A Study of Talquetamab in Participants 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).

Conditions

Hematological Malignancies

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Study Overview

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Study Details

Study 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).

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

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

Condition
Hematological Malignancies
Intervention / Treatment

-

Contacts and Locations

Birmingham

University of Alabama Birmingham, Birmingham, Alabama, United States, 35294

Little Rock

University of Arkansas for Medical Sciences, Little Rock, Arkansas, United States, 72205

Duarte

City of Hope, Duarte, California, United States, 91010

Hollywood

Memorial Healthcare System, Hollywood, Florida, United States, 33021

Atlanta

Emory University - Winship Cancer Institute, Atlanta, Georgia, United States, 30322

Chicago

University of Chicago, Chicago, Illinois, United States, 60637

Louisville

Norton Cancer Institute, Louisville, Kentucky, United States, 40207

Ann Arbor

University of Michigan Health System, Ann Arbor, Michigan, United States, 48109

Saint Louis

Washington University School Of Medicine, Saint Louis, Missouri, United States, 63110

New York

NYU Langone Health, New York, New York, United States, 10016

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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)

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Janssen Research & Development, LLC,

Janssen Research & Development, LLC Clinical Trial, STUDY_DIRECTOR, Janssen Research & Development, LLC

Study Record Dates

2027-03-31