A Study of Talquetamab in Participants With Relapsed or Refractory Multiple Myeloma
Recruiting now · Phase 2
Conditions studied: Hematological Malignancies
In brief
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).
Key facts
- Study ID
- NCT04634552
- Run by
- Janssen Research & Development, LLC
- People needed
- 510
- Starts
- 2021-02-01
- Expected to finish
- 2029-03-30
- Last updated by the study team
- 2026-07-06
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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)
Where it is running
- Mount Sinai Medical Center — New York, New York, United States (enrolling)
- Memorial Healthcare System — Hollywood, Florida, United States (enrolling)
- Hosp. Univ. Marques de Valdecilla — Santander, Spain (enrolling)
- University of Alabama Birmingham — Birmingham, Alabama, United States (enrolling)
- Emory University Winship Cancer Institute — Atlanta, Georgia, United States (enrolling)
- Washington University School Of Medicine — St Louis, Missouri, United States (enrolling)
- Hosp Univ Vall D Hebron — Barcelona, Spain (enrolling)
- Hosp Clinico Univ de Salamanca — Salamanca, Spain (enrolling)
- Hosp. Virgen Del Rocio — Seville, Spain (enrolling)
- University of Rochester Medical Center — Rochester, New York, United States (enrolling)
- University of Arkansas for Medical Sciences — Little Rock, Arkansas, United States (enrolling)
- University of Chicago — Chicago, Illinois, United States (enrolling)
- Norton Cancer Institute — Louisville, Kentucky, United States (enrolling)
- Clinica Univ. de Navarra — Pamplona, Spain (enrolling)
- University of Michigan Health System — Ann Arbor, Michigan, United States (enrolling)
- UZ Antwerpen — Edegem, Belgium
- Tennessee Oncology — Nashville, Tennessee, United States
- The Second Affiliated Hospital of Xi'an Jiaotong University — Xi'an, China
- Institute of Hematology & Blood Disease Hospital Chinese Academy of Medical Science — Tianjin, China
- Providence Portland Medical Center — Portland, Oregon, United States
- First Affiliated Hospital SooChow University — Suzhou, China
- The 1St Affiliated Hospital of Medical College Zhejiang University — Hangzhou, China
- The 1st Affiliated Hospital Of Medical College Zhejiang University 1 — Hangzhou, China
- Sun Yat Sen University Cancer Center — Guangzhou, China
- Peking University Third Hospital — Beijing, China
Full record on ClinicalTrials.gov
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