NCT04634552RecruitingPhase 2
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
Source: ClinicalTrials.gov · Last updated 3 Nov 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 510 (estimated)
- First submitted
- 16 Nov 2020
- Start date
- 1 Feb 2021
- Primary completion date
- 30 Jun 2027
- Lead sponsor
- Janssen Research & Development, LLC
- Diseases
- Multiple myeloma
- NCT number
- NCT04634552
- EU CT number
- 2023-504581-29-00
- EudraCT number
- 2017-002400-26
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 510
- From 1 Feb 2021 to the primary completion date, 30 Jun 2027
- 78 sites in 11 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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)
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (78)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| UZ Antwerpen Coordinator of this site? Confirm its status | Edegem | Belgium | Completed |
| UZ Leuven Coordinator of this site? Confirm its status | Leuven | Belgium | Active, not recruiting |
| CHU de Liège - Domaine Universitaire du Sart Tilman Coordinator of this site? Confirm its status | Liège | Belgium | Active, not recruiting |
| UCL - Saint Luc Coordinator of this site? Confirm its status | Woluwe-Saint-Lambert | Belgium | Completed |
| Peking University Third Hospital Coordinator of this site? Confirm its status | Beijing | China | Completed |
| Sun Yat-sen University Cancer Center Coordinator of this site? Confirm its status | Guangzhou | China | Active, not recruiting |
| The 1st Affiliated Hospital Of Medical College Zhejiang University 1 Coordinator of this site? Confirm its status | Hangzhou | China | Active, not recruiting |
| The 1St Affiliated Hospital of Medical College Zhejiang University Coordinator of this site? Confirm its status | Hangzhou | China | Active, not recruiting |
| First Affiliated Hospital SooChow University Coordinator of this site? Confirm its status | Suzhou | China | Active, not recruiting |
| Institute of Hematology & Blood Disease Hospital Chinese Academy of Medical Science Coordinator of this site? Confirm its status | Tianjin | China | Active, not recruiting |
| The Second Affiliated Hospital of Xi'an Jiaotong University Coordinator of this site? Confirm its status | Xi'an | China | Completed |
| The First Affiliated Hospital of Xian Jiaotong University Coordinator of this site? Confirm its status | Xi'an | China | Completed |
| Charité Campus Benjamin Franklin Coordinator of this site? Confirm its status | Berlin | Germany | Active, not recruiting |
| Universitaetsklinikum Heidelberg Coordinator of this site? Confirm its status | Heidelberg | Germany | Active, not recruiting |
| Universitaetsklinikum Muenster Coordinator of this site? Confirm its status | Münster | Germany | Completed |
| Universitätsklinikum Würzburg Coordinator of this site? Confirm its status | Würzburg | Germany | Active, not recruiting |
| Hosp. Univ. Germans Trias I Pujol Coordinator of this site? Confirm its status | Badalona | Spain | Completed |
| Hosp Univ Vall D Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Inst. Cat. Doncologia-H Duran I Reynals Coordinator of this site? Confirm its status | Barcelona | Spain | Active, not recruiting |
| Hosp. Univ. 12 de Octubre Coordinator of this site? Confirm its status | Madrid | Spain | Completed |
| Hosp Univ Fund Jimenez Diaz Coordinator of this site? Confirm its status | Madrid | Spain | Completed |
| Hosp. Univ. Virgen de La Arrixaca Coordinator of this site? Confirm its status | Murcia | Spain | Active, not recruiting |
| Clinica Univ. de Navarra Coordinator of this site? Confirm its status | Pamplona | Spain | Recruiting |
| Hosp. Quiron Madrid Pozuelo Coordinator of this site? Confirm its status | Pozuelo de Alarcón | Spain | Completed |
| Hosp Clinico Univ de Salamanca Coordinator of this site? Confirm its status | Salamanca | Spain | Recruiting |
| Hosp. Univ. Marques de Valdecilla Coordinator of this site? Confirm its status | Santander | Spain | Recruiting |
| Hosp. Virgen Del Rocio Coordinator of this site? Confirm its status | Seville | Spain | Recruiting |
| CHU Henri Mondor Coordinator of this site? Confirm its status | Créteil | France | Active, not recruiting |
| Hospices Civils de Lyon HCL Coordinator of this site? Confirm its status | Lyon | France | Active, not recruiting |
| CHU de Montpellier Hôpital Saint Eloi Coordinator of this site? Confirm its status | Montpellier | France | Active, not recruiting |
| C.H.U. Hotel Dieu - France Coordinator of this site? Confirm its status | Nantes | France | Active, not recruiting |
| CHU de Bordeaux - Hospital Haut-Leveque Coordinator of this site? Confirm its status | Pessac | France | Active, not recruiting |
| Pôle IUC Oncopole CHU Coordinator of this site? Confirm its status | Toulouse | France | Active, not recruiting |
| Rambam Medical Center Coordinator of this site? Confirm its status | Haifa | Israel | Active, not recruiting |
| Carmel Medical Center Coordinator of this site? Confirm its status | Haifa | Israel | Active, not recruiting |
| Hadassah medical Center Coordinator of this site? Confirm its status | Jerusalem | Israel | Active, not recruiting |
| Sheba medical center Coordinator of this site? Confirm its status | Ramat Gan | Israel | Active, not recruiting |
| Tel-Aviv Sourasky Medical Center Coordinator of this site? Confirm its status | Tel Aviv | Israel | Active, not recruiting |
| Kameda Medical Center Coordinator of this site? Confirm its status | Chiba | Japan | Completed |
| Fukuoka University Hospital Coordinator of this site? Confirm its status | Fukuoka | Japan | Completed |
| Ogaki Municipal Hospital Coordinator of this site? Confirm its status | Gifu | Japan | Completed |
| Teine Keijinkai Hospital Coordinator of this site? Confirm its status | Hokkaido | Japan | Completed |
| Kobe City Medical Center General Hospital Coordinator of this site? Confirm its status | Kobe | Japan | Completed |
| Dokkyo Medical University Saitama Medical Center Coordinator of this site? Confirm its status | Koshigaya | Japan | Completed |
| Kumamoto University Hospital Coordinator of this site? Confirm its status | Kumamoto | Japan | Completed |
| Kurashiki Central Hospital Coordinator of this site? Confirm its status | Kurashiki | Japan | Completed |
| National Hospital Organization Matsumoto Medical Center Coordinator of this site? Confirm its status | Matsumoto | Japan | Completed |
| National Hospital Organization Okayama Medical Center Coordinator of this site? Confirm its status | Okayama | Japan | Completed |
| Japanese Red Cross Osaka Hospital Coordinator of this site? Confirm its status | Osaka | Japan | Completed |
| National Hospital Organization Hiroshima-Nishi Medical Center Coordinator of this site? Confirm its status | Ōtake | Japan | Active, not recruiting |
| Iwate Medical University Hospital Coordinator of this site? Confirm its status | Shiwa-gun | Japan | Completed |
| Chonnam National University Hwasun Hospital Coordinator of this site? Confirm its status | Jeollanam-do | South Korea | Completed |
| Asan Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Completed |
| Samsung Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Completed |
| Seoul National University Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Completed |
| The Catholic University of Korea Seoul St Marys Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Completed |
| Severance Hospital, Yonsei University Health System Coordinator of this site? Confirm its status | Seoul | South Korea | Completed |
| VU Medisch Centrum Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Completed |
| UMCU Coordinator of this site? Confirm its status | Utrecht | Netherlands | Completed |
| Uniwersyteckie Centrum Kliniczne Coordinator of this site? Confirm its status | Gdansk | Poland | Active, not recruiting |
| Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut BadawczyOddz w Gliwicach Coordinator of this site? Confirm its status | Gliwice | Poland | Completed |
| Uniwersytecki Szpital Kliniczny w Poznaniu Coordinator of this site? Confirm its status | Poznan | Poland | Active, not recruiting |
| Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy Coordinator of this site? Confirm its status | Warsaw | Poland | Completed |
| Uniwersytecki Szpital Kliniczny im Jana Mikulicza Radeckiego we Wroclawiu Coordinator of this site? Confirm its status | Wroclaw | Poland | Active, not recruiting |
| University of Michigan Health System Coordinator of this site? Confirm its status | Ann Arbor | United States | Recruiting |
| Emory University/Winship Cancer Institute Coordinator of this site? Confirm its status | Atlanta | United States | Recruiting |
| University of Alabama Birmingham Coordinator of this site? Confirm its status | Birmingham | United States | Recruiting |
| University of Chicago Coordinator of this site? Confirm its status | Chicago | United States | Completed |
| City of Hope Coordinator of this site? Confirm its status | Duarte | United States | Completed |
| Memorial Healthcare System Coordinator of this site? Confirm its status | Hollywood | United States | Recruiting |
| University of Arkansas for Medical Sciences Coordinator of this site? Confirm its status | Little Rock | United States | Recruiting |
| Norton Cancer Institute Coordinator of this site? Confirm its status | Louisville | United States | Recruiting |
| Tennessee Oncology Coordinator of this site? Confirm its status | Nashville | United States | Completed |
| NYU Langone Health Coordinator of this site? Confirm its status | New York | United States | Active, not recruiting |
| Mount SInai Medical Center Coordinator of this site? Confirm its status | New York | United States | Recruiting |
| Providence Portland Medical Center Coordinator of this site? Confirm its status | Portland | United States | Completed |
| University of Rochester Medical Center Coordinator of this site? Confirm its status | Rochester | United States | Recruiting |
| Washington University School of Medicine Coordinator of this site? Confirm its status | St Louis | United States | Recruiting |
Related publications
- Infections in MonumenTAL-1: a plain language summary of talquetamab treatment for relapsed/refractory multiple myeloma.Future Oncol · 2026 · PMID 42803498
- Talquetamab for people living with relapsed/ refractory multiple myeloma: plain language summary of the MonumenTAL-1 study.Future Oncol · 2026 · PMID 42669079
- Talquetamab in patients with relapsed/refractory multiple myeloma: 3-year follow-up of the phase 1/2 MonumenTAL-1 study.Blood · 2026 · PMID 42561120
- A plain language summary describing how talquetamab affects the way people with multiple myeloma feel and function in the MonumenTAL-1 study.Future Oncol · 2026 · PMID 42299486
- Talquetamab in Japanese patients with relapsed/refractory multiple myeloma in the MonumenTAL-1 study.Int J Hematol · 2026 · PMID 41405810
- Comparative Efficacy of Talquetamab vs. Real-World Physician's Choice of Treatment in Triple-Class-Exposed Relapsed/Refractory Multiple Myeloma: Updated Analyses of MonumenTAL-1 vs. LocoMMotion/MoMMent.Adv Ther · 2026 · PMID 41313549
This page is information, not medical advice. Discuss any trial with your doctor.