재발 또는 불응성 다발성 골수종 환자를 대상으로 JNJ-79635322와 항 B 세포 성숙 항원(BCMA)xCD3 이중특이항체를 비교하는 연구 (TRIlogy-4)
재발성 또는 불응성 다발성 골수종 환자를 대상으로 한 JNJ-79635322와 항-BCMAxCD3 이중특이성 항체 비교 3상 무작위 연구: PI, IMiD 및 항-CD38 항체를 포함한 최소 3가지 이전 치료 요법을 받은 환자 대상
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.
연구 개요
연구 유형
등록 (추정된)
단계
- 3단계
연락처 및 위치
연구 연락처
- 이름: Study Contact
- 전화번호: 844-434-4210
- 이메일: Participate-In-This-Study1@its.jnj.com
연구 장소
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Athens, 그리스, 11528
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- Alexandra General Hospital of Athens
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Athens, 그리스, 106 76
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- Evangelismos S A
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Thessaloniki, 그리스, 570 10
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- Geniko Nosokomeio Thessalonikis George Papanikolaou
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Thessaloniki, 그리스, 546 39
- 모병
- Theageneio Cancer Hospital
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Amsterdam, 네덜란드, 1081 HV
- 모병
- VU Medisch Centrum
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Groningen, 네덜란드, 9713 GZ
- 모병
- Universitair Medisch Centrum Groningen
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Nieuwegein, 네덜란드, 3435 CM
- 모병
- St. Antonius Ziekenhuis Nieuwegein
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Nijmegen, 네덜란드, 6525 GA
- 모병
- Radboud Umcn
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Rotterdam, 네덜란드, 3015
- 모병
- Erasmus MC
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The Hague, 네덜란드, 2545 AA
- 모병
- Haga ziekenhuis
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Lorenskog, 노르웨이, 1478
- 모병
- Akershus Universitetssykehus
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Oslo, 노르웨이, 0450
- 모병
- Oslo University Hospital HF Ulleval sykehus
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Stavanger, 노르웨이, 4021
- 모병
- Stavanger University Hospital Ullandhaug
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Trondheim, 노르웨이, 7030
- 모병
- St. Olavs Hospital
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Düsseldorf, 독일, 40479
- 모병
- Marien Hospital Dusseldorf
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Heidelberg, 독일, 69120
- 모병
- Universitaetsklinikum Heidelberg
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Jena, 독일, 07747
- 모병
- Universitatsklinikum Jena
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Würzburg, 독일, 97080
- 모병
- Universitaetsklinikum Wuerzburg
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Arizona
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Phoenix, Arizona, 미국, 85054
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- Mayo Clinic Phoenix
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Arkansas
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Little Rock, Arkansas, 미국, 72205
- 모병
- UAMS
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California
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Duarte, California, 미국, 91010
- 모병
- City of Hope Duarte
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Irvine, California, 미국, 92618
- 모병
- City of Hope Orange County Lennar Foundation Cancer Center
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Los Angeles, California, 미국, 90095
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- UCLA Medical Center
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Los Angeles, California, 미국, 90033
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- USC Norris Comprehensive Cancer Center
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San Francisco, California, 미국, 94122
- 모병
- University of California San Francisco
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Colorado
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Denver, Colorado, 미국, 80218
- 모병
- Colorado Blood Cancer Institute
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Connecticut
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Farmington, Connecticut, 미국, 06030
- 모병
- University of Connecticut Health Center
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New Haven, Connecticut, 미국, 06510
- 모병
- Yale Cancer Center
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Florida
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Fort Myers, Florida, 미국, 33901
- 모병
- Florida Cancer Specialists & Research Institute
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Jacksonville, Florida, 미국, 32224
- 모병
- Mayo Clinic Jacksonville
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Miami, Florida, 미국, 33136
- 모병
- University of Miami Hospital
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Tampa, Florida, 미국, 33612
- 모병
- Moffit Cancer center
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Georgia
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Atlanta, Georgia, 미국, 30322
- 모병
- Emory University
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Illinois
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Zion, Illinois, 미국, 60099
- 모병
- City of Hope Chicago
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Iowa
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Iowa City, Iowa, 미국, 52242
- 모병
- University of Iowa Hospital and Clinics
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Waukee, Iowa, 미국, 50263
- 모병
- Mission Cancer Blood
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Kansas
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Kansas City, Kansas, 미국, 66160
- 모병
- University of Kansas Cancer Center
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Kentucky
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Louisville, Kentucky, 미국, 40207
- 모병
- Norton Cancer Institute
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Maryland
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Baltimore, Maryland, 미국, 21201
- 모병
- University of Maryland School of Medicine
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Massachusetts
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Boston, Massachusetts, 미국, 02215
- 모병
- Beth Israel Deaconess Medical Center
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Boston, Massachusetts, 미국, 02115
- 모병
- Dana Farber Cancer Institute
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Boston, Massachusetts, 미국, 02118
- 모병
- Boston University Medical Center
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Michigan
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Ann Arbor, Michigan, 미국, 48109
- 모병
- University of Michigan Rogel Cancer Center
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Minnesota
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Rochester, Minnesota, 미국, 55905
- 모병
- Mayo Clinic Rochester
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New York
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Brooklyn, New York, 미국, 11234
- 모병
- Mount Sinai Brooklyn
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Mineola, New York, 미국, 11501
- 모병
- NYU Winthrop
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New York, New York, 미국, 10065
- 모병
- Memorial Sloan Kettering Cancer Center
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New York, New York, 미국, 10011
- 모병
- Mount Sinai Chelsea
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New York, New York, 미국, 10029
- 모병
- Icahn School of Medicine at Mount Sinai
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New York, New York, 미국, 10016
- 모병
- Laura and Isaac Perlmutter Cancer Center NYU ACC
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North Carolina
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Chapel Hill, North Carolina, 미국, 27514
- 모병
- University of North Carolina
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Durham, North Carolina, 미국, 27705
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- Durham VAMC
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Ohio
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Cleveland, Ohio, 미국, 44195
- 모병
- Cleveland Clinic
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Oregon
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Portland, Oregon, 미국, 97239
- 모병
- Oregon Health And Science University
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Pennsylvania
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Philadelphia, Pennsylvania, 미국, 19107
- 모병
- Thomas Jefferson University Hospital
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Philadelphia, Pennsylvania, 미국, 19111
- 모병
- Fox Chase Cancer Center
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Tennessee
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Nashville, Tennessee, 미국, 37232
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- Vanderbilt University Medical Center
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Nashville, Tennessee, 미국, 37203
- 모병
- SCRI Oncology Partners
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Texas
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Austin, Texas, 미국, 78704
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- St. David's South Austin Medical Center
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Dallas, Texas, 미국, 75390
- 모병
- UT Southwestern Medical Center
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Dallas, Texas, 미국, 75246
- 모병
- Baylor University Medical Center
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Houston, Texas, 미국, 77030
- 모병
- MD Anderson Cancer Center
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San Antonio, Texas, 미국, 78229
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- Texas Transplant Institute
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Utah
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Salt Lake City, Utah, 미국, 84112
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- Huntsman Cancer Institute
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Wisconsin
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Milwaukee, Wisconsin, 미국, 53226
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- Medical College Of Wisconsin
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Campinas, 브라질, 13083-888
- 모병
- Hospital das Clinicas da Universidade Estadual de Campinas UNICAMP
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Caxias do Sul, 브라질, 95070 560
- 모병
- Fundacao Universidade de Caxias do Sul
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Curitiba, 브라질, 81520-060
- 모병
- Hospital Erasto Gaertner- Liga Paranaense de Combate ao Cancer
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Florianópolis, 브라질, 88020 210
- 모병
- Grupo ELORA Centro de Pesquisa e Ensino em Saude de Santa Catarina
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Rio de Janeiro, 브라질, 22775 001
- 모병
- Instituto de Educacao, Pesquisa e Gestao em Saude Instituto Americas (COI)
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Salvador, 브라질, 41253-190
- 모병
- IDOR - Regional Bahia
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São José do Rio Preto, 브라질, 15090-000
- 모병
- Funfarme Sjrp
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São Paulo, 브라질, 01509 900
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- Fundacao Antonio Prudente A C Camargo Cancer Center
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São Paulo, 브라질, 05652 900
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- Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein
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São Paulo, 브라질, 04537 081
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- Clinica Medica Sao Germano LTDA
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São Paulo, 브라질, 01401 002
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- IDOR - Regional Sao Paulo
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Badalona, 스페인, 08916
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- Hosp. Univ. Germans Trias I Pujol
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Barcelona, 스페인, 08036
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- Hosp. Clinic de Barcelona
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Barcelona, 스페인, 08035
- 모병
- H. Vall D'Hebron
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Granada, 스페인, 18014
- 모병
- Hosp. Univ. Virgen de Las Nieves
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Madrid, 스페인, 28041
- 모병
- Hosp. Univ. 12 de Octubre
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Pozuelo de Alarcón, 스페인, 28223
- 모병
- Hosp. Quiron Madrid Pozuelo
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Salamanca, 스페인, 37007
- 모병
- Hosp Clinico Univ de Salamanca
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Usansolo, 스페인, 48960
- 모병
- Hosp de Galdakao
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Valencia, 스페인, 46026
- 모병
- Hosp. Univ. I Politecni La Fe
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Canterbury, 영국, CT1 3NG
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- Kent and Canterbury Hospital
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Cardiff, 영국, CF14 4XW
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- Cardiff and Vale UHB - University Hospital of Wales
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Dundee, 영국, DD1 9SY
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- Ninewells Hospital & Medical School
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London, 영국, NW1 2PG
- 모병
- University College London Hospitals
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Nottingham, 영국, NG5 1PB
- 모병
- Nottingham City Hospital
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Portsmouth, 영국, PO6 3LY
- 모병
- Queen Alexandra Hospital
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Sutton, 영국, SM2 5PT
- 모병
- Royal Marsden Hospital
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Beersheba, 이스라엘, 8457108
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- Soroka Medical Center
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Haifa, 이스라엘, 3109601
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- Rambam Medical Center
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Haifa, 이스라엘, 34362
- 모병
- Carmel Medical Center
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Haifa, 이스라엘, 31048
- 모병
- Bnai Zion Medical Center
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Jerusalem, 이스라엘, 9103102
- 모병
- Shaare Zedek MC
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Ramat Gan, 이스라엘, 52621
- 모병
- Sheba Medical Center
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Ramat Poriya, 이스라엘, 1520800
- 모병
- Baruch Padeh MC
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Tel Aviv, 이스라엘, 69710
- 모병
- Assuta MC
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Alessandria, 이탈리아, 15121
- 모병
- A.O.U. SS. Antonio e Biagio e Cesare Arrigo
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Brescia, 이탈리아, 25123
- 모병
- Spedali Civili di Brescia
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Milan, 이탈리아, 20122
- 모병
- Fondazione IRCCS Ca Granda Ospedale Policlinico Di Milano
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Naples, 이탈리아, 80131
- 모병
- Azienda Ospedaliera Universitaria Federico II
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Pisa, 이탈리아, 56126
- 모병
- Ospedale Santa Chiara AO Universitaria Pisana
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Reggio Emilia, 이탈리아, 42123
- 모병
- Arcispedale Santa Maria Nuova - IRCCS
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Roma, 이탈리아, 00168
- 모병
- Fondazione Policlinico Universitario A Gemelli IRCCS
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Roma, 이탈리아, 00128
- 모병
- Campus Bio Medico di Roma
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Rozzano, 이탈리아, 20089
- 모병
- Humanitas Hospital
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San Giovanni Rotondo, 이탈리아, 71013
- 모병
- Casa Sollievo Della Sofferenza IRCCS
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Turin, 이탈리아, 10126
- 모병
- A.O.U. Citta della Salute e della Scienza di Torino - Presidio Molinette
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Vicenza, 이탈리아, 36100
- 모병
- U.O. Ematologia Ospedale San Bortolo
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Bunkyō City, 일본, 113 8677
- 모병
- Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
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Chiba, 일본, 260 0801
- 모병
- Chiba Cancer Center
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Kamakura-shi, 일본, 247-8533
- 모병
- Shonan Kamakura General Hospital
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Kamogawa, 일본, 296-8602
- 모병
- Kameda Medical Center
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Kofu, 일본, 400-0027
- 모병
- Yamanashi Prefectural Central Hospital
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Minato, 일본, 105-8471
- 모병
- The Jikei University Hospital
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Shibuya City, 일본, 150-8935
- 모병
- Japanese Red Cross Medical Center
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Yokohama, 일본, 241 8515
- 모병
- Kanagawa Cancer Center
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Beijing, 중국, 100034
- 모병
- Peking University First Hospital
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Beijing, 중국, 100044
- 모병
- Peking University People's Hospital
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Chengdu, 중국, 610032
- 모병
- Sichuan Provincial Peoples Hospital
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Guangzhou, 중국, 510060
- 모병
- Sun Yat Sen University Cancer Center
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Hangzhou, 중국, 310003
- 모병
- First affiliated Hospital of Zhejiang University
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Nanjing, 중국, 210008
- 모병
- Nanjing Drum Tower Hospital
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Nanning, 중국, 530021
- 모병
- The First Affiliated Hospital of Guangxi Medical University
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Shanghai, 중국, 200434
- 모병
- Shanghai Fourth People s Hospital
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Wenzhou, 중국, 325000
- 모병
- The First Affiliated Hospital of Wenzhou Medical University
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Wuhan, 중국, 430032
- 모병
- Wuhan Tongji Hospital Tongji Medical College
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Xi'an, 중국, 710006
- 모병
- The Second Affiliated Hospital of Xi'an Jiaotong University
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Alberta
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Calgary, Alberta, 캐나다, T2N 4N1
- 모병
- Arthur J E Child Comprehensive Cancer Centre
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British Columbia
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Vancouver, British Columbia, 캐나다, V5Z4E6
- 모병
- British Columbia Cancer Agency
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Nova Scotia
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Halifax, Nova Scotia, 캐나다, B3H 3A7
- 모병
- Queen Elizabeth II Health Sciences Centre
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Ontario
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Hamilton, Ontario, 캐나다, L8V5C2
- 모병
- Juravinski Cancer Centre
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London, Ontario, 캐나다, N6A 5W9
- 모병
- London Health Sciences Centre
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Toronto, Ontario, 캐나다, M5G 2M9
- 모병
- University Health Network UHN Princess Margaret Cancer Centre
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Quebec
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Montreal, Quebec, 캐나다, H1T 2M4
- 모병
- CIUSSS de l Est de l Ile de Montreal Installation Hopital Maisonneuve Rosemont
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-
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Lille, 프랑스, 59000
- 모병
- CHRU de Lille Hopital Claude Huriez
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Lyon, 프랑스, 69002
- 모병
- Hospices Civils de Lyon HCL
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Nancy, 프랑스, 54000
- 모병
- Centre Hospitalier Universitaire de Nancy - Hôpital Central
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Nantes, 프랑스, 44000
- 모병
- Hotel Dieu CHU de Nantes
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Paris, 프랑스, 75010
- 모병
- Hopital Saint Louis APHP
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Paris, 프랑스, 75012
- 모병
- APHP
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Paris, 프랑스, 75015
- 모병
- Necker Hospital APHP
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Pessac, 프랑스, 33600
- 모병
- CHU de Bordeaux - Hospital Haut-Leveque
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Poitiers, 프랑스, 86021
- 모병
- CHU De Poitiers
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Toulouse, 프랑스, 31300
- 모병
- CHU Toulouse
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Tours, 프랑스, 37000
- 모병
- CHRU de Tours
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Box Hill, 호주, 3128
- 모병
- Box Hill Hospital
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Brisbane, 호주, 4101
- 모병
- Mater Misericordiae Ltd
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Clayton, 호주, 3168
- 모병
- Monash Medical Centre
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Fitzroy, 호주, 3065
- 모병
- St Vincents Hospital Melbourne
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Melbourne, 호주, 3004
- 모병
- The Alfred Hospital
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Murdoch, 호주, 6150
- 모병
- Fiona Stanley Hospital
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Nedlands, 호주, 6009
- 모병
- Sir Charles Gairdner Hospital
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Southport, 호주, 4215
- 모병
- Gold Coast University Hospital
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
-
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
-
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
-
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: 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. |
|
활성 비교기: 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. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Overall Response
기간: 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)
기간: 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
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Very Good Partial Response (VGPR) or Better
기간: 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
기간: 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)
기간: 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
기간: 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
기간: 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
기간: 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)
기간: 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)
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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)
기간: 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
기간: 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
기간: 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
기간: 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
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 79635322MMY3001
- 2025-522007-18-00 (레지스트리 식별자: EUCT number)
- 2025 (미국 NIH 보조금/계약)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
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
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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