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一项在接受抗 CD38 抗体和来那度胺治疗的复发性或难治性骨髓瘤受试者中比较他克他单抗加泊马度胺、他克他单抗加特克司他单抗和 Elotuzumab、泊马度胺和地塞米松或泊马度胺、硼替佐米和地塞米松的研究 (MonumenTAL-6)

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

一项 3 期随机研究，比较他克他单抗与泊马度胺 (Tal-P) 联用、他克他单抗与特克司单抗 (Tal-Tec) 联用，以及研究者选择埃罗妥珠单抗、泊马度胺和地塞米松 (EPd) 或泊马度胺、硼替佐米和地塞米松 ( PVd）适用于已接受过 1 至 4 种既往治疗（包括抗 CD38 抗体和来那度胺）的复发性或难治性骨髓瘤参与者

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).

研究概览

地位

主动，不招人

条件

多发性骨髓瘤

干预/治疗

研究类型

介入性

注册 (实际的)

838

阶段

第三阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

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
丹麦
- - Aarhus、丹麦、8200
    - Aarhus University Hospital
  - Odense C、丹麦、5000
    - Odense University Hospital
  - Vejle、丹麦、7100
    - Vejle Hospital
以色列
- - Be’er Ya‘aqov、以色列、70300
    - Shamir Medical Center Assaf Harofeh
  - Haifa、以色列、3436212
    - Carmel Medical Center
  - Petah Tikva、以色列、49100
    - Rabin Medical center - Petah-Tikva
  - Ramat Gan、以色列、52621
    - Sheba Medical Center
  - Tel Aviv、以色列、64239
    - Tel Aviv Sourasky Medical Center
加拿大
- Alberta
  - Calgary、Alberta、加拿大、T2N 5G2
    - Arthur J E Child Comprehensive Cancer Centre
- British Columbia
  - Vancouver、British Columbia、加拿大、V5Z4E6
    - British Columbia Cancer Agency
- Nova Scotia
  - Halifax、Nova Scotia、加拿大、B3H 1V7
    - Nova Scotia Health Authority
- Ontario
  - Hamilton、Ontario、加拿大、L8V5C2
    - Juravinski Cancer Centre
  - Toronto、Ontario、加拿大、M5G2M9
    - Princess Margaret Cancer Centre University Health Network
- Quebec
  - Montreal、Quebec、加拿大、H1T 2M4
    - CIUSSS de l Est de l Ile de Montreal Installation Hopital Maisonneuve Rosemont
- Saskatchewan
  - Saskatoon、Saskatchewan、加拿大、S7N 4H4
    - Saskatoon Cancer Centre
匈牙利
- - Budapest、匈牙利、1088
    - Semmelweis Egyetem, Belgyogyaszati es Hematologiai Klinika
  - Budapest、匈牙利、1097
    - Del Pesti Centrumkorhaz Orszagos Hematologiai es Infektologiai Intezet Szent Laszlo Telephely
  - Debrecen、匈牙利、4032
    - Debreceni Egyetem Klinikai Kozpont
  - Nyíregyháza、匈牙利、4400
    - Szabolcs Szatmar Bereg Varmegyei Oktatokorhaz
  - Pécs、匈牙利、7624
    - Pecsi Tudomanyegyetem Klinikai Kozpont
印度
- - Gūrgaon、印度、122002
    - Fortis Memorial Research Institute
  - Lucknow、印度、226014
    - Sanjay Gandhi Postgraduate Institute of Medical Sciences
  - Pune、印度、411004
    - Deenanath Mangeshkar Hospital and Research Centre
土耳其（türkiye）
- - Ankara、土耳其（türkiye）、06680
    - Liv Hospital Ankara
  - Ankara、土耳其（türkiye）、06620
    - Ankara Universitesi Tip Fakultesi Cebeci Arastirma ve Uygulama Hastanesi
  - Denizli、土耳其（türkiye）、20070
    - Pamukkale Universitesi Tip Fakultesi
  - Istanbul、土耳其（türkiye）、34214
    - Medipol University Hospital
  - Samsun、土耳其（türkiye）、55200
    - Ondokuz Mayis Universitesi Saglik Uygulama ve Arastirma Merkezi
墨西哥
- - Guadalajara、墨西哥、45645
    - Centro de Quimioterapia e Investigacion
  - Huixquilucan、墨西哥、52787
    - Hematologica Alta Especialidad
  - Monterrey、墨西哥、64460
    - Hospital Universitario Dr Jose Eleuterio Gonzalez
奥地利
- - Salzburg、奥地利、05020
    - LKH - Universitätsklinikum der PMU Salzburg
  - Vienna、奥地利、1160
    - Klinik Ottakring
  - Vienna、奥地利、A-1090
    - Medical University Vienna MUV
巴西
- - Belo Horizonte、巴西、30110-022
    - Cetus Oncologia
  - Brasília、巴西、70390 700
    - IDOR - Regional Brasilia
  - Caxias do Sul、巴西、95070 560
    - Fundacao Universidade de Caxias do Sul
  - Curitiba、巴西、81520-060
    - Hospital Erasto Gaertner- Liga Paranaense de Combate ao Cancer
  - Porto Alegre、巴西、90035-903
    - Hospital De Clinicas De Porto Alegre
  - Recife、巴西、50070-480
    - IDOR - Regional Pernambuco
  - Rio de Janeiro、巴西、22793-080
    - Instituto de Educacao, Pesquisa e Gestao em Saude Instituto Americas (COI)
  - Salvador、巴西、41253-190
    - IDOR - Regional Bahia
  - São José do Rio Preto、巴西、15090-000
    - Funfarme Sjrp
  - São Paulo、巴西、01509 900
    - Fundacao Antonio Prudente A C Camargo Cancer Center
  - São Paulo、巴西、04537 081
    - Clinica Medica Sao Germano LTDA
  - São Paulo、巴西、01323 001
    - Real e Benemerita Associacao Portuguesa de Beneficencia
  - São Paulo、巴西、01401 002
    - IDOR - Regional Sao Paulo
希腊
- - Athens、希腊、115 28
    - Alexandra General Hospital of Athens
  - Athens、希腊、115 25
    - 251 Airforces Hospital
  - Thessaloniki、希腊、546 39
    - Theageneio Cancer Hospital
德国
- - Augsburg、德国、86156
    - Klinikum Augsburg
  - Halle、德国、06120
    - Universitaetsklinikum Halle Saale
  - Heidelberg、德国、69120
    - Universitaetsklinikum Heidelberg
  - Magdeburg、德国、39120
    - Universitaetsklinikum Magdeburg A.oe.R
  - München、德国、81675
    - Klinikum rechts der Isar der TU Muenchen
  - Tübingen、德国、72076
    - Universitaetsklinikum Tuebingen
  - Würzburg、德国、97080
    - Universitaetsklinikum Wuerzburg
意大利
- - Alessandria、意大利、15121
    - Azienda Ospedaliera Nazionale SS. Antonio e Biagio e Cesare Arrigo Alessandria
  - Bologna、意大利、40138
    - A O U Sant Orsola Malpighi
  - Brindisi、意大利、72100
    - Ospedale Perrino
  - Catania、意大利、95122
    - ARNAS Garibaldi P O Nesima
  - Genova、意大利、16132
    - Ospedale Policlinico San Martino IRCCS
  - Legnano、意大利、20025
    - Asst Ovest Milanese - Ospedale Di Legnano
  - Milan、意大利、20132
    - IRCCS Ospedale San Raffaele
  - Milan、意大利、20122
    - Fondazione IRCCS Ca Granda Ospedale Policlinico Di Milano
  - Pavia、意大利、27100
    - Fondazione IRCCS Policlinico San Matteo
  - Pescara、意大利、65124
    - Presidio Ospedaliero Pescara
  - Ravenna、意大利、48121
    - Ospedale S. Maria Delle Croci
  - Torino、意大利、10126
    - Oncologia Medica-Città Della Salute E Della Scienza Di Torino
  - Verona、意大利、37134
    - Azienda Ospedaliera Universitaria Integrata Verona
捷克语
- - Brno-Bohunice、捷克语、625 00
    - Fakultni nemocnice Brno
  - Hradec Králové、捷克语、500 05
    - Fakultni nemocnice Hradec Kralove
  - Olomouc、捷克语、779 00
    - University Hospital Olomouc
  - Ostrava、捷克语、708 52
    - Fakultni Nemocnice Ostrava
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
比利时
- - Charleroi、比利时、6060
    - Grand Hopital De Charleroi Site Les Viviers
  - Genk、比利时、3600
    - Ziekenhuis Oost-Limburg
  - Ghent、比利时、9000
    - Ghent University Hospital
  - Sint-Niklaas、比利时、9100
    - AZ Nikolaas - Campus Sint-Niklaas Moerland
沙特阿拉伯
- - Riyadh、沙特阿拉伯、11564
    - King Faisal Specialist Hospital & Research Center
  - Riyadh、沙特阿拉伯、12231
    - King Fahad Medical City
  - Riyadh、沙特阿拉伯、11481
    - King Abdullah International Medical Research Center (KAIMRC)
法国
- - Lille、法国、59000
    - Hopital Claude Huriez
  - Limoges、法国、87042
    - CHU de Limoges Hopital Dupuytren
  - Lyon、法国、69002
    - Hospices Civils de Lyon HCL
  - Marseille、法国、13009
    - Institut Paoli Calmettes
  - Nantes、法国、44093
    - CHU Nantes
  - Paris、法国、75010
    - Hopital Saint Louis
  - Pessac、法国、33604
    - CHU de Bordeaux - Hospital Haut-Leveque
  - Strasbourg、法国、67200
    - Institut de Cancerologie Strasbourg Europe ICANS
  - Toulouse、法国、31100
    - Institut Universitaire du Cancer Toulouse Oncopole
  - Tours、法国、37044
    - CHRU Tours Hopital Bretonneau
波兰
- - Biała Podlaska、波兰、21 500
    - Wojewodzki Szpital Specjalistyczny
  - Brzozów、波兰、36-200
    - Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologiczny im Ks B Markiewicza
  - Kielce、波兰、25 734
    - Swietokrzyskie Centrum Onkologii SPZOZ w Kielcach
  - Lublin、波兰、20-090
    - Centrum Onkologii Ziemii Lubelskiej
  - Szczecin、波兰、71-252
    - Uniwersytecki Szpital Kliniczny Nr 1 PUM im prof Tadeusza Sokolowskiego w Szczecinie
  - Wroclaw、波兰、50 367
    - Uniwersytecki Szpital Kliniczny im Jana Mikulicza Radeckiego we Wroclawiu
澳大利亚
- - Adelaide、澳大利亚、5000
    - Royal Adelaide Hospital
  - Box Hill、澳大利亚、3128
    - Box Hill Hospital
  - Darlinghurst、澳大利亚、2010
    - St Vincents Hospital
  - Fitzroy、澳大利亚、3065
    - St Vincents Hospital Melbourne
  - Southport、澳大利亚、4215
    - Gold Coast University Hospital
  - West Perth、澳大利亚、6005
    - Perth Blood Institute
  - Wollongong、澳大利亚、2500
    - Wollongong Hospital
瑞典
- - Lund、瑞典、221 85
    - Skanes universitetssjukhus
  - Umeå、瑞典、901 85
    - Norrlands Universitetssjukhus
  - Uppsala、瑞典、75185
    - Akademiska Sjukhuset
  - Varberg、瑞典、432 81
    - Varberg Hospital
美国
- California
  - Clovis、California、美国、93611
    - UCSF Fresno
  - Santa Monica、California、美国、90404
    - UCLA
- Connecticut
  - New Haven、Connecticut、美国、06519
    - Yale University School Of Medicine
- Delaware
  - Newark、Delaware、美国、19713
    - Medical Oncology Hematology Consultants, PA
- Florida
  - Hollywood、Florida、美国、33021
    - Memorial Healthcare System
  - Tampa、Florida、美国、33612
    - Moffitt Cancer Center
- Georgia
  - Atlanta、Georgia、美国、30322
    - Winship Cancer Institute Emory University
  - Newnan、Georgia、美国、30265
    - City of Hope Cancer Center
- Idaho
  - Coeur d'Alene、Idaho、美国、83814
    - Kootenai Health
- Illinois
  - Maywood、Illinois、美国、60153
    - Loyola University Medical Center
- Iowa
  - Waukee、Iowa、美国、50263
    - University of Iowa Health Care
- Kentucky
  - Louisville、Kentucky、美国、40207
    - Norton Cancer Institute
- Louisiana
  - Baton Rouge、Louisiana、美国、70808
    - Our Lady of the Lake Hospital
- Maryland
  - Annapolis、Maryland、美国、21401
    - Luminis Health Center for Cancer and Blood Disorders
  - Baltimore、Maryland、美国、21201
    - University of Maryland School of Medicine
  - Baltimore、Maryland、美国、21287
    - The Sidney Kimmel Comprehensive Cancer Center at John Hopkins
- Michigan
  - Ann Arbor、Michigan、美国、48109
    - University of Michigan
  - Detroit、Michigan、美国、48202
    - Henry Ford Cancer Institute
  - Southfield、Michigan、美国、48075
    - Henry Ford Health Providence Southfield Hospital
- Minnesota
  - Minneapolis、Minnesota、美国、55455
    - University Of Minnesota
  - Rochester、Minnesota、美国、55905
    - Mayo Clinic Rochester
  - Saint Paul、Minnesota、美国、55101
    - Regions Hospital
- Nebraska
  - Omaha、Nebraska、美国、68105
    - University of Nebraska
- New Hampshire
  - Lebanon、New Hampshire、美国、03756
    - Dartmouth Hitchcock Medical Center
- New Jersey
  - Hackensack、New Jersey、美国、07601
    - John Theurer Cancer Center at Hackensack University Medical Center
- New York
  - Buffalo、New York、美国、14263
    - Roswell Park Cancer Institute
  - New York、New York、美国、10065
    - Weill Cornell Medical College
  - Syracuse、New York、美国、13210
    - SUNY Upstate Medical University
- North Carolina
  - Durham、North Carolina、美国、27705
    - Duke University Medical Center
- Ohio
  - Canton、Ohio、美国、44718
    - Gabrail Cancer Center
  - Cleveland、Ohio、美国、44195
    - Cleveland Clinic
  - Cleveland、Ohio、美国、44106
    - Louis Stokes Cleveland VA Med Ctr
- Oregon
  - Portland、Oregon、美国、97239
    - Oregon Health And Science University
- Pennsylvania
  - Hershey、Pennsylvania、美国、17033
    - Penn State Milton S Hershey Medical Ctr
  - Philadelphia、Pennsylvania、美国、19107 4215
    - Thomas Jefferson University
  - Pittsburgh、Pennsylvania、美国、15224
    - West Penn Hospital
  - Pittsburgh、Pennsylvania、美国、15232
    - University Of Pittsburgh Medical Center UPMC Hillman Cancer Center
- South Carolina
  - Charleston、South Carolina、美国、29425-8900
    - Medical University of South Carolina
  - Greenville、South Carolina、美国、29607
    - Bon Secours Saint Francis Cancer Center
- Texas
  - Dallas、Texas、美国、75390
    - UT Southwestern Parkland Hospital
  - Dallas、Texas、美国、75390
    - UT Southwestern
  - Houston、Texas、美国、77030
    - Houston Methodist Neal Cancer Center at Texas Medical Center
- Utah
  - Salt Lake City、Utah、美国、84112
    - Huntsman Cancer Institute
- Virginia
  - Charlottesville、Virginia、美国、22903
    - University of Virginia
- Washington
  - Seattle、Washington、美国、98109
    - Fred Hutchinson Cancer Research Center
  - Seattle、Washington、美国、98104
    - Swedish Cancer Institute
  - Tacoma、Washington、美国、98405
    - NorthWest Medical Specialties, PLLC
- Wisconsin
  - La Crosse、Wisconsin、美国、54601
    - Gundersen Health System
  - Milwaukee、Wisconsin、美国、53226
    - Medical College Of Wisconsin
英国
- - Blackpool、英国、FY3 8NR
    - Blackpool Victoria Hospital
  - Cardiff、英国、CF14 4HY
    - University Hospital of Wales
  - Dundee、英国、DD1 9SY
    - Ninewells Hospital
  - Leeds、英国、LS9 7TF
    - St James University Hospital
  - London、英国、SE5 9RS
    - Kings College Hospital
  - Nottingham、英国、NG5 1PB
    - Nottingham City Hospital
  - Plymouth、英国、PL6 8DH
    - University Hospitals Plymouth NHS Trust
  - Portsmouth、英国、PO6 3LY
    - Queen Alexandra Hospital
荷兰
- - Almere Stad、荷兰、1315RA
    - Flevoziekenhuis
  - Eindhoven、荷兰、5623 EJ
    - Catharinaziekenhuis
  - Nieuwegein、荷兰、3435 CM
    - St. Antonius Ziekenhuis Nieuwegein
  - The Hague、荷兰、2545 CH
    - Haga ziekenhuis
  - Zwolle、荷兰、8025 AB
    - Isala Kliniek
西班牙
- - Asturias、西班牙、33394
    - Hosp. de Cabuenes
  - Barcelona、西班牙、08035
    - Hosp Univ Vall D Hebron
  - Burgos、西班牙、09003
    - Hosp. Univ. de Burgos
  - Cáceres、西班牙、10003
    - Hosp. San Pedro de Alcantara
  - Donostia / San Sebastian、西班牙、20014
    - Hosp. Univ. Donostia
  - Granada、西班牙、18014
    - Hosp. Univ. Virgen de Las Nieves
  - Lugo、西班牙、27003
    - Hosp. Univ. Lucus Augusti
  - Madrid、西班牙、28046
    - Hosp. Univ. La Paz
  - Palma de Mallorca、西班牙、07120
    - Hosp. Univ. Son Espases
  - Pamplona、西班牙、31008
    - Clinica Univ. de Navarra
  - Pamplona、西班牙、31008
    - Complejo Hosp de Navarra - Hosp de Navarra
  - Salamanca、西班牙、37007
    - Hosp Clinico Univ de Salamanca
  - Santander、西班牙、39008
    - Hosp. Univ. Marques de Valdecilla
  - Santiago de Compostela、西班牙、15706
    - Hosp. Clinico Univ. de Santiago
阿根廷
- - Buenos Aires、阿根廷、C1280AEB
    - Hospital Britanico de Buenos Aires
  - Buenos Aires、阿根廷、C1114AAN
    - Fundaleu
  - CABA、阿根廷、C1118AAT
    - Hospital Aleman
韩国
- - Busan、韩国、49201
    - Dong-A University Hospital
  - Busan、韩国、49241
    - Pusan National University Hospital
  - Jeollanam-do、韩国、58128
    - Chonnam National University Hwasun Hospital
  - Seoul、韩国、03080
    - Seoul National University Hospital
  - Seoul、韩国、06351
    - Samsung Medical Center
  - Seoul、韩国、06591
    - The Catholic University of Korea Seoul St Mary s Hospital
  - Ulsan、韩国、44033
    - Ulsan University Hospital

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

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

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

主要用途：治疗
分配：随机化
介入模型：并行分配
屏蔽：无（打开标签）

手臂数量

武器和干预

参与者组/臂	干预/治疗
实验性的：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.	药品：Pomalidomide Pomalidomide will be administered orally. 其他名称： Pomalyst 免疫力药品：Dexamethasone Dexamethasone will be administered either orally or intravenously. 药品：Talquetamab Talquetamab will be administered as a SC injection. 其他名称： JNJ-64407564 塔尔维
实验性的：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.	药品：Teclistamab Teclistamab will be administered as a SC injection. 其他名称： JNJ-64007957 特茨瓦伊利药品：Dexamethasone Dexamethasone will be administered either orally or intravenously. 药品：Talquetamab Talquetamab will be administered as a SC injection. 其他名称： JNJ-64407564 塔尔维
有源比较器：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.	药品：Pomalidomide Pomalidomide will be administered orally. 其他名称： Pomalyst 免疫力药品：Dexamethasone Dexamethasone will be administered either orally or intravenously. 药品：Elotuzumab Elotuzumab will be administered intravenously. 其他名称：隐含的药品：Bortezomib Bortezomib will be administered as a SC injection. 其他名称：万珂

研究衡量的是什么？

主要结果指标

结果测量	措施说明	大体时间
Progression Free Survival (PFS) 大体时间：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

次要结果测量

结果测量	措施说明	大体时间
Overall Response Rate (ORR) 大体时间：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 大体时间：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 大体时间：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 大体时间：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) 大体时间：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) 大体时间：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) 大体时间：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 大体时间：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 大体时间：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) 大体时间：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 大体时间：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) 大体时间：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) 大体时间：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 大体时间：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 大体时间：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 大体时间：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 大体时间：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 大体时间：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 大体时间：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 大体时间：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 大体时间：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

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Janssen Research & Development, LLC

调查人员

研究主任：Janssen Research & Development, LLC Clinical Trial、Janssen Research & Development, LLC

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2024年1月22日

初级完成 (实际的)

2026年4月1日

研究完成 (估计的)

2028年3月31日

研究注册日期

首次提交

2024年1月5日

首先提交符合 QC 标准的

2024年1月5日

首次发布 (实际的)

2024年1月17日

研究记录更新

最后更新发布 (实际的)

2026年11月3日

上次提交的符合 QC 标准的更新

2026年11月2日

最后验证

2026年11月1日

一项在接受抗 CD38 抗体和来那度胺治疗的复发性或难治性骨髓瘤受试者中比较他克他单抗加泊马度胺、他克他单抗加特克司他单抗和 Elotuzumab、泊马度胺和地塞米松或泊马度胺、硼替佐米和地塞米松的研究 (MonumenTAL-6)

研究概览

地位

条件

干预/治疗

研究类型

注册 (实际的)

阶段

联系人和位置

学习地点

参与标准

资格标准

适合学习的年龄

接受健康志愿者

有资格学习的性别

描述

学习计划

研究是如何设计的？

设计细节

手臂数量

武器和干预

参与者组/臂

干预/治疗

研究衡量的是什么？

主要结果指标

结果测量

措施说明

大体时间

次要结果测量

结果测量

措施说明

大体时间

合作者和调查者

赞助

调查人员

研究记录日期

研究主要日期

学习开始 (实际的)

初级完成 (实际的)

研究完成 (估计的)

研究注册日期

首次提交

首先提交符合 QC 标准的

首次发布 (实际的)

研究记录更新

最后更新发布 (实际的)

上次提交的符合 QC 标准的更新

最后验证

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

IPD 计划说明

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品