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Evaluating talquetamab for patients 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

Phase 2 Interventional Janssen Research & Development, LLC · NCT04634552

This study is testing a new drug called talquetamab to see if it can help people with relapsed or refractory multiple myeloma feel better and manage their disease.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment510 (estimated)
Ages18 Years and up
SexAll
SponsorJanssen Research & Development, LLC Industry-sponsored
Drugs / interventionsCAR-T, prednisone, talquetamab
Locations78 sites (Birmingham, Alabama and 77 other locations)
Trial IDNCT04634552 on ClinicalTrials.gov

What this trial studies

This study aims to assess the efficacy and safety of talquetamab in patients suffering from relapsed or refractory multiple myeloma. Participants will be grouped into different cohorts based on specific criteria, and the study will focus on measuring the disease's response to the treatment. The trial will follow a Phase 2 design, utilizing recommended doses to determine the drug's effectiveness. Patients will be monitored for both therapeutic outcomes and any adverse effects throughout the study.

Who should consider this trial

Good fit: Ideal candidates are individuals with a documented diagnosis of relapsed or refractory multiple myeloma who meet specific inclusion criteria.

Not a fit: Patients who have recently undergone CAR-T or T cell redirection therapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with difficult-to-treat multiple myeloma.

How similar studies have performed: Other studies have shown promise with similar therapies targeting multiple myeloma, indicating potential for success in this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
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)

Where this trial is running

Birmingham, Alabama and 77 other locations

+28 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Hematological MalignanciesMultiple Myeloma
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.