A Study Comparing Anitocabtagene Autoleucel to Standard of Care Therapy in Participants With Relapsed/ Refractory Multiple Myeloma

Part of paid clinical trials in Gilbert, Arizona.

Sponsor
Kite, A Gilead Company
Study ID
NCT06413498
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

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

Interventions

  • Anitocabtagene Autoleucel — DRUG
    A single infusion of CAR+ transduced autologous T cells
  • Cyclophosphamide — DRUG
    Administered intravenously
  • Fludarabine — DRUG
    Administered intravenously
  • Pomalidomide — DRUG
    Tablet administered orally
  • Bortezomib — DRUG
    Administered intravenously or subcutaneously
  • Dexamethasone — DRUG
    Tablet administered orally
  • Daratumumab — DRUG
    Administered intravenously or subcutaneously
  • Carfilzomib — DRUG
    Administered intravenously

Study Details

The goal of this study (iMMagine-3) is to compare the study drug, anitocabtagene autoleucel to standard of care therapy (SOCT) in participants with relapsed/refractory multiple myeloma who have received 1 to 3 prior lines of therapy, including an anti-CD38 monoclonal antibody and an immunomodulatory drug. The primary objective of this study is to compare the efficacy of anitocabtagene autoleucel versus SOCT in participants with RRMM.

Key Dates

Start date
Aug 23, 2024
Status verified
May 2026
Primary completion
Jul 31, 2028
Completion
Jul 31, 2031

Study Design

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

Arms

  • Experimental: Anitocabtagene Autoleucel
    Participants with RRMM will receive lymphodepletion chemotherapy with cyclophosphamide and fludarabine for 3 days followed by single dose of anitocabtagene autoleucel chimeric antigen receptor positive (CAR+) on Day 1.
  • Active Comparator: Standard of Care Therapy (SOCT)
    Participants will receive the investigator's choice of one of the following therapies: * pomalidomide, bortezomib, and dexamethasone (PVd) (21-day cycles) * daratumumab, pomalidomide, and dexamethasone (DPd) (28-day cycles) * carfilzomib, daratumumab, and dexamethasone (KDd) (28-day cycles) * carfilzomib and dexamethasone (Kd) (28-day cycles)

Primary Outcome Measure

Progression-Free Survival (PFS) [ Time Frame: Up to 4 years ]

Central Contacts

Locations (50)

FacilityCityStateZIPSite coordinators
Banner MD Anderson Cancer CenterGilbertArizona85234-
Mayo Clinic HospitalGilbertArizona85234-
City of Hope (City of Hope National Medical Center, City of Hope Medical Center)DuarteCalifornia91010-
USC/Norris Comprehensive Cancer CenterLos AngelesCalifornia90033-
University of California Davis Comprehensive Cancer CenterSacramentoCalifornia95817-
UC San Diego Moores Cancer CenterSan DiegoCalifornia92037-
University of California San Francisco Medical CenterSan FranciscoCalifornia94143-
UCLA Hematology/Oncology (Bowyer Infusion Clinic)Santa MonicaCalifornia90404-
Stanford Cancer InstituteStanfordCalifornia94305-
Colorado Blood Cancer InstituteDenverColorado80218-
Sylvester Comprehensive Cancer CenterCoral GablesFlorida33146-
Mayo ClinicJacksonvilleFlorida32256-
Moffitt Cancer CenterTampaFlorida33612-
Winship Cancer Institute, Emory UniversityAtlantaGeorgia30322-
Southeastern Regional Medical Center, Inc. dba City of Hope AtlantaNewnanGeorgia30265-
St. Luke's Cancer InstituteBoiseIdaho83712-
University of Illinois Hospital and Health Sciences SystemChicagoIllinois60612-
IU Melvin and Bren Simon Comprehensive Cancer CenterIndianapolisIndiana46202-
Norton Cancer Institute, St. Matthews CampusLouisvilleKentucky40207-
Ochsner Clinical FoundationNew OrleansLouisiana70121-
University of Maryland Greenebaum Comprehensive Cancer CenterBaltimoreMaryland21201-
Boston Medical CenterBostonMassachusetts02118-
Massachusetts General HospitalBostonMassachusetts02114-
University of MichiganAnn ArborMichigan48109-
Corewell Health - Lemmen-Holton Cancer PavilionGrand RapidsMichigan49503-
Mayo ClinicRochesterMinnesota55902-
Oncology Hematology West, PC dba Nebraska Cancer Specialists - LegacyOmahaNebraska68130-
Dartmouth Hitchcock Medical CenterLebanonNew Hampshire03756-
New Mexico Cancer Research AllianceAlbuquerqueNew Mexico87102-
Icahn School of Medicine at Mount SinaiNew YorkNew York10029-
Laura & Isaac Perlmutter Cancer Center at NYU Langone HealthNew YorkNew York10016-
Weill Cornell Medicine - New York Presbyterian HosptialNew YorkNew York10021-
Levine Cancer InstituteCharlotteNorth Carolina28204-
Novant Health Cancer Institute - HematologyCharlotteNorth Carolina28204-
Novant Health Cancer Institute Hematology- ForsythWinston-SalemNorth Carolina27103-
Oncology Hematology Care Clinical Trials, LLCCincinnatiOhio45236-
University of Cincinnati Cancer CenterCincinnatiOhio45219-
Oregon Health and Science UniversityPortlandOregon97239-
University of Tennessee Medical CenterKnoxvilleTennessee37920-
Baptist Cancer CenterMemphisTennessee38104-
Henry-Joyce Cancer ClinicNashvilleTennessee37232-
Tennessee Oncology, PLLC - Greco-Hainsworth Centers for ResearchNashvilleTennessee37203-
St. David's South Austin Medical CenterAustinTexas78704-
Houston Methodist Hospital Cancer CenterHoustonTexas77030-
The University of Texas MD Anderson Cancer CenterHoustonTexas77030-
Huntsman Cancer Institute, University of UtahSalt Lake CityUtah84112-
LDS HospitalSalt Lake CityUtah84143-
Fred Hutchinson Cancer CenterSeattleWashington98109-
Swedish Cancer InstituteSeattleWashington98104-
West Virginia UniversityMorgantownWest Virginia26506-

Find similar trials in Gilbert, AZ

By condition
Multiple myeloma
By specialty
OncologyBlood cancer
By research site
Banner MD Anderson Cancer Center· Gilbert, AZMayo Clinic Hospital· Gilbert, AZCity of Hope (City of Hope National Medical Center, City of Hope Medical Center)· Duarte, CAUSC/Norris Comprehensive Cancer Center· Los Angeles, CAUniversity of California Davis Comprehensive Cancer Center· Sacramento, CAUC San Diego Moores Cancer Center· San Diego, CA

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