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A Study of Talquetamab in Participants With Relapsed or Refractory Multiple Myeloma
Trial Status: active
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 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)
Additional locations may be listed on ClinicalTrials.gov for NCT04634552.
Locations matching your search criteria
United States
Georgia
Atlanta
Emory University Hospital/Winship Cancer Institute
Status: Active
Name Not Available
Illinois
Chicago
University of Chicago Comprehensive Cancer Center
Status: Active
Name Not Available
New York
New York
Icahn School of Medicine at Mount Sinai
Status: Active
Name Not Available
Laura and Isaac Perlmutter Cancer Center at NYU Langone
Status: Temporarily closed to accrual
Name Not Available
Texas
Houston
M D Anderson Cancer Center
Status: Approved
Name Not Available
Trial PhasePhase II
Trial Typetreatment
Lead OrganizationJanssen Research & Development, LLC
