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).
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
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)
Parallel
Talquetamab
DrugTalquetamab will be administered SC until disease progression.
Overall Response Rate (ORR)
ORR is defined as the proportion of participants who have a partial response (PR) or better according to the international myeloma working group (IMWG) criteria.
Duration of Response (DOR)
DOR is defined as time from date of initial documentation of a response (PR or better) to date of first documented evidence of progressive disease (PD), per IMWG criteria, or death due to PD, whichever occurs first.
Very Good Partial Response (VGPR) or Better Rate
VGPR or better rate is defined as the percentage of patients who achieve a VGPR or better according to IMWG response criteria.
Complete Response (CR) or Better Rate
CR or better rate is defined as the percentage of patients who achieve CR or better according to IMWG response criteria.
Stringent Complete Response (sCR) Rate
sCR rate is defined as the percentage of patients who achieve sCR according to IMWG response criteria.
Click on the lead sponsor to view all of their trials.
