A Study of Talquetamab in Participants With Relapsed or Refractory Multiple Myeloma
A Phase 1/2, First-in-Human, Open-Label, Dose Escalation Study of Talquetamab, a Humanized GPRC5D x CD3 Bispecific Antibody, in Subjects With Relapsed or Refractory Multiple Myeloma
- Hematological Malignancies
At a glance
- Phase
- Phase 2
- Study type
- Interventional
- Sponsor
- Janssen Research & Development, LLC
- Enrolment target
- 510
- Started
- 1 February 2021
- Main results due
- 30 June 2027
- Study sites
- 78
- Registry updated
- 25 September 2026
Can you take part?
- Aged 18 years and over.
- Open to any sex.
- You need the condition being studied — healthy volunteers are not accepted.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full eligibility criteria
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)
What this study is about
In the sponsor’s own words, from the registry.
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).
Study sites(78)
University of Alabama Birmingham
Birmingham, Alabama, United States
Recruiting
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
Recruiting
City of Hope
Duarte, California, United States
Completed
Memorial Healthcare System
Hollywood, Florida, United States
Recruiting
Emory University Winship Cancer Institute
Atlanta, Georgia, United States
Recruiting
University of Chicago
Chicago, Illinois, United States
Completed
Norton Cancer Institute
Louisville, Kentucky, United States
Recruiting
University of Michigan Health System
Ann Arbor, Michigan, United States
Recruiting
Washington University School Of Medicine
St Louis, Missouri, United States
Recruiting
NYU Langone Health
New York, New York, United States
Active, not recruiting
Mount Sinai Medical Center
New York, New York, United States
Recruiting
University of Rochester Medical Center
Rochester, New York, United States
Recruiting
Providence Portland Medical Center
Portland, Oregon, United States
Completed
Tennessee Oncology
Nashville, Tennessee, United States
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
Completed
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
Tel Aviv Sourasky Medical Center
Tel Aviv, Israel
Active, not recruiting
Kameda Medical Center
Chiba, Japan
Completed
Fukuoka University Hospital
Fukuoka, Japan
Completed
Ogaki Municipal Hospital
Gifu, Japan
Completed
Teine Keijinkai Hospital
Hokkaido, Japan
Completed
Kobe City Medical Center General Hospital
Kobe, Japan
Completed
Dokkyo Medical University Saitama Medical Center
Koshigaya, Japan
Completed
Kumamoto University Hospital
Kumamoto, Japan
Completed
Kurashiki Central Hospital
Kurashiki, Japan
Completed
National Hospital Organization Matsumoto Medical Center
Matsumoto, Japan
Completed
National Hospital Organization Okayama Medical Center
Okayama, Japan
Completed
Japanese Red Cross Osaka Hospital
Osaka, Japan
Completed
National Hospital Organization Hiroshima-Nishi Medical Center
Ōtake, Japan
Active, not recruiting
Iwate Medical University Hospital
Shiwa-gun, Japan
Completed
VU Medisch Centrum
Amsterdam, Netherlands
Completed
UMCU
Utrecht, Netherlands
Completed
Uniwersyteckie Centrum Kliniczne
Gdansk, Poland
Active, not recruiting
Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut BadawczyOddz w Gliwicach
Gliwice, Poland
Completed
Uniwersytecki Szpital Kliniczny w Poznaniu
Poznan, Poland
Active, not recruiting
Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy
Warsaw, Poland
Completed
Showing 60 of 78 sites — filter to narrow it down. 14 of the 78 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT04634552. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
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