
- St. Olavs Hospital
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Badalona, Spanien, 08916
- Rekruttering
- Hosp. Univ. Germans Trias I Pujol
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Barcelona, Spanien, 08036
- Rekruttering
- Hosp. Clinic de Barcelona
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Barcelona, Spanien, 08035
- Rekruttering
- H. Vall D'Hebron
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Granada, Spanien, 18014
- Rekruttering
- Hosp. Univ. Virgen de Las Nieves
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Madrid, Spanien, 28041
- Rekruttering
- Hosp. Univ. 12 de Octubre
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Pozuelo de Alarcón, Spanien, 28223
- Rekruttering
- Hosp. Quiron Madrid Pozuelo
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Salamanca, Spanien, 37007
- Rekruttering
- Hosp Clinico Univ de Salamanca
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Usansolo, Spanien, 48960
- Rekruttering
- Hosp de Galdakao
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Valencia, Spanien, 46026
- Rekruttering
- Hosp. Univ. I Politecni La Fe
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Düsseldorf, Tyskland, 40479
- Rekruttering
- Marien Hospital Düsseldorf
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Heidelberg, Tyskland, 69120
- Rekruttering
- Universitaetsklinikum Heidelberg
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Jena, Tyskland, 07747
- Rekruttering
- Universitatsklinikum Jena
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Würzburg, Tyskland, 97080
- Rekruttering
- Universitaetsklinikum Wuerzburg
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Beskrivelse
Inklusion:
Dokumenteret diagnose af multipelt myelom (MM) som defineret af kriterierne nedenfor:
- MM-diagnose i henhold til de internationale myeloma working group (IMWG) diagnostiske kriterier
- Målbar sygdom ved screening som vurderet af centralt laboratorium
- Har modtaget mindst 3 tidligere linjer af antimyelomaterapi inklusive en proteasomhæmmer (PI), et immunmodulerende lægemiddel (IMiD) og et antistof mod cluster of differentiation (CD)38
- Dokumenteret bevis for progressiv sygdom (PD) eller manglende respons (det vil sige delvist respons [PR] eller bedre) til den sidste behandlingslinje baseret på undersøgerens vurdering af respons ved IMWG-kriterier
- Har afbrudt samtidig brug af anden antikraeftbehandling (inklusive ikke-palliativ strålebehandling) eller undersøgelsesmedicin
- Har en eastern cooperative oncology group (ECOG) performance status på 0 til 2 ved screening og umiddelbart før start af studiemedicinering
Eksklusion:
- Aktiv hepatitis af infektionsoprindelse
- Kendt aktiv eller tidligere centralnervesystem (CNS) involvering eller viser kliniske tegn på meningeal involvering af MM
- Mistænkt eller kendte allergier, overfølsomhed eller intolerance overfor hjælpestofferne i JNJ-79635322 og Teclistamab
- Større kirurgi, (for eksempel krævende generel anæstesi) inden for 2 uger før screening, eller er ikke fuldt ud kommet sig efter kirurgi, eller har planlagt kirurgi i den periode deltageren forventes at deltage i studiet
- Har modtaget eller planlægger at modtage enhver levende, svækket vaccine inden for 4 uger før den første dosis af studiemedicin, under eller inden for 90 dage efter den sidste dosis af studiemedicin
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: JNJ-79635322
Deltagerne vil modtage en subkutan (SC) dosis af JNJ-79635322 indtil progressiv sygdom (PD) eller utålelig toksicitet.
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JNJ-79635322 vil blive administreret som SC-injektion.
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Aktiv komparator: Anti BCMAxCD3 Bispecifikt Antistof
Deltagerne vil modtage teclistamab (en anti-BCMAxCD3 bispecifikt antistof) som en SC-injektion indtil PD eller utålelig toksicitet.
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Teclistamab vil blive administreret som subkutan injektion.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Overall Response
Tidsramme: 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)
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Very Good Partial Response (VGPR) or Better
Tidsramme: Up to 5 years and 7 months
|
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
Tidsramme: Up to 5 years and 7 months
|
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)
Tidsramme: 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
Tidsramme: Up to 5 years and 7 months
|
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
Tidsramme: 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
Tidsramme: Up to 5 years and 7 months
|
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
|
|
Progression-Free Survival on the First Subsequent Line of Antimyeloma Therapy (PFS2)
Tidsramme: 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
|
|
Overall Survival (OS)
Tidsramme: Up to 5 years and 7 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 5 years and 7 months
|
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Time to Subsequent Anti-Myeloma Therapy
Tidsramme: Up to 5 years and 7 months
|
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
Tidsramme: Up to 5 years and 7 months
|
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
Tidsramme: Up to 5 years and 7 months
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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
Tidsramme: Baseline up to 5 years and 7 months
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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.
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Baseline up to 5 years and 7 months
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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
Tidsramme: 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.
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Baseline up to 5 years and 7 months
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Change from Baseline in Symptoms, Functioning, and HRQoL as Assessed by European Quality of Life 5-Dimensions 5-Level Version (EQ-5D-5L) Score
Tidsramme: 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.
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Baseline up to 5 years and 7 months
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Time to Worsening in Symptoms, Functioning, and HRQoL as Assessed by MySIm-Q Score
Tidsramme: 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
|
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Time to Worsening in Symptoms, Functioning, and HRQoL as Assessed by EORTC-QLQ-C30 Score
Tidsramme: 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
Tidsramme: 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
|
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Percentage of Participants With Meaningful Improvement in Symptoms, Functioning, and HRQoL as Assessed by MySIm-Q Score
Tidsramme: 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.
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Up to 5 years and 7 months
|
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Percentage of Participants With Meaningful Improvement in Symptoms, Functioning, and HRQoL as Assessed by EORTC-QLQ-C30 Score
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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.
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Up to 5 years and 7 months
|
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Serum Concentrations for JNJ-79635322
Tidsramme: Up to 5 years and 7 months
|
Serum concentrations of JNJ-79635322 will be reported.
|
Up to 5 years and 7 months
|
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Number of Participants With Anti-drug Antibodies (ADA) to JNJ-79635322
Tidsramme: 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.
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Up to 5 years and 7 months
|
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Number of Participants With Neutralizing Antibodies (NAb) to JNJ-79635322
Tidsramme: Up to 5 years and 7 months
|
Number of participants who are ADA-positive will be assessed for the presence of NAbs.
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Up to 5 years and 7 months
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
4. februar 2026
Primær færdiggørelse (Anslået)
12. december 2028
Studieafslutning (Anslået)
30. september 2031
Datoer for studieregistrering
Først indsendt
21. november 2025
Først indsendt, der opfyldte QC-kriterier
21. november 2025
Først opslået (Faktiske)
2. december 2025
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
28. august 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
27. august 2026
Sidst verificeret
1. august 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Karsygdomme
- Hjerte-kar-sygdomme
- Neoplasmer
- Sygdomme i immunsystemet
- Neoplasmer efter histologisk type
- Hæmatologiske sygdomme
- Lymfoproliferative lidelser
- Immunproliferative lidelser
- Neoplasmer, Plasmacelle
- Hæmostatiske lidelser
- Paraproteinæmier
- Blodproteinforstyrrelser
- Hæmoragiske lidelser
- Hemiske og lymfatiske sygdomme
- Myelomatose
Andre undersøgelses-id-numre
- 79635322MMY3001 (Janssen Research & Development, LLC)
- 2025 (U.S. NIH-bevilling/kontrakt: Faculty of Social Sciences Scientific Grant at the University of Gdańsk)
- 2025-522007-18-00 (Registry Identifier: EUCT number)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
JA
IPD-planbeskrivelse
Johnson & Johnson Innovative Medicines datadelingspolitik er tilgængelig på innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency.
Som nævnt på dette websted kan anmodninger om adgang til studiedata indsendes via Yale Open Data Access (YODA) Projects websted på yoda.yale.edu
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ja
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .