Tests talquetamab in adults with relapsed or refractory multiple myeloma
Tests talquetamab in adults whose multiple myeloma returned or did not respond to treatment.
Plain-language title generated from the registry record
Registry title: A Study of Talquetamab in Participants With Relapsed or Refractory Multiple Myeloma
Key facts
- Where
- Chiba, Fukuoka, Gifu, Hokkaido, Kobe, Koshigaya, Kumamoto, Kurashiki, Matsumoto, Okayama, Osaka, Ōtake, and Shiwa-gun, JapanSee the 13 sites
- Phase
- Phase 2
Where in Japan
- Kameda Medical CenterChiba, JapanNo longer taking part
- Fukuoka University HospitalFukuoka, JapanNo longer taking part
- Ogaki Municipal HospitalGifu, JapanNo longer taking part
- Teine Keijinkai HospitalHokkaido, JapanNo longer taking part
- Kobe City Medical Center General HospitalKobe, JapanNo longer taking part
- Dokkyo Medical University Saitama Medical CenterKoshigaya, JapanNo longer taking part
- Kumamoto University HospitalKumamoto, JapanNo longer taking part
- Kurashiki Central HospitalKurashiki, JapanNo longer taking part
- National Hospital Organization Matsumoto Medical CenterMatsumoto, JapanNo longer taking part
- National Hospital Organization Okayama Medical CenterOkayama, JapanNo longer taking part
- Japanese Red Cross Osaka HospitalOsaka, JapanNo longer taking part
- National Hospital Organization Hiroshima-Nishi Medical CenterŌtake, JapanNo longer taking part
- Iwate Medical University HospitalShiwa-gun, JapanNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Janssen Research & Development, LLC
- Trial code
- NCT04634552EU 2023-504581-29-00
- Record updated
- 3 November 2026
- Original description
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).Read full original descriptionShow less
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
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).
Inclusion: 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: 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).