Clinical Trials in Spain / NCT04634552
Recruiting
Phase 2
A Study of Talquetamab in Participants With Relapsed or Refractory Multiple Myeloma
NCT04634552 · tracked via the Priya Life Science Spain tracker
Condition(s) studied
Hematological Malignancies
Investigational drug(s) / intervention(s)
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
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)
- Overall Response Rate (ORR) — 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.
Trial sites (78)
| Facility | City | Region | Status |
|---|---|---|---|
| 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 | 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 |
+ 38 more sites — see the full list on the official registry below.
More Janssen Research & Development, LLC trials in Spain
Other trials for the same condition
A Study of Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma
Active, not recruiting
Durvalumab and Tremelimumab for Pediatric Malignancies
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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 Spain