Um estudo comparando Talquetamab Plus Pomalidomida, Talquetamab Plus Teclistamab e Elotuzumab, Pomalidomida e Dexametasona ou Pomalidomida, Bortezomibe e Dexametasona em participantes com mieloma recidivante ou refratário que receberam um anticorpo anti-CD38 e lenalidomida (MonumenTAL-6)
Um estudo randomizado de fase 3 comparando talquetamabe em combinação com pomalidomida (Tal-P), talquetamabe em combinação com teclistamabe (Tal-Tec) e a escolha do investigador de elotuzumabe, pomalidomida e dexametasona (EPd) ou pomalidomida, bortezomibe e dexametasona ( PVd) em participantes com mieloma recidivante ou refratário que receberam 1 a 4 linhas de terapia anteriores, incluindo um anticorpo anti-CD38 e lenalidomida
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).
Visão geral do estudo
Status
Condições
Tipo de estudo
Inscrição (Real)
Estágio
- Fase 3
Contactos e Locais
Locais de estudo
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Augsburg, Alemanha, 86156
- Klinikum Augsburg
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Halle, Alemanha, 06120
- Universitaetsklinikum Halle Saale
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Heidelberg, Alemanha, 69120
- Universitaetsklinikum Heidelberg
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Magdeburg, Alemanha, 39120
- Universitaetsklinikum Magdeburg A.oe.R
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München, Alemanha, 81675
- Klinikum rechts der Isar der TU Muenchen
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Tübingen, Alemanha, 72076
- Universitaetsklinikum Tuebingen
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Würzburg, Alemanha, 97080
- Universitaetsklinikum Wuerzburg
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Buenos Aires, Argentina, C1280AEB
- Hospital Britanico de Buenos Aires
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Buenos Aires, Argentina, C1114AAN
- Fundaleu
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CABA, Argentina, C1118AAT
- Hospital Aleman
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Riyadh, Arábia Saudita, 11564
- King Faisal Specialist Hospital & Research Center
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Riyadh, Arábia Saudita, 12231
- King Fahad Medical City
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Riyadh, Arábia Saudita, 11481
- King Abdullah International Medical Research Center (KAIMRC)
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Adelaide, Austrália, 5000
- Royal Adelaide Hospital
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Box Hill, Austrália, 3128
- Box Hill Hospital
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Darlinghurst, Austrália, 2010
- St Vincents Hospital
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Fitzroy, Austrália, 3065
- St Vincents Hospital Melbourne
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Southport, Austrália, 4215
- Gold Coast University Hospital
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West Perth, Austrália, 6005
- Perth Blood Institute
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Wollongong, Austrália, 2500
- Wollongong Hospital
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Belo Horizonte, Brasil, 30110-022
- Cetus Oncologia
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Brasília, Brasil, 70390 700
- IDOR - Regional Brasilia
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Caxias do Sul, Brasil, 95070 560
- Fundacao Universidade de Caxias do Sul
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Curitiba, Brasil, 81520-060
- Hospital Erasto Gaertner- Liga Paranaense de Combate ao Cancer
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Porto Alegre, Brasil, 90035-903
- Hospital De Clinicas De Porto Alegre
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Recife, Brasil, 50070-480
- IDOR - Regional Pernambuco
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Rio de Janeiro, Brasil, 22793-080
- Instituto de Educacao, Pesquisa e Gestao em Saude Instituto Americas (COI)
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Salvador, Brasil, 41253-190
- IDOR - Regional Bahia
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São José do Rio Preto, Brasil, 15090-000
- Funfarme Sjrp
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São Paulo, Brasil, 01509 900
- Fundacao Antonio Prudente A C Camargo Cancer Center
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São Paulo, Brasil, 04537 081
- Clinica Medica Sao Germano LTDA
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São Paulo, Brasil, 01323 001
- Real e Benemerita Associacao Portuguesa de Beneficencia
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São Paulo, Brasil, 01401 002
- IDOR - Regional Sao Paulo
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Charleroi, Bélgica, 6060
- Grand Hopital De Charleroi Site Les Viviers
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Genk, Bélgica, 3600
- Ziekenhuis Oost-Limburg
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Ghent, Bélgica, 9000
- Ghent University Hospital
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Sint-Niklaas, Bélgica, 9100
- AZ Nikolaas - Campus Sint-Niklaas Moerland
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Alberta
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Calgary, Alberta, Canadá, T2N 5G2
- Arthur J E Child Comprehensive Cancer Centre
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British Columbia
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Vancouver, British Columbia, Canadá, V5Z4E6
- British Columbia Cancer Agency
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Nova Scotia
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Halifax, Nova Scotia, Canadá, B3H 1V7
- Nova Scotia Health Authority
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Ontario
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Hamilton, Ontario, Canadá, L8V5C2
- Juravinski Cancer Centre
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Toronto, Ontario, Canadá, M5G2M9
- Princess Margaret Cancer Centre University Health Network
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Quebec
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Montreal, Quebec, Canadá, H1T 2M4
- CIUSSS de l Est de l Ile de Montreal Installation Hopital Maisonneuve Rosemont
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Saskatchewan
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Saskatoon, Saskatchewan, Canadá, S7N 4H4
- Saskatoon Cancer Centre
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Beijing, China, 100034
- Peking University First Hospital
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Beijing, China, 100020
- Beijing Chaoyang Hospital
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Beijing, China, 101199
- Peking University People's Hospital
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Changsha, China, 410011
- The Second Xiangya Hospital of Central South Hospital
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Changzhou, China, 213000
- Changzhou No 2 Peoples Hospital
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Chengdu, China, 610032
- Sichuan Provincial Peoples Hospital
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Fuzhou, China, 350005
- The First Affiliated Hospital of Fujian Medical University
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Fuzhou, China, 350001
- Fujian Meidical University Union Hospital
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Guangzhou, China, 510515
- Nanfang Hospital of Southern Medical Hospital
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Guangzhou, China, 510060
- Sun Yat Sen University Cancer Center
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Hangzhou, China, 310009
- The Second Affiliated Hospital of Zhejiang University College of Medicine
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Hangzhou, China, 310003
- First hospital affiliated of Zhejiang Medical university
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Hohhot, China, 010051
- The Affiliated Hospital of Inner Mongolia Medical College
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Jinan, China, 250012
- Qilu Hospital of Shandong University
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Nanchang, China, 330006
- The First Affiliated Hospital of NanChang University
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Nanjing, China, 210008
- Nanjing Drum Tower Hospital
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Nanning, China, 530021
- The First Affiliated Hospital of Guangxi Medical University
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Shanghai, China, 200025
- Ruijing Hospital Affiliated To Shanghai Jiaotong University School Of Medicine
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Shanghai, China, 200065
- Tongji Hospital of Tongji University
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Shanghai, China, 200434
- Shanghai Fourth People s Hospital
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Shenyang, China, 110055
- Shengjing Hospital Of China Medical University
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Shenzhen, China, 518036
- Peking University Shenzhen Hospital
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Taiyuan, China, 030032
- Shanxi Bethune Hospital
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Tianjin, China, 30060
- Tianjin Medical University Cancer Institute and Hospital
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Wenzhou, China, 325000
- The First Affiliated Hospital of Wenzhou Medical University
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Wuhan, China, 430030
- Tongji Hospital, Tongji Medical College of HUST
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Xi'an, China, 710004
- The Second Affiliated Hospital of Xi'an Jiaotong University
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Xiamen, China, 361026
- The first affiliated hospital of xiamen university
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Busan, Coréia do Sul, 49201
- Dong-A University Hospital
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Busan, Coréia do Sul, 49241
- Pusan National University Hospital
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Jeollanam-do, Coréia do Sul, 58128
- Chonnam National University Hwasun Hospital
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Seoul, Coréia do Sul, 03080
- Seoul National University Hospital
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Seoul, Coréia do Sul, 06351
- Samsung Medical Center
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Seoul, Coréia do Sul, 06591
- The Catholic University of Korea Seoul St Mary s Hospital
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Ulsan, Coréia do Sul, 44033
- Ulsan University Hospital
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Aarhus, Dinamarca, 8200
- Aarhus University Hospital
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Odense C, Dinamarca, 5000
- Odense University Hospital
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Vejle, Dinamarca, 7100
- Vejle Hospital
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Asturias, Espanha, 33394
- Hosp. de Cabuenes
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Barcelona, Espanha, 08035
- Hosp Univ Vall D Hebron
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Burgos, Espanha, 09003
- Hosp. Univ. de Burgos
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Cáceres, Espanha, 10003
- Hosp. San Pedro de Alcantara
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Donostia / San Sebastian, Espanha, 20014
- Hosp. Univ. Donostia
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Granada, Espanha, 18014
- Hosp. Univ. Virgen de Las Nieves
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Lugo, Espanha, 27003
- Hosp. Univ. Lucus Augusti
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Madrid, Espanha, 28046
- Hosp. Univ. La Paz
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Palma de Mallorca, Espanha, 07120
- Hosp. Univ. Son Espases
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Pamplona, Espanha, 31008
- Clinica Univ. de Navarra
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Pamplona, Espanha, 31008
- Complejo Hosp de Navarra - Hosp de Navarra
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Salamanca, Espanha, 37007
- Hosp Clinico Univ de Salamanca
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Santander, Espanha, 39008
- Hosp. Univ. Marques de Valdecilla
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Santiago de Compostela, Espanha, 15706
- Hosp. Clinico Univ. de Santiago
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California
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Clovis, California, Estados Unidos, 93611
- UCSF Fresno
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Santa Monica, California, Estados Unidos, 90404
- UCLA
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Connecticut
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New Haven, Connecticut, Estados Unidos, 06519
- Yale University School Of Medicine
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Delaware
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Newark, Delaware, Estados Unidos, 19713
- Medical Oncology Hematology Consultants, PA
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Florida
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Hollywood, Florida, Estados Unidos, 33021
- Memorial Healthcare System
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Tampa, Florida, Estados Unidos, 33612
- Moffitt Cancer Center
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Georgia
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Atlanta, Georgia, Estados Unidos, 30322
- Winship Cancer Institute Emory University
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Newnan, Georgia, Estados Unidos, 30265
- City of Hope Cancer Center
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Idaho
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Coeur d'Alene, Idaho, Estados Unidos, 83814
- Kootenai Health
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Illinois
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Maywood, Illinois, Estados Unidos, 60153
- Loyola University Medical Center
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Iowa
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Waukee, Iowa, Estados Unidos, 50263
- University of Iowa Health Care
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Kentucky
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Louisville, Kentucky, Estados Unidos, 40207
- Norton Cancer Institute
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Louisiana
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Baton Rouge, Louisiana, Estados Unidos, 70808
- Our Lady of the Lake Hospital
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Maryland
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Annapolis, Maryland, Estados Unidos, 21401
- Luminis Health Center for Cancer and Blood Disorders
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Baltimore, Maryland, Estados Unidos, 21201
- University of Maryland School of Medicine
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Baltimore, Maryland, Estados Unidos, 21287
- The Sidney Kimmel Comprehensive Cancer Center at John Hopkins
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Michigan
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Ann Arbor, Michigan, Estados Unidos, 48109
- University of Michigan
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Detroit, Michigan, Estados Unidos, 48202
- Henry Ford Cancer Institute
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Southfield, Michigan, Estados Unidos, 48075
- Henry Ford Health Providence Southfield Hospital
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Minnesota
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Minneapolis, Minnesota, Estados Unidos, 55455
- University Of Minnesota
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Rochester, Minnesota, Estados Unidos, 55905
- Mayo Clinic Rochester
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Saint Paul, Minnesota, Estados Unidos, 55101
- Regions Hospital
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Nebraska
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Omaha, Nebraska, Estados Unidos, 68105
- University of Nebraska
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New Hampshire
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Lebanon, New Hampshire, Estados Unidos, 03756
- Dartmouth Hitchcock Medical Center
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New Jersey
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Hackensack, New Jersey, Estados Unidos, 07601
- John Theurer Cancer Center at Hackensack University Medical Center
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New York
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Buffalo, New York, Estados Unidos, 14263
- Roswell Park Cancer Institute
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New York, New York, Estados Unidos, 10065
- Weill Cornell Medical College
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Syracuse, New York, Estados Unidos, 13210
- SUNY Upstate Medical University
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North Carolina
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Durham, North Carolina, Estados Unidos, 27705
- Duke University Medical Center
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Ohio
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Canton, Ohio, Estados Unidos, 44718
- Gabrail Cancer Center
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Cleveland, Ohio, Estados Unidos, 44195
- Cleveland Clinic
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Cleveland, Ohio, Estados Unidos, 44106
- Louis Stokes Cleveland VA Med Ctr
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Oregon
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Portland, Oregon, Estados Unidos, 97239
- Oregon Health And Science University
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Pennsylvania
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Hershey, Pennsylvania, Estados Unidos, 17033
- Penn State Milton S Hershey Medical Ctr
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Philadelphia, Pennsylvania, Estados Unidos, 19107 4215
- Thomas Jefferson University
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Pittsburgh, Pennsylvania, Estados Unidos, 15224
- West Penn Hospital
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Pittsburgh, Pennsylvania, Estados Unidos, 15232
- University Of Pittsburgh Medical Center UPMC Hillman Cancer Center
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South Carolina
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Charleston, South Carolina, Estados Unidos, 29425-8900
- Medical University of South Carolina
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Greenville, South Carolina, Estados Unidos, 29607
- Bon Secours Saint Francis Cancer Center
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Texas
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Dallas, Texas, Estados Unidos, 75390
- UT Southwestern Parkland Hospital
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Dallas, Texas, Estados Unidos, 75390
- UT Southwestern
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Houston, Texas, Estados Unidos, 77030
- Houston Methodist Neal Cancer Center at Texas Medical Center
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Utah
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Salt Lake City, Utah, Estados Unidos, 84112
- Huntsman Cancer Institute
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Virginia
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Charlottesville, Virginia, Estados Unidos, 22903
- University of Virginia
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Washington
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Seattle, Washington, Estados Unidos, 98109
- Fred Hutchinson Cancer Research Center
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Seattle, Washington, Estados Unidos, 98104
- Swedish Cancer Institute
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Tacoma, Washington, Estados Unidos, 98405
- NorthWest Medical Specialties, PLLC
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Wisconsin
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La Crosse, Wisconsin, Estados Unidos, 54601
- Gundersen Health System
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Milwaukee, Wisconsin, Estados Unidos, 53226
- Medical College Of Wisconsin
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Lille, França, 59000
- Hopital Claude Huriez
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Limoges, França, 87042
- CHU de Limoges Hopital Dupuytren
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Lyon, França, 69002
- Hospices Civils de Lyon HCL
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Marseille, França, 13009
- Institut Paoli Calmettes
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Nantes, França, 44093
- CHU Nantes
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Paris, França, 75010
- Hopital Saint Louis
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Pessac, França, 33604
- CHU de Bordeaux - Hospital Haut-Leveque
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Strasbourg, França, 67200
- Institut de Cancerologie Strasbourg Europe ICANS
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Toulouse, França, 31100
- Institut Universitaire du Cancer Toulouse Oncopole
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Tours, França, 37044
- CHRU Tours Hopital Bretonneau
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Athens, Grécia, 115 28
- Alexandra General Hospital of Athens
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Athens, Grécia, 115 25
- 251 Airforces Hospital
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Thessaloniki, Grécia, 546 39
- Theageneio Cancer Hospital
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Almere Stad, Holanda, 1315RA
- Flevoziekenhuis
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Eindhoven, Holanda, 5623 EJ
- Catharinaziekenhuis
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Nieuwegein, Holanda, 3435 CM
- St. Antonius Ziekenhuis Nieuwegein
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The Hague, Holanda, 2545 CH
- Haga ziekenhuis
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Zwolle, Holanda, 8025 AB
- Isala Kliniek
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Budapest, Hungria, 1088
- Semmelweis Egyetem, Belgyogyaszati es Hematologiai Klinika
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Budapest, Hungria, 1097
- Del Pesti Centrumkorhaz Orszagos Hematologiai es Infektologiai Intezet Szent Laszlo Telephely
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Debrecen, Hungria, 4032
- Debreceni Egyetem Klinikai Kozpont
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Nyíregyháza, Hungria, 4400
- Szabolcs Szatmar Bereg Varmegyei Oktatokorhaz
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Pécs, Hungria, 7624
- Pecsi Tudomanyegyetem Klinikai Kozpont
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Be’er Ya‘aqov, Israel, 70300
- Shamir Medical Center Assaf Harofeh
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Haifa, Israel, 3436212
- Carmel Medical Center
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Petah Tikva, Israel, 49100
- Rabin Medical center - Petah-Tikva
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Ramat Gan, Israel, 52621
- Sheba Medical Center
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Tel Aviv, Israel, 64239
- Tel Aviv Sourasky Medical Center
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Alessandria, Itália, 15121
- Azienda Ospedaliera Nazionale SS. Antonio e Biagio e Cesare Arrigo Alessandria
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Bologna, Itália, 40138
- A O U Sant Orsola Malpighi
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Brindisi, Itália, 72100
- Ospedale Perrino
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Catania, Itália, 95122
- ARNAS Garibaldi P O Nesima
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Genova, Itália, 16132
- Ospedale Policlinico San Martino IRCCS
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Legnano, Itália, 20025
- Asst Ovest Milanese - Ospedale Di Legnano
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Milan, Itália, 20132
- IRCCS Ospedale San Raffaele
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Milan, Itália, 20122
- Fondazione IRCCS Ca Granda Ospedale Policlinico Di Milano
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Pavia, Itália, 27100
- Fondazione IRCCS Policlinico San Matteo
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Pescara, Itália, 65124
- Presidio Ospedaliero Pescara
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Ravenna, Itália, 48121
- Ospedale S. Maria Delle Croci
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Torino, Itália, 10126
- Oncologia Medica-Città Della Salute E Della Scienza Di Torino
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Verona, Itália, 37134
- Azienda Ospedaliera Universitaria Integrata Verona
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Bunkyō City, Japão, 113 8431
- Juntendo University Hospital
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Fukuoka, Japão, 814-0180
- Fukuoka University Hospital
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Hamamatsu, Japão, 431 3192
- Hamamatsu University Hospital
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Kanazawa, Japão, 920 8641
- Kanazawa University Hospital
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Kyoto, Japão, 602-8566
- University Hospital Kyoto Prefectural University of Medicine
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Nagasaki, Japão, 856-8562
- National Hospital Organization Nagasaki Medical Center
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Narita, Japão, 286-8523
- Japanese Red Cross Narita Hospital
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Niigata, Japão, 951-8566
- Niigata Cancer Center Hospital
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Nishinomiya Shi, Japão, 663 8501
- Hyogo Medical University Hospital
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Osaka, Japão, 543-8555
- Japanese Red Cross Osaka Hospital
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Sapporo, Japão, 060-8604
- Sapporo City General Hospital
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Sendai, Japão, 980 8574
- Tohoku University Hospital
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Shibuya-ku, Japão, 150-8935
- Japanese Red Cross Medical Center
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Shiwa-gun, Japão, 028-3695
- Iwate Medical University Hospital
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Suita, Japão, 565 0871
- The University of Osaka Hospital
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Sunto Gun, Japão, 411 8777
- Shizuoka Cancer Center
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Tokyo, Japão, 135 8550
- The Cancer Institute Hospital of JFCR
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Tottori, Japão, 683-0824
- Tottori University Hospital
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Tsukuba, Japão, 305 8576
- University of Tsukuba Hospital
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Yokohama, Japão, 241 8515
- Kanagawa Cancer Center
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Guadalajara, México, 45645
- Centro de Quimioterapia e Investigacion
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Huixquilucan, México, 52787
- Hematologica Alta Especialidad
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Monterrey, México, 64460
- Hospital Universitario Dr Jose Eleuterio Gonzalez
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Biała Podlaska, Polônia, 21 500
- Wojewodzki Szpital Specjalistyczny
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Brzozów, Polônia, 36-200
- Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologiczny im Ks B Markiewicza
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Kielce, Polônia, 25 734
- Swietokrzyskie Centrum Onkologii SPZOZ w Kielcach
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Lublin, Polônia, 20-090
- Centrum Onkologii Ziemii Lubelskiej
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Szczecin, Polônia, 71-252
- Uniwersytecki Szpital Kliniczny Nr 1 PUM im prof Tadeusza Sokolowskiego w Szczecinie
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Wroclaw, Polônia, 50 367
- Uniwersytecki Szpital Kliniczny im Jana Mikulicza Radeckiego we Wroclawiu
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Blackpool, Reino Unido, FY3 8NR
- Blackpool Victoria Hospital
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Cardiff, Reino Unido, CF14 4HY
- University Hospital of Wales
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Dundee, Reino Unido, DD1 9SY
- Ninewells Hospital
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Leeds, Reino Unido, LS9 7TF
- St James University Hospital
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London, Reino Unido, SE5 9RS
- Kings College Hospital
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Nottingham, Reino Unido, NG5 1PB
- Nottingham City Hospital
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Plymouth, Reino Unido, PL6 8DH
- University Hospitals Plymouth NHS Trust
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Portsmouth, Reino Unido, PO6 3LY
- Queen Alexandra Hospital
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Lund, Suécia, 221 85
- Skanes universitetssjukhus
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Umeå, Suécia, 901 85
- Norrlands Universitetssjukhus
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Uppsala, Suécia, 75185
- Akademiska Sjukhuset
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Varberg, Suécia, 432 81
- Varberg Hospital
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Brno-Bohunice, Tcheca, 625 00
- Fakultni nemocnice Brno
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Hradec Králové, Tcheca, 500 05
- Fakultni nemocnice Hradec Kralove
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Olomouc, Tcheca, 779 00
- University Hospital Olomouc
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Ostrava, Tcheca, 708 52
- Fakultni Nemocnice Ostrava
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Ankara, Turquia (Türkiye), 06680
- Liv Hospital Ankara
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Ankara, Turquia (Türkiye), 06620
- Ankara Universitesi Tip Fakultesi Cebeci Arastirma ve Uygulama Hastanesi
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Denizli, Turquia (Türkiye), 20070
- Pamukkale Universitesi Tip Fakultesi
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Istanbul, Turquia (Türkiye), 34214
- Medipol University Hospital
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Samsun, Turquia (Türkiye), 55200
- Ondokuz Mayis Universitesi Saglik Uygulama ve Arastirma Merkezi
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Salzburg, Áustria, 05020
- LKH - Universitätsklinikum der PMU Salzburg
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Vienna, Áustria, 1160
- Klinik Ottakring
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Vienna, Áustria, A-1090
- Medical University Vienna MUV
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Gūrgaon, Índia, 122002
- Fortis Memorial Research Institute
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Lucknow, Índia, 226014
- Sanjay Gandhi Postgraduate Institute of Medical Sciences
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Pune, Índia, 411004
- Deenanath Mangeshkar Hospital and Research Centre
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: 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.
Outros nomes:
Dexamethasone will be administered either orally or intravenously. Talquetamab will be administered as a SC injection.
Outros nomes:
|
|
Experimental: 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.
Outros nomes:
Dexamethasone will be administered either orally or intravenously. Talquetamab will be administered as a SC injection.
Outros nomes:
|
|
Comparador Ativo: 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.
Outros nomes:
Dexamethasone will be administered either orally or intravenously. Elotuzumab will be administered intravenously.
Outros nomes:
Bortezomib will be administered as a SC injection.
Outros nomes:
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Progression Free Survival (PFS)
Prazo: 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
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Overall Response Rate (ORR)
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: 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
Prazo: 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)
Prazo: 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)
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Diretor de estudo: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
- Doenças Vasculares
- Doenças cardiovasculares
- Neoplasias
- Doenças do sistema imunológico
- Neoplasias por Tipo Histológico
- Doenças Hematológicas
- Distúrbios Linfoproliferativos
- Distúrbios imunoproliferativos
- Neoplasias de Células Plasmáticas
- Distúrbios hemostáticos
- Paraproteinemias
- Distúrbios das Proteínas Sanguíneas
- Distúrbios hemorrágicos
- Doenças hemic e linfáticas
- Mieloma múltiplo
- Produtos químicos orgânicos
- Compostos heterocíclicos, 1 anel
- Compostos heterocíclicos
- Compostos policíclicos
- Produtos químicos inorgânicos
- Pregada
- Pregnas
- Esteróides
- Compostos de anel fundido
- Esteróides, fluorados
- Pregadienetriols
- Ácidos borônicos
- Ácidos, não carboxílico
- Ácidos
- Compostos de boro
- Pirazinas
- Bortezomibe
- Dexametasona
- pomalidomida
- Elotuzumab
- Talquetamab
Outros números de identificação do estudo
- 64407564MMY3009
- 64407564MMY3009 (Outro identificador: Janssen Research & Development, LLC)
- 2022-502446-27-00 (Identificador de registro: EUCT number)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
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.
Informações sobre medicamentos e dispositivos, documentos de estudo
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