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
- Badalona, Barcelona, L'Hospitalet de Llobregat, Madrid, Murcia, Pamplona, Pozuelo de Alarcón, Salamanca, Santander, and Sevilla, SpainSee the 10 sites
- Phase
- Phase 2
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with multiple myeloma that has come back or has stopped responding to treatment. The disease must be measurable by laboratory tests.
- Age
- 18 years or older
- Sex
- All sexes can join.
- Disease stage
- Multiple myeloma confirmed by IMWG diagnostic criteria. It must be measurable by laboratory assessment (central laboratory for cohorts A to D, local laboratory for cohort E). The disease has relapsed or is refractory.
- Earlier treatment
- Part 3, cohorts A and C: no earlier CAR-T or T cell redirection therapy at any time. Cohorts B, D and E: no T cell redirection therapy within 3 months. Side effects of earlier cancer treatment must have settled to Grade 1 or less, except hair loss or nerve problems in the hands and feet.
Main reasons for not taking part
- Earlier CAR-T or T cell redirection therapy (timing depends on the cohort)
- Side effects of earlier cancer treatment above Grade 1, except hair loss or nerve problems in the hands and feet
- Corticosteroids equal to 140 mg or more of prednisone in the 14 days before the first dose (not counting medicine given before treatment)
- Stroke or seizure in the 6 months before signing consent
Read by machine on 9 November 2026.
Where in Spain
- Institut Catala d'OncologiaBadalona, SpainNo longer taking part
- Hospital Universitari Vall d'HebronBarcelona, SpainNo longer taking part
- Institut Catala D'oncologiaL'Hospitalet de Llobregat, SpainNo longer taking part
- Hospital Universitario 12 de OctubreMadrid, SpainNo longer taking part
- University Clinical Hospital Virgen De La ArrixacaMurcia, SpainNo longer taking part
- Clínica Universidad de navarraPamplona, SpainNo longer taking part
- Hospital Universitario Quironsalud MadridPozuelo de Alarcón, SpainNo longer taking part
- Hospital Universitario De SalamancaSalamanca, SpainNo longer taking part
- Hospital Universitario Marqués de ValdecillaSantander, SpainNo longer taking part
- University Hospital Virgen Del Rocio S.L.Sevilla, SpainNo 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).