A Study of Teclistamab in Combination With Daratumumab and Lenalidomide (Tec-DR) and Talquetamab in Combination With Daratumumab and Lenalidomide (Tal-DR) in Participants With Newly Diagnosed Multiple Myeloma

Part of paid clinical trials in Gilbert, Arizona.

Sponsor
Janssen Research & Development, LLC
Study ID
NCT05552222
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Teclistamab — DRUG
    Teclistamab will be administered as SC injection.
  • Daratumumab — DRUG
    Daratumumab will be administered as SC injection.
  • Lenalidomide — DRUG
    Lenalidomide will be administered orally.
  • Dexamethasone — DRUG
    Dexamethasone will be administered either orally or intravenously (IV).
  • Talquetamab — DRUG
    Talquetamab will be administered as SC injection.

Study Details

The purpose of this study is to compare the efficacy of teclistamab in combination with daratumumab and lenalidomide (Tec-DR) and talquetamab in combination with daratumumab and lenalidomide (Tal-DR) versus daratumumab, lenalidomide, dexamethasone (DRd).

Key Dates

Start date
Oct 25, 2022
Status verified
Jun 2026
Primary completion
Apr 30, 2031
Completion
Oct 28, 2033

Study Design

Enrollment
1,590 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Teclistamab, Daratumumab SC, and Lenalidomide (Tec-DR)
    Participants will receive teclistamab as subcutaneous (SC) injection in combination with daratumumab and lenalidomide.
  • Experimental: Talquetamab, Daratumumab SC, and Lenalidomide (Tal-DR)
    Participants will receive talquetamab as SC injection in combination with daratumumab and lenalidomide.
  • Active Comparator: Daratumumab SC, Lenalidomide, and Dexamethasone (DRd)
    Participants will receive daratumumab as SC injection with lenalidomide and dexamethasone.

Primary Outcome Measure

Progression Free Survival (PFS) [ Time Frame: From randomization to the date of disease progression or death (Up to 09 years) ]

Central Contacts

Locations (67)

FacilityCityStateZIPSite coordinators
Banner MD Anderson Cancer CenterGilbertArizona85234-
University of Arizona Cancer CenterTucsonArizona85719-
UCSF FresnoClovisCalifornia93611-
City of Hope DuarteDuarteCalifornia91010-
City of Hope Orange County Lennar Foundation Cancer CenterIrvineCalifornia92618-
Cancer and Blood Specialty ClinicLos AlamitosCalifornia90720-
Valkyrie Clinical TrialsLos AngelesCalifornia90067-
University of ConnecticutFarmingtonConnecticut06030-
Yale New Haven HospitalNew HavenConnecticut06510-
ChristianaCare Helen F Graham Cancer Center and Research InstituteNewarkDelaware19713-
Memorial Healthcare SystemHollywoodFlorida33021-
AdventHealth Medical Group Blood & Marrow Transplant at OrlandoOrlandoFlorida32804-
Cleveland Clinic FloridaWestonFlorida33331-
City of Hope Cancer CenterNewnanGeorgia30265-
University Of Illinois Medical CenterChicagoIllinois60612-
Loyola University Medical CenterMaywoodIllinois60153-
University of Iowa Health CareWaukeeIowa50263-
Norton Cancer InstituteLouisvilleKentucky40207-
LSUHSC Shreveport Feist-Weiller Cancer CenterShreveportLouisiana71103-
Johns Hopkins University School of Medicine JHUSOMBaltimoreMaryland21231-
Center for Cancer and Blood DisordersBethesdaMaryland20817-
University of MichiganAnn ArborMichigan48109-
Henry Ford Cancer - Detroit Brigitte Harris Cancer PavilionDetroitMichigan48202-
Cancer And Hematology Centers of Western Michigan PCGrand RapidsMichigan49503-
Henry Ford Providence Novi HospitalNoviMichigan48374-
Henry Ford Providence Southfield CK Potluri Cancer CenterSouthfieldMichigan48075-
MidAmerica Cancer CareKansas CityMissouri64132-
Nebraska Cancer SpecialistsOmahaNebraska68130-
University of Nebraska Medical CenterOmahaNebraska68198-
Dartmouth Hitchcock Medical CenterLebanonNew Hampshire03756-
Astera Cancer CareEast BrunswickNew Jersey08816-
Christus St. Vincent Regional Cancer CenterSanta FeNew Mexico87505-
Hematology-Oncology Associates of CNYEast SyracuseNew York13057-
Northwell Health Cancer InstituteLake SuccessNew York11042-
NYU Langone Hospital Long IslandMineolaNew York11500-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-
Perlmutter Cancer Center at NYU Langone HealthNew YorkNew York10016-
Weill Cornell Medical CollegeNew YorkNew York10065-
Levine Cancer InstituteCharlotteNorth Carolina28204-
Novant HealthCharlotteNorth Carolina28204-
Durham VAMCDurhamNorth Carolina27705-
Novant Health Zimmer Cancer InstituteWilmingtonNorth Carolina28401-
Atrium Health Wake Forest Baptist Comprehensive Cancer CenterWinston-SalemNorth Carolina27157-
Novant Health Forsyth Medical CenterWinston-SalemNorth Carolina27103-
Oncology Hematology CareCincinnatiOhio45236-
The Christ Hospital Cancer CenterCincinnatiOhio45219-
University of CincinnatiCincinnatiOhio45267-
Cleveland Clinic Main CampusClevelandOhio44195-
University Hospitals Cleveland Medical CenterClevelandOhio44106-
OhioHealthColumbusOhio43214-
The Ohio State University- James Cancer HospitalColumbusOhio43210-
Penn State Milton S Hershey Medical CtrHersheyPennsylvania17033-
Allegheny Health NetworkPittsburghPennsylvania15224-
Rhode Island HospitalProvidenceRhode Island02903-
MUSC-Hollings Cancer CenterCharlestonSouth Carolina29425-
Henry-Joyce Cancer ClinicNashvilleTennessee37232-
University of Texas Southwestern Medical CenterDallasTexas75235-
Houston Methodist HospitalHoustonTexas77030-
Joe Arrington Cancer Research Treatment CenterLubbockTexas79410-
Huntsman Cancer InstituteSalt Lake CityUtah84112-
Utah Cancer SpecialistsSalt Lake CityUtah84106-
University of VirginiaCharlottesvilleVirginia22903-
Alexander T. Augusta Military Medical CenterFort BelvoirVirginia22060-
Virginia Oncology Associates Brock Cancer CenterNorfolkVirginia23502-
Richmond VA Medical CenterRichmondVirginia23249-
Virginia Commonwealth University Medical CenterRichmondVirginia23298-
NorthWest Medical Specialties, PLLCTacomaWashington98405-

Find similar trials in Gilbert, AZ

By condition
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By specialty
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