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

ID#: NCT04634552

Age: 18 years - 66+

Gender: All

Healthy Subjects: No

Study Phase: Phase 2

Recruitment Status: Recruiting

Start Date: January 08, 2021

End Date: September 29, 2023

Contact Information:
Study Contact
844-434-4210
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).
Eligibility:

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)