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

Sponsor: Janssen Research & Development, LLC

Sponsor score: 60

ClinicalTrials ID:NCT04634552

This study assesses the efficacy and safety of talquetamab, administered subcutaneously, in participants with relapsed or refractory multiple myeloma. Eligible participants must have a documented diagnosis, measurable disease, and an ECOG score of 0-2. Women of childbearing potential require a negative pregnancy test before starting treatment.

Patient Parameters

Program Overview

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
  • 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 and Cohort D: 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)

Locations

FACILITYZIPCITYSTATE
University of Alabama Birmingham35294BirminghamAlabama
University of Arkansas for Medical Sciences72205Little RockArkansas
City of Hope91010DuarteCalifornia
Memorial Healthcare System33021HollywoodFlorida
Emory University Winship Cancer Institute30322AtlantaGeorgia
University of Chicago60637ChicagoIllinois
Norton Cancer Institute40207LouisvilleKentucky
University of Michigan Health System48109Ann ArborMichigan
Washington University School Of Medicine63110Saint LouisMissouri
NYU Langone Health10016New YorkNew York

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