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一项比较JNJ-79635322和Teclistamab在复发或难治性多发性骨髓瘤参与者中的研究 (TRIlogy-5)

2026年9月24日 更新者：Janssen Research & Development, LLC

一项比较JNJ-79635322与Teclistamab在既往接受过1至3线治疗（包括抗CD38抗体和来那度胺）的复发或难治性多发性骨髓瘤患者中的3期随机研究

The purpose of this study is to evaluate how well JNJ-79635322 works when compared with teclistamab.

研究概览

地位

招聘中

条件

干预/治疗

研究类型

介入性

注册 (估计的)

700

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。

学习联系方式

学习地点

  • 中国
      • Beijing、中国、100034
        • 招聘中
        • Peking University First Hospital
      • Beijing、中国、100006
        • 招聘中
        • Peking Union Medical College Hospital
      • Changchun、中国、130061
        • 招聘中
        • The First Hospital of Jilin University
      • Chaoyang District、中国、100020
        • 招聘中
        • Beijing Chaoyang Hospital
      • Chengdu、中国、610072
        • 招聘中
        • Sichuan Academy of Medical Science Sichuan Provincial Peoples Hospital
      • Guangzhou、中国、510710
        • 招聘中
        • Sun Yat Sen University Cancer Center
      • Hangzhou、中国、310003
        • 招聘中
        • The First Affiliated Hospital Zhejiang University College of Medicine
      • Nanchang、中国、330006
        • 招聘中
        • The First Affiliated Hospital of NanChang University
      • Nanjing、中国、210008
        • 招聘中
        • Nanjing Drum Tower Hospital
      • Shanghai、中国、200434
        • 招聘中
        • Shanghai Fourth People s Hospital
      • Shenzhen、中国、518036
        • 招聘中
        • Peking University Shenzhen Hospital
      • Tianjin、中国、300060
        • 招聘中
        • Tianjin Medical University Cancer Institute and Hospital
      • Tijian、中国、300020
        • 招聘中
        • Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences
      • Wenzhou、中国、325000
        • 招聘中
        • The First Affiliated Hospital of Wenzhou Medical University
      • Wuhan、中国、430032
        • 招聘中
        • Wuhan Tongji Hospital Tongji Medical College
      • Xi'an、中国、710004
        • 招聘中
        • The Second Affiliated Hospital of Xi'an Jiaotong University
  • 以色列
      • Ashdod、以色列、7747629
        • 招聘中
        • Samson Assuta Ashdod University Hospital
      • Haifa、以色列、3436212
        • 招聘中
        • Carmel Medical Center
      • Haifa、以色列、3109601
        • 招聘中
        • Rambam Med.Center - Hematology Institute
      • Petah Tikva、以色列、4941492
        • 招聘中
        • Rabin Medical Center
      • Ramat Gan、以色列、5266202
        • 招聘中
        • Sheba Medical Center
      • Tel Aviv、以色列、6423906
        • 招聘中
        • Tel Aviv Sourasky Medical Center
  • 加拿大
    • Alberta
      • Calgary、Alberta、加拿大、T2N 5G2
        • 招聘中
        • Arthur J E Child Comprehensive Cancer Centre
      • Edmonton、Alberta、加拿大、T6G 1Z2
        • 招聘中
        • Cross Cancer Institute
    • Ontario
      • Oshawa、Ontario、加拿大、L1G-2B9
        • 招聘中
        • Lakeridge Health Oshawa
      • Toronto、Ontario、加拿大、M5G 2M9
        • 招聘中
        • Princess Margaret Hospital
  • 印度
      • Bengaluru、印度、560054
        • 招聘中
        • M S Ramaiah Medical College and Hospital
      • Gūrgaon、印度、122002
        • 招聘中
        • Fortis Memorial Research Institute
      • Jaipur、印度、302017
        • 招聘中
        • Bhagwan Mahaveer Cancer Hospital & Research Centre
      • Kolkata、印度、700156
        • 招聘中
        • Tata Medical Center
      • Kolkata、印度、700014
        • 招聘中
        • Nil Ratan Sircar Medical College and Hospital
      • New Delhi、印度、110085
        • 招聘中
        • Rajiv Gandhi Cancer Institute and Research Centre
      • Pune、印度、411004
        • 招聘中
        • Deenanath Mangeshkar Hospital and Research Centre
  • 台湾
      • Kaohsiung City、台湾、833
        • 招聘中
        • Chang Kung Memorial Hospital
      • Taichung、台湾、40705
        • 招聘中
        • Taichung Veterans General Hospital
      • Taichung、台湾、40447
        • 招聘中
        • China Medical University Hospital
      • Tainan、台湾、70403
        • 招聘中
        • National Cheng Kung University Hospital
      • Taipei、台湾、100
        • 招聘中
        • National Taiwan University Hospital
      • Taipei、台湾、112
        • 招聘中
        • Taipei Veterans General Hospital
  • 土耳其（türkiye）
      • Ankara、土耳其（türkiye）、06680
        • 招聘中
        • Liv Hospital Ankara
      • Ankara、土耳其（türkiye）、06010
        • 招聘中
        • Gulhane Egitim ve Arastirma Hastanesi
      • Ankara、土耳其（türkiye）、06200
        • 招聘中
        • Dr Abdurrahman Yurtaslan Oncology Training and Research Hospital
      • Ankara、土耳其（türkiye）、06620
        • 招聘中
        • Ankara University Medical Faculty
      • Ankara、土耳其（türkiye）、6170
        • 招聘中
        • Ankara Etlik Sehir Hastanesi
      • Antalya、土耳其（türkiye）、07025
        • 招聘中
        • Memorial Antalya Hospital
      • Istanbul、土耳其（türkiye）、34214
        • 招聘中
        • Medipol Mega University Hospital
      • Istanbul、土耳其（türkiye）、34381
        • 招聘中
        • Istanbul Florance Nightingale Hospital
      • Izmir、土耳其（türkiye）、35001
        • 招聘中
        • Izmir Tinaztepe University Galen Hospital
      • Mersin、土耳其（türkiye）、33110
        • 招聘中
        • Mersin University Medical Faculty
      • Samsun、土耳其（türkiye）、55420
        • 招聘中
        • Ondokuz Mayis University
  • 巴西
      • Brasília、巴西、70200 730
        • 招聘中
        • Sociedade Beneficente de Senhoras - Hospital Sirio Libanes HSL Unidade Brasilia
      • Curitiba、巴西、81520-060
        • 招聘中
        • Hospital Erasto Gaertner- Liga Paranaense de Combate ao Cancer
      • Florianópolis、巴西、88020 210
        • 招聘中
        • Grupo ELORA Centro de Pesquisa e Ensino em Saude de Santa Catarina
      • Joinville、巴西、89201-260
        • 招聘中
        • Instituto Joinvilense de Hematologia e Oncologia Ltda Centro de Hematologia e Oncologia
      • Porto Alegre、巴西、90050 170
        • 招聘中
        • Irmandade Santa Casa de Misericordia de Porto Alegre
      • Rio de Janeiro、巴西、22775-002
        • 招聘中
        • Instituto de Educacao, Pesquisa e Gestao em Saude Instituto Americas (COI)
      • São José do Rio Preto、巴西、15090-000
        • 招聘中
        • Funfarme Sjrp
      • São Paulo、巴西、01323 001
        • 招聘中
        • Real e Benemerita Associacao Portuguesa de Beneficencia
      • São Paulo、巴西、05651 901
        • 招聘中
        • Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein
      • São Paulo、巴西、04537 081
        • 招聘中
        • Clinica Medica Sao Germano LTDA
  • 希腊
      • Athens、希腊、11528
        • 招聘中
        • Alexandra General Hospital of Athens
      • Athens、希腊、106 76
        • 招聘中
        • Evangelismos S A
      • Athens、希腊、124 62
        • 招聘中
        • University General Hospital Attikon General Hospital Of West Attica H Agia Varvara
      • Ioannina、希腊、455 00Q
        • 招聘中
        • University General Hospital of Ioannina
  • 德国
      • Freiburg im Breisgau、德国、79106
        • 招聘中
        • Universitaetsklinikum Freiburg
      • Hamburg、德国、22763
        • 招聘中
        • Asklepios Klinik Altona
      • Hamburg、德国、20251
        • 招聘中
        • Universitaetsklinikum Hamburg Eppendorf
      • Tübingen、德国、72076
        • 招聘中
        • Universitaetsklinik Tuebingen
  • 意大利
      • Bari、意大利、70124
        • 招聘中
        • IRCCS Istituto Tumori Giovanni Paolo II
      • Bologna、意大利、40138
        • 招聘中
        • A O U Sant Orsola Malpighi
      • Bolzano、意大利、39100
        • 招聘中
        • Azienda Sanitaria dell'Alto Adige - Ospedale di Bolzano
      • Milan、意大利、20132
        • 招聘中
        • Ospedale San Raffaele di Milano
      • Milan、意大利、20153
        • 招聘中
        • ASST Santi Paolo e Carlo
      • Novara、意大利、28100
        • 招聘中
        • Azienda Ospedaliero Universitaria Maggiore della Carita di Novara
      • Palermo、意大利、90146
        • 招聘中
        • Casa di Cura La Maddalena
      • Pescara、意大利、65124
        • 招聘中
        • Ospedale S. Spirito, Azienda Sanitaria Pescara
      • Rimini、意大利、47900
        • 招聘中
        • Ospedale Infermi Rimini
      • Varese、意大利、21100
        • 招聘中
        • ASST dei Sette Laghi, Ospedale di Circolo e Fonazione Macchi
  • 捷克语
      • Brno、捷克语、625 00
        • 招聘中
        • Fakultni nemocnice Brno
      • Hradec Králové、捷克语、500 05
        • 招聘中
        • FN Hradec Kralove
      • Ostrava、捷克语、708 52
        • 招聘中
        • Fakultni Nemocnice Ostrava
      • Plzen-Lochotin、捷克语、323 00
        • 招聘中
        • FN Plzen
      • Prague、捷克语、128 08
        • 招聘中
        • VFN Praha
  • 日本
      • Chiba、日本、260-8717
        • 招聘中
        • Chiba Cancer Center
      • Fukuoka、日本、810 8563
        • 招聘中
        • National Hospital Organization Kyushu Medical Center
      • Gunma、日本、371-0034
        • 招聘中
        • Gunma University Hospital
      • Kamakura-shi、日本、247-8533
        • 招聘中
        • Shonan Kamakura General Hospital
      • Kyoto、日本、602-8566
        • 招聘中
        • University Hospital Kyoto Prefectural University of Medicine
      • Matsuyama、日本、790-8524
        • 招聘中
        • Matsuyama Red Cross Hospital
      • Okayama、日本、701-1192
        • 招聘中
        • National Hospital Organization Okayama Medical Center
      • Sapporo、日本、060-8604
        • 招聘中
        • Sapporo City General Hospital
      • Tokyo、日本、135-8550
        • 招聘中
        • The Cancer Institute Hospital of JFCR
      • Yokohama、日本、241 8515
        • 招聘中
        • Kanagawa Cancer Center
  • 法国
      • Amiens、法国、80000
        • 招聘中
        • CHU Amiens
      • Lyon、法国、69002
        • 招聘中
        • Hospices Civils de Lyon HCL
      • Montpellier、法国、34295
        • 招聘中
        • CHRU Montpellier - Hopital Saint-Eloi
      • Nantes、法国、44000
        • 招聘中
        • CHU Nantes - Hotel Dieu
      • Poitiers、法国、86021
        • 招聘中
        • CHU Poitiers - Hopital la Miletrie
      • Talence、法国、33400
        • 招聘中
        • CHU Bordeaux
      • Toulouse、法国、31300
        • 招聘中
        • CHU Toulouse
      • Tours、法国、37000
        • 招聘中
        • CHRU de Tours
  • 波兰
      • Bydgoszcz、波兰、85 168
        • 招聘中
        • Szpital Uniwersytecki nr 2 im dr Jana Biziela w Bydgoszczy
      • Gdansk、波兰、80 214
        • 招聘中
        • Uniwersyteckie Centrum Kliniczne
      • Katowice、波兰、40 519
        • 招聘中
        • Pratia Onkologia Katowice
      • Lublin、波兰、20 090
        • 招聘中
        • Centrum Onkologii Ziemi Lubelskiej im sw Jana z Dukli
      • Warsaw、波兰、02-172
        • 招聘中
        • MTZ Clinical Research Powered by Pratia
      • Wałbrzych、波兰、58 309
        • 招聘中
        • Specjalistyczny Szpital im dra Alfreda Sokolowskiego w Walbrzychu
  • 澳大利亚
      • Darlinghurst、澳大利亚、2010
        • 招聘中
        • St Vincent s Hospital Sydney
      • Garran、澳大利亚、2605
        • 招聘中
        • Canberra Hospital
      • Heidelberg、澳大利亚、3084
        • 招聘中
        • Austin Hospital
      • Macquarie University、澳大利亚、2109
        • 招聘中
        • Macquarie University Hospital
      • Melbourne、澳大利亚、3128
        • 招聘中
        • Box Hill Hospital
      • Perth、澳大利亚、6000
        • 招聘中
        • Royal Perth Hospital
      • Port Macquarie、澳大利亚、2444
        • 招聘中
        • Port Macquarie Base Hospital
  • 美国
    • Alabama
      • Birmingham、Alabama、美国、35211
        • 招聘中
        • Alabama Oncology
    • Arizona
      • Phoenix、Arizona、美国、85054
        • 招聘中
        • Mayo Clinic 1
    • Arkansas
      • Springdale、Arkansas、美国、72762
        • 招聘中
        • Highlands Oncology Group
    • California
      • Beverly Hills、California、美国、90211
        • 招聘中
        • Beverly Hills Cancer Center Clinical Research Advisors LLC
      • Irvine、California、美国、92612
        • 招聘中
        • UC Irvine Health Chao Family Comprehensive Cancer Center and Ambulatory Care
      • Los Angeles、California、美国、90067
        • 招聘中
        • Valkyrie Clinical Trials
      • Orange、California、美国、92868
        • 招聘中
        • University of California Irvine Medical Center
    • Colorado
      • Denver、Colorado、美国、80218
        • 招聘中
        • Colorado Blood Cancer Institute
    • Connecticut
      • Farmington、Connecticut、美国、06030
        • 招聘中
        • University of Connecticut Health Center
    • Florida
      • Jacksonville、Florida、美国、32224
        • 招聘中
        • Mayo Clinic Jacksonville
      • Pembroke Pines、Florida、美国、33026
        • 招聘中
        • Memorial Cancer Institute
    • Georgia
      • Atlanta、Georgia、美国、30322
        • 招聘中
        • Emory University
    • Illinois
      • Chicago、Illinois、美国、60607
        • 招聘中
        • Rush University System for Health
    • Indiana
      • Indianapolis、Indiana、美国、46237-8601
        • 招聘中
        • Franciscan Health
    • Iowa
      • Iowa City、Iowa、美国、52242
        • 招聘中
        • University of Iowa Hospitals and Clinics
      • Waukee、Iowa、美国、50263
        • 招聘中
        • Mission Cancer Blood University of Iowa Health Care
    • Kentucky
      • Louisville、Kentucky、美国、40207
        • 招聘中
        • Norton Cancer Institute
    • Louisiana
      • Shreveport、Louisiana、美国、71103
        • 招聘中
        • LSU Health Feist Weiller Cancer Center
    • Maryland
      • Baltimore、Maryland、美国、21287
        • 招聘中
        • Johns Hopkins Hospital
    • Massachusetts
      • Boston、Massachusetts、美国、02111
        • 招聘中
        • Tufts Medical Center
    • Michigan
      • Detroit、Michigan、美国、48201
        • 招聘中
        • Karmanos Cancer Institute
    • Minnesota
      • Minneapolis、Minnesota、美国、55455
        • 招聘中
        • University Of Minnesota Medical Center
      • Rochester、Minnesota、美国、55905
        • 招聘中
        • Mayo Clinic
    • Nebraska
      • Omaha、Nebraska、美国、68130
        • 招聘中
        • Nebraska Cancer Specialists
    • New Jersey
      • East Brunswick、New Jersey、美国、08816
        • 招聘中
        • Astera Cancer Care
    • New Mexico
      • Santa Fe、New Mexico、美国、87505
        • 招聘中
        • Christus St. Vincent Regional Cancer Center
    • New York
      • Albany、New York、美国、12208
        • 招聘中
        • New York Oncology Hematology
      • Mineola、New York、美国、11501
        • 招聘中
        • Laura & Isaac Perlmutter Cancer Center at NYU Langone Hospital - Long Island
      • New York、New York、美国、10016
        • 招聘中
        • NYU Langone Health Manhattan
      • Shirley、New York、美国、11967
        • 招聘中
        • New York Cancer and Blood Specialists
    • North Carolina
      • Durham、North Carolina、美国、27705
        • 招聘中
        • Duke University Medical Center
    • Ohio
      • Canton、Ohio、美国、44718
        • 招聘中
        • Gabrail Cancer Center
      • Cincinnati、Ohio、美国、45069
        • 招聘中
        • The Christ Hospital
      • Dayton、Ohio、美国、45415
        • 招聘中
        • Dayton Physicians Network Urology
    • Oregon
      • Eugene、Oregon、美国、97401
        • 招聘中
        • Willamette Valley Cancer Institute and Research Center
    • South Carolina
      • Greenville、South Carolina、美国、29607
        • 招聘中
        • Bon Secours Saint Francis Cancer Center
    • Tennessee
      • Nashville、Tennessee、美国、37203
        • 招聘中
        • Tennessee Oncology, PLLC
    • Texas
      • Dallas、Texas、美国、75246
        • 招聘中
        • Baylor University Medical Center
      • Lubbock、Texas、美国、79410
        • 招聘中
        • Joe Arrington Cancer Research Treatment Center
    • Utah
      • Salt Lake City、Utah、美国、84102
        • 招聘中
        • Utah Cancer Specialists
    • Washington
      • Tacoma、Washington、美国、98405
        • 招聘中
        • NorthWest Medical Specialties, PLLC
  • 西班牙
      • Barcelona、西班牙、08036
        • 招聘中
        • Hosp. Clinic de Barcelona
      • Barcelona、西班牙、08035
        • 招聘中
        • Hosp Univ Vall D Hebron
      • Cáceres、西班牙、10003
        • 招聘中
        • Hosp. San Pedro de Alcantara
      • Córdoba、西班牙、14004
        • 招聘中
        • Hosp Reina Sofia
      • Jerez de la Frontera、西班牙、11407
        • 招聘中
        • Hosp. de Jerez de La Frontera
      • Madrid、西班牙、28041
        • 招聘中
        • Hosp. Univ. 12 de Octubre
      • Pamplona、西班牙、31008
        • 招聘中
        • Clinica Univ. de Navarra
      • Salamanca、西班牙、37007
        • 招聘中
        • Hosp Clinico Univ de Salamanca
      • Santander、西班牙、39008
        • 招聘中
        • Hosp. Univ. Marques de Valdecilla
      • Santiago de Compostela、西班牙、15706
        • 招聘中
        • Hosp. Clinico Univ. de Santiago
      • Seville、西班牙、41013
        • 招聘中
        • Hosp. Virgen Del Rocio
  • 韩国
      • Goyang-si、韩国、10408
        • 招聘中
        • National Cancer Center
      • Gyeonggi-do、韩国、13620
        • 招聘中
        • Seoul National University Bundang Hospital
      • Hwasun、韩国、58128
        • 招聘中
        • Chonnam National University Hwasun Hospital
      • Seoul、韩国、05505
        • 招聘中
        • Asan Medical Center
      • Seoul、韩国、03080
        • 招聘中
        • Seoul National University Hospital
      • Seoul、韩国、06351
        • 招聘中
        • Samsung Medical Center
      • Seoul、韩国、06591
        • 招聘中
        • The Catholic University of Korea Seoul St Marys 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 diagnosis of multiple myeloma (MM) as defined by the criteria below: a. MM diagnosis according to the international myeloma working group (IMWG) diagnostic criteria, b. Measurable disease at screening as assessed by central laboratory
  • Received 1 to 3 prior lines of antimyeloma therapy, including an anti-cluster of differentiation (CD) 38 antibody and lenalidomide
  • Have an eastern cooperative oncology group (ECOG) performance status of 0 to 2 at screening and immediately before the first dose of study medication
  • Have clinical laboratory values meeting the criteria specified in the protocol during the screening and within 1 day of the start of administration of study treatment

Exclusion criteria:

  • Major surgery, (for example, requiring general anesthesia) or significant traumatic injury within 2 weeks prior to first dose, or will not have fully recovered from surgery, or has surgery planned during the time the participant is expected to participate in the study
  • Suspected or known allergies, hypersensitivity, intolerance or other contraindications to the use of JNJ-79635322 or teclistamab or their excipients
  • Presence of any of the following: i. Any ongoing myelodysplastic syndrome or B-cell malignancy (other than MM); ii. Any history of malignancy, other than MM, that is considered at high risk of recurrence requiring systemic therapy; iii. Any active malignancy (that is, progressing or requiring treatment change in the last 24 months) other than MM
  • Known active or prior central nervous system (CNS) involvement or exhibits clinical signs of meningeal involvement of MM. 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）

武器和干预

参与者组/臂
干预/治疗
实验性的：Arm A: JNJ-79635322

Participants will receive subcutaneous (SC) dose of JNJ-79635322 treatment of a finite duration or intolerable toxicity (whichever is first).
药品：JNJ-79635322

JNJ-79635322 will be administered as SC injection.
有源比较器：Arm B: Teclistamab

Participants will receive teclistamab as a SC injection until PD or intolerable toxicity.
药品：Teclistamab

Teclistamab will be administered as SC injection.

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
Complete Response (CR) or Better
大体时间：Up to approximately 41 months

CR or better is defined as the percentage of participants achieving CR or stringent complete response (sCR) prior to subsequent antimyeloma therapy in accordance with the international myeloma working group (IMWG) criteria during or after the study treatment.
Up to approximately 41 months
Progression-Free Survival (PFS)
大体时间：Up to approximately 41 months

PFS is defined as the duration from the date of randomization to either progressive disease (PD) or death, whichever comes first. Disease progression will be determined according to the IMWG response criteria.
Up to approximately 41 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 approximately 41 months

ORR is defined as the percentage of participants who achieve partial response (PR) or better prior to subsequent antimyeloma therapy in accordance with the IMWG criteria.
Up to approximately 41 months
Very Good Partial Response (VGPR) or Better
大体时间：Up to approximately 41 months

VGPR or better is defined as the percentage of participants achieving VGPR, CR, or sCR prior to subsequent antimyeloma therapy in accordance with the IMWG criteria during or after the study treatment.
Up to approximately 41 months
Duration of Response (DoR)
大体时间：Up to approximately 41 months

DoR is defined as the time interval between the date of initial documentation of a response (PR or better) to the date of first documented evidence of progressive disease according to the IMWG response criteria or death due to any cause, whichever occurs first.
Up to approximately 41 months
Minimal Residual Disease (MRD)-negative CR
大体时间：Up to approximately 41 months

MRD-negative CR is defined as the percentage of participants with CR or better who achieve MRD-negative status, as determined by next-generation flow cytometry (NGF), at any time point after randomization and prior to PD or subsequent antimyeloma therapy.
Up to approximately 41 months
MRD-negative CR at 1 Year
大体时间：At 1 Year

MRD-negative CR at 1 year is defined as the percentage of participants who achieve MRD-negative status at 12 months as determined by NGF, prior to PD or subsequent antimyeloma therapy and who also achieve CR or better according to IMWG criteria.
At 1 Year
MRD-negative CR at 5 Years
大体时间：At 5 Years

MRD-negative CR at 5 years is defined as the percentage of participants who achieve MRD-negative status at 5 years as determined by NGF, prior to PD or subsequent antimyeloma therapy and who also achieve CR or better according to IMWG criteria.
At 5 Years
Progression-Free Survival on the First Subsequent Line of Antimyeloma Therapy (PFS2)
大体时间：Up to approximately 41 months

PFS2 is defined as the time interval between the date of randomization and date of event, which is defined as progressive disease as assessed by investigator on the first subsequent line of antimyeloma therapy, or death from any cause, whichever occurs first. Those who are alive and for whom a second disease progression has not been observed are censored at the last date of follow-up.
Up to approximately 41 months
Overall Survival (OS)
大体时间：Up to approximately 41 months

OS is defined as the time from the date of randomization to the date of the participant's death due to any cause.
Up to approximately 41 months
Time To Next Line of Therapy (TTNT)
大体时间：Up to approximately 41 months

TTNT is defined as the time from randomization to the start of subsequent antimyeloma treatment. Death due to progressive disease without the start of any subsequent antimyeloma therapy will be considered as an event.
Up to approximately 41 months
Number of Participants With Treatment-Emergent Adverse Event (TEAE) by Severity
大体时间：Up to approximately 41 months

An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non investigational) product. Any new or worsening AE occurring at or after the initial administration of study treatment through the day of last dose plus 30 days or prior to the start of subsequent anticancer therapy will be considered treatment-related regardless of the start date of the event. TEAEs will be graded according to the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 6.0. Severity scale ranges from Grade 1= mild, Grade 2= moderate, Grade 3= severe, Grade 4= life-threatening, Grade 5= death related to adverse event.
Up to approximately 41 months
Number of Participants with Abnormalities in Laboratory Parameters
大体时间：Up to approximately 41 months

Number of participants with abnormalities in laboratory parameters (serum chemistry, hematology, and urinalysis) will be reported.
Up to approximately 41 months
Change from Baseline in Health-related Quality of Life (HRQoL), Symptoms and Functioning using the Multiple Myeloma Symptom and Impact Questionnaire (MySIm-Q) Scale Scores
大体时间：From Baseline up to approximately 41 months

Change from baseline in HRQoL, symptoms and functioning as assessed by MySIm-Q score will be reported. The MySIm-Q is a disease-specific patient-reported outcome (PRO) assessment with established content validity for participants with relapsed or refractory multiple myeloma (RRMM) and newly diagnosed MM.
From Baseline up to approximately 41 months
Change from Baseline in HRQoL, Symptoms and Functioning Using the European Organization for Research and Treatment of Cancer Quality of life Questionnaire Core 30 (EORTC-QLQ-C30) Scale Scores
大体时间：From Baseline up to approximately 41 months

Change from baseline in symptoms, functioning, and HRQoL as assessed by EORTC-QLQ-C30 score will be reported.
From Baseline up to approximately 41 months
Change from Baseline in HRQoL, Symptoms and Functioning Using the European Quality of Life 5-Dimensions 5-Level Version (EQ-5D-5L) Scale Scores
大体时间：From Baseline up to approximately 41 months

The EQ-5D-5L is a generic measure of health status that contains 5-item questionnaire that assesses 5 domains (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). The scores for the 5 dimensions are used to compute a single utility score, ranging from zero (0.0) to 1 (1.0), representing the general health status of the individual.
From Baseline up to approximately 41 months
Time to Worsening in HRQoL, Symptoms and Functioning Using the MySIm-Q Scale Scores
大体时间：Up to approximately 41 months

Time to worsening in HRQoL, symptoms and functioning using the MySIm-Q scale scores will be reported. The MySIm-Q is a disease-specific patient-reported outcome (PRO) assessment with established content validity for participants with RRMM and newly diagnosed MM.
Up to approximately 41 months
Time to Worsening in HRQoL, Symptoms and Functioning Using the EORTC-QLQ-C30 Scale Scores
大体时间：Up to approximately 41 months

Time to worsening in HRQoL, symptoms and functioning using the EORTC-QLQ-C30 score will be reported.
Up to approximately 41 months
Time to Worsening in HRQoL, Symptoms and Functioning using the EQ-5D-5L Scale Scores
大体时间：Up to approximately 41 months

The EQ-5D-5L is a generic measure of health status that contains 5-item questionnaire that assesses 5 domains (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). The scores for the 5 dimensions are used to compute a single utility score, ranging from zero (0.0) to 1 (1.0), representing the general health status of the individual.
Up to approximately 41 months
Percentage of Participants With Meaningful Improvement in HRQoL, Symptoms and Functioning Using the MySIm-Q Scale Scores
大体时间：Up to approximately 41 months

The MySIm-Q is a disease-specific PRO assessment with established content validity for participants with RRMM and newly diagnosed MM.
Up to approximately 41 months
Percentage of Participants With Meaningful Improvement in HRQoL, Symptoms and Functioning Using the EORTC-QLQ-C30 Scale Scores
大体时间：Up to approximately 41 months

Percentage of participants with meaningful improvement in symptoms, functioning, and HRQoL as assessed by EORTC-QLQ-C30 score will be reported.
Up to approximately 41 months
Percentage of Participants With Meaningful Improvement in HRQoL, Symptoms and Functioning Using the EQ-5D-5L Scale Scores
大体时间：Up to approximately 41 months

The EQ-5D-5L is a generic measure of health status that contains 5-item questionnaire that assesses 5 domains (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). The scores for the 5 dimensions are used to compute a single utility score, ranging from zero (0.0) to 1 (1.0), representing the general health status of the individual.
Up to approximately 41 months
Percentage of Participants who Report Side Effects Burden on the European Organization for Research and Treatment of Cancer Item List (EORTC IL) 46
大体时间：Up to approximately 41 months

The EORTC IL46 consists of one single question that measures global impression of burden due to treatment-related symptoms. The response options range from "not at all" to "very much" on a 4-point scale.
Up to approximately 41 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)

2026年5月31日

初级完成 (估计的)

2029年4月29日

研究完成 (估计的)

2032年12月8日

研究注册日期

首次提交

2026年4月1日

首先提交符合 QC 标准的

2026年4月1日

首次发布 (实际的)

2026年4月8日

研究记录更新

最后更新发布 (实际的)

2026年9月25日

上次提交的符合 QC 标准的更新

2026年9月24日

最后验证

2026年9月1日

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

  • 79635322MMY3002

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

The data sharing policy of Johnson & Johnson Innovative Medicine is available at 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

药物和器械信息、研究文件

研究美国 FDA 监管的药品

是的

研究美国 FDA 监管的设备产品

不

在美国制造并从美国出口的产品

是的

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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