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Исследование, сравнивающее талькетамаб с помалидомидом, талькетамаб с теклистамабом и элотузумабом, помалидомидом и дексаметазоном или помалидомидом, бортезомибом и дексаметазоном у участников с рецидивирующей или рефрактерной миеломой, получивших антитела против CD38 и леналидомид (MonumenTAL-6)

2 ноября 2026 г. обновлено: Janssen Research & Development, LLC

Рандомизированное исследование фазы 3, сравнивающее талькетамаб в комбинации с помалидомидом (Tal-P), талькетамабом в комбинации с теклистамабом (Tal-Tec) и элотузумабом, помалидомидом и дексаметазоном (EPd) или помалидомидом, бортезомибом и дексаметазоном по выбору исследователя ( PVd) у участников с рецидивирующей или рефрактерной миеломой, которые ранее получали от 1 до 4 линий терапии, включая антитела против CD38 и леналидомид

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).

Обзор исследования

Статус

Активный, не рекрутирующий

Условия

Вмешательство/лечение

Тип исследования

Интервенционный

Регистрация (Действительный)

838

Фаза

  • Фаза 3

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Места учебы

  • Австралия
      • Adelaide, Австралия, 5000
        • Royal Adelaide Hospital
      • Box Hill, Австралия, 3128
        • Box Hill Hospital
      • Darlinghurst, Австралия, 2010
        • St Vincents Hospital
      • Fitzroy, Австралия, 3065
        • St Vincents Hospital Melbourne
      • Southport, Австралия, 4215
        • Gold Coast University Hospital
      • West Perth, Австралия, 6005
        • Perth Blood Institute
      • Wollongong, Австралия, 2500
        • Wollongong Hospital
  • Австрия
      • Salzburg, Австрия, 05020
        • LKH - Universitätsklinikum der PMU Salzburg
      • Vienna, Австрия, 1160
        • Klinik Ottakring
      • Vienna, Австрия, A-1090
        • Medical University Vienna MUV
  • Аргентина
      • Buenos Aires, Аргентина, C1280AEB
        • Hospital Britanico de Buenos Aires
      • Buenos Aires, Аргентина, C1114AAN
        • Fundaleu
      • CABA, Аргентина, C1118AAT
        • Hospital Aleman
  • Бельгия
      • Charleroi, Бельгия, 6060
        • Grand Hopital De Charleroi Site Les Viviers
      • Genk, Бельгия, 3600
        • Ziekenhuis Oost-Limburg
      • Ghent, Бельгия, 9000
        • Ghent University Hospital
      • Sint-Niklaas, Бельгия, 9100
        • AZ Nikolaas - Campus Sint-Niklaas Moerland
  • Бразилия
      • Belo Horizonte, Бразилия, 30110-022
        • Cetus Oncologia
      • Brasília, Бразилия, 70390 700
        • IDOR - Regional Brasilia
      • Caxias do Sul, Бразилия, 95070 560
        • Fundacao Universidade de Caxias do Sul
      • Curitiba, Бразилия, 81520-060
        • Hospital Erasto Gaertner- Liga Paranaense de Combate ao Cancer
      • Porto Alegre, Бразилия, 90035-903
        • Hospital De Clinicas De Porto Alegre
      • Recife, Бразилия, 50070-480
        • IDOR - Regional Pernambuco
      • Rio de Janeiro, Бразилия, 22793-080
        • Instituto de Educacao, Pesquisa e Gestao em Saude Instituto Americas (COI)
      • Salvador, Бразилия, 41253-190
        • IDOR - Regional Bahia
      • São José do Rio Preto, Бразилия, 15090-000
        • Funfarme Sjrp
      • São Paulo, Бразилия, 01509 900
        • Fundacao Antonio Prudente A C Camargo Cancer Center
      • São Paulo, Бразилия, 04537 081
        • Clinica Medica Sao Germano LTDA
      • São Paulo, Бразилия, 01323 001
        • Real e Benemerita Associacao Portuguesa de Beneficencia
      • São Paulo, Бразилия, 01401 002
        • IDOR - Regional Sao Paulo
  • Венгрия
      • Budapest, Венгрия, 1088
        • Semmelweis Egyetem, Belgyogyaszati es Hematologiai Klinika
      • Budapest, Венгрия, 1097
        • Del Pesti Centrumkorhaz Orszagos Hematologiai es Infektologiai Intezet Szent Laszlo Telephely
      • Debrecen, Венгрия, 4032
        • Debreceni Egyetem Klinikai Kozpont
      • Nyíregyháza, Венгрия, 4400
        • Szabolcs Szatmar Bereg Varmegyei Oktatokorhaz
      • Pécs, Венгрия, 7624
        • Pecsi Tudomanyegyetem Klinikai Kozpont
  • Германия
      • Augsburg, Германия, 86156
        • Klinikum Augsburg
      • Halle, Германия, 06120
        • Universitaetsklinikum Halle Saale
      • Heidelberg, Германия, 69120
        • Universitaetsklinikum Heidelberg
      • Magdeburg, Германия, 39120
        • Universitaetsklinikum Magdeburg A.oe.R
      • München, Германия, 81675
        • Klinikum rechts der Isar der TU Muenchen
      • Tübingen, Германия, 72076
        • Universitaetsklinikum Tuebingen
      • Würzburg, Германия, 97080
        • Universitaetsklinikum Wuerzburg
  • Греция
      • Athens, Греция, 115 28
        • Alexandra General Hospital of Athens
      • Athens, Греция, 115 25
        • 251 Airforces Hospital
      • Thessaloniki, Греция, 546 39
        • Theageneio Cancer Hospital
  • Дания
      • Aarhus, Дания, 8200
        • Aarhus University Hospital
      • Odense C, Дания, 5000
        • Odense University Hospital
      • Vejle, Дания, 7100
        • Vejle Hospital
  • Израиль
      • Be’er Ya‘aqov, Израиль, 70300
        • Shamir Medical Center Assaf Harofeh
      • Haifa, Израиль, 3436212
        • Carmel Medical Center
      • Petah Tikva, Израиль, 49100
        • Rabin Medical center - Petah-Tikva
      • Ramat Gan, Израиль, 52621
        • Sheba Medical Center
      • Tel Aviv, Израиль, 64239
        • Tel Aviv Sourasky Medical Center
  • Индия
      • Gūrgaon, Индия, 122002
        • Fortis Memorial Research Institute
      • Lucknow, Индия, 226014
        • Sanjay Gandhi Postgraduate Institute of Medical Sciences
      • Pune, Индия, 411004
        • Deenanath Mangeshkar Hospital and Research Centre
  • Испания
      • Asturias, Испания, 33394
        • Hosp. de Cabuenes
      • Barcelona, Испания, 08035
        • Hosp Univ Vall D Hebron
      • Burgos, Испания, 09003
        • Hosp. Univ. de Burgos
      • Cáceres, Испания, 10003
        • Hosp. San Pedro de Alcantara
      • Donostia / San Sebastian, Испания, 20014
        • Hosp. Univ. Donostia
      • Granada, Испания, 18014
        • Hosp. Univ. Virgen de Las Nieves
      • Lugo, Испания, 27003
        • Hosp. Univ. Lucus Augusti
      • Madrid, Испания, 28046
        • Hosp. Univ. La Paz
      • Palma de Mallorca, Испания, 07120
        • Hosp. Univ. Son Espases
      • Pamplona, Испания, 31008
        • Clinica Univ. de Navarra
      • Pamplona, Испания, 31008
        • Complejo Hosp de Navarra - Hosp de Navarra
      • Salamanca, Испания, 37007
        • Hosp Clinico Univ de Salamanca
      • Santander, Испания, 39008
        • Hosp. Univ. Marques de Valdecilla
      • Santiago de Compostela, Испания, 15706
        • Hosp. Clinico Univ. de Santiago
  • Италия
      • Alessandria, Италия, 15121
        • Azienda Ospedaliera Nazionale SS. Antonio e Biagio e Cesare Arrigo Alessandria
      • Bologna, Италия, 40138
        • A O U Sant Orsola Malpighi
      • Brindisi, Италия, 72100
        • Ospedale Perrino
      • Catania, Италия, 95122
        • ARNAS Garibaldi P O Nesima
      • Genova, Италия, 16132
        • Ospedale Policlinico San Martino IRCCS
      • Legnano, Италия, 20025
        • Asst Ovest Milanese - Ospedale Di Legnano
      • Milan, Италия, 20132
        • IRCCS Ospedale San Raffaele
      • Milan, Италия, 20122
        • Fondazione IRCCS Ca Granda Ospedale Policlinico Di Milano
      • Pavia, Италия, 27100
        • Fondazione IRCCS Policlinico San Matteo
      • Pescara, Италия, 65124
        • Presidio Ospedaliero Pescara
      • Ravenna, Италия, 48121
        • Ospedale S. Maria Delle Croci
      • Torino, Италия, 10126
        • Oncologia Medica-Città Della Salute E Della Scienza Di Torino
      • Verona, Италия, 37134
        • Azienda Ospedaliera Universitaria Integrata Verona
  • Канада
    • Alberta
      • Calgary, Alberta, Канада, T2N 5G2
        • Arthur J E Child Comprehensive Cancer Centre
    • British Columbia
      • Vancouver, British Columbia, Канада, V5Z4E6
        • British Columbia Cancer Agency
    • Nova Scotia
      • Halifax, Nova Scotia, Канада, B3H 1V7
        • Nova Scotia Health Authority
    • Ontario
      • Hamilton, Ontario, Канада, L8V5C2
        • Juravinski Cancer Centre
      • Toronto, Ontario, Канада, M5G2M9
        • Princess Margaret Cancer Centre University Health Network
    • Quebec
      • Montreal, Quebec, Канада, H1T 2M4
        • CIUSSS de l Est de l Ile de Montreal Installation Hopital Maisonneuve Rosemont
    • Saskatchewan
      • Saskatoon, Saskatchewan, Канада, S7N 4H4
        • Saskatoon Cancer Centre
  • Китай
      • Beijing, Китай, 100034
        • Peking University First Hospital
      • Beijing, Китай, 100020
        • Beijing Chaoyang Hospital
      • Beijing, Китай, 101199
        • Peking University People's Hospital
      • Changsha, Китай, 410011
        • The Second Xiangya Hospital of Central South Hospital
      • Changzhou, Китай, 213000
        • Changzhou No 2 Peoples Hospital
      • Chengdu, Китай, 610032
        • Sichuan Provincial Peoples Hospital
      • Fuzhou, Китай, 350005
        • The First Affiliated Hospital of Fujian Medical University
      • Fuzhou, Китай, 350001
        • Fujian Meidical University Union Hospital
      • Guangzhou, Китай, 510515
        • Nanfang Hospital of Southern Medical Hospital
      • Guangzhou, Китай, 510060
        • Sun Yat Sen University Cancer Center
      • Hangzhou, Китай, 310009
        • The Second Affiliated Hospital of Zhejiang University College of Medicine
      • Hangzhou, Китай, 310003
        • First hospital affiliated of Zhejiang Medical university
      • Hohhot, Китай, 010051
        • The Affiliated Hospital of Inner Mongolia Medical College
      • Jinan, Китай, 250012
        • Qilu Hospital of Shandong University
      • Nanchang, Китай, 330006
        • The First Affiliated Hospital of NanChang University
      • Nanjing, Китай, 210008
        • Nanjing Drum Tower Hospital
      • Nanning, Китай, 530021
        • The First Affiliated Hospital of Guangxi Medical University
      • Shanghai, Китай, 200025
        • Ruijing Hospital Affiliated To Shanghai Jiaotong University School Of Medicine
      • Shanghai, Китай, 200065
        • Tongji Hospital of Tongji University
      • Shanghai, Китай, 200434
        • Shanghai Fourth People s Hospital
      • Shenyang, Китай, 110055
        • Shengjing Hospital Of China Medical University
      • Shenzhen, Китай, 518036
        • Peking University Shenzhen Hospital
      • Taiyuan, Китай, 030032
        • Shanxi Bethune Hospital
      • Tianjin, Китай, 30060
        • Tianjin Medical University Cancer Institute and Hospital
      • Wenzhou, Китай, 325000
        • The First Affiliated Hospital of Wenzhou Medical University
      • Wuhan, Китай, 430030
        • Tongji Hospital, Tongji Medical College of HUST
      • Xi'an, Китай, 710004
        • The Second Affiliated Hospital of Xi'an Jiaotong University
      • Xiamen, Китай, 361026
        • The first affiliated hospital of xiamen university
  • Мексика
      • Guadalajara, Мексика, 45645
        • Centro de Quimioterapia e Investigacion
      • Huixquilucan, Мексика, 52787
        • Hematologica Alta Especialidad
      • Monterrey, Мексика, 64460
        • Hospital Universitario Dr Jose Eleuterio Gonzalez
  • Нидерланды
      • Almere Stad, Нидерланды, 1315RA
        • Flevoziekenhuis
      • Eindhoven, Нидерланды, 5623 EJ
        • Catharinaziekenhuis
      • Nieuwegein, Нидерланды, 3435 CM
        • St. Antonius Ziekenhuis Nieuwegein
      • The Hague, Нидерланды, 2545 CH
        • Haga ziekenhuis
      • Zwolle, Нидерланды, 8025 AB
        • Isala Kliniek
  • Польша
      • Biała Podlaska, Польша, 21 500
        • Wojewodzki Szpital Specjalistyczny
      • Brzozów, Польша, 36-200
        • Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologiczny im Ks B Markiewicza
      • Kielce, Польша, 25 734
        • Swietokrzyskie Centrum Onkologii SPZOZ w Kielcach
      • Lublin, Польша, 20-090
        • Centrum Onkologii Ziemii Lubelskiej
      • Szczecin, Польша, 71-252
        • Uniwersytecki Szpital Kliniczny Nr 1 PUM im prof Tadeusza Sokolowskiego w Szczecinie
      • Wroclaw, Польша, 50 367
        • Uniwersytecki Szpital Kliniczny im Jana Mikulicza Radeckiego we Wroclawiu
  • Саудовская Аравия
      • Riyadh, Саудовская Аравия, 11564
        • King Faisal Specialist Hospital & Research Center
      • Riyadh, Саудовская Аравия, 12231
        • King Fahad Medical City
      • Riyadh, Саудовская Аравия, 11481
        • King Abdullah International Medical Research Center (KAIMRC)
  • Соединенное Королевство
      • Blackpool, Соединенное Королевство, FY3 8NR
        • Blackpool Victoria Hospital
      • Cardiff, Соединенное Королевство, CF14 4HY
        • University Hospital of Wales
      • Dundee, Соединенное Королевство, DD1 9SY
        • Ninewells Hospital
      • Leeds, Соединенное Королевство, LS9 7TF
        • St James University Hospital
      • London, Соединенное Королевство, SE5 9RS
        • Kings College Hospital
      • Nottingham, Соединенное Королевство, NG5 1PB
        • Nottingham City Hospital
      • Plymouth, Соединенное Королевство, PL6 8DH
        • University Hospitals Plymouth NHS Trust
      • Portsmouth, Соединенное Королевство, PO6 3LY
        • Queen Alexandra Hospital
  • Соединенные Штаты
    • California
      • Clovis, California, Соединенные Штаты, 93611
        • UCSF Fresno
      • Santa Monica, California, Соединенные Штаты, 90404
        • UCLA
    • Connecticut
      • New Haven, Connecticut, Соединенные Штаты, 06519
        • Yale University School Of Medicine
    • Delaware
      • Newark, Delaware, Соединенные Штаты, 19713
        • Medical Oncology Hematology Consultants, PA
    • Florida
      • Hollywood, Florida, Соединенные Штаты, 33021
        • Memorial Healthcare System
      • Tampa, Florida, Соединенные Штаты, 33612
        • Moffitt Cancer Center
    • Georgia
      • Atlanta, Georgia, Соединенные Штаты, 30322
        • Winship Cancer Institute Emory University
      • Newnan, Georgia, Соединенные Штаты, 30265
        • City of Hope Cancer Center
    • Idaho
      • Coeur d'Alene, Idaho, Соединенные Штаты, 83814
        • Kootenai Health
    • Illinois
      • Maywood, Illinois, Соединенные Штаты, 60153
        • Loyola University Medical Center
    • Iowa
      • Waukee, Iowa, Соединенные Штаты, 50263
        • University of Iowa Health Care
    • Kentucky
      • Louisville, Kentucky, Соединенные Штаты, 40207
        • Norton Cancer Institute
    • Louisiana
      • Baton Rouge, Louisiana, Соединенные Штаты, 70808
        • Our Lady of the Lake Hospital
    • Maryland
      • Annapolis, Maryland, Соединенные Штаты, 21401
        • Luminis Health Center for Cancer and Blood Disorders
      • Baltimore, Maryland, Соединенные Штаты, 21201
        • University of Maryland School of Medicine
      • Baltimore, Maryland, Соединенные Штаты, 21287
        • The Sidney Kimmel Comprehensive Cancer Center at John Hopkins
    • Michigan
      • Ann Arbor, Michigan, Соединенные Штаты, 48109
        • University of Michigan
      • Detroit, Michigan, Соединенные Штаты, 48202
        • Henry Ford Cancer Institute
      • Southfield, Michigan, Соединенные Штаты, 48075
        • Henry Ford Health Providence Southfield Hospital
    • Minnesota
      • Minneapolis, Minnesota, Соединенные Штаты, 55455
        • University Of Minnesota
      • Rochester, Minnesota, Соединенные Штаты, 55905
        • Mayo Clinic Rochester
      • Saint Paul, Minnesota, Соединенные Штаты, 55101
        • Regions Hospital
    • Nebraska
      • Omaha, Nebraska, Соединенные Штаты, 68105
        • University of Nebraska
    • New Hampshire
      • Lebanon, New Hampshire, Соединенные Штаты, 03756
        • Dartmouth Hitchcock Medical Center
    • New Jersey
      • Hackensack, New Jersey, Соединенные Штаты, 07601
        • John Theurer Cancer Center at Hackensack University Medical Center
    • New York
      • Buffalo, New York, Соединенные Штаты, 14263
        • Roswell Park Cancer Institute
      • New York, New York, Соединенные Штаты, 10065
        • Weill Cornell Medical College
      • Syracuse, New York, Соединенные Штаты, 13210
        • SUNY Upstate Medical University
    • North Carolina
      • Durham, North Carolina, Соединенные Штаты, 27705
        • Duke University Medical Center
    • Ohio
      • Canton, Ohio, Соединенные Штаты, 44718
        • Gabrail Cancer Center
      • Cleveland, Ohio, Соединенные Штаты, 44195
        • Cleveland Clinic
      • Cleveland, Ohio, Соединенные Штаты, 44106
        • Louis Stokes Cleveland VA Med Ctr
    • Oregon
      • Portland, Oregon, Соединенные Штаты, 97239
        • Oregon Health And Science University
    • Pennsylvania
      • Hershey, Pennsylvania, Соединенные Штаты, 17033
        • Penn State Milton S Hershey Medical Ctr
      • Philadelphia, Pennsylvania, Соединенные Штаты, 19107 4215
        • Thomas Jefferson University
      • Pittsburgh, Pennsylvania, Соединенные Штаты, 15224
        • West Penn Hospital
      • Pittsburgh, Pennsylvania, Соединенные Штаты, 15232
        • University Of Pittsburgh Medical Center UPMC Hillman Cancer Center
    • South Carolina
      • Charleston, South Carolina, Соединенные Штаты, 29425-8900
        • Medical University of South Carolina
      • Greenville, South Carolina, Соединенные Штаты, 29607
        • Bon Secours Saint Francis Cancer Center
    • Texas
      • Dallas, Texas, Соединенные Штаты, 75390
        • UT Southwestern Parkland Hospital
      • Dallas, Texas, Соединенные Штаты, 75390
        • UT Southwestern
      • Houston, Texas, Соединенные Штаты, 77030
        • Houston Methodist Neal Cancer Center at Texas Medical Center
    • Utah
      • Salt Lake City, Utah, Соединенные Штаты, 84112
        • Huntsman Cancer Institute
    • Virginia
      • Charlottesville, Virginia, Соединенные Штаты, 22903
        • University of Virginia
    • Washington
      • Seattle, Washington, Соединенные Штаты, 98109
        • Fred Hutchinson Cancer Research Center
      • Seattle, Washington, Соединенные Штаты, 98104
        • Swedish Cancer Institute
      • Tacoma, Washington, Соединенные Штаты, 98405
        • NorthWest Medical Specialties, PLLC
    • Wisconsin
      • La Crosse, Wisconsin, Соединенные Штаты, 54601
        • Gundersen Health System
      • Milwaukee, Wisconsin, Соединенные Штаты, 53226
        • Medical College Of Wisconsin
  • Турция (Туркие)
      • Ankara, Турция (Туркие), 06680
        • Liv Hospital Ankara
      • Ankara, Турция (Туркие), 06620
        • Ankara Universitesi Tip Fakultesi Cebeci Arastirma ve Uygulama Hastanesi
      • Denizli, Турция (Туркие), 20070
        • Pamukkale Universitesi Tip Fakultesi
      • Istanbul, Турция (Туркие), 34214
        • Medipol University Hospital
      • Samsun, Турция (Туркие), 55200
        • Ondokuz Mayis Universitesi Saglik Uygulama ve Arastirma Merkezi
  • Франция
      • Lille, Франция, 59000
        • Hopital Claude Huriez
      • Limoges, Франция, 87042
        • CHU de Limoges Hopital Dupuytren
      • Lyon, Франция, 69002
        • Hospices Civils de Lyon HCL
      • Marseille, Франция, 13009
        • Institut Paoli Calmettes
      • Nantes, Франция, 44093
        • CHU Nantes
      • Paris, Франция, 75010
        • Hopital Saint Louis
      • Pessac, Франция, 33604
        • CHU de Bordeaux - Hospital Haut-Leveque
      • Strasbourg, Франция, 67200
        • Institut de Cancerologie Strasbourg Europe ICANS
      • Toulouse, Франция, 31100
        • Institut Universitaire du Cancer Toulouse Oncopole
      • Tours, Франция, 37044
        • CHRU Tours Hopital Bretonneau
  • Чехия
      • Brno-Bohunice, Чехия, 625 00
        • Fakultni nemocnice Brno
      • Hradec Králové, Чехия, 500 05
        • Fakultni nemocnice Hradec Kralove
      • Olomouc, Чехия, 779 00
        • University Hospital Olomouc
      • Ostrava, Чехия, 708 52
        • Fakultni Nemocnice Ostrava
  • Швеция
      • Lund, Швеция, 221 85
        • Skanes universitetssjukhus
      • Umeå, Швеция, 901 85
        • Norrlands Universitetssjukhus
      • Uppsala, Швеция, 75185
        • Akademiska Sjukhuset
      • Varberg, Швеция, 432 81
        • Varberg Hospital
  • Южная Корея
      • Busan, Южная Корея, 49201
        • Dong-A University Hospital
      • Busan, Южная Корея, 49241
        • Pusan National University Hospital
      • Jeollanam-do, Южная Корея, 58128
        • Chonnam National University Hwasun Hospital
      • Seoul, Южная Корея, 03080
        • Seoul National University Hospital
      • Seoul, Южная Корея, 06351
        • Samsung Medical Center
      • Seoul, Южная Корея, 06591
        • The Catholic University of Korea Seoul St Mary s Hospital
      • Ulsan, Южная Корея, 44033
        • Ulsan University Hospital
  • Япония
      • Bunkyō City, Япония, 113 8431
        • Juntendo University Hospital
      • Fukuoka, Япония, 814-0180
        • Fukuoka University Hospital
      • Hamamatsu, Япония, 431 3192
        • Hamamatsu University Hospital
      • Kanazawa, Япония, 920 8641
        • Kanazawa University Hospital
      • Kyoto, Япония, 602-8566
        • University Hospital Kyoto Prefectural University of Medicine
      • Nagasaki, Япония, 856-8562
        • National Hospital Organization Nagasaki Medical Center
      • Narita, Япония, 286-8523
        • Japanese Red Cross Narita Hospital
      • Niigata, Япония, 951-8566
        • Niigata Cancer Center Hospital
      • Nishinomiya Shi, Япония, 663 8501
        • Hyogo Medical University Hospital
      • Osaka, Япония, 543-8555
        • Japanese Red Cross Osaka Hospital
      • Sapporo, Япония, 060-8604
        • Sapporo City General Hospital
      • Sendai, Япония, 980 8574
        • Tohoku University Hospital
      • Shibuya-ku, Япония, 150-8935
        • Japanese Red Cross Medical Center
      • Shiwa-gun, Япония, 028-3695
        • Iwate Medical University Hospital
      • Suita, Япония, 565 0871
        • The University of Osaka Hospital
      • Sunto Gun, Япония, 411 8777
        • Shizuoka Cancer Center
      • Tokyo, Япония, 135 8550
        • The Cancer Institute Hospital of JFCR
      • Tottori, Япония, 683-0824
        • Tottori University Hospital
      • Tsukuba, Япония, 305 8576
        • University of Tsukuba Hospital
      • Yokohama, Япония, 241 8515
        • Kanagawa Cancer Center

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

18 лет и старше (Взрослый, Пожилой взрослый)

Принимает здоровых добровольцев

Нет

Полы, имеющие право на обучение

Все

Описание

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

Учебный план

В этом разделе представлена ​​подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

  • Основная цель: Уход
  • Распределение: Рандомизированный
  • Интервенционная модель: Параллельное назначение
  • Маскировка: Нет (открытая этикетка)

Оружие и интервенции

Группа участников / Армия
Вмешательство/лечение
Экспериментальный: 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.
Лекарство: Pomalidomide

Pomalidomide will be administered orally.

Другие имена:
  • Помалист
  • Имновид
Лекарство: Dexamethasone

Dexamethasone will be administered either orally or intravenously.

Лекарство: Talquetamab

Talquetamab will be administered as a SC injection.

Другие имена:
  • JNJ-64407564
  • Талви
Экспериментальный: 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.
Лекарство: Teclistamab

Teclistamab will be administered as a SC injection.

Другие имена:
  • JNJ-64007957
  • Теквайли
Лекарство: Dexamethasone

Dexamethasone will be administered either orally or intravenously.

Лекарство: Talquetamab

Talquetamab will be administered as a SC injection.

Другие имена:
  • JNJ-64407564
  • Талви
Активный компаратор: 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.
Лекарство: Pomalidomide

Pomalidomide will be administered orally.

Другие имена:
  • Помалист
  • Имновид
Лекарство: Dexamethasone

Dexamethasone will be administered either orally or intravenously.

Лекарство: Elotuzumab

Elotuzumab will be administered intravenously.

Другие имена:
  • Эмплицити
Лекарство: Bortezomib

Bortezomib will be administered as a SC injection.

Другие имена:
  • Велкейд

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Progression Free Survival (PFS)
Временное ограничение: 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

Вторичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Overall Response Rate (ORR)
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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)
Временное ограничение: 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
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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

Соавторы и исследователи

Здесь вы найдете людей и организации, участвующие в этом исследовании.

Спонсор

Janssen Research & Development, LLC

Следователи

  • Директор по исследованиям: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования (Действительный)

22 января 2024 г.

Первичное завершение (Действительный)

1 апреля 2026 г.

Завершение исследования (Оцененный)

31 марта 2028 г.

Даты регистрации исследования

Первый отправленный

5 января 2024 г.

Впервые представлено, что соответствует критериям контроля качества

5 января 2024 г.

Первый опубликованный (Действительный)

17 января 2024 г.

Обновления учебных записей

Последнее опубликованное обновление (Действительный)

3 ноября 2026 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

2 ноября 2026 г.

Последняя проверка

1 ноября 2026 г.

Дополнительная информация

Термины, связанные с этим исследованием

Дополнительные соответствующие термины MeSH

Другие идентификационные номера исследования

  • 64407564MMY3009
  • 64407564MMY3009 (Другой идентификатор: Janssen Research & Development, LLC)
  • 2022-502446-27-00 (Идентификатор реестра: EUCT number)

Планирование данных отдельных участников (IPD)

Планируете делиться данными об отдельных участниках (IPD)?

ДА

Описание плана 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.

Информация о лекарствах и устройствах, исследовательские документы

Изучает лекарственный продукт, регулируемый FDA США.

Да

Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.

Нет

Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .

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