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一项比较JNJ-79635322与抗B细胞成熟抗原（BCMA）xCD3双特异性抗体在复发或难治性多发性骨髓瘤参与者中的研究 (TRIlogy-4)

2026年8月27日 更新者：Janssen Research & Development, LLC

一项3期随机研究，比较JNJ-79635322与抗BCMAxCD3双特异性抗体在复发或难治性多发性骨髓瘤参与者中的疗效，这些参与者既往接受过至少3线治疗，包括PI、IMiD和抗CD38抗体

本研究的目的是评估JNJ-79635322与抗B细胞成熟抗原（BCMA）xCD3双特异性抗体相比的疗效。

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)

400

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、100044
        • 招聘中
        • Peking University People's Hospital
      • Chengdu、中国、610032
        • 招聘中
        • Sichuan Provincial Peoples Hospital
      • Guangzhou、中国、510060
        • 招聘中
        • Sun Yat Sen University Cancer Center
      • Hangzhou、中国、310003
        • 招聘中
        • First affiliated Hospital of Zhejiang University
      • Nanjing、中国、210008
        • 招聘中
        • Nanjing Drum Tower Hospital
      • Nanning、中国、530021
        • 招聘中
        • The First Affiliated Hospital of Guangxi Medical University
      • Shanghai、中国、200434
        • 招聘中
        • Shanghai Fourth People s Hospital
      • Wenzhou、中国、325000
        • 招聘中
        • The First Affiliated Hospital of Wenzhou Medical University
      • Xi'an、中国、710006
        • 招聘中
        • The Second Affiliated Hospital of Xi'an Jiaotong University
  • 以色列
      • Beersheba、以色列、8457108
        • 招聘中
        • Soroka Medical Center
      • Haifa、以色列、3109601
        • 招聘中
        • Rambam Medical Center
      • Haifa、以色列、34362
        • 招聘中
        • Carmel Medical Center
      • Haifa、以色列、31048
        • 招聘中
        • Bnai Zion Medical Center
      • Jerusalem、以色列、9103102
        • 招聘中
        • Shaare Zedek Mc
      • Ramat Gan、以色列、52621
        • 招聘中
        • Sheba medical center
      • Ramat Poriya、以色列、1520800
        • 招聘中
        • Baruch Padeh MC
      • Tel Aviv、以色列、69710
        • 招聘中
        • Assuta MC
  • 加拿大
    • Alberta
      • Calgary、Alberta、加拿大、T2N 4N1
        • 招聘中
        • Arthur J E Child Comprehensive Cancer Centre
    • British Columbia
      • Vancouver、British Columbia、加拿大、V5Z4E6
        • 招聘中
        • British Columbia Cancer Agency
    • Nova Scotia
      • Halifax、Nova Scotia、加拿大、B3H 3A7
        • 招聘中
        • Queen Elizabeth Ii Health Sciences Centre
    • Ontario
      • Hamilton、Ontario、加拿大、L8V5C2
        • 招聘中
        • Juravinski Cancer Centre
      • London、Ontario、加拿大、N6A 5W9
        • 招聘中
        • London Health Sciences Centre
      • Toronto、Ontario、加拿大、M5G 2M9
        • 招聘中
        • University Health Network UHN Princess Margaret Cancer Centre
    • Quebec
      • Montreal、Quebec、加拿大、H1T 2M4
        • 招聘中
        • CIUSSS de l Est de l Ile de Montreal Installation Hopital Maisonneuve Rosemont
  • 巴西
      • Campinas、巴西、13083-888
        • 招聘中
        • Hospital das Clinicas da Universidade Estadual de Campinas UNICAMP
      • Caxias do Sul、巴西、95070 560
        • 招聘中
        • Fundacao Universidade de Caxias Do Sul
      • 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
      • Rio de Janeiro、巴西、22775 001
        • 招聘中
        • Instituto de Educacao, Pesquisa e Gestao em Saude Instituto Americas (COI)
      • Salvador、巴西、41253-190
        • 招聘中
        • IDOR - Regional Bahia
      • São José do Rio Preto、巴西、15090-000
        • 招聘中
        • Funfarme Sjrp
      • São Paulo、巴西、01509 900
        • 招聘中
        • Fundacao Antonio Prudente A C Camargo Cancer Center
      • São Paulo、巴西、05652 900
        • 招聘中
        • Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein
      • São Paulo、巴西、04537 081
        • 招聘中
        • Clinica Medica Sao Germano LTDA
      • São Paulo、巴西、01401 002
        • 招聘中
        • IDOR - Regional Sao Paulo
  • 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
      • Thessaloniki、希腊、570 10
        • 招聘中
        • Geniko Nosokomeio Thessalonikis George Papanikolaou
      • Thessaloniki、希腊、546 39
        • 招聘中
        • Theageneio Cancer Hospital
  • 德国
      • Düsseldorf、德国、40479
        • 招聘中
        • Marien Hospital Düsseldorf
      • Heidelberg、德国、69120
        • 招聘中
        • Universitaetsklinikum Heidelberg
      • Jena、德国、07747
        • 招聘中
        • Universitatsklinikum Jena
      • Würzburg、德国、97080
        • 招聘中
        • Universitaetsklinikum Wuerzburg
  • 意大利
      • Alessandria、意大利、15121
        • 招聘中
        • A.O.U. SS. Antonio e Biagio e Cesare Arrigo
      • Brescia、意大利、25123
        • 招聘中
        • Spedali Civili di Brescia
      • Milan、意大利、20122
        • 招聘中
        • Fondazione IRCCS Ca Granda Ospedale Policlinico Di Milano
      • Pisa、意大利、56126
        • 招聘中
        • Ospedale Santa Chiara AO Universitaria Pisana
      • Reggio Emilia、意大利、42123
        • 招聘中
        • Arcispedale Santa Maria Nuova - IRCCS
      • Roma、意大利、00168
        • 招聘中
        • Fondazione Policlinico Universitario A Gemelli IRCCS
      • Roma、意大利、00128
        • 招聘中
        • Campus Bio Medico di Roma
      • Rozzano、意大利、20089
        • 招聘中
        • Humanitas Hospital
      • San Giovanni Rotondo、意大利、71013
        • 招聘中
        • Casa Sollievo Della Sofferenza IRCCS
      • Vicenza、意大利、36100
        • 招聘中
        • U.O. Ematologia Ospedale San Bortolo
  • 挪威
      • Lorenskog、挪威、1478
        • 招聘中
        • Akershus universitetssykehus
      • Oslo、挪威、0450
        • 招聘中
        • Oslo University Hospital HF Ulleval sykehus
      • Stavanger、挪威、4021
        • 招聘中
        • Stavanger University Hospital Ullandhaug
      • Trondheim、挪威、7030
        • 招聘中
        • St. Olavs Hospital
  • 日本
      • Bunkyō City、日本、113 8677
        • 招聘中
        • Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital
      • Chiba、日本、260 0801
        • 招聘中
        • Chiba Cancer Center
      • Kamakura-shi、日本、247-8533
        • 招聘中
        • Shonan Kamakura General Hospital
      • Kamogawa、日本、296-8602
        • 招聘中
        • Kameda Medical Center
      • Kofu、日本、400-0027
        • 招聘中
        • Yamanashi Prefectural Central Hospital
      • Minato、日本、105-8471
        • 招聘中
        • The Jikei University Hospital
      • Shibuya City、日本、150-8935
        • 招聘中
        • Japanese Red Cross Medical Center
      • Yokohama、日本、241 8515
        • 招聘中
        • Kanagawa Cancer Center
  • 法国
      • Lille、法国、59000
        • 招聘中
        • CHRU de Lille Hopital Claude Huriez
      • Lyon、法国、69002
        • 招聘中
        • Hospices Civils de Lyon HCL
      • Nantes、法国、44000
        • 招聘中
        • Hotel Dieu CHU de Nantes
      • Paris、法国、75010
        • 招聘中
        • Hopital Saint Louis APHP
      • Paris、法国、75012
        • 招聘中
        • APHP
      • Pessac、法国、33600
        • 招聘中
        • CHU de Bordeaux - Hospital Haut-Leveque
      • Poitiers、法国、86021
        • 招聘中
        • CHU De Poitiers
      • Toulouse、法国、31300
        • 招聘中
        • CHU Toulouse
      • Tours、法国、37000
        • 招聘中
        • CHRU de Tours
  • 澳大利亚
      • Box Hill、澳大利亚、3128
        • 招聘中
        • Box Hill Hospital
      • Brisbane、澳大利亚、4101
        • 招聘中
        • Mater Misericordiae Ltd
      • Clayton、澳大利亚、3168
        • 招聘中
        • Monash Medical Centre
      • Fitzroy、澳大利亚、3065
        • 招聘中
        • St Vincents Hospital Melbourne
      • Melbourne、澳大利亚、3004
        • 招聘中
        • The Alfred Hospital
      • Murdoch、澳大利亚、6150
        • 招聘中
        • Fiona Stanley Hospital
      • Nedlands、澳大利亚、6009
        • 招聘中
        • Sir Charles Gairdner Hospital
      • Southport、澳大利亚、4215
        • 招聘中
        • Gold Coast University Hospital
  • 美国
    • Arizona
      • Phoenix、Arizona、美国、85054
        • 招聘中
        • Mayo Clinic Phoenix
    • Arkansas
      • Little Rock、Arkansas、美国、72205
        • 招聘中
        • UAMS
    • California
      • Duarte、California、美国、91010
        • 招聘中
        • City of Hope Duarte
      • Irvine、California、美国、92618
        • 招聘中
        • City of Hope Orange County Lennar Foundation Cancer Center
      • Los Angeles、California、美国、90033
        • 招聘中
        • USC Norris Comprehensive Cancer Center
      • San Francisco、California、美国、94122
        • 招聘中
        • University of California San Francisco
    • 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
      • New Haven、Connecticut、美国、06510
        • 招聘中
        • Yale Cancer Center
    • Florida
      • Fort Myers、Florida、美国、33901
        • 招聘中
        • Florida Cancer Specialists & Research Institute
      • Jacksonville、Florida、美国、32224
        • 招聘中
        • Mayo Clinic Jacksonville
      • Tampa、Florida、美国、33612
        • 招聘中
        • Moffit Cancer Center
    • Georgia
      • Atlanta、Georgia、美国、30322
        • 招聘中
        • Emory University
    • Illinois
      • Zion、Illinois、美国、60099
        • 招聘中
        • City of Hope Chicago
    • Iowa
      • Iowa City、Iowa、美国、52242
        • 招聘中
        • University of Iowa Hospital and Clinics
      • Waukee、Iowa、美国、50263
        • 招聘中
        • Mission Cancer Blood
    • Kansas
      • Kansas City、Kansas、美国、66160
        • 招聘中
        • University of Kansas Cancer Center
    • Kentucky
      • Louisville、Kentucky、美国、40207
        • 招聘中
        • Norton Cancer Institute
    • Maryland
      • Baltimore、Maryland、美国、21201
        • 招聘中
        • University of Maryland School of Medicine
    • Minnesota
      • Rochester、Minnesota、美国、55905
        • 招聘中
        • Mayo Clinic Rochester
    • New York
      • Brooklyn、New York、美国、11234
        • 招聘中
        • Mount Sinai Brooklyn
      • Mineola、New York、美国、11501
        • 招聘中
        • NYU Winthrop
      • New York、New York、美国、10065
        • 招聘中
        • Memorial Sloan Kettering Cancer Center
      • New York、New York、美国、10011
        • 招聘中
        • Mount Sinai Chelsea
      • New York、New York、美国、10029
        • 招聘中
        • Icahn School of Medicine at Mount Sinai
      • New York、New York、美国、10016
        • 招聘中
        • Laura and Isaac Perlmutter Cancer Center NYU ACC
    • North Carolina
      • Chapel Hill、North Carolina、美国、27514
        • 招聘中
        • University of North Carolina
      • Durham、North Carolina、美国、27705
        • 招聘中
        • Durham VAMC
    • Oregon
      • Portland、Oregon、美国、97239
        • 招聘中
        • Oregon Health and Science University
    • Pennsylvania
      • Philadelphia、Pennsylvania、美国、19107
        • 招聘中
        • Thomas Jefferson University Hospital
      • Philadelphia、Pennsylvania、美国、19111
        • 招聘中
        • Fox Chase Cancer Center
    • Tennessee
      • Nashville、Tennessee、美国、37232
        • 招聘中
        • Vanderbilt University Medical Center
      • Nashville、Tennessee、美国、37203
        • 招聘中
        • SCRI Oncology Partners
    • Texas
      • Austin、Texas、美国、78704
        • 招聘中
        • St. David's South Austin Medical Center
      • Dallas、Texas、美国、75390
        • 招聘中
        • UT Southwestern Medical Center
      • Dallas、Texas、美国、75246
        • 招聘中
        • Baylor University Medical Center
      • San Antonio、Texas、美国、78229
        • 招聘中
        • Texas Transplant Institute
    • Utah
      • Salt Lake City、Utah、美国、84112
        • 招聘中
        • Huntsman Cancer Institute
    • Wisconsin
      • Milwaukee、Wisconsin、美国、53226
        • 招聘中
        • Medical College of Wisconsin
  • 英国
      • Canterbury、英国、CT1 3NG
        • 招聘中
        • Kent and Canterbury Hospital
      • Cardiff、英国、CF14 4XW
        • 招聘中
        • Cardiff and Vale UHB - University Hospital of Wales
      • Dundee、英国、DD1 9SY
        • 招聘中
        • Ninewells Hospital & Medical School
      • London、英国、NW1 2PG
        • 招聘中
        • University College London Hospitals
      • Nottingham、英国、NG5 1PB
        • 招聘中
        • Nottingham City Hospital
      • Portsmouth、英国、PO6 3LY
        • 招聘中
        • Queen Alexandra Hospital
      • Sutton、英国、SM2 5PT
        • 招聘中
        • Royal Marsden Hospital
  • 荷兰
      • Amsterdam、荷兰、1081 HV
        • 招聘中
        • VU Medisch Centrum
      • Groningen、荷兰、9713 GZ
        • 招聘中
        • Universitair Medisch Centrum Groningen
      • Nieuwegein、荷兰、3435 CM
        • 招聘中
        • St. Antonius Ziekenhuis Nieuwegein
      • Nijmegen、荷兰、6525 GA
        • 招聘中
        • Radboud Umcn
      • Rotterdam、荷兰、3015
        • 招聘中
        • Erasmus MC
      • The Hague、荷兰、2545 AA
        • 招聘中
        • Haga Ziekenhuis
  • 西班牙
      • Badalona、西班牙、08916
        • 招聘中
        • Hosp. Univ. Germans Trias I Pujol
      • Barcelona、西班牙、08036
        • 招聘中
        • Hosp. Clinic de Barcelona
      • Barcelona、西班牙、08035
        • 招聘中
        • H. Vall D'Hebron
      • Granada、西班牙、18014
        • 招聘中
        • Hosp. Univ. Virgen de Las Nieves
      • Madrid、西班牙、28041
        • 招聘中
        • Hosp. Univ. 12 de Octubre
      • Pozuelo de Alarcón、西班牙、28223
        • 招聘中
        • Hosp. Quiron Madrid Pozuelo
      • Salamanca、西班牙、37007
        • 招聘中
        • Hosp Clinico Univ de Salamanca
      • Usansolo、西班牙、48960
        • 招聘中
        • Hosp de Galdakao
      • Valencia、西班牙、46026
        • 招聘中
        • Hosp. Univ. I Politecni La Fe

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

  • 成人
  • 年长者

接受健康志愿者

不

描述

纳入标准：

  • 根据以下标准确诊为多发性骨髓瘤（MM）：

    1. 根据国际骨髓瘤工作组（IMWG）诊断标准确诊为MM
    2. 经中心实验室评估，筛查时存在可测量病灶
  • 既往至少接受过3线抗骨髓瘤治疗，包括蛋白酶体抑制剂（PI）、免疫调节药物（IMiD）和抗分化簇（CD）38抗体
  • 根据研究者依据IMWG标准评估的疗效，有证据表明末次治疗后出现疾病进展（PD）或未达到缓解（即部分缓解[PR]或更好）
  • 已停止同时使用任何其他抗癌治疗（包括非姑息性放疗）或研究药物
  • 筛查时和研究治疗开始前即刻，东部肿瘤协作组（ECOG）体能状态评分为0至2分

排除标准：

  • 活动性感染性肝炎
  • 已知活动性或既往中枢神经系统（CNS）受累，或出现MM脑膜受累的临床症状
  • 疑似或已知对JNJ-79635322和Teclistamab的辅料过敏、超敏或不耐受
  • 筛查前2周内接受过大手术（例如需要全身麻醉），或手术未完全恢复，或在预期参与研究期间计划进行手术
  • 在研究治疗首次给药前4周内、研究治疗期间或末次给药后90天内，已接种或计划接种任何减毒活疫苗

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：JNJ-79635322
参与者将接受JNJ-79635322的皮下（SC）给药，直至疾病进展（PD）或出现不可耐受的毒性。
药品：JNJ-79635322
JNJ-79635322 将作为 SC 注射给药。
有源比较器：抗BCMAxCD3双特异性抗体
参与者将接受 teclistamab（一种抗 BCMAxCD3 双特异性抗体）的皮下注射，直至疾病进展或出现不可耐受的毒性。
药品：泰克司他单抗
Teclistamab 将作为 SC 注射给药。

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
Overall Response
大体时间：Up to 5 years and 7 months
Overall response is defined as having achieved partial response (PR) or better, according to the international myeloma working group (IMWG) response criteria, as assessed any time after first administration of study treatment, but prior to progression of disease (PD) or subsequent antimyeloma therapy.
Up to 5 years and 7 months
Progression-Free Survival (PFS)
大体时间：Up to 5 years and 7 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 5 years and 7 months

次要结果测量

结果测量
措施说明
大体时间
Very Good Partial Response (VGPR) or Better
大体时间：Up to 5 years and 7 months
VGPR or better is defined as achieving VGPR, complete response (CR), or stringent complete response (sCR) in accordance with the IMWG criteria during or after the study treatment but prior to subsequent antimyeloma therapy.
Up to 5 years and 7 months
Complete Response (CR) or Better
大体时间：Up to 5 years and 7 months
CR or better is defined as achieving CR or sCR in accordance with the IMWG criteria during or after the study treatment but prior to subsequent antimyeloma therapy.
Up to 5 years and 7 months
Duration of Response (DoR)
大体时间：Up to 5 years and 7 months
DoR is defined as the time interval between the date of initial documentation of a response (partial 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 5 years and 7 months
Minimal Residual Disease (MRD)-negative CR
大体时间：Up to 5 years and 7 months
MRD-negative CR is defined as the participants who achieve MRD-negative status, as determined by next-generation flow cytometry (NGF), at any time point after the date of randomization and prior to PD or subsequent antimyeloma therapy. Additionally, participants must achieve CR or better, according to IMWG response criteria at any time from the date of randomization and within 3 months after achieving MRD negative status, prior to PD or subsequent antimyeloma therapy.
Up to 5 years and 7 months
MRD-Negative CR at 12 months
大体时间：12 months
MRD-negative CR at 12 months is defined as the participants who achieve MRD-negative status at the analysis time window of 12 months (+/-3 months) from the date of randomization, as determined by NGF prior to PD or subsequent anti-myeloma therapy. Additionally, participants must also achieve CR or better, according to IMWG criteria at any time from the date of randomization up to and including 12 months (+/-3 months), prior to PD or subsequent antimyeloma therapy.
12 months
Sustained MRD-negative CR
大体时间：Up to 5 years and 7 months
Sustained MRD-negative CR is defined as participants who achieve MRD-negative CR status, as determined by NGF, for at least 12 months without any examination showing MRD-positive status and prior to PD or subsequent anti-myeloma therapy.
Up to 5 years and 7 months
Progression-Free Survival on the First Subsequent Line of Antimyeloma Therapy (PFS2)
大体时间：Up to 5 years and 7 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 5 years and 7 months
Overall Survival (OS)
大体时间：Up to 5 years and 7 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 5 years and 7 months
Time to Subsequent Anti-Myeloma Therapy
大体时间：Up to 5 years and 7 months
Time to subsequent anti-myeloma therapy 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 5 years and 7 months
Number of Participants With Treatment-Emergent Adverse Events (TEAE) by Severity
大体时间：Up to 5 years and 7 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. 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, whichever is earlier, or any follow-up AE with onset date and time beyond 30 days after the last dose of study treatment but prior to the start of subsequent therapy or any AE that is considered treatment-related regardless of the start date of the event is considered to be treatment-emergent. 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, to Grade 5= death related to adverse event.
Up to 5 years and 7 months
Number of Participants with Abnormalities in Clinical Laboratories Results
大体时间：Up to 5 years and 7 months
Number of participants with abnormalities in clinical laboratories results (serum chemistry and hematology) will be reported.
Up to 5 years and 7 months
Change from Baseline in Symptoms, Functioning, and Health-related Quality of Life (HRQoL) as Assessed by Multiple Myeloma Symptom and Impact Questionnaire (MySIm-Q) Score
大体时间：Baseline up to 5 years and 7 months
Change from baseline in symptoms, functioning, and health-related quality of life (HRQoL) as assessed by multiple myeloma symptom and impact questionnaire (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.
Baseline up to 5 years and 7 months
Change from Baseline in Symptoms, Functioning, and HRQoL as Assessed by European Organization for Research and Treatment of Cancer Quality of life Questionnaire Core 30 (EORTC-QLQ-C30) Score
大体时间：Baseline up to 5 years and 7 months
Change from baseline in symptoms, functioning, and HRQoL as assessed by european organization for research and treatment of cancer quality of life questionnaire core 30 (EORTC-QLQ-C30) score will be reported.
Baseline up to 5 years and 7 months
Change from Baseline in Symptoms, Functioning, and HRQoL as Assessed by European Quality of Life 5-Dimensions 5-Level Version (EQ-5D-5L) Score
大体时间：Baseline up to 5 years and 7 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.
Baseline up to 5 years and 7 months
Time to Worsening in Symptoms, Functioning, and HRQoL as Assessed by MySIm-Q Score
大体时间：Up to 5 years and 7 months
Time to worsening in symptoms, functioning, and HRQoL as assessed by MySIm-Q score will be reported. The MySIm-Q is a disease-specific PRO assessment with established content validity for participants with RRMM and newly diagnosed MM.
Up to 5 years and 7 months
Time to Worsening in Symptoms, Functioning, and HRQoL as Assessed by EORTC-QLQ-C30 Score
大体时间：Up to 5 years and 7 months
Time to worsening in symptoms, functioning, and HRQoL as assessed by EORTC-QLQ-C30 score will be reported.
Up to 5 years and 7 months
Time to Worsening in Symptoms, Functioning, and HRQoL as Assessed by EQ-5D-5L Score
大体时间：Up to 5 years and 7 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 5 years and 7 months
Percentage of Participants With Meaningful Improvement in Symptoms, Functioning, and HRQoL as Assessed by MySIm-Q Score
大体时间：Up to 5 years and 7 months
The MySIm-Q is a disease-specific PRO assessment with established content validity for participants with RRMM and newly diagnosed MM. It is included to be complementary to the EORTC-QLQ-C30. It includes 17 items resulting in a symptom subscale and an impact subscale. The recall period is the "past 7 days" and responses are reported on a 5-point verbal rating scale.
Up to 5 years and 7 months
Percentage of Participants With Meaningful Improvement in Symptoms, Functioning, and HRQoL as Assessed by EORTC-QLQ-C30 Score
大体时间：Up to 5 years and 7 months
Percentage of participants with meaningful improvement in symptoms, functioning, and HRQoL as assessed by EORTC-QLQ-C30 score will be reported.
Up to 5 years and 7 months
Percentage of Participants With Meaningful Improvement in Symptoms, Functioning, and HRQoL as Assessed by EQ-5D-5L Score
大体时间：Up to 5 years and 7 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 5 years and 7 months
Percentage of Participants With Side Effects Burden on the European Organization for Research and Treatment of Cancer Item List 46 (EORTC IL46)
大体时间：Up to 5 years and 7 months
Percentage of participants with side effects burden on the EORTC IL46 will be reported. The EORTC IL46 measures the global impression of burden due to treatment-related symptoms.
Up to 5 years and 7 months
Serum Concentrations for JNJ-79635322
大体时间：Up to 5 years and 7 months
Serum concentrations of JNJ-79635322 will be reported.
Up to 5 years and 7 months
Number of Participants With Anti-drug Antibodies (ADA) to JNJ-79635322
大体时间：Up to 5 years and 7 months
Serum samples will be analyzed for the detection of ADA to JNJ-79635322 using a validated assay method.
Up to 5 years and 7 months
Number of Participants With Neutralizing Antibodies (NAb) to JNJ-79635322
大体时间：Up to 5 years and 7 months
Number of participants who are ADA-positive will be assessed for the presence of NAbs.
Up to 5 years and 7 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。

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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2月4日

初级完成 (估计的)

2028年12月12日

研究完成 (估计的)

2031年9月30日

研究注册日期

首次提交

2025年11月21日

首先提交符合 QC 标准的

2025年11月21日

首次发布 (实际的)

2025年12月2日

研究记录更新

最后更新发布 (实际的)

2026年8月28日

上次提交的符合 QC 标准的更新

2026年8月27日

最后验证

2026年8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

  • 79635322MMY3001 (Janssen Research & Development, LLC)
  • 2025 (美国 NIH 拨款/合同：Faculty of Social Sciences Scientific Grant at the University of Gdańsk)
  • 2025-522007-18-00 (注册表标识符：EUCT number)

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

强生创新医药的数据共享政策可在innovativedicine.jnj.com/our-innovation/clinical-trials/transparency查阅。 如该网站所述，获取研究数据的请求可通过耶鲁开放数据获取（YODA）项目网站yoda.yale.edu提交。

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

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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