An Efficacy and Safety Study of bb2121 in Subjects With Relapsed and Refractory Multiple Myeloma and in Subjects With High-Risk Multiple Myeloma

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
Celgene
Study ID
NCT03601078
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • bb2121 — BIOLOGICAL
    bb2121 consists of autologous T lymphocytes transduced with an anti-BCMA CAR lentiviral vector to express a chimeric antigen receptor targeting the human B cell maturation antigen (anti-BCMA CAR)
  • Lenalomide — DRUG
    Specified dose on specified days
  • Talquetamab — DRUG
    Specified dose on specified days

Study Details

This study is a multi-cohort, open-label, multicenter Phase 2 study to evaluate the efficacy and safety of bb2121 in participants with relapsed and refractory multiple myeloma (RRMM) (Cohort 1), in participants with RRMM who receive bridging therapy with talquetamab (Cohort 1b), in participants with multiple myeloma (MM) having progressed within 18 months of initial treatment with autologous stem cell transplantation (ASCT) (Cohort 2a) and without ASCT (Cohort 2b) or, in participants with inadequate response post ASCT during initial treatment (Cohort 2c) and the efficacy and safety of bb2121 used in combination with lenalidomide maintenance in participants with suboptimal response post ASCT (Cohort 3). Approximately 248 participants will be enrolled into one of three cohorts. Cohort 1 (including cohort 1b) will enroll approximately 126 RRMM subjects with ≥ 3 prior anti-myeloma treatment regimens. Cohort 2a will enroll approximately 39 MM subjects, with 1 prior anti-myeloma therapy including ASCT and with early relapse. Cohort 2b will enroll approximately 39 MM subjects with 1 prior anti-myeloma therapy not including ASCT and with early relapse. Cohort 2c will enroll approximately 30 MM subjects with inadequate response to ASCT during their initial anti-myeloma therapy. The cohorts will start in parallel and independently. Cohort 3 will enroll approximately 30 newly diagnosed multiple myeloma (NDMM) participants with suboptimal response to ASCT.

Key Dates

Start date
Dec 13, 2018
Status verified
Mar 2026
Primary completion
Jan 15, 2026
Completion
Jan 15, 2026

Study Design

Enrollment
312 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 1: BB2121 in relapsed and refractory multiple myeloma participants
    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: Cohort 1b: BB2121 with talquetamab in relapsed and refractory multiple myeloma participants
  • Experimental: Cohort 2a: BB2121 in multiple myeloma with Autologous stem cell transplantation participants
  • Experimental: Cohort 2b: BB2121 in multiple myeloma without Autologous stem cell transplantation participants
  • Experimental: Cohort 2c: BB2121 in multiple myeloma participants with inadequate response post ASCT
  • Experimental: Cohort 3: BB2121 with lenalidomide maintenance in newly diagnosed multiple myeloma

Primary Outcome Measure

Overall response rate (ORR)- Cohort 1 [ Time Frame: Up to approximately 5 years (Participants will transition to the long term follow-up (LTFU) study after a minimum of 12 months post-infusion for Cohorts 1, 2a, 2b, and 2c; and after a minimum of 6 months post-infusion for Cohort 1b, at their next visit) ]

Locations (18)

FacilityCityStateZIPSite coordinators
Mayo Clinic in Arizona - ScottsdaleScottsdaleArizona85259-
University Of California San Francisco Medical CenterSan FranciscoCalifornia94143-
Moffitt Cancer CenterTampaFlorida33612-
Emory University School of MedicineAtlantaGeorgia30322-
Beth Israel Deaconess Medical CenterBostonMassachusetts02215-
Dana Farber Cancer InstituteBostonMassachusetts02215-5450-
Massachusetts General HospitalBostonMassachusetts02117-
Washington UniversitySt LouisMissouri63110-
University Of NebraskaOmahaNebraska68198-7680-
John Theurer Cancer Center at Hackensack University Medical CenterHackensackNew Jersey07601-
Columbia University Medical Center/New York-Presbyterian HospitalNew YorkNew York10032-
Mt Sinai Medical Center - NYNew YorkNew York10029-
Levine Cancer InstituteCharlotteNorth Carolina28204-
Tennessee Oncology PLLCNashvilleTennessee37203-
University Of Texas Southwestern Medical CenterDallasTexas75390-
MD Anderson Cancer Center The University of TexasHoustonTexas77030-
Swedish Cancer InstSeattleWashington98104-
Froedtert Hospital BMT Medical College of WisconsinMilwaukeeWisconsin53226-

Find similar trials in Scottsdale, AZ

By condition
Multiple myeloma
By specialty
OncologyBlood cancer
By research site
Mayo Clinic in Arizona - Scottsdale· Scottsdale, AZUniversity Of California San Francisco Medical Center· San Francisco, CAMoffitt Cancer Center· Tampa, FLEmory University School of Medicine· Atlanta, GABeth Israel Deaconess Medical Center· Boston, MADana Farber Cancer Institute· Boston, MA

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