En studie som sammenligner JNJ-79635322 og et anti-B-celle modningsantigen (BCMA)xCD3 bispesifikt antistoff hos deltakere med tilbakevendende eller refraktær myelomatose (TRIlogy-4)
27. august 2026 oppdatert av: Janssen Research & Development, LLC
En fase 3 randomisert studie som sammenligner JNJ-79635322 og en anti-BCMAxCD3 bispesifikk antistoff hos deltakere med tilbakevendende eller refraktær myelomatose som har mottatt minst 3 tidligere behandlingslinjer inkludert en PI, en IMiD og et anti-CD38-antistoff
Formålet med denne studien er å evaluere hvor godt JNJ-79635322 fungerer sammenlignet med en anti-B-celle modningsantigen (BCMA)xCD3 bispesifikk antistoff.
Studieoversikt
Status
Rekruttering
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Antatt)
400
Fase
- Fase 3
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Study Contact
- Telefonnummer: 844-434-4210
- E-post: Participate-In-This-Study1@its.jnj.com
Studiesteder
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Box Hill, Australia, 3128
- Rekruttering
- Box Hill Hospital
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Brisbane, Australia, 4101
- Rekruttering
- Mater Misericordiae Ltd
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Clayton, Australia, 3168
- Rekruttering
- Monash Medical Centre
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Fitzroy, Australia, 3065
- Rekruttering
- St Vincents Hospital Melbourne
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Melbourne, Australia, 3004
- Rekruttering
- The Alfred Hospital
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Murdoch, Australia, 6150
- Rekruttering
- Fiona Stanley Hospital
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Nedlands, Australia, 6009
- Rekruttering
- Sir Charles Gairdner Hospital
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Southport, Australia, 4215
- Rekruttering
- Gold Coast University Hospital
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Campinas, Brasil, 13083-888
- Rekruttering
- Hospital das Clinicas da Universidade Estadual de Campinas UNICAMP
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Caxias do Sul, Brasil, 95070 560
- Rekruttering
- Fundacao Universidade de Caxias Do Sul
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Curitiba, Brasil, 81520-060
- Rekruttering
- Hospital Erasto Gaertner- Liga Paranaense de Combate ao Cancer
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Florianópolis, Brasil, 88020 210
- Rekruttering
- Grupo ELORA Centro de Pesquisa e Ensino em Saude de Santa Catarina
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Rio de Janeiro, Brasil, 22775 001
- Rekruttering
- Instituto de Educacao, Pesquisa e Gestao em Saude Instituto Americas (COI)
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Salvador, Brasil, 41253-190
- Rekruttering
- IDOR - Regional Bahia
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São José do Rio Preto, Brasil, 15090-000
- Rekruttering
- Funfarme Sjrp
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São Paulo, Brasil, 01509 900
- Rekruttering
- Fundacao Antonio Prudente A C Camargo Cancer Center
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São Paulo, Brasil, 05652 900
- Rekruttering
- Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein
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São Paulo, Brasil, 04537 081
- Rekruttering
- Clinica Medica Sao Germano LTDA
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São Paulo, Brasil, 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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Arizona
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Phoenix, Arizona, Forente stater, 85054
- Rekruttering
- Mayo Clinic Phoenix
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Arkansas
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Little Rock, Arkansas, Forente stater, 72205
- Rekruttering
- UAMS
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California
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Duarte, California, Forente stater, 91010
- Rekruttering
- City of Hope Duarte
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Irvine, California, Forente stater, 92618
- Rekruttering
- City of Hope Orange County Lennar Foundation Cancer Center
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Los Angeles, California, Forente stater, 90033
- Rekruttering
- USC Norris Comprehensive Cancer Center
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San Francisco, California, Forente stater, 94122
- Rekruttering
- University of California San Francisco
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Colorado
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Denver, Colorado, Forente stater, 80218
- Rekruttering
- Colorado Blood Cancer Institute
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Connecticut
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Farmington, Connecticut, Forente stater, 06030
- Rekruttering
- University of Connecticut Health Center
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New Haven, Connecticut, Forente stater, 06510
- Rekruttering
- Yale Cancer Center
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Florida
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Fort Myers, Florida, Forente stater, 33901
- Rekruttering
- Florida Cancer Specialists & Research Institute
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Jacksonville, Florida, Forente stater, 32224
- Rekruttering
- Mayo Clinic Jacksonville
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Tampa, Florida, Forente stater, 33612
- Rekruttering
- Moffit Cancer Center
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Georgia
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Atlanta, Georgia, Forente stater, 30322
- Rekruttering
- Emory University
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Illinois
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Zion, Illinois, Forente stater, 60099
- Rekruttering
- City of Hope Chicago
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Iowa
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Iowa City, Iowa, Forente stater, 52242
- Rekruttering
- University of Iowa Hospital and Clinics
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Waukee, Iowa, Forente stater, 50263
- Rekruttering
- Mission Cancer Blood
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Kansas
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Kansas City, Kansas, Forente stater, 66160
- Rekruttering
- University of Kansas Cancer Center
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Kentucky
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Louisville, Kentucky, Forente stater, 40207
- Rekruttering
- Norton Cancer Institute
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Maryland
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Baltimore, Maryland, Forente stater, 21201
- Rekruttering
- University of Maryland School of Medicine
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Minnesota
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Rochester, Minnesota, Forente stater, 55905
- Rekruttering
- Mayo Clinic Rochester
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New York
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Brooklyn, New York, Forente stater, 11234
- Rekruttering
- Mount Sinai Brooklyn
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Mineola, New York, Forente stater, 11501
- Rekruttering
- NYU Winthrop
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New York, New York, Forente stater, 10065
- Rekruttering
- Memorial Sloan Kettering Cancer Center
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New York, New York, Forente stater, 10011
- Rekruttering
- Mount Sinai Chelsea
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New York, New York, Forente stater, 10029
- Rekruttering
- Icahn School of Medicine at Mount Sinai
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New York, New York, Forente 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, Forente stater, 27514
- Rekruttering
- University of North Carolina
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Durham, North Carolina, Forente stater, 27705
- Rekruttering
- Durham VAMC
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Oregon
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Portland, Oregon, Forente stater, 97239
- Rekruttering
- Oregon Health and Science University
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Pennsylvania
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Philadelphia, Pennsylvania, Forente stater, 19107
- Rekruttering
- Thomas Jefferson University Hospital
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Philadelphia, Pennsylvania, Forente stater, 19111
- Rekruttering
- Fox Chase Cancer Center
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Tennessee
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Nashville, Tennessee, Forente stater, 37232
- Rekruttering
- Vanderbilt University Medical Center
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Nashville, Tennessee, Forente stater, 37203
- Rekruttering
- SCRI Oncology Partners
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Texas
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Austin, Texas, Forente stater, 78704
- Rekruttering
- St. David's South Austin Medical Center
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Dallas, Texas, Forente stater, 75390
- Rekruttering
- UT Southwestern Medical Center
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Dallas, Texas, Forente stater, 75246
- Rekruttering
- Baylor University Medical Center
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San Antonio, Texas, Forente stater, 78229
- Rekruttering
- Texas Transplant Institute
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Utah
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Salt Lake City, Utah, Forente stater, 84112
- Rekruttering
- Huntsman Cancer Institute
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Wisconsin
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Milwaukee, Wisconsin, Forente stater, 53226
- Rekruttering
- Medical College of Wisconsin
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Lille, Frankrike, 59000
- Rekruttering
- CHRU de Lille Hopital Claude Huriez
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Lyon, Frankrike, 69002
- Rekruttering
- Hospices Civils de Lyon HCL
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Nantes, Frankrike, 44000
- Rekruttering
- Hotel Dieu CHU de Nantes
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Paris, Frankrike, 75010
- Rekruttering
- Hopital Saint Louis APHP
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Paris, Frankrike, 75012
- Rekruttering
- APHP
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Pessac, Frankrike, 33600
- Rekruttering
- CHU de Bordeaux - Hospital Haut-Leveque
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Poitiers, Frankrike, 86021
- Rekruttering
- CHU De Poitiers
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Toulouse, Frankrike, 31300
- Rekruttering
- CHU Toulouse
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Tours, Frankrike, 37000
- Rekruttering
- CHRU de Tours
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Athens, Hellas, 11528
- Rekruttering
- Alexandra General Hospital of Athens
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Athens, Hellas, 106 76
- Rekruttering
- Evangelismos S A
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Thessaloniki, Hellas, 570 10
- Rekruttering
- Geniko Nosokomeio Thessalonikis George Papanikolaou
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Thessaloniki, Hellas, 546 39
- Rekruttering
- Theageneio Cancer Hospital
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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, Italia, 15121
- Rekruttering
- A.O.U. SS. Antonio e Biagio e Cesare Arrigo
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Brescia, Italia, 25123
- Rekruttering
- Spedali Civili di Brescia
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Milan, Italia, 20122
- Rekruttering
- Fondazione IRCCS Ca Granda Ospedale Policlinico Di Milano
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Pisa, Italia, 56126
- Rekruttering
- Ospedale Santa Chiara AO Universitaria Pisana
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Reggio Emilia, Italia, 42123
- Rekruttering
- Arcispedale Santa Maria Nuova - IRCCS
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Roma, Italia, 00168
- Rekruttering
- Fondazione Policlinico Universitario A Gemelli IRCCS
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Roma, Italia, 00128
- Rekruttering
- Campus Bio Medico di Roma
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Rozzano, Italia, 20089
- Rekruttering
- Humanitas Hospital
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San Giovanni Rotondo, Italia, 71013
- Rekruttering
- Casa Sollievo Della Sofferenza IRCCS
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Vicenza, Italia, 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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Amsterdam, Nederland, 1081 HV
- Rekruttering
- VU Medisch Centrum
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Groningen, Nederland, 9713 GZ
- Rekruttering
- Universitair Medisch Centrum Groningen
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Nieuwegein, Nederland, 3435 CM
- Rekruttering
- St. Antonius Ziekenhuis Nieuwegein
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Nijmegen, Nederland, 6525 GA
- Rekruttering
- Radboud Umcn
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Rotterdam, Nederland, 3015
- Rekruttering
- Erasmus MC
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The Hague, Nederland, 2545 AA
- Rekruttering
- Haga Ziekenhuis
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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, Spania, 08916
- Rekruttering
- Hosp. Univ. Germans Trias I Pujol
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Barcelona, Spania, 08036
- Rekruttering
- Hosp. Clinic de Barcelona
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Barcelona, Spania, 08035
- Rekruttering
- H. Vall D'Hebron
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Granada, Spania, 18014
- Rekruttering
- Hosp. Univ. Virgen de Las Nieves
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Madrid, Spania, 28041
- Rekruttering
- Hosp. Univ. 12 de Octubre
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Pozuelo de Alarcón, Spania, 28223
- Rekruttering
- Hosp. Quiron Madrid Pozuelo
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Salamanca, Spania, 37007
- Rekruttering
- Hosp Clinico Univ de Salamanca
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Usansolo, Spania, 48960
- Rekruttering
- Hosp de Galdakao
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Valencia, Spania, 46026
- Rekruttering
- Hosp. Univ. I Politecni La Fe
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Canterbury, Storbritannia, CT1 3NG
- Rekruttering
- Kent and Canterbury Hospital
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Cardiff, Storbritannia, CF14 4XW
- Rekruttering
- Cardiff and Vale UHB - University Hospital of Wales
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Dundee, Storbritannia, DD1 9SY
- Rekruttering
- Ninewells Hospital & Medical School
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London, Storbritannia, NW1 2PG
- Rekruttering
- University College London Hospitals
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Nottingham, Storbritannia, NG5 1PB
- Rekruttering
- Nottingham City Hospital
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Portsmouth, Storbritannia, PO6 3LY
- Rekruttering
- Queen Alexandra Hospital
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Sutton, Storbritannia, SM2 5PT
- Rekruttering
- Royal Marsden Hospital
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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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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Beskrivelse
Inklusjon:
Dokumentert diagnose av multippel myelom (MM) som definert av kriteriene nedenfor:
- MM-diagnose i henhold til de internasjonale myelom arbeidsgruppens (IMWG) diagnostiske kriterier
- Målbar sykdom ved screening vurdert av sentrallaboratorium
- Har mottatt minst 3 tidligere behandlingslinjer med antimyelomterapi inkludert en proteasomhemmer (PI), et immunmodulerende legemiddel (IMiD) og et antistoff mot differensieringskluster (CD)38
- Dokumentert bevis på progressiv sykdom (PD) eller manglende respons (dvs. delvis respons [PR] eller bedre) på siste behandlingslinje basert på forskerens vurdering av respons etter IMWG-kriterier
- Har avsluttet samtidig bruk av annen kreftbehandling (inkludert ikke-palliativ stråleterapi) eller forsøkspreparat
- Har en Eastern Cooperative Oncology Group (ECOG) ytelsesstatus på 0 til 2 ved screening og umiddelbart før start av studibehandling
Eksklusjon:
- Aktiv hepatitt av infeksiøs opprinnelse
- Kjent aktiv eller tidligere sentralnervesystem (CNS) involvering eller viser kliniske tegn på meningeal involvering av MM
- Mistenkt eller kjent allergi, overfølsomhet eller intoleranse mot hjelpestoffene i JNJ-79635322 og Teclistamab
- Større kirurgi (for eksempel som krever generell anestesi) innen 2 uker før screening, eller har ikke fullstendig restituert seg fra kirurgi, eller har planlagt kirurgi i perioden deltakeren forventes å delta i studien
- Har mottatt eller planlegger å motta levende, attenuert vaksine innen 4 uker før første dose studibehandling, under eller innen 90 dager etter siste dose studibehandling
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: JNJ-79635322
Deltakerne vil motta subkutan (SC) dose av JNJ-79635322 inntil progresjon av sykdom (PD) eller uutholdelig toksisitet.
|
JNJ-79635322 vil bli administrert som SC-injeksjon.
|
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Aktiv komparator: Anti BCMAxCD3 Bispesifikt Antistoff
Deltakerne vil motta teclistamab (en Anti BCMAxCD3 bispesifikk antistoff) som en subkutan injeksjon inntil PD eller uutholdelig toksisitet.
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Teclistamab vil bli administrert som subkutan injeksjon.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Overall Response
Tidsramme: Up to 5 years and 7 months
|
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
|
PFS is defined as the duration from the date of randomization to either progressive disease (PD) or death, whichever comes first.
Disease progression will be determined according to the IMWG response criteria.
|
Up to 5 years and 7 months
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
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.
|
Up to 5 years and 7 months
|
|
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.
|
Up to 5 years and 7 months
|
|
Duration of Response (DoR)
Tidsramme: Up to 5 years and 7 months
|
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.
|
Up to 5 years and 7 months
|
|
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.
|
Up to 5 years and 7 months
|
|
MRD-Negative CR at 12 months
Tidsramme: 12 months
|
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.
|
12 months
|
|
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.
|
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.
|
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
|
|
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.
|
Up to 5 years and 7 months
|
|
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.
|
Up to 5 years and 7 months
|
|
Number of Participants with Abnormalities in Clinical Laboratories Results
Tidsramme: 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
Tidsramme: 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
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.
|
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
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.
|
Baseline up to 5 years and 7 months
|
|
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
|
|
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
|
|
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.
|
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
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.
|
Up to 5 years and 7 months
|
|
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
|
|
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.
|
Up to 5 years and 7 months
|
|
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.
|
Up to 5 years and 7 months
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
4. februar 2026
Primær fullføring (Antatt)
12. desember 2028
Studiet fullført (Antatt)
30. september 2031
Datoer for studieregistrering
Først innsendt
21. november 2025
Først innsendt som oppfylte QC-kriteriene
21. november 2025
Først lagt ut (Faktiske)
2. desember 2025
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
28. august 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
27. august 2026
Sist bekreftet
1. august 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Vaskulære sykdommer
- Kardiovaskulære sykdommer
- Neoplasmer
- Sykdommer i immunsystemet
- Neoplasmer etter histologisk type
- Hematologiske sykdommer
- Lymfoproliferative lidelser
- Immunproliferative lidelser
- Neoplasmer, plasmacelle
- Hemostatiske lidelser
- Paraproteinemier
- Blodproteinforstyrrelser
- Hemoragiske lidelser
- Hemic og lymfatiske sykdommer
- Multippelt myelom
Andre studie-ID-numre
- 79635322MMY3001 (Janssen Research & Development, LLC)
- 2025 (U.S. NIH-stipend/kontrakt: Faculty of Social Sciences Scientific Grant at the University of Gdańsk)
- 2025-522007-18-00 (Registeridentifikator: EUCT number)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
JA
IPD-planbeskrivelse
Datadelingspolitikken til Johnson & Johnson Innovative Medicine er tilgjengelig på innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency.
Som nevnt på dette nettstedet, kan forespørsler om tilgang til studiedata sendes gjennom Yale Open Data Access (YODA) Project-nettstedet på yoda.yale.edu
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Ja
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .