A Study Comparing Teclistamab Monotherapy Versus Pomalidomide, Bortezomib, Dexamethasone (PVd) or Carfilzomib, Dexamethasone (Kd) in Participants With Relapsed or Refractory Multiple Myeloma

Part of paid clinical trials in Anchorage, Alaska.

Sponsor
Janssen Research & Development, LLC
Study ID
NCT05572515
Phase
PHASE3
Status
Active Not Recruiting

Conditions

  • Relapsed or Refractory Multiple Myeloma

Eligibility Criteria

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

Interventions

  • Teclistamab — DRUG
    Teclistamab will be administered subcutaneously.
  • Pomalidomide — DRUG
    Pomalidomide will be administered orally.
  • Bortezomib — DRUG
    Bortezomib will be administered subcutaneously.
  • Dexamethasone — DRUG
    Dexamethasone will be administered orally in PVd and intravenously or orally in Kd.
  • Carfilzomib — DRUG
    Carfilzomib will be administered intravenously.

Study Details

The purpose of this study is to compare the efficacy of teclistamab with PVd/Kd in Part 1 and to further characterize safety and efficacy of an alternative dosing for teclistamab in Part 2 in participants with relapsed or refractory multiple myeloma.

Key Dates

Start date
Mar 29, 2023
Status verified
Apr 2026
Primary completion
Oct 13, 2025
Completion
Aug 31, 2031

Study Design

Enrollment
614 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Teclistamab
    Participants will receive teclistamab monotherapy in Part 1 and an alternative dosing regimen of teclistamab in Part 2.
  • Experimental: Pomalidomide, Bortezomib and Dexamethasone (PVd) or Carfilzomib and Dexamethasone (Kd)
    Participants will receive either PVd or Kd based on principal investigator's choice during Part 1 of the study.

Primary Outcome Measure

Part 1: Progression-free Survival (PFS) [ Time Frame: Up to 9 years ]

Locations (30)

FacilityCityStateZIPSite coordinators
Alaska Oncology and Hematology LLCAnchorageAlaska99508-
Banner MD Anderson Cancer CenterGilbertArizona85234-
Alta Bates Comprehensive Cancer CenterBerkeleyCalifornia94704-
MemorialCare Long Beach Medical CenterLong BeachCalifornia90806-
University of California IrvineOrangeCalifornia92868-
PIH Health HospitalWhittierCalifornia90602-
Rocky Mountain Cancer CentersAuroraColorado80218-
University of ConnecticutFarmingtonConnecticut06030-
University of Miami Sylvester Cancer CenterMiamiFlorida33136-
Orlando Health Cancer InstituteOrlandoFlorida32806-
Cleveland Clinic FloridaWestonFlorida33331-
Mission Cancer BloodWaukeeIowa50263-
East Jefferson General Hospital Bone Marrow Transport ClinicMetairieLouisiana70006-
Walter Reed National Military Medical CenterBethesdaMaryland20889-
Maryland Oncology Hematology P ASilver SpringMaryland20904-
Boston University Medical CenterBostonMassachusetts02118-
Saint Lukes Hospital Saint Lukes Cancer SpecialistsChesterfieldMissouri63017-
Cooper Health System MD Anderson Cancer Center at CooperCamdenNew Jersey08103-
Herbert Irving Comprehensive Cancer Center Columbia University Medical CenterNew YorkNew York10032-
Durham VAMCDurhamNorth Carolina27705-
Penn Medicine Lancaster General HealthLancasterPennsylvania17601-
Tennessee OncologyNashvilleTennessee37203-
Brooke Army Medical CenterFort Sam HoustonTexas78234-
Baylor College of MedicineHoustonTexas77030-
Harris Health Smith ClinicHoustonTexas77054-
Michael E DeBakey VA Medical CenterHoustonTexas77030-
Utah Cancer SpecialistsSalt Lake CityUtah84106-
Alexander T. Augusta Military Medical CenterFort BelvoirVirginia22060-
Virginia Oncology AssociatesNorfolkVirginia23502-
NorthWest Medical Specialties, PLLCTacomaWashington98405-

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By research site
Alaska Oncology and Hematology LLC· Anchorage, AKBanner MD Anderson Cancer Center· Gilbert, AZAlta Bates Comprehensive Cancer Center· Berkeley, CAMemorialCare Long Beach Medical Center· Long Beach, CAUniversity of California Irvine· Orange, CAPIH Health Hospital· Whittier, CA

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