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Clinical Trials in China / NCT04634552
Recruiting Phase 2

A Study of Talquetamab in Participants With Relapsed or Refractory Multiple Myeloma

NCT04634552 · tracked via the Priya Life Science China tracker
Sponsor
Janssen Research & Development, LLC
Phase
Phase 2
Started
2021-02-01
Last updated
2026-08-28

Condition(s) studied

Hematological Malignancies

Investigational drug(s) / intervention(s)

Talquetamab

Talquetamab: Talquetamab will be administered SC until disease progression.

Study summary

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).

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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)

Primary outcome measure(s)

Trial sites (78)

FacilityCityRegionStatus
University of Alabama Birmingham Birmingham Alabama Recruiting
University of Arkansas for Medical Sciences Little Rock Arkansas Recruiting
City of Hope Duarte California Completed
Memorial Healthcare System Hollywood Florida Recruiting
Emory University Winship Cancer Institute Atlanta Georgia Recruiting
University of Chicago Chicago Illinois Completed
Norton Cancer Institute Louisville Kentucky Recruiting
University of Michigan Health System Ann Arbor Michigan Recruiting
Washington University School Of Medicine St Louis Missouri Recruiting
NYU Langone Health New York New York Active Not Recruiting
Mount Sinai Medical Center New York New York Recruiting
University of Rochester Medical Center Rochester New York Recruiting
Providence Portland Medical Center Portland Oregon Completed
Tennessee Oncology Nashville Tennessee Completed
UZ Antwerpen Edegem Belgium Completed
UZ Leuven Leuven Belgium Active Not Recruiting
CHU de Liège - Domaine Universitaire du Sart Tilman Liège Belgium Active Not Recruiting
UCL - Saint Luc Woluwe-Saint-Lambert Belgium Completed
Peking University Third Hospital Beijing China Active Not Recruiting
Sun Yat Sen University Cancer Center Guangzhou China Active Not Recruiting
The 1st Affiliated Hospital Of Medical College Zhejiang University 1 Hangzhou China Active Not Recruiting
The 1St Affiliated Hospital of Medical College Zhejiang University Hangzhou China Active Not Recruiting
First Affiliated Hospital SooChow University Suzhou China Active Not Recruiting
Institute of Hematology & Blood Disease Hospital Chinese Academy of Medical Science Tianjin China Active Not Recruiting
The Second Affiliated Hospital of Xi'an Jiaotong University Xi'an China Completed
The First Affiliated Hospital of Xian Jiaotong University Xi'an China Completed
CHU Henri Mondor Créteil France Active Not Recruiting
Hospices Civils de Lyon HCL Lyon France Active Not Recruiting
CHU de Montpellier Hopital Saint Eloi Montpellier France Active Not Recruiting
C.H.U. Hotel Dieu - France Nantes France Active Not Recruiting
CHU de Bordeaux - Hospital Haut-Leveque Pessac France Active Not Recruiting
Pôle IUC Oncopole CHU Toulouse France Active Not Recruiting
Charite Campus Benjamin Franklin Berlin Germany Active Not Recruiting
Universitaetsklinikum Heidelberg Heidelberg Germany Active Not Recruiting
Universitaetsklinikum Muenster Münster Germany Completed
Universitatsklinikum Wurzburg Würzburg Germany Active Not Recruiting
Rambam Medical Center Haifa Israel Active Not Recruiting
Carmel Medical Center Haifa Israel Active Not Recruiting
Hadassah Medical Center Jerusalem Israel Active Not Recruiting
Sheba Medical Center Ramat Gan Israel Active Not Recruiting

+ 38 more sites — see the full list on the official registry below.

More Janssen Research & Development, LLC trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04634552 on ClinicalTrials.gov ↗ ← All trials in China