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Studies

Interventional Active not recruiting Phase 3

NCT05455320 on ClinicalTrials.gov

A Study Comparing Talquetamab in Combination With Daratumumab or in Combination With Daratumumab and Pomalidomide Versus Daratumumab in Combination With Pomalidomide and Dexamethasone in Participants With Multiple Myeloma That Returns After Treatment or is Resistant to Treatment

Official title: A Phase 3 Randomized Study Comparing Talquetamab SC in Combination With Daratumumab SC and Pomalidomide (Tal-DP) or Talquetamab SC in Combination With Daratumumab SC (Tal-D) Versus Daratumumab SC, Pomalidomide and Dexamethasone (DPd), in Participants With Relapsed or Refractory Multiple Myeloma Who Have Received at Least 1 Prior Line of Therapy

  • Sponsor: Janssen Research & Development, LLC
  • Enrollment: 864 (Actual)
  • Study start: 2022-10-13 (Actual)
  • Primary completion: 2027-07-30 (Estimated)
  • Study completion: 2028-05-25 (Estimated)
  • Allocation: Randomized
  • InterventionModel: Parallel
  • Masking: None
  • PrimaryPurpose: Treatment

Brief Summary

The purpose of the study is to compare the efficacy of talquetamab subcutaneous(ly) (SC) in combination with daratumumab SC and pomalidomide (Tal-DP) and talquetamab SC in combination with daratumumab SC (Tal-D), respectively, with daratumumab SC in combination with pomalidomide and dexamethasone (DPd).

Conditions

  • Multiple Myeloma

Intervention / Treatment

  • Drug: Talquetamab
  • Drug: Daratumumab
  • Drug: Pomalidomide
  • Drug: Dexamethasone

Primary Outcome Measures

  • Progression-Free Survival (PFS) (Up to 6 years 6 months)
    PFS is defined as time from the date of randomization to the first documentation of disease progression, or death due to any cause, whichever is reported first.

Countries

Belgium, Brazil, China, Czechia, France, Germany, Greece, Israel, Italy, Japan, Netherlands, Poland, South Korea, Spain, Taiwan, Turkey (Türkiye), United Kingdom, United States

Locations and Investigators

  • The University of Arizona Cancer Center, Tucson, United States
  • University of Arkansas for Medical Sciences, Little Rock, United States
  • Norwalk Hospital-oncology, Norwalk, United States
  • MedStar Georgetown University Hospital, Washington D.C., United States
  • George Washington University, Washington D.C., United States
  • Memorial Healthcare System, Hollywood, United States
  • University of Miami Health System, Miami, United States
  • University Of Illinois, Chicago, United States
  • University of Kansas, Westwood, United States
  • Tulane University Hospital & Clinics, New Orleans, United States
  • Ochsner Health System, New Orleans, United States
  • Johns Hopkins University, Baltimore, United States
  • Massachusetts General, Boston, United States
  • Boston University Medical Center, Boston, United States
  • University of Massachusetts Medical School, Worcester, United States
  • University of Michigan Health System, Ann Arbor, United States
  • University Of Minnesota, Minneapolis, United States
  • University of Mississippi Medical Center, Jackson, United States
  • Washington University School Of Medicine, St Louis, United States
  • Rutgers Cancer Institute of New Jersey, New Brunswick, United States
  • NYU Langone Health, New York, United States
  • SUNY Upstate Medical University, Syracuse, United States
  • University of North Carolina, Chapel Hill, United States
  • Levine Cancer Institute, Carolinas HealthCare System, Charlotte, United States
  • Novant Health 1, Charlotte, United States
  • Novant Health, Winston-Salem, United States
  • Wake Forest Baptist Medical Center, Winston-Salem, United States
  • University Hospitals Cleveland Medical Center, Cleveland, United States
  • The Ohio State University Wexner Medical Center - James Cancer Hospital, Columbus, United States
  • OhioHealth, Columbus, United States
  • Thomas Jefferson University, Philadelphia, United States
  • Medical University of South Carolina, Charleston, United States
  • Baptist Cancer Center, Memphis, United States
  • Houston Methodist Hospital, Houston, United States
  • MD Anderson Cancer Center, Houston, United States
  • Joe Arrington Cancer Research Treatment Center, Lubbock, United States
  • Huntsman Cancer Institute, Salt Lake City, United States
  • University of Virginia, Charlottesville, United States
  • Virginia Commonwealth University - Massey Cancer Center, Richmond, United States
  • Fred Hutchinson Cancer Research Center, Seattle, United States
  • UZ Brussel, Brussels, Belgium
  • UZA, Edegem, Belgium
  • Virga Jessa Ziekenhuis, Hasselt, Belgium
  • CHC MontLegia, Liège, Belgium
  • Clinique Saint Pierre, Ottignies, Belgium
  • UCL Mont Godinne, Yvoir, Belgium
  • Fundacao Pio XII, Barretos, Brazil
  • Santa Casa de Misericordia de Belo Horizonte, Belo Horizonte, Brazil
  • IDOR - Regional Brasilia, Brasília, Brazil
  • Fundacao Universidade de Caxias do Sul, Caxias do Sul, Brazil

And 166 other sites.

Study Officials

  • Janssen Research & Development, LLC Clinical Trial (Study Director) — Janssen Research & Development, LLC