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NCT01245673 · FLOW

Participant flow

Combination Immunotherapy and Autologous Stem Cell Transplantation for Myeloma · Source last updated 2020-04-06

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

groups
  1. description
    MAGE-A3, GM-CSF, Hiltonol® (Poly-ICLC), PCV vaccine prior to apheresis. Stem cell mobilization. High-dose melphalan, then hematopoietic stem cells on Day 0. Day 2 Activated/costimulated autologous T cells. Days 14, 42 and 90 MAGE-A3, Hiltonol® and PVC. Day 100 start Lenalidomide. Day 120 and 150 MAGE-A3 and PVC.
    id
    FG000
    title
    MAGE A-3, GM-CSF, Hiltonol®, T Cells, Lenalidomide,
periods
  1. milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        28
      type
      STARTED
    2. achievements
      1. comment
        One subject failed to meet screening criteria for the trial.
        group Id
        FG000
        num Subjects
        27
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        1
      type
      NOT COMPLETED
    title
    Enrollment
  2. milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        27
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        27
      comment
      MAGE-A3, GM-CSF, Hiltonol®, PCV vaccine \~10 days before apheresis.
      type
      Pre Transplant Vaccinations 1-3
    3. achievements
      1. group Id
        FG000
        num Subjects
        27
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Pre Transplant Vaccinations
  3. milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        27
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        27
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Activated/Costimulated Autologous T Cell
  4. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Off Study due to Disease Progression
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        27
      comment
      On study Days 14, 42 and 90 study participants will receive MAGE-A3, Hiltonol® and PVC vaccine.
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        26
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        1
      type
      NOT COMPLETED
    title
    MAGE-A3, Hiltonol®, PVC After T Cells
  5. milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        26
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        26
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Start Lenalidomide
  6. milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        26
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        26
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Maintenance: MAGE-A3, PVC After T Cells
Complete source fields
groups
  1. description
    MAGE-A3, GM-CSF, Hiltonol® (Poly-ICLC), PCV vaccine prior to apheresis. Stem cell mobilization. High-dose melphalan, then hematopoietic stem cells on Day 0. Day 2 Activated/costimulated autologous T cells. Days 14, 42 and 90 MAGE-A3, Hiltonol® and PVC. Day 100 start Lenalidomide. Day 120 and 150 MAGE-A3 and PVC.
    id
    FG000
    title
    MAGE A-3, GM-CSF, Hiltonol®, T Cells, Lenalidomide,
periods
  1. milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        28
      type
      STARTED
    2. achievements
      1. comment
        One subject failed to meet screening criteria for the trial.
        group Id
        FG000
        num Subjects
        27
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        1
      type
      NOT COMPLETED
    title
    Enrollment
  2. milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        27
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        27
      comment
      MAGE-A3, GM-CSF, Hiltonol®, PCV vaccine \~10 days before apheresis.
      type
      Pre Transplant Vaccinations 1-3
    3. achievements
      1. group Id
        FG000
        num Subjects
        27
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Pre Transplant Vaccinations
  3. milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        27
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        27
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Activated/Costimulated Autologous T Cell
  4. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Off Study due to Disease Progression
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        27
      comment
      On study Days 14, 42 and 90 study participants will receive MAGE-A3, Hiltonol® and PVC vaccine.
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        26
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        1
      type
      NOT COMPLETED
    title
    MAGE-A3, Hiltonol®, PVC After T Cells
  5. milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        26
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        26
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Start Lenalidomide
  6. milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        26
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        26
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Maintenance: MAGE-A3, PVC After T Cells

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Preserved source evidence · Not medical advice