En undersøgelse til sammenligning af Teclistamab i kombination med Daratumumab og Lenalidomid (Tec-DR) hos deltagere med nyligt diagnosticeret myelomatose (MajesTEC-7)
2. november 2026 opdateret af: Janssen Research & Development, LLC
Et fase 3 randomiseret studie, der sammenligner Teclistamab i kombination med Daratumumab SC og Lenalidomide (Tec-DR) versus Daratumumab SC, Lenalidomid og Dexamethason (DRd) hos deltagere med nyligt diagnosticeret myelomatose, som enten er uegnede eller ikke er beregnet til autolog celletransplantation Indledende terapi
The purpose of this study is to compare the efficacy of teclistamab in combination with daratumumab and lenalidomide (Tec-DR) and talquetamab in combination with daratumumab and lenalidomide (Tal-DR) versus daratumumab, lenalidomide, dexamethasone (DRd).
Studieoversigt
Status
Status
Rekruttering
Betingelser
Betingelser
Intervention / Behandling
Intervention / Behandling
Undersøgelsestype
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
Tilmelding
1590
Fase
Fase
- Fase 3
Udvidet adgang
Udvidet adgang
Godkendt
til salg til offentligheden.
Se udvidet adgangsregistrering.
Godkendt
- Tilgængelig: Udvidet adgang er i øjeblikket tilgængelig for denne forsøgsbehandling, og patienter, der ikke er deltagere i den kliniske undersøgelse, kan muligvis få adgang til lægemidlet, det biologiske eller medicinske udstyr undersøgt.
- Ikke længere tilgængelig: Udvidet adgang var tilgængelig for denne intervention tidligere, men er ikke tilgængelig i øjeblikket og vil ikke være tilgængelig i fremtiden.
- Midlertidigt ikke tilgængelig: Udvidet adgang er i øjeblikket ikke tilgængelig for denne intervention, men forventes at være tilgængelig i fremtiden.
- Godkendt til markedsføring: Interventionen er blevet godkendt af U.S. Food and Drug Administration til brug for offentligheden.
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
Studiekontakt
- Navn: Study Contact
- Telefonnummer: 844-434-4210
- E-mail: Participate-In-This-Study1@its.jnj.com
Studiesteder
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Camperdown, Australien, 2050
- Aktiv, ikke rekrutterende
- Royal Prince Alfred Hospital
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Geelong, Australien, 3220
- Aktiv, ikke rekrutterende
- Barwon Health - University Hospital Geelong
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Liverpool, Australien, 2170
- Aktiv, ikke rekrutterende
- Liverpool Hospital
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Nedlands, Australien, 6009
- Aktiv, ikke rekrutterende
- Sir Charles Gairdner Hospital
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New South Wales, Australien, 2298
- Aktiv, ikke rekrutterende
- Calvary Mater Newcastle Hospital
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Wollongong, Australien, 2500
- Aktiv, ikke rekrutterende
- Wollongong Hospital
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Woolloongabba, Australien, 4102
- Aktiv, ikke rekrutterende
- Princess Alexandra Hospital
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-
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Anderlecht, Belgien, 1070
- Aktiv, ikke rekrutterende
- Institut Jules Bordet
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Antwerp, Belgien, 2610
- Afsluttet
- ZAS Augustinus
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Antwerp, Belgien, 2030
- Aktiv, ikke rekrutterende
- ZAS Cadix
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Ghent, Belgien, 9000
- Aktiv, ikke rekrutterende
- Ghent University Hospital
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Haine Saint Paul La Louviere, Belgien, 7100
- Afsluttet
- Jolimont
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Kortrijk, Belgien, 8500
- Aktiv, ikke rekrutterende
- Az Groeninge
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Leuven, Belgien, 3000
- Aktiv, ikke rekrutterende
- Universitair Ziekenhuis Leuven
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-
-
-
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Barretos, Brasilien, 14784 400
- Afsluttet
- Fundacao Pio XII
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Belo Horizonte, Brasilien, 30150 320
- Aktiv, ikke rekrutterende
- Santa Casa de Misericordia de Belo Horizonte
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Curitiba, Brasilien, 81520-060
- Aktiv, ikke rekrutterende
- Hospital Erasto Gaertner- Liga Paranaense de Combate ao Cancer
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Fortaleza, Brasilien, 60430-230
- Aktiv, ikke rekrutterende
- Instituto Do Cancer Do Ceara
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Natal, Brasilien, 59062-000
- Aktiv, ikke rekrutterende
- Liga Norte Riograndense Contra O Cancer
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Niterói, Brasilien, 24030-103
- Aktiv, ikke rekrutterende
- Complexo Hospitalar de Niteroi
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Porto Alegre, Brasilien, 90035 903
- Aktiv, ikke rekrutterende
- Hospital De Clinicas De Porto Alegre
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Ribeirão Preto, Brasilien, 14051140
- Aktiv, ikke rekrutterende
- Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto
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Salvador, Brasilien, 41253-190
- Aktiv, ikke rekrutterende
- IDOR - Regional Bahia
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São Paulo, Brasilien, 04537 081
- Aktiv, ikke rekrutterende
- Clinica Medica Sao Germano LTDA
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São Paulo, Brasilien, 01409-902
- Aktiv, ikke rekrutterende
- Hospital Nove de Julho
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São Paulo, Brasilien, 05403 000
- Aktiv, ikke rekrutterende
- Hospital Das Clinicas Da Faculdade De Medicina Da USP
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Alberta
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Calgary, Alberta, Canada, T2N 5G2
- Aktiv, ikke rekrutterende
- Arthur J E Child Comprehensive Cancer Centre
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Edmonton, Alberta, Canada, T6G 1Z2
- Afsluttet
- Cross Cancer Institute
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British Columbia
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Vancouver, British Columbia, Canada, V5Z4E6
- Aktiv, ikke rekrutterende
- British Columbia Cancer Agency
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Ontario
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Oshawa, Ontario, Canada, L1G-2B9
- Rekruttering
- Lakeridge Health Oshawa
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Quebec
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Québec, Quebec, Canada, G1J 1Z4
- Aktiv, ikke rekrutterende
- CHU de Quebec L Hotel Dieu de Quebec
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-
-
-
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Aalborg, Danmark, 9000
- Aktiv, ikke rekrutterende
- Aalborg University Hospital
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Herning, Danmark, 7400
- Aktiv, ikke rekrutterende
- Regionshospitalet Godstrup
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Køge, Danmark, 4600
- Aktiv, ikke rekrutterende
- Zealand University Hospital
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Vejle, Danmark, 7100
- Aktiv, ikke rekrutterende
- Vejle Sygehus
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Birmingham, Det Forenede Kongerige, B15 2GW
- Afsluttet
- University Hospitals Birmingham NHS Foundation Trust
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Blackpool, Det Forenede Kongerige, FY3 8NR
- Aktiv, ikke rekrutterende
- Blackpool Victoria Hospital
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Bristol, Det Forenede Kongerige, BS1 3NU
- Aktiv, ikke rekrutterende
- Bristol NHS Foundation Trust
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Cambridge, Det Forenede Kongerige, CB2 0QQ
- Aktiv, ikke rekrutterende
- Addenbrooke's Hospital
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Canterbury, Det Forenede Kongerige, CT1 3NG
- Aktiv, ikke rekrutterende
- Kent and Canterbury Hospital
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Edinburgh, Det Forenede Kongerige, EH4 2XU
- Aktiv, ikke rekrutterende
- Western General Hospital
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London, Det Forenede Kongerige, NW1 2BU
- Aktiv, ikke rekrutterende
- University College London Hospitals
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London, Det Forenede Kongerige, W12 0HS
- Aktiv, ikke rekrutterende
- Imperial College Healthcare
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Wolverhampton, Det Forenede Kongerige, WV10 0QP
- Aktiv, ikke rekrutterende
- New Cross Hospital
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Arizona
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Gilbert, Arizona, Forenede Stater, 85234
- Rekruttering
- Banner MD Anderson Cancer Center
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Tucson, Arizona, Forenede Stater, 85719
- Rekruttering
- University of Arizona Cancer Center
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California
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Clovis, California, Forenede Stater, 93611
- Rekruttering
- UCSF Fresno
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Duarte, California, Forenede Stater, 91010
- Rekruttering
- City of Hope Duarte
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Irvine, California, Forenede Stater, 92618
- Rekruttering
- City of Hope Orange County Lennar Foundation Cancer Center
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Los Alamitos, California, Forenede Stater, 90720
- Rekruttering
- Cancer and Blood Specialty Clinic
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Los Angeles, California, Forenede Stater, 90067
- Rekruttering
- Valkyrie Clinical Trials
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Connecticut
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Farmington, Connecticut, Forenede Stater, 06030
- Rekruttering
- University of Connecticut
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New Haven, Connecticut, Forenede Stater, 06510
- Rekruttering
- Yale New Haven Hospital
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Delaware
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Newark, Delaware, Forenede Stater, 19713
- Rekruttering
- ChristianaCare Helen F Graham Cancer Center and Research Institute
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Florida
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Hollywood, Florida, Forenede Stater, 33021
- Rekruttering
- Memorial Healthcare System
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Orlando, Florida, Forenede Stater, 32804
- Rekruttering
- AdventHealth Medical Group Blood & Marrow Transplant at Orlando
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Weston, Florida, Forenede Stater, 33331
- Rekruttering
- Cleveland Clinic Florida
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Georgia
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Newnan, Georgia, Forenede Stater, 30265
- Rekruttering
- City of Hope Cancer Center
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Illinois
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Chicago, Illinois, Forenede Stater, 60612
- Rekruttering
- University Of Illinois Medical Center
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Maywood, Illinois, Forenede Stater, 60153
- Rekruttering
- Loyola University Medical Center
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Iowa
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Waukee, Iowa, Forenede Stater, 50263
- Rekruttering
- University of Iowa Health Care
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Kentucky
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Louisville, Kentucky, Forenede Stater, 40207
- Rekruttering
- Norton Cancer Institute
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Louisiana
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Shreveport, Louisiana, Forenede Stater, 71103
- Rekruttering
- LSUHSC Shreveport Feist-Weiller Cancer Center
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Maryland
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Baltimore, Maryland, Forenede Stater, 21231
- Rekruttering
- Johns Hopkins University School of Medicine JHUSOM
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Bethesda, Maryland, Forenede Stater, 20817
- Rekruttering
- Center for Cancer and Blood Disorders
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Michigan
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Ann Arbor, Michigan, Forenede Stater, 48109
- Rekruttering
- University of Michigan
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Detroit, Michigan, Forenede Stater, 48202
- Rekruttering
- Henry Ford Cancer - Detroit Brigitte Harris Cancer Pavilion
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Grand Rapids, Michigan, Forenede Stater, 49503
- Rekruttering
- Cancer And Hematology Centers of Western Michigan PC
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Novi, Michigan, Forenede Stater, 48374
- Rekruttering
- Henry Ford Providence Novi Hospital
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Southfield, Michigan, Forenede Stater, 48075
- Rekruttering
- Henry Ford Providence Southfield CK Potluri Cancer Center
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Missouri
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Kansas City, Missouri, Forenede Stater, 64132
- Afsluttet
- MidAmerica Cancer Care
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Nebraska
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Omaha, Nebraska, Forenede Stater, 68198
- Rekruttering
- University of Nebraska Medical Center
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Omaha, Nebraska, Forenede Stater, 68130
- Rekruttering
- Nebraska Cancer Specialists
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New Hampshire
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Lebanon, New Hampshire, Forenede Stater, 03756
- Rekruttering
- Dartmouth Hitchcock Medical Center
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New Jersey
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East Brunswick, New Jersey, Forenede Stater, 08816
- Rekruttering
- Astera Cancer Care
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New Mexico
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Santa Fe, New Mexico, Forenede Stater, 87505
- Rekruttering
- Christus St. Vincent Regional Cancer Center
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New York
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East Syracuse, New York, Forenede Stater, 13057
- Rekruttering
- Hematology-Oncology Associates of CNY
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Lake Success, New York, Forenede Stater, 11042
- Rekruttering
- Northwell Health Cancer Institute
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Mineola, New York, Forenede Stater, 11500
- Rekruttering
- NYU Langone Hospital Long Island
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New York, New York, Forenede Stater, 10065
- Rekruttering
- Memorial Sloan Kettering Cancer Center
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New York, New York, Forenede Stater, 10065
- Rekruttering
- Weill Cornell Medical College
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New York, New York, Forenede Stater, 10016
- Rekruttering
- Perlmutter Cancer Center at NYU Langone Health
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North Carolina
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Charlotte, North Carolina, Forenede Stater, 28204
- Rekruttering
- Levine Cancer Institute
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Charlotte, North Carolina, Forenede Stater, 28204
- Rekruttering
- Novant Health
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Durham, North Carolina, Forenede Stater, 27705
- Rekruttering
- Durham VAMC
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Wilmington, North Carolina, Forenede Stater, 28401
- Rekruttering
- Novant Health Zimmer Cancer Institute
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Winston-Salem, North Carolina, Forenede Stater, 27103
- Rekruttering
- Novant Health Forsyth Medical Center
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Winston-Salem, North Carolina, Forenede Stater, 27157
- Rekruttering
- Atrium Health Wake Forest Baptist Comprehensive Cancer Center
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Ohio
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Cincinnati, Ohio, Forenede Stater, 45267
- Rekruttering
- University of Cincinnati
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Cincinnati, Ohio, Forenede Stater, 45219
- Rekruttering
- The Christ Hospital Cancer Center
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Cincinnati, Ohio, Forenede Stater, 45236
- Rekruttering
- Oncology Hematology Care
-
Cleveland, Ohio, Forenede Stater, 44106
- Rekruttering
- University Hospitals Cleveland Medical Center
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Cleveland, Ohio, Forenede Stater, 44195
- Rekruttering
- Cleveland Clinic Main Campus
-
Columbus, Ohio, Forenede Stater, 43214
- Rekruttering
- OhioHealth
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Columbus, Ohio, Forenede Stater, 43210
- Rekruttering
- The Ohio State University- James Cancer Hospital
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Pennsylvania
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Hershey, Pennsylvania, Forenede Stater, 17033
- Rekruttering
- Penn State Milton S Hershey Medical Ctr
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Pittsburgh, Pennsylvania, Forenede Stater, 15224
- Rekruttering
- Allegheny Health Network
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Rhode Island
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Providence, Rhode Island, Forenede Stater, 02903
- Rekruttering
- Rhode Island Hospital
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South Carolina
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Charleston, South Carolina, Forenede Stater, 29425
- Rekruttering
- MUSC-Hollings Cancer Center
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Tennessee
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Nashville, Tennessee, Forenede Stater, 37232
- Rekruttering
- Henry-Joyce Cancer Clinic
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-
Texas
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Dallas, Texas, Forenede Stater, 75235
- Rekruttering
- University of Texas Southwestern Medical Center
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Houston, Texas, Forenede Stater, 77030
- Rekruttering
- Houston Methodist Hospital
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Lubbock, Texas, Forenede Stater, 79410
- Rekruttering
- Joe Arrington Cancer Research Treatment Center
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Utah
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Salt Lake City, Utah, Forenede Stater, 84106
- Rekruttering
- Utah Cancer Specialists
-
Salt Lake City, Utah, Forenede Stater, 84112
- Rekruttering
- Huntsman Cancer Institute
-
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Virginia
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Charlottesville, Virginia, Forenede Stater, 22903
- Afsluttet
- University of Virginia
-
Fort Belvoir, Virginia, Forenede Stater, 22060
- Rekruttering
- Alexander T. Augusta Military Medical Center
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Norfolk, Virginia, Forenede Stater, 23502
- Rekruttering
- Virginia Oncology Associates Brock Cancer Center
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Richmond, Virginia, Forenede Stater, 23298
- Rekruttering
- Virginia Commonwealth University Medical Center
-
Richmond, Virginia, Forenede Stater, 23249
- Rekruttering
- Richmond VA Medical Center
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Washington
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Tacoma, Washington, Forenede Stater, 98405
- Rekruttering
- NorthWest Medical Specialties, PLLC
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-
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-
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Créteil, Frankrig, 94010
- Afsluttet
- CHU Henri Mondor
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Lille, Frankrig, 59000
- Aktiv, ikke rekrutterende
- Hopital Claude Huriez
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Lyon, Frankrig, 69002
- Aktiv, ikke rekrutterende
- Hospices Civils de Lyon HCL
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Nantes, Frankrig, 44093
- Aktiv, ikke rekrutterende
- CHU Nantes
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Paris, Frankrig, 75571
- Afsluttet
- CHU Hopital Saint Antoine
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Pessac, Frankrig, 33604
- Aktiv, ikke rekrutterende
- CHU de Bordeaux - Hospital Haut-Leveque
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Poitiers, Frankrig, 86021
- Aktiv, ikke rekrutterende
- CHU Poitiers - Hopital la Miletrie
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Rennes, Frankrig, 35033
- Aktiv, ikke rekrutterende
- CHU de Rennes - Hopital Pontchaillou
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Strasbourg, Frankrig, 67200
- Aktiv, ikke rekrutterende
- Hôpitaux Universitaires de Strasbourg - Hôpital de Hautepierre
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Toulouse, Frankrig, 31059
- Aktiv, ikke rekrutterende
- Institut Universitaire du Cancer Toulouse Oncopole
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-
-
-
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Athens Attica, Grækenland, 115 28
- Aktiv, ikke rekrutterende
- Alexandra General Hospital of Athens
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Thessaloniki, Grækenland, 546 39
- Aktiv, ikke rekrutterende
- Theageneio Cancer Hospital
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Thessalonikis, Grækenland, 570 10
- Aktiv, ikke rekrutterende
- G Papanikolaou Hospital of Thessaloniki
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-
-
-
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Amsterdam, Holland, 1081 HV
- Aktiv, ikke rekrutterende
- VUMC Amsterdam
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Apeldoorn, Holland, 7334 DZ
- Aktiv, ikke rekrutterende
- Gelre Ziekenhuis
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Delft, Holland, 2625 AD
- Aktiv, ikke rekrutterende
- Reinier de Graaf Gasthuis
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Nieuwegein, Holland, 3435 CM
- Aktiv, ikke rekrutterende
- St. Antonius Ziekenhuis Nieuwegein
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Sittard-Geleen, Holland, 6162 BG
- Aktiv, ikke rekrutterende
- Zuyderland Medical Center
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-
-
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Beersheba, Israel, 8457108
- Aktiv, ikke rekrutterende
- Soroka Medical Center
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Haifa, Israel, 3109601
- Aktiv, ikke rekrutterende
- Rambam Medical Center
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Jerusalem, Israel, 9103102
- Aktiv, ikke rekrutterende
- Shaare Zedek Medical Center
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Petah Tikva, Israel, 49100
- Aktiv, ikke rekrutterende
- Rabin
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Ramat Gan, Israel, 52621
- Aktiv, ikke rekrutterende
- Sheba Medical Center
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Tel Aviv, Israel, 6423906
- Aktiv, ikke rekrutterende
- Tel Aviv Sourasky Medical Center
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-
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Bergamo, Italien, 24127
- Aktiv, ikke rekrutterende
- ASST Papa Giovanni XXIII Bergamo
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Bologna, Italien, 40138
- Aktiv, ikke rekrutterende
- A O U Sant Orsola Malpighi
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Florence, Italien, 50134
- Aktiv, ikke rekrutterende
- Careggi University Hospital
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Milan, Italien, 20132
- Aktiv, ikke rekrutterende
- Ospedale San Raffaele
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Naples, Italien, 80131
- Aktiv, ikke rekrutterende
- Azienda Ospedaliera di Rilievo Nazionale A Cardarelli
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Pavia, Italien, 27100
- Aktiv, ikke rekrutterende
- IRCCS Policlinico San Matteo, Università degli studi di Pavi
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Roma, Italien, 00133
- Aktiv, ikke rekrutterende
- Universita Degli Studi di Roma Tor Vergata
-
Rozzano, Italien, 20089
- Aktiv, ikke rekrutterende
- Istituto Clinico Humanitas
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Torino, Italien, 10126
- Aktiv, ikke rekrutterende
- Azienda Ospedaliera Universitaria Citta della Salute e della Scienza di Torino
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-
-
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Bunkyō City, Japan, 113 8431
- Aktiv, ikke rekrutterende
- Juntendo University Hospital
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Chiba, Japan, 260 0801
- Aktiv, ikke rekrutterende
- Chiba Cancer Center
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Chiba, Japan, 296-0041
- Aktiv, ikke rekrutterende
- Kameda Medical Center
-
Higashiibaraki-gun, Japan, 311-3193
- Aktiv, ikke rekrutterende
- National Hospital Organization Mito Medical Center
-
Hirakata, Japan, 573 1191
- Aktiv, ikke rekrutterende
- Kansai Medical University Hospital
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Hyôgo, Japan, 663-8501
- Aktiv, ikke rekrutterende
- Hyogo Medical University Hospital
-
Iruma-gun, Japan, 350-0495
- Aktiv, ikke rekrutterende
- Saitama Medical University Hospital
-
Kanagawa, Japan, 259-1193
- Aktiv, ikke rekrutterende
- Tokai University Hospital
-
Kanazawa, Japan, 920 8641
- Aktiv, ikke rekrutterende
- Kanazawa University Hospital
-
Kumamoto, Japan, 860-8556
- Aktiv, ikke rekrutterende
- Kumamoto University Hospital
-
Matsuyama, Japan, 790-8524
- Aktiv, ikke rekrutterende
- Matsuyama Red Cross Hospital
-
Nagasaki, Japan, 856-8562
- Aktiv, ikke rekrutterende
- National Hospital Organization Nagasaki Medical Center
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Okayama, Japan, 701-1192
- Aktiv, ikke rekrutterende
- National Hospital Organization Okayama Medical Center
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Osaka, Japan, 545 8586
- Aktiv, ikke rekrutterende
- Osaka Metropolitan University Hospital
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Sapporo, Japan, 003-0804
- Aktiv, ikke rekrutterende
- National Hospital Organization Hokkaido Cancer Center
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Shibukawa, Japan, 377-0280
- Aktiv, ikke rekrutterende
- National Hospital Organization Shibukawa Medical Center
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Shibuya-ku, Japan, 150-8935
- Aktiv, ikke rekrutterende
- Japanese Red Cross Medical Center
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Sunto Gun, Japan, 411 8777
- Aktiv, ikke rekrutterende
- Shizuoka Cancer Center
-
Toyoake, Japan, 470-1192
- Aktiv, ikke rekrutterende
- Fujita Health University Hospital
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Yamagata, Japan, 990 2331
- Aktiv, ikke rekrutterende
- Yamagata University Hospital
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Yamanashi, Japan, 400-8506
- Aktiv, ikke rekrutterende
- Yamanashi Prefectural Central Hospital
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-
-
-
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Beijing, Kina, 100034
- Aktiv, ikke rekrutterende
- Peking University First Hospital
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Beijing, Kina, 100006
- Aktiv, ikke rekrutterende
- Peking Union Medical College Hospital
-
Beijing, Kina, 100051
- Aktiv, ikke rekrutterende
- Beijing Tongren Hospital CMU
-
Changchun, Kina, 130061
- Aktiv, ikke rekrutterende
- The First Hospital of Jilin University
-
Changsha, Kina, 410011
- Aktiv, ikke rekrutterende
- The Second Xiangya Hospital of Central South Hospital
-
Changzhou, Kina, 213004
- Aktiv, ikke rekrutterende
- Changzhou No 2 Peoples Hospital
-
Chaoyang District, Kina, 100020
- Aktiv, ikke rekrutterende
- Beijing Chaoyang Hospital
-
Chengdu, Kina, 610072
- Aktiv, ikke rekrutterende
- Sichuan Provincial Peoples Hospital
-
Chongqing, Kina, 400030
- Aktiv, ikke rekrutterende
- Chongqing University Cancer Hospital
-
Fuzhou, Kina, 350001
- Aktiv, ikke rekrutterende
- Fujian Meidical University Union Hospital
-
Guangzhou, Kina, 510515
- Aktiv, ikke rekrutterende
- Nanfang Hospital
-
Guangzhou, Kina, 511363
- Aktiv, ikke rekrutterende
- Sun Yat -Sen University Cancer Center
-
Hangzhou, Kina, 310003
- Aktiv, ikke rekrutterende
- No.1 Affiliated Hospital, Medical College of Zhejiang University
-
Hangzhou, Kina, 310003
- Aktiv, ikke rekrutterende
- The Second Affiliated Hospital of Zhejiang University
-
Harbin, Kina, 150081
- Afsluttet
- Harbin medical university cancer hospital
-
Jinan, Kina, 250012
- Afsluttet
- Qilu Hospital of Shandong University
-
Nanchang, Kina, 330006
- Aktiv, ikke rekrutterende
- The First Affliated Hospital Of Nanchang University
-
Nanjing, Kina, 210008
- Aktiv, ikke rekrutterende
- Nanjing Drum Tower Hospital
-
Nanjing, Kina, 214135
- Aktiv, ikke rekrutterende
- Zhongda Hospital Southeast University
-
Nanning, Kina, 530021
- Aktiv, ikke rekrutterende
- The First Affiliated Hospital of Guangxi Medical University
-
Shanghai, Kina, 200434
- Aktiv, ikke rekrutterende
- Shanghai Fourth People s Hospital
-
Shanghai, Kina, 200127
- Aktiv, ikke rekrutterende
- Renji Hospital, Shanghai Jiaotong University School of Medicine
-
Shanghai, Kina, 200025
- Aktiv, ikke rekrutterende
- Ruijin Hospital Shanghai Jiao Tong University
-
Shenyang, Kina, 110022
- Aktiv, ikke rekrutterende
- Shengjing Hospital Of China Medical University
-
Shenzhen, Kina, 518036
- Aktiv, ikke rekrutterende
- Peking University Shenzhen Hospital
-
Tianjin, Kina, 300060
- Aktiv, ikke rekrutterende
- Tianjin Medical University Cancer Institute and Hospital
-
Tianjin, Kina, 301609
- Aktiv, ikke rekrutterende
- Institute of Hematology and Blood Diseases Hospital
-
Wenzhou, Kina, 325000
- Aktiv, ikke rekrutterende
- The First Affiliated Hospital of Wenzhou Medical University
-
Wuhan, Kina, 430032
- Aktiv, ikke rekrutterende
- Wuhan Tongji Hospital Tongji Medical College
-
Xi'an, Kina, 710004
- Aktiv, ikke rekrutterende
- The Second Affiliated Hospital of Xi'an Jiaotong University
-
Xiamen, Kina, 361003
- Aktiv, ikke rekrutterende
- The first affiliated hospital of xiamen university
-
Zhengzhou, Kina, 450008
- Aktiv, ikke rekrutterende
- Henan Cancer Hospital
-
-
-
-
-
Oslo, Norge, 0450
- Aktiv, ikke rekrutterende
- Oslo University Hospital HF Ulleval sykehus
-
Trondheim, Norge, 7030
- Aktiv, ikke rekrutterende
- St. Olavs Hospital
-
-
-
-
-
Biała Podlaska, Polen, 21 500
- Afsluttet
- Wojewodzki Szpital Kliniczny w Bialej Podlaskiej
-
Brzozów, Polen, 36-200
- Aktiv, ikke rekrutterende
- Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologiczny im Ks B Markiewicza
-
Bydgoszcz, Polen, 85-168
- Aktiv, ikke rekrutterende
- Szpital Uniwersytecki nr 2 im. Jana Biziela w Bydgoszczy
-
Katowice, Polen, 40 519
- Aktiv, ikke rekrutterende
- Pratia Onkologia Katowice
-
Kielce, Polen, 25 734
- Aktiv, ikke rekrutterende
- Swietokrzyskie Centrum Onkologii SPZOZ w Kielcach
-
Lodz, Polen, 93 513
- Aktiv, ikke rekrutterende
- Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im M Kopernika w Lodzi
-
Lublin, Polen, 20 090
- Aktiv, ikke rekrutterende
- Centrum Onkologii Ziemi Lubelskiej im sw Jana z Dukli
-
Lublin, Polen, 20-081
- Aktiv, ikke rekrutterende
- Uniwersytecki Szpital Kliniczny Nr 1 w Lublinie
-
Poznan, Polen, 60-569
- Aktiv, ikke rekrutterende
- Uniwersytecki Szpital Kliniczny w Poznaniu
-
Warsaw, Polen, 02 097
- Aktiv, ikke rekrutterende
- Uniwersyteckie Centrum Kliniczne
-
Zielona Góra, Polen, 65 046
- Afsluttet
- Szpital Uniwersytecki im Karola Marcinkowskiego w Zielonej Gorze
-
-
-
-
-
Braga, Portugal, 4710-243
- Aktiv, ikke rekrutterende
- Uls Braga - Hosp. Braga
-
Lisbon, Portugal, 1400-038
- Aktiv, ikke rekrutterende
- Champalimaud Foundation Champalimaud Centre
-
Porto, Portugal, 4200 319
- Aktiv, ikke rekrutterende
- Uls Hosp Sao Joao
-
Porto, Portugal, 4200072
- Aktiv, ikke rekrutterende
- Instituto Portugues de Oncologia do Porto Francisco Gentil, E.P.E.
-
-
-
-
-
Bern, Schweiz, 3010
- Aktiv, ikke rekrutterende
- Inselspital Universitatsspital Bern
-
Sankt Gallen, Schweiz, 9007
- Aktiv, ikke rekrutterende
- Kantonsspital St Gallen
-
-
-
-
-
Badalona, Spanien, 08916
- Aktiv, ikke rekrutterende
- Hosp. Univ. Germans Trias I Pujol
-
Barcelona, Spanien, 08041
- Aktiv, ikke rekrutterende
- Hosp. de La Santa Creu I Sant Pau
-
Barcelona, Spanien, 08035
- Aktiv, ikke rekrutterende
- Hosp Univ Vall D Hebron
-
Barcelona, Spanien, 08908
- Aktiv, ikke rekrutterende
- Institut Catala d Oncologia L Hospitalet
-
Granada, Spanien, 18014
- Aktiv, ikke rekrutterende
- Hosp. Univ. Virgen de Las Nieves
-
Jerez de la Frontera, Spanien, 11407
- Aktiv, ikke rekrutterende
- Hosp. de Jerez de La Frontera
-
Madrid, Spanien, 28041
- Aktiv, ikke rekrutterende
- Hosp. Univ. 12 de Octubre
-
Madrid, Spanien, 28046
- Aktiv, ikke rekrutterende
- Hosp. Univ. La Paz
-
Madrid, Spanien, 28050
- Aktiv, ikke rekrutterende
- Hosp Univ Hm Sanchinarro
-
Palma de Mallorca, Spanien, 07120
- Aktiv, ikke rekrutterende
- Hosp. Univ. Son Espases
-
Pozuelo de Alarcón, Spanien, 28223
- Aktiv, ikke rekrutterende
- Hosp. Quiron Madrid Pozuelo
-
Salamanca, Spanien, 37007
- Aktiv, ikke rekrutterende
- Hosp Clinico Univ de Salamanca
-
Terrassa, Spanien, 08221
- Aktiv, ikke rekrutterende
- Hosp. Mutua Terrassa
-
Valencia, Spanien, 46010
- Aktiv, ikke rekrutterende
- Hosp. Clinico Univ. de Valencia
-
-
-
-
-
Falun, Sverige, 791 82
- Aktiv, ikke rekrutterende
- Falu Lasarett
-
Lund, Sverige, 221 85
- Aktiv, ikke rekrutterende
- Skanes universitetssjukhus
-
Stockholm, Sverige, 141 86
- Aktiv, ikke rekrutterende
- Karolinska University Hospital Huddinge
-
Örebro, Sverige, 701 85
- Aktiv, ikke rekrutterende
- Universitetssjukhuset Orebro
-
-
-
-
-
Busan, Sydkorea, 49241
- Aktiv, ikke rekrutterende
- Pusan National University Hospital
-
Busan, Sydkorea, 49201
- Aktiv, ikke rekrutterende
- Dong-A University Hospital
-
Daegu, Sydkorea, 41944
- Aktiv, ikke rekrutterende
- Kyungpook National University Hospital
-
Goyang-si, Sydkorea, 10408
- Aktiv, ikke rekrutterende
- National Cancer Center
-
Hwasun, Sydkorea, 58128
- Aktiv, ikke rekrutterende
- Chonnam National University Hwasun Hospital
-
Incheon, Sydkorea, 21565
- Aktiv, ikke rekrutterende
- Gachon University Gil Medical Center
-
Seoul, Sydkorea, 03080
- Aktiv, ikke rekrutterende
- Seoul National University Hospital
-
Seoul, Sydkorea, 06351
- Aktiv, ikke rekrutterende
- Samsung Medical Center
-
Seoul, Sydkorea, 05505
- Aktiv, ikke rekrutterende
- Asan Medical Center
-
Seoul, Sydkorea, 06591
- Aktiv, ikke rekrutterende
- The Catholic University of Korea Seoul St Mary s Hospital
-
Seoul, Sydkorea, 03722
- Aktiv, ikke rekrutterende
- Severance Hospital Yonsei University Health System
-
-
-
-
-
Brno-Bohunice, Tjekkiet, 625 00
- Aktiv, ikke rekrutterende
- Fakultni nemocnice Brno
-
Hradec Králové, Tjekkiet, 500 05
- Aktiv, ikke rekrutterende
- Fakultni nemocnice Hradec Kralove
-
Olomouc, Tjekkiet, 779 00
- Aktiv, ikke rekrutterende
- Fakultni nemocnice Olomouc
-
Ostrava, Tjekkiet, 708 52
- Aktiv, ikke rekrutterende
- Fakultni Nemocnice Ostrava
-
Pilsen, Tjekkiet, 304 60
- Aktiv, ikke rekrutterende
- Fakultni nemocnice Plzen
-
Prague, Tjekkiet, 128 08
- Aktiv, ikke rekrutterende
- VFN v Praze
-
-
-
-
-
Ankara, Tyrkiet (Türkiye), 06680
- Aktiv, ikke rekrutterende
- Liv Hospital Ankara
-
Ankara, Tyrkiet (Türkiye), 06200
- Aktiv, ikke rekrutterende
- Dr Abdurrahman Yurtaslan Oncology Training and Research Hospital
-
Ankara, Tyrkiet (Türkiye), 06620
- Aktiv, ikke rekrutterende
- Ankara Universitesi Tip Fakultesi Cebeci Arastirma ve Uygulama Hastanesi
-
Antalya, Tyrkiet (Türkiye), 07025
- Aktiv, ikke rekrutterende
- Memorial Antalya Hospital
-
Denizli, Tyrkiet (Türkiye), 20160
- Afsluttet
- Pamukkale University Medical Faculty
-
Istanbul, Tyrkiet (Türkiye), 34214
- Aktiv, ikke rekrutterende
- Medipol Mega Universite Hastanesi
-
Izmir, Tyrkiet (Türkiye), 35340
- Afsluttet
- Dokuz Eylul University Medical Faculty
-
Samsun, Tyrkiet (Türkiye), 55280
- Aktiv, ikke rekrutterende
- Ondokuz Mayis Universitesi Tip Fakultesi Hastanesi
-
-
-
-
-
Berlin, Tyskland, 13125
- Aktiv, ikke rekrutterende
- Helios Kliniken Berlin Buch Gmbh
-
Essen, Tyskland, 45147
- Afsluttet
- Med. Universitatsklinik Essen
-
Halle, Tyskland, 06120
- Aktiv, ikke rekrutterende
- Universitaetsklinikum Halle Saale
-
Hamburg, Tyskland, 20251
- Aktiv, ikke rekrutterende
- Universitaetsklinik Hamburg-Eppendorf
-
Nuremberg, Tyskland, 90419
- Aktiv, ikke rekrutterende
- Klinikum Nuernberg Nord
-
Tübingen, Tyskland, 72076
- Aktiv, ikke rekrutterende
- Universitaetsklinikum Tuebingen der Eberhard-Karls-Universitaet, Abteilung fuer Innere Medizin II,
-
Würzburg, Tyskland, 97080
- Aktiv, ikke rekrutterende
- Universitaetsklinikum Wuerzburg
-
-
-
-
-
Linz, Østrig, 4020
- Aktiv, ikke rekrutterende
- Ordensklinikum Linz GmbH Elisabethinen
-
Salzburg, Østrig, 5020
- Aktiv, ikke rekrutterende
- SCRI CCCIT gem GmbH
-
Vienna, Østrig, 1140
- Aktiv, ikke rekrutterende
- Hanusch Krankenhaus
-
Vienna, Østrig, 1090
- Aktiv, ikke rekrutterende
- Medical University Vienna
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Have a diagnosis of multiple myeloma according to the International Myeloma Working Group (IMWG) diagnostic criteria
- Be newly diagnosed and not considered a candidate for high-dose chemotherapy with autologous stem cell transplant (ASCT) due to: ineligible due to advanced age OR; ineligible due to the presence of comorbid condition(s) likely to have a negative impact on tolerability of high-dose chemotherapy with ASCT OR; deferral of high-dose chemotherapy with ASCT as initial treatment
- Have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2
- 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
- A participant must agree not to plan to father a child while enrolled in this study or within 100 days after the last dose of study treatment
Exclusion Criteria:
- Received any prior therapy for multiple myeloma or smoldering myeloma other than a short course of corticosteroids (not to exceed total of 160 milligrams [mg] dexamethasone or equivalent). In addition, received a cumulative dose of systemic corticosteroids equivalent to greater than or equals to (>=) 20 mg of dexamethasone within 14 days before randomization
- Had plasmapheresis within 28 days of randomization
- Had a stroke, transient ischemic attack, or seizure within 6 months prior to randomization
- Known allergies, hypersensitivity, or intolerance to teclistamab or talquetamab excipients
- Known contraindications to the use of daratumumab or lenalidomide per local prescribing information
- Myeloma Frailty Index of >=2 with the exception of participants who have a score of 2 based on age alone
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Antal våben
3
Våben og indgreb
Deltagergruppe / ArmDeltagergruppe / Arm |
Intervention / BehandlingIntervention / Behandling |
|---|---|
|
Eksperimentel: Teclistamab, Daratumumab SC, and Lenalidomide (Tec-DR)
Participants will receive teclistamab as subcutaneous (SC) injection in combination with daratumumab and lenalidomide. |
Lenalidomide will be administered orally. Teclistamab will be administered as SC injection.
Andre navne:
Daratumumab will be administered as SC injection. |
|
Eksperimentel: Talquetamab, Daratumumab SC, and Lenalidomide (Tal-DR)
Participants will receive talquetamab as SC injection in combination with daratumumab and lenalidomide. |
Lenalidomide will be administered orally. Daratumumab will be administered as SC injection. Talquetamab will be administered as SC injection.
Andre navne:
|
|
Aktiv komparator: Daratumumab SC, Lenalidomide, and Dexamethasone (DRd)
Participants will receive daratumumab as SC injection with lenalidomide and dexamethasone. |
Lenalidomide will be administered orally. Daratumumab will be administered as SC injection. Dexamethasone will be administered either orally or intravenously (IV). |
Hvad måler undersøgelsen?
Primære resultatmål
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Progression Free Survival (PFS)
Tidsramme: From randomization to the date of disease progression or death (Up to 09 years)
|
PFS is defined as the duration from the date of randomization to either progressive disease or death, whichever comes first. Disease progression will be determined according to the International Myeloma Working Group (IMWG) response criteria. |
From randomization to the date of disease progression or death (Up to 09 years)
|
|
12-Month Minimal Residual Disease (MRD)-Negative Complete Response (CR)
Tidsramme: At Month 12
|
12-month MRD-negative CR is defined as participants who achieve MRD-negative status at 12 months, as determined by next-generation sequencing (NGS) with sensitivity of 10^-5, prior to progressive disease or subsequent anti-myeloma therapy and who also achieve CR or better, according to IMWG criteria. |
At Month 12
|
Sekundære resultatmål
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Very Good Partial Response (VGPR) or Better
Tidsramme: From randomization up to 09 years
|
VGPR or better is defined as the percentage of participants achieving VGPR and CR (including stringent complete response [sCR]) prior to subsequent antimyeloma therapy in accordance with the IMWG criteria during or after the study treatment. |
From randomization up to 09 years
|
|
Complete Response (CR) or Better
Tidsramme: From randomization up to 09 years
|
CR or better is defined as the percentage of participants achieving CR or sCR prior to subsequent antimyeloma therapy in accordance with the IMWG criteria during or after the study treatment. |
From randomization up to 09 years
|
|
Sustained Minimal Residual disease (MRD)-negative Complete Response (CR)
Tidsramme: From randomization up to 09 years
|
Sustained MRD-negative CR is defined as participants with CR or better who sustain MRD-negative status, as determined by NGS with sensitivity of 10^-5, for at least 12 months without any examination showing MRD positive status or progressive disease in between. |
From randomization up to 09 years
|
|
MRD-negative CR
Tidsramme: From randomization up to 09 years
|
MRD-negative CR is defined as the percentage of participants who achieve MRD-negative status, as determined by NGS with sensitivity of 10^-5, at any time after randomization and prior to progressive disease or subsequent antimyeloma therapy and who achieve CR or better. |
From randomization up to 09 years
|
|
Progression Free Survival on Next-line Therapy (PFS2)
Tidsramme: From randomization up to 09 years
|
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 that starts after the next line of subsequent therapy, or death from any cause, whichever occurs first. |
From randomization up to 09 years
|
|
Overall Survival (OS)
Tidsramme: From randomization to the date of death (up to 09 years)
|
OS is defined as the time from the date of randomization to the date of death due to any cause. |
From randomization to the date of death (up to 09 years)
|
|
Number of Participants with Adverse Events (AEs) by Severity
Tidsramme: From randomization up to 09 years
|
An adverse event is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An adverse event does not necessarily have a causal relationship with the treatment. Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Severity scale ranges from Grade 1: mild, Grade 2: moderate, Grade 3: severe, Grade 4: life-threatening, and Grade 5: death related to adverse event. |
From randomization up to 09 years
|
|
Number of Participants with Abnormalities in Laboratory Parameters
Tidsramme: From randomization up to 09 years
|
Number of participants with abnormalities in laboratory parameters (serum chemistry and hematology) will be reported. |
From randomization up to 09 years
|
|
Number of Participants with Abnormalities in Vital Signs
Tidsramme: From randomization up to 09 years
|
Number of participants with abnormalities in vital signs (temperature, pulse/heart rate, respiratory rate, blood pressure) will be reported. |
From randomization up to 09 years
|
|
Number of Participants with Abnormalities in Physical Examination
Tidsramme: From randomization up to 09 years
|
Number of participants with abnormalities in physical examination will be reported. |
From randomization up to 09 years
|
|
Number of Participants with Abnormalities in Electrocardiogram (ECG)
Tidsramme: From randomization up to 09 years
|
Number of participants with abnormalities in ECG will be reported. |
From randomization up to 09 years
|
|
Serum Concentrations of Teclistamab and Talquetamab
Tidsramme: From randomization up to 09 years
|
Serum samples will be analyzed to determine concentrations of teclistamab and talquetamab using validated, specific, and sensitive methods. |
From randomization up to 09 years
|
|
Number of Participants with Anti-drug Antibodies (ADAs) to Teclistamab and Talquetamab
Tidsramme: From randomization up to 09 years
|
Number of participants with ADAs to teclistamab and talquetamab will be reported. |
From randomization up to 09 years
|
|
Change from Baseline in Symptoms, Functioning, and Health-related Quality of Life (HRQoL) as Assessed by European Organization for Research and Treatment of Cancer Quality-of-life Questionnaire Core 30 (EORTC-QLQ-C30)
Tidsramme: From baseline up to 9 years
|
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/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/healthy level of functioning and a high score for the global health status represents high HRQoL, but a high score for a symptom scale/item represents a high level of symptomatology/problems. |
From baseline up to 9 years
|
|
Change from Baseline in Treatment-related Symptoms as Assessed by Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Tidsramme: Baseline through Cycle 6 (each cycle of 28 days) (up to 196 days)
|
The National Cancer Institute's (NCI's) PRO-CTCAE is an item library of common AEs experienced by people with cancer that are appropriate for self-reporting of treatment tolerability. Each symptom selected for inclusion can be rated by up to 3 attributes characterizing the presence/frequency, severity, and/or interference of the AEs. It ranges from 0 to 4 with higher scores indicating higher frequency or greater severity/impact. |
Baseline through Cycle 6 (each cycle of 28 days) (up to 196 days)
|
|
Change from Baseline in Symptoms, Functioning, and Overall HRQoL as Assessed by EuroQol Five Dimension Questionnaire 5-Level (EQ-5D-5L)
Tidsramme: From baseline up to 9 years
|
The EQ-5D-5L is a 5-item questionnaire that assesses 5 domains including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression plus a visual analog scale rating "health today" with anchors ranging from 0 (worst imaginable health state) to 100 (best imaginable health state). |
From baseline up to 9 years
|
|
Time to Sustained Worsening in Symptoms, Functioning, and HRQoL
Tidsramme: From randomization up to 09 years
|
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. |
From randomization up to 09 years
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Sponsor
Efterforskere
Efterforskere
- Studieleder: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
Studiestart
25. oktober 2022
Primær færdiggørelse (Anslået)
Primær færdiggørelse
30. april 2031
Studieafslutning (Anslået)
Studieafslutning
28. oktober 2033
Datoer for studieregistrering
Først indsendt
Først indsendt
21. september 2022
Først indsendt, der opfyldte QC-kriterier
Først indsendt, der opfyldte QC-kriterier
21. september 2022
Først opslået (Faktiske)
Først opslået
23. september 2022
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering sendt
3. november 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
2. november 2026
Sidst verificeret
Sidst verificeret
1. november 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Karsygdomme
- Hjerte-kar-sygdomme
- Neoplasmer
- Sygdomme i immunsystemet
- Neoplasmer efter histologisk type
- Hæmatologiske sygdomme
- Lymfoproliferative lidelser
- Immunproliferative lidelser
- Neoplasmer, Plasmacelle
- Hæmostatiske lidelser
- Paraproteinæmier
- Blodproteinforstyrrelser
- Hæmoragiske lidelser
- Hemiske og lymfatiske sygdomme
- Myelomatose
- Organiske kemikalier
- Heterocykliske forbindelser, 1-ring
- Heterocykliske forbindelser
- Heterocykliske forbindelser, 2-ring
- Heterocykliske forbindelser, smeltet ring
- Carboxylsyrer
- Polycykliske forbindelser
- Piperidiner
- Gravidier
- Graviditet
- Steroider
- SMUSED-RING-forbindelser
- Steroider, fluoreret
- Gravideretrioler
- Phthalimider
- Phthalinsyrer
- Syrer, carbocykliske
- Piperidones
- Isoindoler
- Lenalidomid
- Dexamethason
- Daratumumab
- Talquetamab
Andre undersøgelses-id-numre
Andre undersøgelses-id-numre
- CR109237
- 64007957MMY3005 (Anden identifikator: Janssen Research & Development, LLC)
- 2022-000909-28 (EudraCT nummer)
- 2023-503442-30-00 (Registry Identifier: EUCT number)
- 2023 (U.S. NIH-bevilling/kontrakt)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
JA
IPD-planbeskrivelse
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/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
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ja
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .