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抗CD38抗体とレナリドマイドの投与を受けた再発または難治性骨髄腫の参加者を対象に、タルケタマブとポマリドミド、タルケタマブとテクリスタマブ、エロツズマブ、ポマリドミド、デキサメタゾンまたはポマリドミド、ボルテゾミブ、デキサメタゾンを比較した研究 (MonumenTAL-6)

2026年11月2日 更新者：Janssen Research & Development, LLC

タルケタマブとポマリドミドの併用（Tal-P）、タルケタマブとテクリスタマブの併用（Tal-Tec）、およびエロツズマブ、ポマリドミド、デキサメタゾン（EPd）またはポマリドミド、ボルテゾミブ、デキサメタゾンのいずれかを研究者が選択したものを比較する第3相ランダム化試験（ PVd) 抗CD38抗体およびレナリドマイドを含む1～4回の治療歴がある再発または難治性骨髄腫の参加者を対象とした

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).

調査の概要

状態

積極的、募集していない

条件

介入・治療

研究の種類

介入

入学 (実際)

838

段階

  • フェーズ 3

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

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

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年歳以上 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：なし（オープンラベル）

武器と介入

参加者グループ / アーム
介入・治療
実験的：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.
薬：Pomalidomide

Pomalidomide will be administered orally.

他の名前：
  • ポマリスト
  • イムノビッド
薬：Dexamethasone

Dexamethasone will be administered either orally or intravenously.

薬：Talquetamab

Talquetamab will be administered as a SC injection.

他の名前：
  • JNJ-64407564
  • タルヴィー
実験的：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.
薬：Teclistamab

Teclistamab will be administered as a SC injection.

他の名前：
  • JNJ-64007957
  • テクヴァイリ
薬：Dexamethasone

Dexamethasone will be administered either orally or intravenously.

薬：Talquetamab

Talquetamab will be administered as a SC injection.

他の名前：
  • JNJ-64407564
  • タルヴィー
アクティブコンパレータ：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.
薬：Pomalidomide

Pomalidomide will be administered orally.

他の名前：
  • ポマリスト
  • イムノビッド
薬：Dexamethasone

Dexamethasone will be administered either orally or intravenously.

薬：Elotuzumab

Elotuzumab will be administered intravenously.

他の名前：
  • 明示的
薬：Bortezomib

Bortezomib will be administered as a SC injection.

他の名前：
  • ベルケード

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Progression Free Survival (PFS)
時間枠：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

二次結果の測定

結果測定
メジャーの説明
時間枠
Overall Response Rate (ORR)
時間枠：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
時間枠：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
時間枠：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
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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
時間枠：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
時間枠：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)
時間枠：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
時間枠：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)
時間枠：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)
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Janssen Research & Development, LLC

捜査官

  • スタディディレクター：Janssen Research & Development, LLC Clinical Trial、Janssen Research & Development, LLC

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2024年1月22日

一次修了 (実際)

2026年4月1日

研究の完了 (推定)

2028年3月31日

試験登録日

最初に提出

2024年1月5日

QC基準を満たした最初の提出物

2024年1月5日

最初の投稿 (実際)

2024年1月17日

学習記録の更新

投稿された最後の更新 (実際)

2026年11月3日

QC基準を満たした最後の更新が送信されました

2026年11月2日

最終確認日

2026年11月1日

詳しくは

本研究に関する用語

追加の関連 MeSH 用語

その他の研究ID番号

  • 64407564MMY3009
  • 64407564MMY3009 (その他の識別子：Janssen Research & Development, LLC)
  • 2022-502446-27-00 (レジストリ識別子：EUCT number)

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

はい

IPD プランの説明

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.

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

はい

米国FDA規制機器製品の研究

いいえ

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