A Study of Talquetamab in Participants With Relapsed or Refractory Multiple Myeloma

• Status: Recruiting
• Trial end date: 2024-12-06
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the efficacy of talquetamab in participants with relapsed or refractory multiple myeloma at the recommended Phase 2 dose(s) (RP2Ds) (Part 3).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Janssen Research & Development, LLC

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, and cohort C: multiple myeloma must be measurable by central 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: T cell redirection therapy within 3 months

• Vaccinated with live, attenuated vaccine within 4 weeks or as recommended by the product manufacturer prior to the first dose, during treatment, or within 100 days of the last dose of talquetamab

• 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)