RECRUITING

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

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Conditions

Hematological MalignanciesMultiple Myeloma

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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).

Official Title

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

Quick Facts

Study Start:2021-02-01
Study Completion:2027-03-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04634552

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Documented initial diagnosis of multiple myeloma according to international myeloma working group (IMWG) diagnostic criteria
  2. * Part 3: Measurable disease cohort A, cohort B, cohort C, and cohort D: multiple myeloma must be measurable by central laboratory assessment
  3. * Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2
  4. * 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
  5. * Willing and able to adhere to the prohibitions and restrictions specified in this protocol
  1. * 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
  2. * Toxicities from previous anticancer therapies should have resolved to baseline levels or to Grade 1 or less except for alopecia or peripheral neuropathy
  3. * 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)
  4. * Stroke or seizure within 6 months prior to signing the informed consent form (ICF)

Contacts and Locations

Study Contact

Study Contact
CONTACT
844-434-4210
Participate-In-This-Study@its.jnj.com

Principal Investigator

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

Study Locations (Sites)

University of Alabama Birmingham
Birmingham, Alabama, 35294
United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
United States
City of Hope
Duarte, California, 91010
United States
Memorial Healthcare System
Hollywood, Florida, 33021
United States
Emory University - Winship Cancer Institute
Atlanta, Georgia, 30322
United States
University of Chicago
Chicago, Illinois, 60637
United States
Norton Cancer Institute
Louisville, Kentucky, 40207
United States
University of Michigan Health System
Ann Arbor, Michigan, 48109
United States
Washington University School Of Medicine
Saint Louis, Missouri, 63110
United States
NYU Langone Health
New York, New York, 10016
United States
Mount Sinai Medical Center
New York, New York, 10023
United States
University of Rochester Medical Center
Rochester, New York, 14642
United States
Providence Portland Medical Center
Portland, Oregon, 97213
United States
Tennessee Oncology
Nashville, Tennessee, 37203
United States

Collaborators and Investigators

Sponsor: Janssen Research & Development, LLC

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-02-01
Study Completion Date2027-03-31

Study Record Updates

Study Start Date2021-02-01
Study Completion Date2027-03-31

Terms related to this study

Keywords Provided by Researchers

  • Multiple Myeloma

Additional Relevant MeSH Terms

  • Hematological Malignancies