A Study of Teclistamab in Combination With Daratumumab Subcutaneously (SC) (Tec-Dara) Versus Daratumumab SC, Pomalidomide, and Dexamethasone (DPd) or Daratumumab SC, Bortezomib, and Dexamethasone (DVd) in Participants With Relapsed or Refractory Multiple Myeloma

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Janssen Research & Development, LLC
Study ID
NCT05083169
Phase
PHASE3
Status
Active Not Recruiting

Conditions

Eligibility Criteria

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

Interventions

  • Daratumumab — DRUG
    Daratumumab will be administered SC injection.
  • Pomalidomide — DRUG
    Pomalidomide will be administered orally.
  • Dexamethasone — DRUG
    Dexamethasone will be administered orally or intravenously.
  • Bortezomib — DRUG
    Bortezomib will be administered SC injection.
  • Teclistamab — DRUG
    Teclistamab will be administered SC injection.

Study Details

The purpose of this study is to compare the efficacy of teclistamab daratumumab (Tec-Dara) with daratumumab subcutaneously (SC) in combination with pomalidomide and dexamethasone (DPd) or daratumumab SC in combination with bortezomib and dexamethasone (DVd).

Key Dates

Start date
Oct 14, 2021
Status verified
May 2026
Primary completion
Dec 8, 2028
Completion
Dec 8, 2028

Study Design

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

Arms

  • Experimental: Arm A: Teclistamab-daratumumab (Tec-Dara)
    Participants will receive teclistamab and daratumumab by subcutaneous (SC) injection. Step-up doses of teclistamab will be given prior to the first full dose.
  • Experimental: Arm B: DPd or DVd
    Participants will be randomized either to daratumumab, pomalidomide, dexamethasone (DPd) treatment to receive daratumumab SC injection; pomalidomide orally; dexamethasone orally or intravenously, or to Daratumumab, Bortezomib, Dexamethasone (DVd) treatment to receive daratumumab SC injection; bortezomib SC injection, and dexamethasone orally or intravenously.

Primary Outcome Measure

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

Locations (18)

FacilityCityStateZIPSite coordinators
University of Alabama BirminghamBirminghamAlabama35294-
City of HopeDuarteCalifornia91010-
Stanford University Medical CenterStanfordCalifornia94305-5623-
Yale UniversityNew HavenConnecticut06510-
Emory University Winship Cancer InstituteAtlantaGeorgia30322-
Tufts Medical CenterBostonMassachusetts02111-
Henry Ford HospitalDetroitMichigan48202-
Henry Ford Health SystemSouthfieldMichigan48075-
Cleveland ClinicClevelandOhio44195-
University of Pittsburgh Medical CenterPittsburghPennsylvania15232-
West Penn HospitalPittsburghPennsylvania15224-
Medical University of South CarolinaCharlestonSouth Carolina29425-8900-
Baptist Cancer CenterMemphisTennessee38120-
Vanderbilt Ingram Cancer CenterNashvilleTennessee37232-
University of Texas Southwestern Medical CenterDallasTexas75235-
Huntsman Cancer InstituteSalt Lake CityUtah84112-
Fred Hutchinson Cancer CenterSeattleWashington98109-
University of Wisconsin Carbone Cancer CenterMadisonWisconsin53792-

Find similar trials in Birmingham, AL

By condition
Multiple myeloma
By specialty
OncologyBlood cancer
By research site
University of Alabama Birmingham· Birmingham, ALCity of Hope· Duarte, CAStanford University Medical Center· Stanford, CAYale University· New Haven, CTEmory University Winship Cancer Institute· Atlanta, GATufts Medical Center· Boston, MA

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