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NCT05032820 · FLOW

Participant flow

Upfront Chimeric Antigen Receptor T-Cell to Upgrade Response in Multiple Myeloma · Source last updated 2026-05-19

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

groups
  1. description
    Patients complete apheresis and proceed to lymphodepleting chemotherapy with cyclophosphamide 300mg/m\^2 and fludarabine 30mg/m\^2 for 3 consecutive days followed by the infusion of BCMA CAR T-cells at a target dose of 450 x10\^6 cells. Maintenance lenalidomide, starting at 5mg a day for 21 days of a 28-day cycle will be initiated at a minimum of at least 30 days, but no later than 180 days after the CAR T-cell infusion and will continue until the patient reaches 12 months post CAR T-cell infusion and continue free of progression. Lenalidomide: Maintenance lenalidomide, starting at 5 mg a day for 21 days of a 28-day cycle, will be initiated at a minimum of at least 30 days, but no later than 180 days after the CAR T-cell infusion and will continue until the participant reaches 12 months post CAR T-cell infusion and continues free of progression bb2121: Participants receive infusion of BCMA CAR T-cells at a target dose of 450 x 10\^6 cells. Cyclophosphamide: 300 mg/m\^2/day for 3 consecutive days prior to the CAR T infusion Fludarabine: 30 mg/m\^2/day or 3 consecutive days prior to the CAR T infusion leukapheresis: Placement of central line catheter and leukapheresis
    id
    FG000
    title
    Lenalidomide and bb2121
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Lost to Follow-up
    2. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Withdrawal by Subject
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        40
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        38
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        2
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
There was a Safety Run-in that included the first three participants enrolled on the study with staggered enrollment to assess for excess early toxicity. These data were reviewed and enrollment was approved in the Continuing Enrollment Phase which began on October 14, 2022.
recruitment Details
BMT CTN 1902's enrollment was between January 2022 and December 2023 with 40 participants enrolled from 12 centers. The study opened to accrual in February 2021. Fifteen centers were activated for enrollment. The study closed to accrual on January 09, 2024.
Complete source fields
groups
  1. description
    Patients complete apheresis and proceed to lymphodepleting chemotherapy with cyclophosphamide 300mg/m\^2 and fludarabine 30mg/m\^2 for 3 consecutive days followed by the infusion of BCMA CAR T-cells at a target dose of 450 x10\^6 cells. Maintenance lenalidomide, starting at 5mg a day for 21 days of a 28-day cycle will be initiated at a minimum of at least 30 days, but no later than 180 days after the CAR T-cell infusion and will continue until the patient reaches 12 months post CAR T-cell infusion and continue free of progression. Lenalidomide: Maintenance lenalidomide, starting at 5 mg a day for 21 days of a 28-day cycle, will be initiated at a minimum of at least 30 days, but no later than 180 days after the CAR T-cell infusion and will continue until the participant reaches 12 months post CAR T-cell infusion and continues free of progression bb2121: Participants receive infusion of BCMA CAR T-cells at a target dose of 450 x 10\^6 cells. Cyclophosphamide: 300 mg/m\^2/day for 3 consecutive days prior to the CAR T infusion Fludarabine: 30 mg/m\^2/day or 3 consecutive days prior to the CAR T infusion leukapheresis: Placement of central line catheter and leukapheresis
    id
    FG000
    title
    Lenalidomide and bb2121
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Lost to Follow-up
    2. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Withdrawal by Subject
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        40
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        38
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        2
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
There was a Safety Run-in that included the first three participants enrolled on the study with staggered enrollment to assess for excess early toxicity. These data were reviewed and enrollment was approved in the Continuing Enrollment Phase which began on October 14, 2022.
recruitment Details
BMT CTN 1902's enrollment was between January 2022 and December 2023 with 40 participants enrolled from 12 centers. The study opened to accrual in February 2021. Fifteen centers were activated for enrollment. The study closed to accrual on January 09, 2024.

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Preserved source evidence · Not medical advice