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Recruiting Phase 2 NCT04634552

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

Trial Parameters

Condition Hematological Malignancies
Sponsor Janssen Research & Development, LLC
Study Type INTERVENTIONAL
Phase Phase 2
Enrollment 510
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2021-02-01
Completion 2026-03-31
Interventions
Talquetamab

Brief Summary

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).

Eligibility 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 ant

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