En studie som jämför JNJ-79635322 och ett anti-B-cellmognadsantigen (BCMA)xCD3 bispecifikt antikropp hos deltagare med återfallande eller refraktär multipelt myelom (TRIlogy-4)
En fas 3-randomiserad studie som jämför JNJ-79635322 och en anti-BCMAxCD3-bispecifik antikropp hos deltagare med återkommande eller refraktär multipel myelom som har fått minst 3 tidigare behandlingslinjer inklusive en PI, en IMiD och en anti-CD38-antikropp
The purpose of this study is to evaluate how well JNJ-79635322 works when compared with an anti-B-cell maturation antigen (BCMA)xCD3 bispecific antibody.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Beräknad)
Fas
- Fas 3
Kontakter och platser
Studiekontakt
- Namn: Study Contact
- Telefonnummer: 844-434-4210
- E-post: Participate-In-This-Study1@its.jnj.com
Studieorter
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Box Hill, Australien, 3128
- Rekrytering
- Box Hill Hospital
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Brisbane, Australien, 4101
- Rekrytering
- Mater Misericordiae Ltd
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Clayton, Australien, 3168
- Rekrytering
- Monash Medical Centre
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Fitzroy, Australien, 3065
- Rekrytering
- St Vincents Hospital Melbourne
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Melbourne, Australien, 3004
- Rekrytering
- The Alfred Hospital
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Murdoch, Australien, 6150
- Rekrytering
- Fiona Stanley Hospital
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Nedlands, Australien, 6009
- Rekrytering
- Sir Charles Gairdner Hospital
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Southport, Australien, 4215
- Rekrytering
- Gold Coast University Hospital
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Campinas, Brasilien, 13083-888
- Rekrytering
- Hospital das Clinicas da Universidade Estadual de Campinas UNICAMP
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Caxias do Sul, Brasilien, 95070 560
- Rekrytering
- Fundacao Universidade de Caxias do Sul
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Curitiba, Brasilien, 81520-060
- Rekrytering
- Hospital Erasto Gaertner- Liga Paranaense de Combate ao Cancer
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Florianópolis, Brasilien, 88020 210
- Rekrytering
- Grupo ELORA Centro de Pesquisa e Ensino em Saude de Santa Catarina
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Rio de Janeiro, Brasilien, 22775 001
- Rekrytering
- Instituto de Educacao, Pesquisa e Gestao em Saude Instituto Americas (COI)
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Salvador, Brasilien, 41253-190
- Rekrytering
- IDOR - Regional Bahia
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São José do Rio Preto, Brasilien, 15090-000
- Rekrytering
- Funfarme Sjrp
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São Paulo, Brasilien, 01509 900
- Rekrytering
- Fundacao Antonio Prudente A C Camargo Cancer Center
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São Paulo, Brasilien, 05652 900
- Rekrytering
- Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein
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São Paulo, Brasilien, 04537 081
- Rekrytering
- Clinica Medica Sao Germano LTDA
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São Paulo, Brasilien, 01401 002
- Rekrytering
- IDOR - Regional Sao Paulo
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Lille, Frankrike, 59000
- Rekrytering
- CHRU de Lille Hopital Claude Huriez
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Lyon, Frankrike, 69002
- Rekrytering
- Hospices Civils de Lyon HCL
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Nancy, Frankrike, 54000
- Rekrytering
- Centre Hospitalier Universitaire de Nancy - Hôpital Central
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Nantes, Frankrike, 44000
- Rekrytering
- Hotel Dieu CHU de Nantes
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Paris, Frankrike, 75010
- Rekrytering
- Hopital Saint Louis APHP
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Paris, Frankrike, 75012
- Rekrytering
- APHP
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Paris, Frankrike, 75015
- Rekrytering
- Necker Hospital APHP
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Pessac, Frankrike, 33600
- Rekrytering
- CHU de Bordeaux - Hospital Haut-Leveque
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Poitiers, Frankrike, 86021
- Rekrytering
- CHU De Poitiers
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Toulouse, Frankrike, 31300
- Rekrytering
- CHU Toulouse
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Tours, Frankrike, 37000
- Rekrytering
- CHRU de Tours
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Arizona
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Phoenix, Arizona, Förenta staterna, 85054
- Rekrytering
- Mayo Clinic Phoenix
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Arkansas
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Little Rock, Arkansas, Förenta staterna, 72205
- Rekrytering
- UAMS
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California
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Duarte, California, Förenta staterna, 91010
- Rekrytering
- City of Hope Duarte
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Irvine, California, Förenta staterna, 92618
- Rekrytering
- City of Hope Orange County Lennar Foundation Cancer Center
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Los Angeles, California, Förenta staterna, 90095
- Rekrytering
- UCLA Medical Center
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Los Angeles, California, Förenta staterna, 90033
- Rekrytering
- USC Norris Comprehensive Cancer Center
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San Francisco, California, Förenta staterna, 94122
- Rekrytering
- University of California San Francisco
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Colorado
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Denver, Colorado, Förenta staterna, 80218
- Rekrytering
- Colorado Blood Cancer Institute
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Connecticut
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Farmington, Connecticut, Förenta staterna, 06030
- Rekrytering
- University of Connecticut Health Center
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New Haven, Connecticut, Förenta staterna, 06510
- Rekrytering
- Yale Cancer Center
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Florida
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Fort Myers, Florida, Förenta staterna, 33901
- Rekrytering
- Florida Cancer Specialists & Research Institute
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Jacksonville, Florida, Förenta staterna, 32224
- Rekrytering
- Mayo Clinic Jacksonville
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Miami, Florida, Förenta staterna, 33136
- Rekrytering
- University of Miami Hospital
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Tampa, Florida, Förenta staterna, 33612
- Rekrytering
- Moffit Cancer center
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Georgia
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Atlanta, Georgia, Förenta staterna, 30322
- Rekrytering
- Emory University
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Illinois
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Zion, Illinois, Förenta staterna, 60099
- Rekrytering
- City of Hope Chicago
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Iowa
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Iowa City, Iowa, Förenta staterna, 52242
- Rekrytering
- University of Iowa Hospital and Clinics
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Waukee, Iowa, Förenta staterna, 50263
- Rekrytering
- Mission Cancer Blood
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Kansas
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Kansas City, Kansas, Förenta staterna, 66160
- Rekrytering
- University of Kansas Cancer Center
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Kentucky
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Louisville, Kentucky, Förenta staterna, 40207
- Rekrytering
- Norton Cancer Institute
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Maryland
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Baltimore, Maryland, Förenta staterna, 21201
- Rekrytering
- University of Maryland School of Medicine
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Massachusetts
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Boston, Massachusetts, Förenta staterna, 02215
- Rekrytering
- Beth Israel Deaconess Medical Center
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Boston, Massachusetts, Förenta staterna, 02115
- Rekrytering
- Dana Farber Cancer Institute
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Boston, Massachusetts, Förenta staterna, 02118
- Rekrytering
- Boston University Medical Center
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Michigan
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Ann Arbor, Michigan, Förenta staterna, 48109
- Rekrytering
- University of Michigan Rogel Cancer Center
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Minnesota
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Rochester, Minnesota, Förenta staterna, 55905
- Rekrytering
- Mayo Clinic Rochester
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New York
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Brooklyn, New York, Förenta staterna, 11234
- Rekrytering
- Mount Sinai Brooklyn
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Mineola, New York, Förenta staterna, 11501
- Rekrytering
- NYU Winthrop
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New York, New York, Förenta staterna, 10065
- Rekrytering
- Memorial Sloan Kettering Cancer Center
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New York, New York, Förenta staterna, 10011
- Rekrytering
- Mount Sinai Chelsea
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New York, New York, Förenta staterna, 10029
- Rekrytering
- Icahn School of Medicine at Mount Sinai
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New York, New York, Förenta staterna, 10016
- Rekrytering
- Laura and Isaac Perlmutter Cancer Center NYU ACC
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North Carolina
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Chapel Hill, North Carolina, Förenta staterna, 27514
- Rekrytering
- University of North Carolina
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Durham, North Carolina, Förenta staterna, 27705
- Rekrytering
- Durham VAMC
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Ohio
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Cleveland, Ohio, Förenta staterna, 44195
- Rekrytering
- Cleveland Clinic
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Oregon
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Portland, Oregon, Förenta staterna, 97239
- Rekrytering
- Oregon Health And Science University
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Pennsylvania
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Philadelphia, Pennsylvania, Förenta staterna, 19107
- Rekrytering
- Thomas Jefferson University Hospital
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Philadelphia, Pennsylvania, Förenta staterna, 19111
- Rekrytering
- Fox Chase Cancer Center
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Tennessee
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Nashville, Tennessee, Förenta staterna, 37232
- Rekrytering
- Vanderbilt University Medical Center
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Nashville, Tennessee, Förenta staterna, 37203
- Rekrytering
- SCRI Oncology Partners
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Texas
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Austin, Texas, Förenta staterna, 78704
- Rekrytering
- St. David's South Austin Medical Center
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Dallas, Texas, Förenta staterna, 75390
- Rekrytering
- UT Southwestern Medical Center
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Dallas, Texas, Förenta staterna, 75246
- Rekrytering
- Baylor University Medical Center
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Houston, Texas, Förenta staterna, 77030
- Rekrytering
- MD Anderson Cancer Center
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San Antonio, Texas, Förenta staterna, 78229
- Rekrytering
- Texas Transplant Institute
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Utah
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Salt Lake City, Utah, Förenta staterna, 84112
- Rekrytering
- Huntsman Cancer Institute
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Wisconsin
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Milwaukee, Wisconsin, Förenta staterna, 53226
- Rekrytering
- Medical College Of Wisconsin
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Athens, Grekland, 11528
- Rekrytering
- Alexandra General Hospital of Athens
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Athens, Grekland, 106 76
- Rekrytering
- Evangelismos S A
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Thessaloniki, Grekland, 570 10
- Rekrytering
- Geniko Nosokomeio Thessalonikis George Papanikolaou
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Thessaloniki, Grekland, 546 39
- Rekrytering
- Theageneio Cancer Hospital
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Beersheba, Israel, 8457108
- Rekrytering
- Soroka Medical Center
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Haifa, Israel, 3109601
- Rekrytering
- Rambam Medical Center
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Haifa, Israel, 34362
- Rekrytering
- Carmel Medical Center
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Haifa, Israel, 31048
- Rekrytering
- Bnai Zion Medical Center
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Jerusalem, Israel, 9103102
- Rekrytering
- Shaare Zedek MC
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Ramat Gan, Israel, 52621
- Rekrytering
- Sheba Medical Center
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Ramat Poriya, Israel, 1520800
- Rekrytering
- Baruch Padeh MC
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Tel Aviv, Israel, 69710
- Rekrytering
- Assuta MC
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Alessandria, Italien, 15121
- Rekrytering
- A.O.U. SS. Antonio e Biagio e Cesare Arrigo
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Brescia, Italien, 25123
- Rekrytering
- Spedali Civili di Brescia
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Milan, Italien, 20122
- Rekrytering
- Fondazione IRCCS Ca Granda Ospedale Policlinico Di Milano
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Naples, Italien, 80131
- Rekrytering
- Azienda Ospedaliera Universitaria Federico II
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Pisa, Italien, 56126
- Rekrytering
- Ospedale Santa Chiara AO Universitaria Pisana
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Reggio Emilia, Italien, 42123
- Rekrytering
- Arcispedale Santa Maria Nuova - IRCCS
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Roma, Italien, 00168
- Rekrytering
- Fondazione Policlinico Universitario A Gemelli IRCCS
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Roma, Italien, 00128
- Rekrytering
- Campus Bio Medico di Roma
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Rozzano, Italien, 20089
- Rekrytering
- Humanitas Hospital
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San Giovanni Rotondo, Italien, 71013
- Rekrytering
- Casa Sollievo Della Sofferenza IRCCS
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Turin, Italien, 10126
- Rekrytering
- A.O.U. Citta della Salute e della Scienza di Torino - Presidio Molinette
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Vicenza, Italien, 36100
- Rekrytering
- U.O. Ematologia Ospedale San Bortolo
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Bunkyō City, Japan, 113 8677
- Rekrytering
- Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
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Chiba, Japan, 260 0801
- Rekrytering
- Chiba Cancer Center
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Kamakura-shi, Japan, 247-8533
- Rekrytering
- Shonan Kamakura General Hospital
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Kamogawa, Japan, 296-8602
- Rekrytering
- Kameda Medical Center
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Kofu, Japan, 400-0027
- Rekrytering
- Yamanashi Prefectural Central Hospital
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Minato, Japan, 105-8471
- Rekrytering
- The Jikei University Hospital
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Shibuya City, Japan, 150-8935
- Rekrytering
- Japanese Red Cross Medical Center
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Yokohama, Japan, 241 8515
- Rekrytering
- Kanagawa Cancer Center
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Alberta
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Calgary, Alberta, Kanada, T2N 4N1
- Rekrytering
- Arthur J E Child Comprehensive Cancer Centre
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British Columbia
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Vancouver, British Columbia, Kanada, V5Z4E6
- Rekrytering
- British Columbia Cancer Agency
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Nova Scotia
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Halifax, Nova Scotia, Kanada, B3H 3A7
- Rekrytering
- Queen Elizabeth II Health Sciences Centre
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Ontario
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Hamilton, Ontario, Kanada, L8V5C2
- Rekrytering
- Juravinski Cancer Centre
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London, Ontario, Kanada, N6A 5W9
- Rekrytering
- London Health Sciences Centre
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Toronto, Ontario, Kanada, M5G 2M9
- Rekrytering
- University Health Network UHN Princess Margaret Cancer Centre
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Quebec
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Montreal, Quebec, Kanada, H1T 2M4
- Rekrytering
- CIUSSS de l Est de l Ile de Montreal Installation Hopital Maisonneuve Rosemont
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Beijing, Kina, 100034
- Rekrytering
- Peking University First Hospital
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Beijing, Kina, 100044
- Rekrytering
- Peking University People's Hospital
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Chengdu, Kina, 610032
- Rekrytering
- Sichuan Provincial Peoples Hospital
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Guangzhou, Kina, 510060
- Rekrytering
- Sun Yat Sen University Cancer Center
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Hangzhou, Kina, 310003
- Rekrytering
- First affiliated Hospital of Zhejiang University
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Nanjing, Kina, 210008
- Rekrytering
- Nanjing Drum Tower Hospital
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Nanning, Kina, 530021
- Rekrytering
- The First Affiliated Hospital of Guangxi Medical University
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Shanghai, Kina, 200434
- Rekrytering
- Shanghai Fourth People s Hospital
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Wenzhou, Kina, 325000
- Rekrytering
- The First Affiliated Hospital of Wenzhou Medical University
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Wuhan, Kina, 430032
- Rekrytering
- Wuhan Tongji Hospital Tongji Medical College
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Xi'an, Kina, 710006
- Rekrytering
- The Second Affiliated Hospital of Xi'an Jiaotong University
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Amsterdam, Nederländerna, 1081 HV
- Rekrytering
- VU Medisch Centrum
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Groningen, Nederländerna, 9713 GZ
- Rekrytering
- Universitair Medisch Centrum Groningen
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Nieuwegein, Nederländerna, 3435 CM
- Rekrytering
- St. Antonius Ziekenhuis Nieuwegein
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Nijmegen, Nederländerna, 6525 GA
- Rekrytering
- Radboud Umcn
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Rotterdam, Nederländerna, 3015
- Rekrytering
- Erasmus MC
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The Hague, Nederländerna, 2545 AA
- Rekrytering
- Haga ziekenhuis
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Lorenskog, Norge, 1478
- Rekrytering
- Akershus Universitetssykehus
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Oslo, Norge, 0450
- Rekrytering
- Oslo University Hospital HF Ulleval sykehus
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Stavanger, Norge, 4021
- Rekrytering
- Stavanger University Hospital Ullandhaug
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Trondheim, Norge, 7030
- Rekrytering
- St. Olavs Hospital
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Badalona, Spanien, 08916
- Rekrytering
- Hosp. Univ. Germans Trias I Pujol
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Barcelona, Spanien, 08036
- Rekrytering
- Hosp. Clinic de Barcelona
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Barcelona, Spanien, 08035
- Rekrytering
- H. Vall D'Hebron
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Granada, Spanien, 18014
- Rekrytering
- Hosp. Univ. Virgen de Las Nieves
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Madrid, Spanien, 28041
- Rekrytering
- Hosp. Univ. 12 de Octubre
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Pozuelo de Alarcón, Spanien, 28223
- Rekrytering
- Hosp. Quiron Madrid Pozuelo
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Salamanca, Spanien, 37007
- Rekrytering
- Hosp Clinico Univ de Salamanca
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Usansolo, Spanien, 48960
- Rekrytering
- Hosp de Galdakao
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Valencia, Spanien, 46026
- Rekrytering
- Hosp. Univ. I Politecni La Fe
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Canterbury, Storbritannien, CT1 3NG
- Rekrytering
- Kent and Canterbury Hospital
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Cardiff, Storbritannien, CF14 4XW
- Rekrytering
- Cardiff and Vale UHB - University Hospital of Wales
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Dundee, Storbritannien, DD1 9SY
- Rekrytering
- Ninewells Hospital & Medical School
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London, Storbritannien, NW1 2PG
- Rekrytering
- University College London Hospitals
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Nottingham, Storbritannien, NG5 1PB
- Rekrytering
- Nottingham City Hospital
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Portsmouth, Storbritannien, PO6 3LY
- Rekrytering
- Queen Alexandra Hospital
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Sutton, Storbritannien, SM2 5PT
- Rekrytering
- Royal Marsden Hospital
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Düsseldorf, Tyskland, 40479
- Rekrytering
- Marien Hospital Dusseldorf
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Heidelberg, Tyskland, 69120
- Rekrytering
- Universitaetsklinikum Heidelberg
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Jena, Tyskland, 07747
- Rekrytering
- Universitatsklinikum Jena
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Würzburg, Tyskland, 97080
- Rekrytering
- Universitaetsklinikum Wuerzburg
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion:
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Documented diagnosis of multiple myeloma (MM) as defined by the criteria below:
- MM diagnosis according to the international myeloma working group (IMWG) diagnostic criteria
- Measurable disease at screening as assessed by central laboratory
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Received at least 3 prior lines of antimyeloma therapy including a proteasome inhibitor (PI), an immunomodulatory drug (IMiD), and an anti-cluster of differentiation (CD)38 antibody
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Documented evidence of progressive disease (PD) or failure to achieve a response to the last line of therapy based on investigator's determination of response by IMWG criteria
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Toxicity related to previous anticancer therapy must have resolved to Grade 1 or better
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Have an eastern cooperative oncology group (ECOG) performance status of 0 to 2 at screening and immediately before the start of study treatment administration
Exclusion:
- Active hepatitis of infectious origin
- Known active or prior central nervous system (CNS) involvement or exhibits clinical signs of meningeal involvement of MM
- Suspected or known allergies, hypersensitivity, or intolerance to the excipients of JNJ-79635322 and Teclistamab
- Major surgery, (example, requiring general anesthesia) within 2 weeks before first dose, or will not have fully recovered from surgery, or has surgery planned during the time the participant is expected to participate in the study
- Received or plans to receive any live, attenuated vaccine within 4 weeks before the first dose of study treatment, or during study treatment
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: JNJ-79635322
Participants will receive subcutaneous (SC) dose of JNJ-79635322 until progressive disease (PD) or intolerable toxicity. |
JNJ-79635322 will be administered as SC injection. |
|
Aktiv komparator: Anti BCMAxCD3 Bispecific Antibody
Participants will receive teclistamab (an Anti BCMAxCD3 bispecific anitbody) as a SC injection until PD or intolerable toxicity. |
Teclistamab will be administered as SC injection. |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Overall Response
Tidsram: 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. |
Up to 5 years and 7 months
|
|
Progression-Free Survival (PFS)
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Very Good Partial Response (VGPR) or Better
Tidsram: 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
Tidsram: 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)
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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)
Tidsram: 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)
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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)
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
|
Samarbetspartners och utredare
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Kärlsjukdomar
- Hjärt-kärlsjukdomar
- Neoplasmer
- Immunsystemets sjukdomar
- Neoplasmer efter histologisk typ
- Hematologiska sjukdomar
- Lymfoproliferativa störningar
- Immunproliferativa störningar
- Neoplasmer, Plasmacell
- Hemostatiska störningar
- Paraproteinemier
- Blodproteinstörningar
- Hemorragiska störningar
- Hemiska och lymfsjukdomar
- Multipelt myelom
Andra studie-ID-nummer
- 79635322MMY3001
- 2025-522007-18-00 (Registeridentifierare: EUCT number)
- 2025 (U.S.S. NIH-anslag/kontrakt)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
IPD-planbeskrivning
The data sharing policy of Johnson & Johnson Innovative Medicine is available at innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
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