A Study Comparing Talquetamab Plus Pomalidomide, Talquetamab Plus Teclistamab, and Elotuzumab, Pomalidomide, and Dexamethasone or Pomalidomide, Bortezomib, and Dexamethasone in Participants With Relapsed or Refractory Myeloma Who Have Received an Anti-CD38 Antibody and Lenalidomide

Part of paid clinical trials in Clovis, California.

Sponsor
Janssen Research & Development, LLC
Study ID
NCT06208150
Phase
PHASE3
Status
Recruiting

Conditions

Eligibility Criteria

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

Interventions

  • Talquetamab — DRUG
    Talquetamab will be administered as a SC injection.
  • Pomalidomide — DRUG
    Pomalidomide will be administered orally.
  • Teclistamab — DRUG
    Teclistamab will be administered as a SC injection.
  • Elotuzumab — DRUG
    Elotuzumab will be administered intravenously.
  • Dexamethasone — DRUG
    Dexamethasone will be administered either orally or intravenously.
  • Bortezomib — DRUG
    Bortezomib will be administered as a SC injection.

Study Details

The purpose of this study is to compare the effectiveness of either talquetamab plus pomalidomide (Tal-P) or talquetamab plus teclistamab (Tal-Tec) with elotuzumab, pomalidomide, and dexamethasone (EPd) or pomalidomide, bortezomib, and dexamethasone (PVd).

Key Dates

Start date
Jan 22, 2024
Status verified
Jun 2026
Primary completion
Apr 1, 2026
Completion
Dec 31, 2028

Study Design

Enrollment
795 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A: Talquetamab + Pomalidomide (Tal-P)
    Participants will receive talquetamab as subcutaneous (SC) injections; pomalidomide will be self-administered as a single dose orally; dexamethasone may be given orally or intravenously as a pretreatment medication and study drug.
  • Experimental: Arm B: Talquetamab + Teclistamab (Tal-Tec)
    Participants will receive teclistamab in combination with talquetamab both as SC injection; dexamethasone may be given orally or intravenously as a pretreatment medication and study drug.
  • Active Comparator: Arm C: Elotuzumab+ Pomalidomide+Dexamethasone (EPd) or Pomalidomide+Bortezomib+Dexamethasone (PVd)
    Participants will either receive elotuzumab intravenous (IV) injection in combination with pomalidomide and dexamethasone orally; or pomalidamide orally in combination with bortezomib SC injection and dexamethasone orally as per investigator choice. Dexamethasone will be administered as a pretreatment medication.

Primary Outcome Measure

Progression Free Survival (PFS) [ Time Frame: Up to 3 years 5 months ]

Central Contacts

Locations (49)

FacilityCityStateZIPSite coordinators
UCSF FresnoClovisCalifornia93611-
UCLASanta MonicaCalifornia90404-
Yale University School Of MedicineNew HavenConnecticut06519-
Medical Oncology Hematology Consultants, PANewarkDelaware19713-
Memorial Healthcare SystemHollywoodFlorida33021-
Moffitt Cancer CenterTampaFlorida33612-
Winship Cancer Institute Emory UniversityAtlantaGeorgia30322-
City of Hope Cancer CenterNewnanGeorgia30265-
Kootenai HealthCoeur d'AleneIdaho83814-
Loyola University Medical CenterMaywoodIllinois60153-
University of Iowa Health CareWaukeeIowa50263-
Norton Cancer InstituteLouisvilleKentucky40207-
Our Lady of the Lake HospitalBaton RougeLouisiana70808-
Luminis Health Center for Cancer and Blood DisordersAnnapolisMaryland21401-
The Sidney Kimmel Comprehensive Cancer Center at John HopkinsBaltimoreMaryland21287-
University of Maryland School of MedicineBaltimoreMaryland21201-
University of MichiganAnn ArborMichigan48109-
Henry Ford Cancer InstituteDetroitMichigan48202-
Henry Ford Health Providence Southfield HospitalSouthfieldMichigan48075-
University Of MinnesotaMinneapolisMinnesota55455-
Mayo Clinic RochesterRochesterMinnesota55905-
Regions HospitalSaint PaulMinnesota55101-
University of NebraskaOmahaNebraska68105-
Dartmouth Hitchcock Medical CenterLebanonNew Hampshire03756-
John Theurer Cancer Center at Hackensack University Medical CenterHackensackNew Jersey07601-
Roswell Park Cancer InstituteBuffaloNew York14263-
Weill Cornell Medical CollegeNew YorkNew York10065-
SUNY Upstate Medical UniversitySyracuseNew York13210-
Duke University Medical CenterDurhamNorth Carolina27705-
Gabrail Cancer CenterCantonOhio44718-
Cleveland ClinicClevelandOhio44195-
Louis Stokes Cleveland VA Med CtrClevelandOhio44106-
Oregon Health And Science UniversityPortlandOregon97239-
Penn State Milton S Hershey Medical CtrHersheyPennsylvania17033-
Thomas Jefferson UniversityPhiladelphiaPennsylvania19107 4215-
University Of Pittsburgh Medical Center UPMC Hillman Cancer CenterPittsburghPennsylvania15232-
West Penn HospitalPittsburghPennsylvania15224-
Medical University of South CarolinaCharlestonSouth Carolina29425-8900-
Bon Secours Saint Francis Cancer CenterGreenvilleSouth Carolina29607-
UT SouthwesternDallasTexas75390-
UT Southwestern Parkland HospitalDallasTexas75390-
Houston Methodist Neal Cancer Center at Texas Medical CenterHoustonTexas77030-
Huntsman Cancer InstituteSalt Lake CityUtah84112-
University of VirginiaCharlottesvilleVirginia22903-
Fred Hutchinson Cancer Research CenterSeattleWashington98109-
Swedish Cancer InstituteSeattleWashington98104-
NorthWest Medical Specialties, PLLCTacomaWashington98405-
Gundersen Health SystemLa CrosseWisconsin54601-
Medical College Of WisconsinMilwaukeeWisconsin53226-

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