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A Phase 1/2, First-in-Human, Open-Label, Dose Escalation Study of Talquetamab, a Humanized GPRC5D x CD3 Bispecific Antibody, in Subjects With Relapsed or Refractory Multiple Myeloma


Description

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).

Trial 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, 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)

Study Info

Organization

Janssen Research & Development, LLC


Primary Outcome

Overall Response Rate (ORR)


Outcome Timeframe Up to 2 years and 10 months

NCTID NCT04634552

Phases PHASE2

Primary Purpose TREATMENT

Start Date 2021-02-01

Completion Date 2026-03-31

Enrollment Target 480

Interventions

DRUG Talquetamab

Locations Recruiting

University of Alabama Birmingham

United States, Alabama, Birmingham


University of Arkansas for Medical Sciences

United States, Arkansas, Little Rock


City of Hope

United States, California, Duarte


Memorial Healthcare System

United States, Florida, Hollywood


Emory University - Winship Cancer Institute

United States, Georgia, Atlanta


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