항-CD38 항체와 레날리도마이드를 투여받은 재발성 또는 불응성 골수종 환자에서 Talquetamab + 포말리도마이드, Talquetamab + Teclistamab, Elotuzumab, 포말리도마이드, 덱사메타손 또는 포말리도마이드, 보르테조밉, 덱사메타손을 비교하는 연구 (MonumenTAL-6)
포말리도마이드(Tal-P)와 결합한 탈케타맙, 테클리스타맙(Tal-Tec)과 결합한 탈케타맙, 그리고 연구자가 선택한 엘로투주맙, 포말리도마이드, 덱사메타손(EPd) 또는 포말리도마이드, 보르테조밉, 덱사메타손을 비교하는 3상 무작위 연구( PVd), 항-CD38 항체와 레날리도마이드를 포함하여 이전에 1~4회 치료를 받은 재발성 또는 불응성 골수종 참가자
The purpose of this study is to compare the effectiveness of either talquetamab plus pomalidomide (Tal-P) or talquetamab plus teclistamab (Tal-Tec) with elotuzumab, pomalidomide, and dexamethasone (EPd) or pomalidomide, bortezomib, and dexamethasone (PVd).
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
연구 유형
연구 유형
등록 (실제)
등록
단계
단계
- 3단계
연락처 및 위치
연구 장소
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Athens, 그리스, 115 28
- Alexandra General Hospital of Athens
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Athens, 그리스, 115 25
- 251 Airforces Hospital
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Thessaloniki, 그리스, 546 39
- Theageneio Cancer Hospital
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-
-
-
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Almere Stad, 네덜란드, 1315RA
- Flevoziekenhuis
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Eindhoven, 네덜란드, 5623 EJ
- Catharinaziekenhuis
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Nieuwegein, 네덜란드, 3435 CM
- St. Antonius Ziekenhuis Nieuwegein
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The Hague, 네덜란드, 2545 CH
- Haga ziekenhuis
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Zwolle, 네덜란드, 8025 AB
- Isala Kliniek
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-
-
-
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Busan, 대한민국, 49201
- Dong-A University Hospital
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Busan, 대한민국, 49241
- Pusan National University Hospital
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Jeollanam-do, 대한민국, 58128
- Chonnam National University Hwasun Hospital
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Seoul, 대한민국, 03080
- Seoul National University Hospital
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Seoul, 대한민국, 06351
- Samsung Medical Center
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Seoul, 대한민국, 06591
- The Catholic University of Korea Seoul St Mary s Hospital
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Ulsan, 대한민국, 44033
- Ulsan University Hospital
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-
-
-
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Aarhus, 덴마크, 8200
- Aarhus University Hospital
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Odense C, 덴마크, 5000
- Odense University Hospital
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Vejle, 덴마크, 7100
- Vejle Hospital
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Augsburg, 독일, 86156
- Klinikum Augsburg
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Halle, 독일, 06120
- Universitaetsklinikum Halle Saale
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Heidelberg, 독일, 69120
- Universitaetsklinikum Heidelberg
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Magdeburg, 독일, 39120
- Universitaetsklinikum Magdeburg A.oe.R
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München, 독일, 81675
- Klinikum rechts der Isar der TU Muenchen
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Tübingen, 독일, 72076
- Universitaetsklinikum Tuebingen
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Würzburg, 독일, 97080
- Universitaetsklinikum Wuerzburg
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Guadalajara, 멕시코, 45645
- Centro de Quimioterapia e Investigacion
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Huixquilucan, 멕시코, 52787
- Hematologica Alta Especialidad
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Monterrey, 멕시코, 64460
- Hospital Universitario Dr Jose Eleuterio Gonzalez
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California
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Clovis, California, 미국, 93611
- UCSF Fresno
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Santa Monica, California, 미국, 90404
- UCLA
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Connecticut
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New Haven, Connecticut, 미국, 06519
- Yale University School Of Medicine
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Delaware
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Newark, Delaware, 미국, 19713
- Medical Oncology Hematology Consultants, PA
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Florida
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Hollywood, Florida, 미국, 33021
- Memorial Healthcare System
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Tampa, Florida, 미국, 33612
- Moffitt Cancer Center
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Georgia
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Atlanta, Georgia, 미국, 30322
- Winship Cancer Institute Emory University
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Newnan, Georgia, 미국, 30265
- City of Hope Cancer Center
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Idaho
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Coeur d'Alene, Idaho, 미국, 83814
- Kootenai Health
-
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Illinois
-
Maywood, Illinois, 미국, 60153
- Loyola University Medical Center
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Iowa
-
Waukee, Iowa, 미국, 50263
- University of Iowa Health Care
-
-
Kentucky
-
Louisville, Kentucky, 미국, 40207
- Norton Cancer Institute
-
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Louisiana
-
Baton Rouge, Louisiana, 미국, 70808
- Our Lady of the Lake Hospital
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-
Maryland
-
Annapolis, Maryland, 미국, 21401
- Luminis Health Center for Cancer and Blood Disorders
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Baltimore, Maryland, 미국, 21201
- University of Maryland School of Medicine
-
Baltimore, Maryland, 미국, 21287
- The Sidney Kimmel Comprehensive Cancer Center at John Hopkins
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Michigan
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Ann Arbor, Michigan, 미국, 48109
- University of Michigan
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Detroit, Michigan, 미국, 48202
- Henry Ford Cancer Institute
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Southfield, Michigan, 미국, 48075
- Henry Ford Health Providence Southfield Hospital
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Minnesota
-
Minneapolis, Minnesota, 미국, 55455
- University Of Minnesota
-
Rochester, Minnesota, 미국, 55905
- Mayo Clinic Rochester
-
Saint Paul, Minnesota, 미국, 55101
- Regions Hospital
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-
Nebraska
-
Omaha, Nebraska, 미국, 68105
- University of Nebraska
-
-
New Hampshire
-
Lebanon, New Hampshire, 미국, 03756
- Dartmouth Hitchcock Medical Center
-
-
New Jersey
-
Hackensack, New Jersey, 미국, 07601
- John Theurer Cancer Center at Hackensack University Medical Center
-
-
New York
-
Buffalo, New York, 미국, 14263
- Roswell Park Cancer Institute
-
New York, New York, 미국, 10065
- Weill Cornell Medical College
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Syracuse, New York, 미국, 13210
- SUNY Upstate Medical University
-
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North Carolina
-
Durham, North Carolina, 미국, 27705
- Duke University Medical Center
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Ohio
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Canton, Ohio, 미국, 44718
- Gabrail Cancer Center
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Cleveland, Ohio, 미국, 44195
- Cleveland Clinic
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Cleveland, Ohio, 미국, 44106
- Louis Stokes Cleveland VA Med Ctr
-
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Oregon
-
Portland, Oregon, 미국, 97239
- Oregon Health And Science University
-
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Pennsylvania
-
Hershey, Pennsylvania, 미국, 17033
- Penn State Milton S Hershey Medical Ctr
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Philadelphia, Pennsylvania, 미국, 19107 4215
- Thomas Jefferson University
-
Pittsburgh, Pennsylvania, 미국, 15224
- West Penn Hospital
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Pittsburgh, Pennsylvania, 미국, 15232
- University Of Pittsburgh Medical Center UPMC Hillman Cancer Center
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South Carolina
-
Charleston, South Carolina, 미국, 29425-8900
- Medical University of South Carolina
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Greenville, South Carolina, 미국, 29607
- Bon Secours Saint Francis Cancer Center
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Texas
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Dallas, Texas, 미국, 75390
- UT Southwestern Parkland Hospital
-
Dallas, Texas, 미국, 75390
- UT Southwestern
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Houston, Texas, 미국, 77030
- Houston Methodist Neal Cancer Center at Texas Medical Center
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Utah
-
Salt Lake City, Utah, 미국, 84112
- Huntsman Cancer Institute
-
-
Virginia
-
Charlottesville, Virginia, 미국, 22903
- University of Virginia
-
-
Washington
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Seattle, Washington, 미국, 98109
- Fred Hutchinson Cancer Research Center
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Seattle, Washington, 미국, 98104
- Swedish Cancer Institute
-
Tacoma, Washington, 미국, 98405
- NorthWest Medical Specialties, PLLC
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Wisconsin
-
La Crosse, Wisconsin, 미국, 54601
- Gundersen Health System
-
Milwaukee, Wisconsin, 미국, 53226
- Medical College Of Wisconsin
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-
-
-
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Charleroi, 벨기에, 6060
- Grand Hopital De Charleroi Site Les Viviers
-
Genk, 벨기에, 3600
- Ziekenhuis Oost-Limburg
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Ghent, 벨기에, 9000
- Ghent University Hospital
-
Sint-Niklaas, 벨기에, 9100
- AZ Nikolaas - Campus Sint-Niklaas Moerland
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-
-
-
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Belo Horizonte, 브라질, 30110-022
- Cetus Oncologia
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Brasília, 브라질, 70390 700
- IDOR - Regional Brasilia
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Caxias do Sul, 브라질, 95070 560
- Fundacao Universidade de Caxias do Sul
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Curitiba, 브라질, 81520-060
- Hospital Erasto Gaertner- Liga Paranaense de Combate ao Cancer
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Porto Alegre, 브라질, 90035-903
- Hospital De Clinicas De Porto Alegre
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Recife, 브라질, 50070-480
- IDOR - Regional Pernambuco
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Rio de Janeiro, 브라질, 22793-080
- Instituto de Educacao, Pesquisa e Gestao em Saude Instituto Americas (COI)
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Salvador, 브라질, 41253-190
- IDOR - Regional Bahia
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São José do Rio Preto, 브라질, 15090-000
- Funfarme Sjrp
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São Paulo, 브라질, 01509 900
- Fundacao Antonio Prudente A C Camargo Cancer Center
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São Paulo, 브라질, 04537 081
- Clinica Medica Sao Germano LTDA
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São Paulo, 브라질, 01323 001
- Real e Benemerita Associacao Portuguesa de Beneficencia
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São Paulo, 브라질, 01401 002
- IDOR - Regional Sao Paulo
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Riyadh, 사우디 아라비아, 11564
- King Faisal Specialist Hospital & Research Center
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Riyadh, 사우디 아라비아, 12231
- King Fahad Medical City
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Riyadh, 사우디 아라비아, 11481
- King Abdullah International Medical Research Center (KAIMRC)
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-
-
-
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Lund, 스웨덴, 221 85
- Skanes universitetssjukhus
-
Umeå, 스웨덴, 901 85
- Norrlands Universitetssjukhus
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Uppsala, 스웨덴, 75185
- Akademiska Sjukhuset
-
Varberg, 스웨덴, 432 81
- Varberg Hospital
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-
-
-
-
Asturias, 스페인, 33394
- Hosp. de Cabuenes
-
Barcelona, 스페인, 08035
- Hosp Univ Vall D Hebron
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Burgos, 스페인, 09003
- Hosp. Univ. de Burgos
-
Cáceres, 스페인, 10003
- Hosp. San Pedro de Alcantara
-
Donostia / San Sebastian, 스페인, 20014
- Hosp. Univ. Donostia
-
Granada, 스페인, 18014
- Hosp. Univ. Virgen de Las Nieves
-
Lugo, 스페인, 27003
- Hosp. Univ. Lucus Augusti
-
Madrid, 스페인, 28046
- Hosp. Univ. La Paz
-
Palma de Mallorca, 스페인, 07120
- Hosp. Univ. Son Espases
-
Pamplona, 스페인, 31008
- Clinica Univ. de Navarra
-
Pamplona, 스페인, 31008
- Complejo Hosp de Navarra - Hosp de Navarra
-
Salamanca, 스페인, 37007
- Hosp Clinico Univ de Salamanca
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Santander, 스페인, 39008
- Hosp. Univ. Marques de Valdecilla
-
Santiago de Compostela, 스페인, 15706
- Hosp. Clinico Univ. de Santiago
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-
-
-
-
Buenos Aires, 아르헨티나, C1280AEB
- Hospital Britanico de Buenos Aires
-
Buenos Aires, 아르헨티나, C1114AAN
- Fundaleu
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CABA, 아르헨티나, C1118AAT
- Hospital Aleman
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-
-
-
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Blackpool, 영국, FY3 8NR
- Blackpool Victoria Hospital
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Cardiff, 영국, CF14 4HY
- University Hospital of Wales
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Dundee, 영국, DD1 9SY
- Ninewells Hospital
-
Leeds, 영국, LS9 7TF
- St James University Hospital
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London, 영국, SE5 9RS
- Kings College Hospital
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Nottingham, 영국, NG5 1PB
- Nottingham City Hospital
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Plymouth, 영국, PL6 8DH
- University Hospitals Plymouth NHS Trust
-
Portsmouth, 영국, PO6 3LY
- Queen Alexandra Hospital
-
-
-
-
-
Salzburg, 오스트리아, 05020
- LKH - Universitätsklinikum der PMU Salzburg
-
Vienna, 오스트리아, 1160
- Klinik Ottakring
-
Vienna, 오스트리아, A-1090
- Medical University Vienna MUV
-
-
-
-
-
Be’er Ya‘aqov, 이스라엘, 70300
- Shamir Medical Center Assaf Harofeh
-
Haifa, 이스라엘, 3436212
- Carmel Medical Center
-
Petah Tikva, 이스라엘, 49100
- Rabin Medical center - Petah-Tikva
-
Ramat Gan, 이스라엘, 52621
- Sheba Medical Center
-
Tel Aviv, 이스라엘, 64239
- Tel Aviv Sourasky Medical Center
-
-
-
-
-
Alessandria, 이탈리아, 15121
- Azienda Ospedaliera Nazionale SS. Antonio e Biagio e Cesare Arrigo Alessandria
-
Bologna, 이탈리아, 40138
- A O U Sant Orsola Malpighi
-
Brindisi, 이탈리아, 72100
- Ospedale Perrino
-
Catania, 이탈리아, 95122
- ARNAS Garibaldi P O Nesima
-
Genova, 이탈리아, 16132
- Ospedale Policlinico San Martino IRCCS
-
Legnano, 이탈리아, 20025
- Asst Ovest Milanese - Ospedale Di Legnano
-
Milan, 이탈리아, 20132
- IRCCS Ospedale San Raffaele
-
Milan, 이탈리아, 20122
- Fondazione IRCCS Ca Granda Ospedale Policlinico Di Milano
-
Pavia, 이탈리아, 27100
- Fondazione IRCCS Policlinico San Matteo
-
Pescara, 이탈리아, 65124
- Presidio Ospedaliero Pescara
-
Ravenna, 이탈리아, 48121
- Ospedale S. Maria Delle Croci
-
Torino, 이탈리아, 10126
- Oncologia Medica-Città Della Salute E Della Scienza Di Torino
-
Verona, 이탈리아, 37134
- Azienda Ospedaliera Universitaria Integrata Verona
-
-
-
-
-
Gūrgaon, 인도, 122002
- Fortis Memorial Research Institute
-
Lucknow, 인도, 226014
- Sanjay Gandhi Postgraduate Institute of Medical Sciences
-
Pune, 인도, 411004
- Deenanath Mangeshkar Hospital and Research Centre
-
-
-
-
-
Bunkyō City, 일본, 113 8431
- Juntendo University Hospital
-
Fukuoka, 일본, 814-0180
- Fukuoka University Hospital
-
Hamamatsu, 일본, 431 3192
- Hamamatsu University Hospital
-
Kanazawa, 일본, 920 8641
- Kanazawa University Hospital
-
Kyoto, 일본, 602-8566
- University Hospital Kyoto Prefectural University of Medicine
-
Nagasaki, 일본, 856-8562
- National Hospital Organization Nagasaki Medical Center
-
Narita, 일본, 286-8523
- Japanese Red Cross Narita Hospital
-
Niigata, 일본, 951-8566
- Niigata Cancer Center Hospital
-
Nishinomiya Shi, 일본, 663 8501
- Hyogo Medical University Hospital
-
Osaka, 일본, 543-8555
- Japanese Red Cross Osaka Hospital
-
Sapporo, 일본, 060-8604
- Sapporo City General Hospital
-
Sendai, 일본, 980 8574
- Tohoku University Hospital
-
Shibuya-ku, 일본, 150-8935
- Japanese Red Cross Medical Center
-
Shiwa-gun, 일본, 028-3695
- Iwate Medical University Hospital
-
Suita, 일본, 565 0871
- The University of Osaka Hospital
-
Sunto Gun, 일본, 411 8777
- Shizuoka Cancer Center
-
Tokyo, 일본, 135 8550
- The Cancer Institute Hospital of JFCR
-
Tottori, 일본, 683-0824
- Tottori University Hospital
-
Tsukuba, 일본, 305 8576
- University of Tsukuba Hospital
-
Yokohama, 일본, 241 8515
- Kanagawa Cancer Center
-
-
-
-
-
Beijing, 중국, 100034
- Peking University First Hospital
-
Beijing, 중국, 100020
- Beijing Chaoyang Hospital
-
Beijing, 중국, 101199
- Peking University People's Hospital
-
Changsha, 중국, 410011
- The Second Xiangya Hospital of Central South Hospital
-
Changzhou, 중국, 213000
- Changzhou No 2 Peoples Hospital
-
Chengdu, 중국, 610032
- Sichuan Provincial Peoples Hospital
-
Fuzhou, 중국, 350005
- The First Affiliated Hospital of Fujian Medical University
-
Fuzhou, 중국, 350001
- Fujian Meidical University Union Hospital
-
Guangzhou, 중국, 510515
- Nanfang Hospital of Southern Medical Hospital
-
Guangzhou, 중국, 510060
- Sun Yat Sen University Cancer Center
-
Hangzhou, 중국, 310009
- The Second Affiliated Hospital of Zhejiang University College of Medicine
-
Hangzhou, 중국, 310003
- First hospital affiliated of Zhejiang Medical university
-
Hohhot, 중국, 010051
- The Affiliated Hospital of Inner Mongolia Medical College
-
Jinan, 중국, 250012
- Qilu Hospital of Shandong University
-
Nanchang, 중국, 330006
- The First Affiliated Hospital of NanChang University
-
Nanjing, 중국, 210008
- Nanjing Drum Tower Hospital
-
Nanning, 중국, 530021
- The First Affiliated Hospital of Guangxi Medical University
-
Shanghai, 중국, 200025
- Ruijing Hospital Affiliated To Shanghai Jiaotong University School Of Medicine
-
Shanghai, 중국, 200065
- Tongji Hospital of Tongji University
-
Shanghai, 중국, 200434
- Shanghai Fourth People s Hospital
-
Shenyang, 중국, 110055
- Shengjing Hospital Of China Medical University
-
Shenzhen, 중국, 518036
- Peking University Shenzhen Hospital
-
Taiyuan, 중국, 030032
- Shanxi Bethune Hospital
-
Tianjin, 중국, 30060
- Tianjin Medical University Cancer Institute and Hospital
-
Wenzhou, 중국, 325000
- The First Affiliated Hospital of Wenzhou Medical University
-
Wuhan, 중국, 430030
- Tongji Hospital, Tongji Medical College of HUST
-
Xi'an, 중국, 710004
- The Second Affiliated Hospital of Xi'an Jiaotong University
-
Xiamen, 중국, 361026
- The first affiliated hospital of xiamen university
-
-
-
-
-
Brno-Bohunice, 체코, 625 00
- Fakultni nemocnice Brno
-
Hradec Králové, 체코, 500 05
- Fakultni nemocnice Hradec Kralove
-
Olomouc, 체코, 779 00
- University Hospital Olomouc
-
Ostrava, 체코, 708 52
- Fakultni Nemocnice Ostrava
-
-
-
-
Alberta
-
Calgary, Alberta, 캐나다, T2N 5G2
- Arthur J E Child Comprehensive Cancer Centre
-
-
British Columbia
-
Vancouver, British Columbia, 캐나다, V5Z4E6
- British Columbia Cancer Agency
-
-
Nova Scotia
-
Halifax, Nova Scotia, 캐나다, B3H 1V7
- Nova Scotia Health Authority
-
-
Ontario
-
Hamilton, Ontario, 캐나다, L8V5C2
- Juravinski Cancer Centre
-
Toronto, Ontario, 캐나다, M5G2M9
- Princess Margaret Cancer Centre University Health Network
-
-
Quebec
-
Montreal, Quebec, 캐나다, H1T 2M4
- CIUSSS de l Est de l Ile de Montreal Installation Hopital Maisonneuve Rosemont
-
-
Saskatchewan
-
Saskatoon, Saskatchewan, 캐나다, S7N 4H4
- Saskatoon Cancer Centre
-
-
-
-
-
Ankara, 터키 (Türkiye), 06680
- Liv Hospital Ankara
-
Ankara, 터키 (Türkiye), 06620
- Ankara Universitesi Tip Fakultesi Cebeci Arastirma ve Uygulama Hastanesi
-
Denizli, 터키 (Türkiye), 20070
- Pamukkale Universitesi Tip Fakultesi
-
Istanbul, 터키 (Türkiye), 34214
- Medipol University Hospital
-
Samsun, 터키 (Türkiye), 55200
- Ondokuz Mayis Universitesi Saglik Uygulama ve Arastirma Merkezi
-
-
-
-
-
Biała Podlaska, 폴란드, 21 500
- Wojewodzki Szpital Specjalistyczny
-
Brzozów, 폴란드, 36-200
- Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologiczny im Ks B Markiewicza
-
Kielce, 폴란드, 25 734
- Swietokrzyskie Centrum Onkologii SPZOZ w Kielcach
-
Lublin, 폴란드, 20-090
- Centrum Onkologii Ziemii Lubelskiej
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Szczecin, 폴란드, 71-252
- Uniwersytecki Szpital Kliniczny Nr 1 PUM im prof Tadeusza Sokolowskiego w Szczecinie
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Wroclaw, 폴란드, 50 367
- Uniwersytecki Szpital Kliniczny im Jana Mikulicza Radeckiego we Wroclawiu
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-
-
-
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Lille, 프랑스, 59000
- Hopital Claude Huriez
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Limoges, 프랑스, 87042
- CHU de Limoges Hopital Dupuytren
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Lyon, 프랑스, 69002
- Hospices Civils de Lyon HCL
-
Marseille, 프랑스, 13009
- Institut Paoli Calmettes
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Nantes, 프랑스, 44093
- CHU Nantes
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Paris, 프랑스, 75010
- Hopital Saint Louis
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Pessac, 프랑스, 33604
- CHU de Bordeaux - Hospital Haut-Leveque
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Strasbourg, 프랑스, 67200
- Institut de Cancerologie Strasbourg Europe ICANS
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Toulouse, 프랑스, 31100
- Institut Universitaire du Cancer Toulouse Oncopole
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Tours, 프랑스, 37044
- CHRU Tours Hopital Bretonneau
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Budapest, 헝가리, 1088
- Semmelweis Egyetem, Belgyogyaszati es Hematologiai Klinika
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Budapest, 헝가리, 1097
- Del Pesti Centrumkorhaz Orszagos Hematologiai es Infektologiai Intezet Szent Laszlo Telephely
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Debrecen, 헝가리, 4032
- Debreceni Egyetem Klinikai Kozpont
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Nyíregyháza, 헝가리, 4400
- Szabolcs Szatmar Bereg Varmegyei Oktatokorhaz
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Pécs, 헝가리, 7624
- Pecsi Tudomanyegyetem Klinikai Kozpont
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Adelaide, 호주, 5000
- Royal Adelaide Hospital
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Box Hill, 호주, 3128
- Box Hill Hospital
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Darlinghurst, 호주, 2010
- St Vincents Hospital
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Fitzroy, 호주, 3065
- St Vincents Hospital Melbourne
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Southport, 호주, 4215
- Gold Coast University Hospital
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West Perth, 호주, 6005
- Perth Blood Institute
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Wollongong, 호주, 2500
- Wollongong Hospital
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참여기준
자격 기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Documented multiple myeloma as defined by the criteria below: (a) multiple myeloma diagnosis according to the international myeloma working group (IMWG) diagnostic criteria (b) measurable disease at screening as assessed by central laboratory, defined by any of the following: (i) serum M-protein level greater than or equal to (>=) 0.5 gram per deciliter (g/dL); or (ii) urine M-protein level >= 200 milligram (mg) per 24 hours; or (iii) light chain multiple myeloma without measurable M-protein in the serum or the urine: serum immunoglobulin (Ig) free light chain (FLC) >= 10 milligrams per deciliter (mg/dL) and abnormal serum Ig kappa lambda FLC ratio
- Relapsed or refractory disease as defined below: a) Relapsed disease is defined as an initial response to prior treatment, followed by confirmed progressive disease (PD) by IMWG criteria greater than (>) 60 days after cessation of treatment. b) Refractory disease is defined as less than (<) 25 percent (%) reduction in M-protein or confirmed PD by IMWG criteria during previous treatment or less than or equal to (<=) 60 days after cessation of treatment
- Documented evidence of PD or failure to achieve a minimal response to the last line of therapy based on investigator's determination of response by IMWG criteria on or after their last regimen
- Have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2 at screening and immediately prior to the start of administration of study treatment
- A participant must agree not to be pregnant, breastfeeding, or planning to become pregnant while enrolled in this study or within 6 months after the last dose of study treatment
Exclusion Criteria:
- Contraindications or life-threatening allergies, hypersensitivity, or intolerance to any study drug or its excipients
- Stroke, transient ischemic attack, or seizure within 6 months prior to signing informed consent form (ICF)
- Major surgery or had significant traumatic injury within 2 weeks prior to the start of administration of study treatment, or will not have fully recovered from surgery, or has major surgery planned during the time the participant is expected to be treated in the study or within 2 weeks after administration of the last dose of study treatment
- A maximum cumulative dose of corticosteroids of >=140 mg of prednisone or equivalent within 14-day period before the first dose of study drug
- Known active central nervous system (CNS) involvement or exhibits clinical signs of meningeal involvement of multiple myeloma. If either is suspected, negative whole brain magnetic resonance imaging (MRI) and lumbar cytology are required
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
|
실험적: Arm A: Talquetamab + Pomalidomide (Tal-P)
Participants will receive talquetamab as subcutaneous (SC) injections; pomalidomide will be self-administered as a single dose orally; dexamethasone may be given orally or intravenously as a pretreatment medication and study drug. |
Pomalidomide will be administered orally.
다른 이름들:
Dexamethasone will be administered either orally or intravenously. Talquetamab will be administered as a SC injection.
다른 이름들:
|
|
실험적: Arm B: Talquetamab + Teclistamab (Tal-Tec)
Participants will receive teclistamab in combination with talquetamab both as SC injection; dexamethasone may be given orally or intravenously as a pretreatment medication and study drug. |
Teclistamab will be administered as a SC injection.
다른 이름들:
Dexamethasone will be administered either orally or intravenously. Talquetamab will be administered as a SC injection.
다른 이름들:
|
|
활성 비교기: Arm C: Elotuzumab+ Pomalidomide+Dexamethasone (EPd) or Pomalidomide+Bortezomib+Dexamethasone (PVd)
Participants will either receive elotuzumab intravenous (IV) injection in combination with pomalidomide and dexamethasone orally; or pomalidamide orally in combination with bortezomib SC injection and dexamethasone orally as per investigator choice. Dexamethasone will be administered as a pretreatment medication. |
Pomalidomide will be administered orally.
다른 이름들:
Dexamethasone will be administered either orally or intravenously. Elotuzumab will be administered intravenously.
다른 이름들:
Bortezomib will be administered as a SC injection.
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Progression Free Survival (PFS)
기간: Up to 3 years 5 months
|
PFS is defined as the duration from the date of randomization to either progressive disease or death, whichever comes first. |
Up to 3 years 5 months
|
2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Overall Response Rate (ORR)
기간: Up to 3 years 5 months
|
ORR is defined as the percentage of participants with best overall response of partial response (PR) or better according to international myeloma working group (IMWG) response criteria. |
Up to 3 years 5 months
|
|
Complete Response (CR) or Better Rate
기간: Up to 3 years 5 months
|
CR or better is defined as the percentage of participants with best overall response of CR or better according to IMWG response criteria. |
Up to 3 years 5 months
|
|
Very Good Partial Response (VGPR) or Better Rate
기간: Up to 3 years 5 months
|
VGPR or better is defined as the percentage of participants with best overall response of VGPR or better rate according to IMWG response criteria. |
Up to 3 years 5 months
|
|
Minimal Residual Disease (MRD)-negative CR Rate
기간: Up to 3 years 5 months
|
MRD-negative CR is defined as the percentage of participants who achieve both CR or better and MRD negativity at a threshold of 10^-5 at any timepoint after the date of randomization and before disease progression or start of subsequent antimyeloma therapy (SST). |
Up to 3 years 5 months
|
|
Overall Survival (OS)
기간: Up to 3 years 5 months
|
OS is defined as the time from randomization to the date of participant's death. |
Up to 3 years 5 months
|
|
Progression Free Survival on Next-line Therapy (PFS2)
기간: Up to 3 years 5 months
|
PFS2 is defined as time from randomization to progression on the next line of therapy or death, whichever comes first. |
Up to 3 years 5 months
|
|
Time to Next Treatment (TTNT)
기간: Up to 3 years 5 months
|
TTNT is defined as the time from randomization to the start of SST. |
Up to 3 years 5 months
|
|
Serum Concentration of Talquetamab and Teclistamab
기간: Up to 3 years 5 months
|
Serum concentration of talquetamab and teclistamab will be reported. |
Up to 3 years 5 months
|
|
Number of Participants with Anti-drug Antibodies (ADAs) to Talquetamab and Teclistamab
기간: Up to 3 years 5 months
|
Number of participants with ADAs to talquetamab and teclistamab will be reported. |
Up to 3 years 5 months
|
|
Time to Sustained Worsening in Symptoms, Functioning, and Health-related Quality of Life (HRQoL) as Assessed by Multiple Myeloma Symptom and Impact Questionnaire (MySIm-Q)
기간: Up to 3 years 5 months
|
Time to sustained worsening in symptoms, functioning and HRQoL is defined as the interval from the date of randomization to the start date of meaningful change. The MySIm-Q is a disease-specific patient-reported outcome (PRO) assessment complementary to the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 item (EORTC-QLQ-C30). It includes 17 items resulting in a symptom subscale and an impact subscale. |
Up to 3 years 5 months
|
|
Time to Sustained Worsening in Symptoms, Functioning, and Health-related Quality of Life (HRQoL) as Assessed by EORTC-QLQ-C30
기간: Up to 3 years 5 months
|
Time to sustained worsening in symptoms, functioning and HRQoL is defined as the interval from the date of randomization to the start date of meaningful change. EORTC-QLQ-C30 Version 3 includes 30 items that make up 5 functional scales (physical role, emotional, cognitive, and social), 1 global health status scale, 3 symptom scales (pain, fatigue, and nausea or vomiting), and 5 single symptom items (dyspnea, insomnia, appetite loss, constipation, and diarrhea) and a single impact item (financial difficulties). The recall period is 7 days ("past week"), and responses are reported using a verbal and numeric rating scales. The item and scale scores are transformed to a 0 to 100 scale. A high scale score represents a higher response level. |
Up to 3 years 5 months
|
|
Time to Sustained Worsening in Symptoms, Functioning, and Health-related Quality of Life (HRQoL) as Assessed by EuroQol Five Dimension Questionnaire 5-Level (EQ-5D-5L)
기간: Up to 3 years 5 months
|
Time to sustained worsening in symptoms, functioning and HRQoL is defined as the interval from the date of randomization to the start date of meaningful change. The EQ-5D-5L is a 5-item questionnaire that assesses 5 domains including 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). |
Up to 3 years 5 months
|
|
Time to Sustained Worsening in Symptoms, Functioning, and Health-related Quality of Life (HRQoL) as Assessed by Patient Global Impression -Severity (PGI-S)
기간: Up to 3 years 5 months
|
Time to sustained worsening in symptoms, functioning and HRQoL is defined as the interval from the date of randomization to the start date of meaningful change. The PGI-S will be used as an anchor, external criterion, to determine meaningful change in scores for the MySIm-Q and EORTC-QLQ-C30 in this population. The response options are presented as a 5-point verbal rating scale from "none" to "very severe." |
Up to 3 years 5 months
|
|
Time to Sustained Worsening in Symptoms, Functioning, and Health-related Quality of Life (HRQoL) as Assessed by Epstein Taste Survey
기간: Up to 3 years 5 months
|
Time to sustained worsening in symptoms, functioning and HRQoL is defined as the interval from the date of randomization to the start date of meaningful change. The epstein taste survey consists of 17 items from the full 71 item PRO instrument, specific to taste changes developed for use in patients with head and neck cancer as a composite of the Vanderbilt Head and Neck Symptom Survey. |
Up to 3 years 5 months
|
|
Change from Baseline in Symptoms, Functioning, and Health-related Quality of Life (HRQoL) as Assessed by MySIm-Q
기간: Up to 3 years 5 months
|
Change from baseline in symptoms, functioning, and HRQoL as assessed by MySIm-Q will be reported. The MySIm-Q is a disease-specific patient-reported outcome (PRO) assessment complementary to the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 item (EORTC-QLQ-C30). It includes 17 items resulting in a symptom subscale and an impact subscale. |
Up to 3 years 5 months
|
|
Change from Baseline in Symptoms, Functioning, and Health-related Quality of Life (HRQoL) as Assessed by EORTC-QLQ-C30
기간: Up to 3 years 5 months
|
Change from baseline in symptoms, functioning, and HRQoL as assessed by EORTC-QLQ-C30 will be reported. The EORTC-QLQ-C30 Version 3 includes 30 items that make up 5 functional scales (physical, role, emotional, cognitive, and social), 1 global health status scale, 3 symptom scales (pain, fatigue, and nausea or vomiting), and 5 single symptom items (dyspnea, insomnia, appetite loss, constipation, and diarrhea) and a single impact item (financial difficulties). The recall period is 7 days ("past week"), and responses are reported using a verbal and numeric rating scales. The item and scale scores are transformed to a 0 to 100 scale. A high scale score represents a higher response level. Thus, a high score for a functional scale represents a high or healthy level of functioning and a high score for the global health status represents high HRQoL, but a high score for a symptom scale or item represents a high level of symptomatology or problems. |
Up to 3 years 5 months
|
|
Change from Baseline in Symptoms, Functioning, and Health-related Quality of Life (HRQoL) as Assessed by EQ-5D-5L
기간: Up to 3 years 5 months
|
Change from baseline in symptoms, functioning, and HRQoL as assessed by EQ-5D-5L will be reported. The EQ-5D-5L is a 5-item questionnaire that assesses 5 domains including 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). |
Up to 3 years 5 months
|
|
Change from Baseline in Symptoms, Functioning, and Health-related Quality of Life (HRQoL) as Assessed by PGI-S
기간: Up to 3 years 5 months
|
Change from baseline in symptoms, functioning, and HRQoL as assessed by PGI-S will be reported. The PGI-S will be used as an anchor, external criterion, to determine meaningful change in scores for the MySIm-Q and EORTC-QLQ-C30 in this population. The response options are presented as a 5-point verbal rating scale from "none" to "very severe." |
Up to 3 years 5 months
|
|
Change from Baseline in Symptoms, Functioning, and Health-related Quality of Life (HRQoL) as Assessed by Epstein Taste Survey
기간: Up to 3 years 5 months
|
Change from baseline in symptoms, functioning, and HRQoL as assessed by epstein taste survey will be reported. The epstein taste survey consists of 17 items from the full 71 item PRO instrument, specific to taste changes. developed for use in patients with head and neck cancer as a composite of the Vanderbilt Head and Neck Symptom Survey. |
Up to 3 years 5 months
|
|
Percentage of Participants With Meaningful Improvement in HRQoL as Assessed by EORTC-QLQ-C30
기간: Up to 3 years 5 months
|
Percentage of participants with meaningful improvement in HRQol as assessed by EORTC-QLQ-C30 will be reported. The EORTC-QLQ-C30 Version 3 includes 30 items that make up 5 functional scales (physical, role, emotional, cognitive, and social), 1 global health status scale, 3 symptom scales (pain, fatigue, and nausea or vomiting), and 5 single symptom items (dyspnea, insomnia, appetite loss, constipation, and diarrhea) and a single impact item (financial difficulties). The recall period is 7 days ("past week"), and responses are reported using a verbal and numeric rating scales. The item and scale scores are transformed to a 0 to 100 scale. A high scale score represents a higher response level. Thus, a high score for a functional scale represents a high or healthy level of functioning and a high score for the global health status represents high HRQoL, but a high score for a symptom scale or item represents a high level of symptomatology or problems. |
Up to 3 years 5 months
|
|
Number of Participants with Adverse Events (AEs) by Severity
기간: Up to 3 years 5 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. Severity of AEs will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0. by using standard grades as follows: Grade 1: Mild; asymptomatic or mild symptoms; Grade 2: Moderate; minimal, local or noninvasive intervention indicated; Grade 3: Severe but not immediately life threatening; hospitalization or prolongation of hospitalization indicated; Grade 4: Life-threatening consequences; and Grade 5: Death related to AE. |
Up to 3 years 5 months
|
공동 작업자 및 조사자
수사관
수사관
- 연구 책임자: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
연구 시작
기본 완료 (실제)
기본 완료
연구 완료 (추정된)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
- 혈관 질환
- 심혈관 질환
- 신생물
- 면역계 질환
- 조직학적 유형에 따른 신생물
- 혈액 질환
- 림프 증식 장애
- 면역증식성 장애
- 신생물, 형질세포
- 지혈 장애
- 파라단백혈증
- 혈액 단백질 장애
- 출혈성 장애
- 헴 및 림프병
- 다발성 골수종
- 유기 화학 물질
- 이종 사이 클릭 화합물, 1- 링
- 이종 사이 클릭 화합물
- 다 환식 화합물
- 무기 화학 물질
- Pretadienes
- 임신
- 스테로이드
- 융합 링 화합물
- 스테로이드, 불소
- Pregnadienetriols
- 보 론산
- 산, 비 카르 복실
- 산
- 붕소 화합물
- 피라진
- 보르테조밉
- 덱사메타손
- Pomalidomide
- 엘로 투 주맙
- 탈케타 맙
기타 연구 ID 번호
기타 연구 ID 번호
- 64407564MMY3009
- 64407564MMY3009 (기타 식별자: Janssen Research & Development, LLC)
- 2022-502446-27-00 (레지스트리 식별자: EUCT number)
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 www.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
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .