Efficacy and Safety Study of bb2121 Versus Standard Regimens in Subjects With Relapsed and Refractory Multiple Myeloma (RRMM)

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Celgene
Study ID
NCT03651128
Phase
PHASE3
Status
Active Not Recruiting

Conditions

Eligibility Criteria

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

Interventions

  • bb2121 — BIOLOGICAL
    bb2121
  • Daratumumab — DRUG
    Daratumumab
  • Pomalidomide — DRUG
    Pomalidomide
  • Dexamethasone — DRUG
    Dexamethasone
  • Bortezomib — DRUG
    Bortezomib
  • Ixazomib — DRUG
    Ixazomib
  • Lenalidomide — DRUG
    Lenalidomide
  • Carfilzomib — DRUG
    Carfilzomib
  • Elotuzumab — DRUG
    Elotuzumab

Study Details

This is a multicenter, randomized, open-label, Phase 3 study comparing the efficacy and safety of bb2121 versus standard regimens in subjects with relapsed and refractory multiple myeloma (RRMM). The study is anticipated to randomize approximately 381 subjects with RRMM. Approximately 254 subjects will be randomized to Treatment Arm A and approximately 127 subjects will be randomized to Treatment Arm B.

Key Dates

Start date
Apr 16, 2019
Status verified
Dec 2022
Primary completion
Apr 8, 2027
Completion
Apr 8, 2027

Study Design

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

Arms

  • Experimental: Arm A - Administration of bb2121
    bb2121 autologous CAR T cells will be infused at a dose ranging from 150 - 450 x 10\^6 CAR+ T cells after receiving lymphodepleting chemotherapy
  • Experimental: Arm B- standard regimens as per Investigator's discretion
    The participants will receive one of following regimens dependent on the subject's most recent anti-myeloma treatment regimen: * Daratumumab (DARA) in combination with pomalidomide (POM) and low-dose dexamethasone (dex) (DPd) OR * DARA in combination with bortezomib (BTZ) and low-dose dex (DVd) OR * Ixazomib (IXA) in combination with lenalidomide (LEN) and low-dose dex (IRd) OR * Carfilzomib (CFZ) in combination with low-dose dexamethasone (Kd) OR * Elotuzumab (ELO) in combination with POM and low-dose dexamethasone (EPd)

Primary Outcome Measure

Progression-free Survival (PFS) [ Time Frame: Minimum of 5 years from randomization ]

Locations (34)

FacilityCityStateZIPSite coordinators
Local Institution - 109BirminghamAlabama10016-
Local Institution - 141ScottsdaleArizona85259-
Local Institution - 122Los AngelesCalifornia90095-
Local Institution - 145Los AngelesCalifornia90048-
Local Institution - 124Palo AltoCalifornia94304-
Local Institution - 142AuroraColorado80045-
Local Institution - 108JacksonvilleFlorida32224-
Local Institution - 102TampaFlorida33612-
Local Institution - 131AtlantaGeorgia30322-
Local Institution - 140AtlantaGeorgia30342-
Local Institution - 139ChicagoIllinois60611-
Local Institution - 100IndianapolisIndiana46202-528-
Local Institution - 112WestwoodKansas66205-2003-
Local Institution - 104BaltimoreMaryland21201-1595-
Local Institution - 123BostonMassachusetts02215-
Local Institution - 134BostonMassachusetts02114-
University Of Michigan Comprehensive Cancer CenterAnn ArborMichigan48109-5936-
Local Institution - 125RochesterMinnesota55905-0001-
Local Institution - 114St LouisMissouri63110-
Local Institution - 138HackensackNew Jersey07601-
Local Institution - 115New YorkNew York10065-
Local Institution - 119New YorkNew York10029-
Local Institution - 135New YorkNew York10065-
Local Institution - 113DurhamNorth Carolina27705-
Local Institution - 110PhiladelphiaPennsylvania19111-
Local Institution - 111PhiladelphiaPennsylvania19107-
University of Pittsburgh Medical Center William M. Cooper Ambulatory Care PavillionPittsburghPennsylvania15232-
Local Institution - 106NashvilleTennessee37203-
Local Institution - 103DallasTexas75390-
Local Institution - 118DallasTexas75246-
Local Institution - 132HoustonTexas77030-
Local Institution - 136Salt Lake CityUtah84112-
Local Institution - 105SeattleWashington98104-
Local Institution - 107MadisonWisconsin53792-

Find similar trials in Birmingham, AL

By condition
Multiple myeloma
By specialty
OncologyBlood cancer
By research site
Local Institution - 109· Birmingham, ALLocal Institution - 141· Scottsdale, AZLocal Institution - 122· Los Angeles, CALocal Institution - 145· Los Angeles, CALocal Institution - 124· Palo Alto, CALocal Institution - 142· Aurora, CO

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