此页面是自动翻译的，不保证翻译的准确性。请参阅 英文版 对于源文本。

Talquetamab 在复发或难治性多发性骨髓瘤患者中的研究 (MonumenTAL-1)

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

Talquetamab（一种人源化 GPRC5D x CD3 双特异性抗体）在复发或难治性多发性骨髓瘤受试者中的 1/2 期、首次人体、开放标签、剂量递增研究

The purpose of this study is to evaluate the efficacy and safety of talquetamab in participants with relapsed or refractory multiple myeloma at the recommended Phase 2 dose(s) (RP2Ds) (Part 3).

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)

510

阶段

  • 阶段2

扩展访问

得到正式认可的 出售给公众。 查看扩展访问记录。

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、100191
        • 完全的
        • Peking University Third Hospital
      • Guangzhou、中国、510060
        • 主动，不招人
        • Sun Yat Sen University Cancer Center
      • Hangzhou、中国、310003
        • 主动，不招人
        • The 1St Affiliated Hospital of Medical College Zhejiang University
      • Hangzhou、中国、310003
        • 主动，不招人
        • The 1st Affiliated Hospital Of Medical College Zhejiang University 1
      • Suzhou、中国、215006
        • 主动，不招人
        • First Affiliated Hospital SooChow University
      • Tianjin、中国、300320
        • 主动，不招人
        • Institute of Hematology & Blood Disease Hospital Chinese Academy of Medical Science
      • Xi'an、中国、710004
        • 完全的
        • The Second Affiliated Hospital of Xi'an Jiaotong University
      • Xi'an、中国、710063
        • 完全的
        • The First Affiliated Hospital of Xian Jiaotong University
  • 以色列
      • Haifa、以色列、31096
        • 主动，不招人
        • Rambam Medical Center
      • Haifa、以色列、3436212
        • 主动，不招人
        • Carmel Medical Center
      • Jerusalem、以色列、91120
        • 主动，不招人
        • Hadassah Medical Center
      • Ramat Gan、以色列、52621
        • 主动，不招人
        • Sheba Medical Center
      • Tel Aviv、以色列、64239
        • 主动，不招人
        • Tel Aviv Sourasky Medical Center
  • 德国
      • Berlin、德国、12203
        • 主动，不招人
        • Charite Campus Benjamin Franklin
      • Heidelberg、德国、69120
        • 主动，不招人
        • Universitaetsklinikum Heidelberg
      • Münster、德国、48149
        • 完全的
        • Universitaetsklinikum Muenster
      • Würzburg、德国、97080
        • 主动，不招人
        • Universitatsklinikum Wurzburg
  • 日本
      • Chiba、日本、296-8602
        • 完全的
        • Kameda Medical Center
      • Fukuoka、日本、814-0180
        • 完全的
        • Fukuoka University Hospital
      • Gifu、日本、503-8502
        • 完全的
        • Ogaki Municipal Hospital
      • Hokkaido、日本、006-8555
        • 完全的
        • Teine Keijinkai Hospital
      • Kobe、日本、650 0047
        • 完全的
        • Kobe City Medical Center General Hospital
      • Koshigaya、日本、343-8555
        • 完全的
        • Dokkyo Medical University Saitama Medical Center
      • Kumamoto、日本、860-8556
        • 完全的
        • Kumamoto University Hospital
      • Kurashiki、日本、710-8602
        • 完全的
        • Kurashiki Central Hospital
      • Matsumoto、日本、399-8701
        • 完全的
        • National Hospital Organization Matsumoto Medical Center
      • Okayama、日本、701-1192
        • 完全的
        • National Hospital Organization Okayama Medical Center
      • Osaka、日本、543 8555
        • 完全的
        • Japanese Red Cross Osaka Hospital
      • Shiwa-gun、日本、028-3695
        • 完全的
        • Iwate Medical University Hospital
      • Ōtake、日本、739-0696
        • 主动，不招人
        • National Hospital Organization Hiroshima-Nishi Medical Center
  • 比利时
      • Edegem、比利时、2650
        • 完全的
        • UZ Antwerpen
      • Leuven、比利时、3000
        • 主动，不招人
        • UZ Leuven
      • Liège、比利时、4000
        • 主动，不招人
        • CHU de Liège - Domaine Universitaire du Sart Tilman
      • Woluwe-Saint-Lambert、比利时、1200
        • 完全的
        • UCL - Saint Luc
  • 法国
      • Créteil、法国、94000
        • 主动，不招人
        • CHU Henri Mondor
      • Lyon、法国、69002
        • 主动，不招人
        • Hospices Civils de Lyon HCL
      • Montpellier、法国、34295
        • 主动，不招人
        • CHU de Montpellier Hopital Saint Eloi
      • Nantes、法国、44093
        • 主动，不招人
        • C.H.U. Hotel Dieu - France
      • Pessac、法国、33604
        • 主动，不招人
        • CHU de Bordeaux - Hospital Haut-Leveque
      • Toulouse、法国、31059
        • 主动，不招人
        • Pôle IUC Oncopole CHU
  • 波兰
      • Gdansk、波兰、80 214
        • 主动，不招人
        • Uniwersyteckie Centrum Kliniczne
      • Gliwice、波兰、44102
        • 完全的
        • Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut BadawczyOddz w Gliwicach
      • Poznan、波兰、60-569
        • 主动，不招人
        • Uniwersytecki Szpital Kliniczny w Poznaniu
      • Warsaw、波兰、02-781
        • 完全的
        • Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy
      • Wroclaw、波兰、50 367
        • 主动，不招人
        • Uniwersytecki Szpital Kliniczny im Jana Mikulicza Radeckiego we Wroclawiu
  • 美国
    • Alabama
      • Birmingham、Alabama、美国、35294
        • 招聘中
        • University of Alabama Birmingham
    • Arkansas
      • Little Rock、Arkansas、美国、72205
        • 招聘中
        • University of Arkansas for Medical Sciences
    • California
      • Duarte、California、美国、91010
        • 完全的
        • City of Hope
    • Florida
      • Hollywood、Florida、美国、33021
        • 招聘中
        • Memorial Healthcare System
    • Georgia
      • Atlanta、Georgia、美国、30322
        • 招聘中
        • Emory University Winship Cancer Institute
    • Illinois
      • Chicago、Illinois、美国、60637
        • 完全的
        • University of Chicago
    • Kentucky
      • Louisville、Kentucky、美国、40207
        • 招聘中
        • Norton Cancer Institute
    • Michigan
      • Ann Arbor、Michigan、美国、48109
        • 招聘中
        • University of Michigan Health System
    • Missouri
      • St Louis、Missouri、美国、63110
        • 招聘中
        • Washington University School Of Medicine
    • New York
      • New York、New York、美国、10023
        • 招聘中
        • Mount Sinai Medical Center
      • New York、New York、美国、10016
        • 主动，不招人
        • NYU Langone Health
      • Rochester、New York、美国、14642
        • 招聘中
        • University of Rochester Medical Center
    • Oregon
      • Portland、Oregon、美国、97213
        • 完全的
        • Providence Portland Medical Center
    • Tennessee
      • Nashville、Tennessee、美国、37203
        • 完全的
        • Tennessee Oncology
  • 荷兰
      • Amsterdam、荷兰、1081 HV
        • 完全的
        • VU Medisch Centrum
      • Utrecht、荷兰、3584 CX
        • 完全的
        • UMCU
  • 西班牙
      • Badalona、西班牙、08916
        • 完全的
        • Hosp. Univ. Germans Trias I Pujol
      • Barcelona、西班牙、8908
        • 主动，不招人
        • Inst. Cat. Doncologia-H Duran I Reynals
      • Barcelona、西班牙、08035
        • 招聘中
        • Hosp Univ Vall D Hebron
      • Madrid、西班牙、28041
        • 完全的
        • Hosp. Univ. 12 de Octubre
      • Madrid、西班牙、28040
        • 完全的
        • Hosp Univ Fund Jimenez Diaz
      • Murcia、西班牙、30120
        • 主动，不招人
        • Hosp. Univ. Virgen de La Arrixaca
      • Pamplona、西班牙、31008
        • 招聘中
        • Clinica Univ. de Navarra
      • Pozuelo de Alarcón、西班牙、28223
        • 完全的
        • Hosp. Quiron Madrid Pozuelo
      • 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
      • Seville、西班牙、41013
        • 招聘中
        • Hosp. Virgen Del Rocio
  • 韩国
      • Jeollanam-do、韩国、58128
        • 完全的
        • Chonnam National University Hwasun Hospital
      • Seoul、韩国、06351
        • 完全的
        • Samsung Medical Center
      • Seoul、韩国、05505
        • 完全的
        • Asan Medical Center
      • Seoul、韩国、03080
        • 完全的
        • Seoul National University Hospital
      • Seoul、韩国、03722
        • 完全的
        • Severance Hospital Yonsei University Health System
      • Seoul、韩国、06591
        • 完全的
        • 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 initial diagnosis of multiple myeloma according to international myeloma working group (IMWG) diagnostic criteria
  • Part 3: Measurable disease cohort A, cohort B, cohort C and cohort D: multiple myeloma must be measurable by central laboratory assessment; Cohort E: Multiple myeloma must be measurable by local laboratory assessment
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2
  • Women of childbearing potential must have a negative pregnancy test at screening and prior to the first dose of study drug using a highly sensitive pregnancy test either serum (beta human chorionic gonadotropin [hCG]) or urine
  • Willing and able to adhere to the prohibitions and restrictions specified in this protocol

Exclusion Criteria:

  • Part 3 only: Cohort A and Cohort C only: exposed to a CAR-T or T cell redirection therapy at any time. Cohort B, Cohort D and Cohort E: T cell redirection therapy within 3 months
  • Toxicities from previous anticancer therapies should have resolved to baseline levels or to Grade 1 or less except for alopecia or peripheral neuropathy
  • Received a cumulative dose of corticosteroids equivalent to >= 140 milligram (mg) of prednisone within the 14-day period before the first dose of study drug (does not include pretreatment medication)
  • Stroke or seizure within 6 months prior to signing the informed consent form (ICF)

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：非随机化
  • 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：Part 3: Cohort A (Talquetamab)

Cohort A will enroll participants with multiple myeloma who have previously received greater than or equal to (>=) 3 prior lines of therapy and have not been exposed to T cell redirection therapies. Participants will receive talquetamab subcutaneously (SC) at a recommended Phase 2 dose (RP2D) selected after review of safety, efficacy, PK, and pharmacodynamic data from Part 1 and Part 2 of this study. All participants (ongoing and those who are in follow-up) will transition to open-label extension (OLE) phase and will continue to receive the study treatment. Upon approval of amendment 19 and notification from the sponsor, participants will transition to the long-term extension (LTE) and will continue to receive study treatment.
药品：Talquetamab

Talquetamab will be administered SC until disease progression.

其他名称：
  • JNJ-64407564
实验性的：Part 3: Cohort B (Talquetamab)

Cohort B will enroll participants with multiple myeloma who have previously received >= 3 prior lines of therapy and have been exposed to T cell redirection therapies. Participants will receive talquetamab subcutaneously (SC) at a recommended Phase 2 dose (RP2D) selected after review of safety, efficacy, PK, and pharmacodynamic data from Part 1 and Part 2 of this study. All participants (ongoing and those who are in follow-up) will transition to OLE phase and will continue to receive the study treatment. Upon approval of amendment 19 and notification from the sponsor, participants will transition to the LTE and will continue to receive study treatment.
药品：Talquetamab

Talquetamab will be administered SC until disease progression.

其他名称：
  • JNJ-64407564
实验性的：Part 3: Cohort C (Talquetamab)

Cohort C will enroll participants with multiple myeloma who have previously received >= 3 prior lines of therapy and have not been exposed to T cell redirection therapies. Participants will receive talquetamab SC biweekly at a RP2D selected after review of safety, efficacy, PK, and pharmacodynamic data from Part 1 and Part 2 of this study. All participants (ongoing and those who are in follow-up) will transition to OLE phase and will continue to receive the study treatment. Upon approval of amendment 19 and notification from the sponsor, participants will transition to the LTE and will continue to receive study treatment.
药品：Talquetamab

Talquetamab will be administered SC until disease progression.

其他名称：
  • JNJ-64407564
实验性的：Part 3: Cohort D (Talquetamab)

Cohort D will enroll participants with multiple myeloma who have previously received >= 3 prior lines of therapy. Participants will receive talquetamab SC biweekly at a RP2D selected after review of safety, efficacy, PK, and pharmacodynamic data from Part 1 and Part 2 of this study. Participants in this cohort will receive tocilizumab prophylaxis for cytokine release syndrome (CRS) including all outpatient dosing. Participants will transition to OLE upon communication by the sponsor. Upon approval of amendment 19 and notification from the sponsor, participants will transition to the LTE and will continue to receive study treatment.
药品：Talquetamab

Talquetamab will be administered SC until disease progression.

其他名称：
  • JNJ-64407564
实验性的：Part 3: Cohort E (Talquetamab)

Cohort E will enroll participants with multiple myeloma who have previously received at least 1 proteasome inhibitor (PI), 1 immunomodulatory imide drug (IMiD), and 1 anti-cluster of differentiation 38 (CD38) monoclonal antibody.

Participants will receive talquetamab SC biweekly at a RP2D selected after review of safety, efficacy, PK, and pharmacodynamic data from Part 1 and Part 2 of this study. Participants will receive tocilizumab prophylaxis for CRS with consolidated priming dose schedules as well as possible transition to outpatient priming dosing transition to OLE upon communication by the sponsor. Upon approval of amendment 19 and notification from the sponsor, participants will transition to the LTE and will continue to receive study treatment.
药品：Talquetamab

Talquetamab will be administered SC until disease progression.

其他名称：
  • JNJ-64407564

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 Rate (ORR)
大体时间：Up to 2 years and 10 months

ORR is defined as the proportion of participants who have a partial response (PR) or better according to the international myeloma working group (IMWG) criteria.
Up to 2 years and 10 months

次要结果测量

结果测量
措施说明
大体时间
Duration of Response (DOR)
大体时间：Up to 2 years and 10 months

DOR is defined as time from date of initial documentation of a response (PR or better) to date of first documented evidence of progressive disease (PD), per IMWG criteria, or death due to PD, whichever occurs first.
Up to 2 years and 10 months
Very Good Partial Response (VGPR) or Better Rate
大体时间：Up to 2 years and 10 months

VGPR or better rate is defined as the percentage of patients who achieve a VGPR or better according to IMWG response criteria.
Up to 2 years and 10 months
Complete Response (CR) or Better Rate
大体时间：Up to 2 years and 10 months

CR or better rate is defined as the percentage of patients who achieve CR or better according to IMWG response criteria.
Up to 2 years and 10 months
Stringent Complete Response (sCR) Rate
大体时间：Up to 2 years and 10 months

sCR rate is defined as the percentage of patients who achieve sCR according to IMWG response criteria.
Up to 2 years and 10 months
Time to Response (TTR)
大体时间：Up to 2 years and 10 months

TTR is defined as the time between date of first dose of study drug and the first efficacy evaluation that the participant has met all criteria for PR or better.
Up to 2 years and 10 months
Progression-Free Survival (PFS)
大体时间：Up to 2 years and 10 months

PFS is defined as time from date of first dose of study drug to date of first documented PD, per IMWG criteria, or death due to any cause, whichever occurs first.
Up to 2 years and 10 months
Overall Survival (OS)
大体时间：Up to 2 years and 10 months

OS is defined as the time from the date of first dose of study drug to the date of the participant's death.
Up to 2 years and 10 months
Minimal Residual Disease (MRD) Negative Rate
大体时间：Up to 2 years and 10 months

MRD negativity rate is measured only for participants who achieve at least a CR but is reported based on all treated similar to the other response data.
Up to 2 years and 10 months
Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability
大体时间：Up to 2 years and 10 months

An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.
Up to 2 years and 10 months
Number of Participants with Serious Adverse Events (SAEs) as a Measure of Safety and Tolerability
大体时间：Up to 2 years and 10 months

An SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening, is a congenital anomaly/birth defect and may jeopardize participant and/or may require medical or surgical intervention to prevent one of the outcomes listed above.
Up to 2 years and 10 months
Number of Participants with AEs by Severity
大体时间：Up to 2 years and 10 months

Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE). Severity scale ranges from Grade 1 (Mild) to Grade 5 (Death). Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening, and Grade 5= Death related to adverse event.
Up to 2 years and 10 months
Number of Participants with Abnormalities in Clinical Laboratory Values
大体时间：Up to 2 years and 10 months

Number of participants with abnormalities in clinical laboratory values (such as hematology, serum chemistry and coagulation) will be reported.
Up to 2 years and 10 months
Serum Concentration of Talquetamab
大体时间：Up to 2 years and 10 months

Serum samples will be analyzed to determine concentrations of talquetamab.
Up to 2 years and 10 months
Number of Participants with Talquetamab Antibodies
大体时间：Up to 2 years and 10 months

Antibodies to talquetamab will be assessed to evaluate potential immunogenicity.
Up to 2 years and 10 months
Change from Baseline in Health-Related Quality of Life (HRQoL) as Assessed by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 item (EORTC QLQ-C30)
大体时间：Baseline up to 2 years and 10 months

The EORTC- QLQ-Core-30 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/vomiting), and 6 single symptom items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). The recall period is 1 week ("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 higher score represents greater HRQoL, better functioning, and more (worse) symptoms.
Baseline up to 2 years and 10 months
Change from Baseline in HRQoL as Assessed by EuroQol Five Dimension Five Level Questionnaire (EQ-5D-5L)
大体时间：Baseline up to 2 years and 10 months

The EQ-5D-5L is a generic measure of health status. The EQ-5D-5L is a 5-item questionnaire that assesses 5 domains including mobility, self-care, usual activities, pain/discomfort and anxiety/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 separate questions are categorical and cannot be analyzed as cardinal numbers.
Baseline up to 2 years and 10 months
Change from Baseline in HRQoL as Assessed by Patient Global Impression of Severity (PGIS)
大体时间：Baseline up to 2 years and 10 months

The PGIS is a single item that assesses severity of the participant's health state, on a 5-point verbal rating scale. Score ranges from 1 (None) to 5 (Very Severe).
Baseline up to 2 years and 10 months
Overall Response Rate (ORR) in Participants with High-risk Molecular Features
大体时间：Up to 2 years and 10 months

ORR in participants with high risk is defined as the overall response rate among the high risk molecular subgroups or other high-risk molecular subtypes.
Up to 2 years and 10 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

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

有用的网址

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)

2021年2月1日

初级完成 (估计的)

2027年6月30日

研究完成 (估计的)

2029年3月30日

研究注册日期

首次提交

2020年11月16日

首先提交符合 QC 标准的

2020年11月16日

首次发布 (实际的)

2020年11月18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

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • CR108920
  • 2017-002400-26 (EudraCT编号)
  • TALMMY1001-PT3 (其他标识符：Janssen Research & Development, LLC)
  • 2017 (美国 NIH 拨款/合同)
  • 2023-504581-29-00 (注册表标识符：EUCT number)
  • 2023 (美国 NIH 拨款/合同)

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

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.

订阅