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NCT03288493 · FLOW

Participant flow

P-BCMA-101 Tscm CAR-T Cells in the Treatment of Patients With Multiple Myeloma (MM) · Source last updated 2024-03-28

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

groups
  1. description
    Single administration dose cohorts, given in a single intravenous infusion of CAR-T cells. Rimiducid may be administered as indicated.
    id
    FG000
    title
    Phase 1: P-BCMA-101 CAR-T Cells
  2. description
    Single dose given across two intravenous infusions of CAR-T cells. Rimiducid may be administered as indicated.
    id
    FG001
    title
    Phase 1 P-BCMA-101 CAR-T Cells (Cohort A)
  3. description
    Single dose given across three intravenous infusions of CAR-T cells. Rimiducid may be administered as indicated.
    id
    FG002
    title
    Phase 1 P-BCMA-101 CAR-T Cells (Cohort B)
  4. description
    Single intravenous infusion of CAR-T cells, with combination therapy, beginning one week before CAR-T infusion.
    id
    FG003
    title
    Phase 1 P-BCMA-101 CAR-T Cells With Comb.Therapy (Cohort R)
  5. description
    Single intravenous infusion of CAR-T cells, with combination therapy, beginning one week before apheresis. Rimiducid may be administered as indicated.
    id
    FG004
    title
    Phase 1 P-BCMA-101 CAR-T Cells With Comb.Therapy (Cohort RP)
  6. description
    Single intravenous infusion of CAR-T cells, with combination therapy, beginning one week before CAR-T infusion. Rimiducid may be administered as indicated.
    id
    FG005
    title
    Phase 1 P-BCMA-101 CAR-T Cells With Comb.Therapy (Cohort RIT)
  7. description
    CAR-T cells administered via intravenous infusion as a total dose
    id
    FG006
    title
    Phase 2: P-BCMA-101 CAR-T Cells
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        2
      7. group Id
        FG006
        num Subjects
        0
      type
      Withdrawal by Subject
    2. reasons
      1. group Id
        FG000
        num Subjects
        52
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        6
      5. group Id
        FG004
        num Subjects
        5
      6. group Id
        FG005
        num Subjects
        10
      7. group Id
        FG006
        num Subjects
        3
      type
      Significant progression of malignancy requiring alternative, medical, radiation or surgical interven
    3. reasons
      1. group Id
        FG000
        num Subjects
        6
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        2
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        4
      7. group Id
        FG006
        num Subjects
        0
      type
      Termination of the study by the PI, the sponsor, the study funder, the IRB/IEC or the FDA
    4. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      type
      Death
    5. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      type
      other reason not listed above
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        69
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        8
      5. group Id
        FG004
        num Subjects
        5
      6. group Id
        FG005
        num Subjects
        16
      7. group Id
        FG006
        num Subjects
        3
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      comment
      Completed Study is defined as a subject completing Post-Treatment Follow-up Visits to Month 24.
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        66
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        8
      5. group Id
        FG004
        num Subjects
        5
      6. group Id
        FG005
        num Subjects
        16
      7. group Id
        FG006
        num Subjects
        3
      type
      NOT COMPLETED
    title
    Overall Study
Complete source fields
groups
  1. description
    Single administration dose cohorts, given in a single intravenous infusion of CAR-T cells. Rimiducid may be administered as indicated.
    id
    FG000
    title
    Phase 1: P-BCMA-101 CAR-T Cells
  2. description
    Single dose given across two intravenous infusions of CAR-T cells. Rimiducid may be administered as indicated.
    id
    FG001
    title
    Phase 1 P-BCMA-101 CAR-T Cells (Cohort A)
  3. description
    Single dose given across three intravenous infusions of CAR-T cells. Rimiducid may be administered as indicated.
    id
    FG002
    title
    Phase 1 P-BCMA-101 CAR-T Cells (Cohort B)
  4. description
    Single intravenous infusion of CAR-T cells, with combination therapy, beginning one week before CAR-T infusion.
    id
    FG003
    title
    Phase 1 P-BCMA-101 CAR-T Cells With Comb.Therapy (Cohort R)
  5. description
    Single intravenous infusion of CAR-T cells, with combination therapy, beginning one week before apheresis. Rimiducid may be administered as indicated.
    id
    FG004
    title
    Phase 1 P-BCMA-101 CAR-T Cells With Comb.Therapy (Cohort RP)
  6. description
    Single intravenous infusion of CAR-T cells, with combination therapy, beginning one week before CAR-T infusion. Rimiducid may be administered as indicated.
    id
    FG005
    title
    Phase 1 P-BCMA-101 CAR-T Cells With Comb.Therapy (Cohort RIT)
  7. description
    CAR-T cells administered via intravenous infusion as a total dose
    id
    FG006
    title
    Phase 2: P-BCMA-101 CAR-T Cells
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        2
      7. group Id
        FG006
        num Subjects
        0
      type
      Withdrawal by Subject
    2. reasons
      1. group Id
        FG000
        num Subjects
        52
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        6
      5. group Id
        FG004
        num Subjects
        5
      6. group Id
        FG005
        num Subjects
        10
      7. group Id
        FG006
        num Subjects
        3
      type
      Significant progression of malignancy requiring alternative, medical, radiation or surgical interven
    3. reasons
      1. group Id
        FG000
        num Subjects
        6
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        2
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        4
      7. group Id
        FG006
        num Subjects
        0
      type
      Termination of the study by the PI, the sponsor, the study funder, the IRB/IEC or the FDA
    4. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      type
      Death
    5. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      type
      other reason not listed above
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        69
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        8
      5. group Id
        FG004
        num Subjects
        5
      6. group Id
        FG005
        num Subjects
        16
      7. group Id
        FG006
        num Subjects
        3
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      comment
      Completed Study is defined as a subject completing Post-Treatment Follow-up Visits to Month 24.
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        66
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        8
      5. group Id
        FG004
        num Subjects
        5
      6. group Id
        FG005
        num Subjects
        16
      7. group Id
        FG006
        num Subjects
        3
      type
      NOT COMPLETED
    title
    Overall Study

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Preserved source evidence · Not medical advice