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NCT01001442 · FLOW

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Safety and Dose Determining Multi-dose Study of BT062 in Patients With Relapsed or Refractory Multiple Myeloma · Source last updated 2019-07-30

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

groups
  1. description
    40 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.
    id
    FG000
    title
    BT062 40 mg/m²
  2. description
    50 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.
    id
    FG001
    title
    BT062 50 mg/m²
  3. description
    65 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.
    id
    FG002
    title
    BT062 65 mg/m²
  4. description
    80 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.
    id
    FG003
    title
    BT062 80 mg/m²
  5. description
    100 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.
    id
    FG004
    title
    BT062 100 mg/m²
  6. description
    120 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.
    id
    FG005
    title
    BT062 120 mg/m²
  7. description
    140 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.
    id
    FG006
    title
    BT062 140 mg/m²
  8. description
    160 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.
    id
    FG007
    title
    BT062 160 mg/m²
periods
  1. milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        4
      4. group Id
        FG003
        num Subjects
        3
      5. group Id
        FG004
        num Subjects
        4
      6. group Id
        FG005
        num Subjects
        3
      7. group Id
        FG006
        num Subjects
        10
      8. group Id
        FG007
        num Subjects
        4
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        4
      4. group Id
        FG003
        num Subjects
        3
      5. group Id
        FG004
        num Subjects
        2
      6. group Id
        FG005
        num Subjects
        3
      7. group Id
        FG006
        num Subjects
        6
      8. group Id
        FG007
        num Subjects
        2
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      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
        2
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        4
      8. group Id
        FG007
        num Subjects
        2
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
The Intention-to-treat (ITT) population included all subjects who were enrolled in the study and received at least 1 dose of BT062 and who had any post-Baseline evaluations or data. One subject did not have at least one post-injection assessment of the treatment response and was excluded from both the ITT and PP populations (n = 34).
Complete source fields
groups
  1. description
    40 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.
    id
    FG000
    title
    BT062 40 mg/m²
  2. description
    50 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.
    id
    FG001
    title
    BT062 50 mg/m²
  3. description
    65 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.
    id
    FG002
    title
    BT062 65 mg/m²
  4. description
    80 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.
    id
    FG003
    title
    BT062 80 mg/m²
  5. description
    100 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.
    id
    FG004
    title
    BT062 100 mg/m²
  6. description
    120 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.
    id
    FG005
    title
    BT062 120 mg/m²
  7. description
    140 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.
    id
    FG006
    title
    BT062 140 mg/m²
  8. description
    160 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.
    id
    FG007
    title
    BT062 160 mg/m²
periods
  1. milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        4
      4. group Id
        FG003
        num Subjects
        3
      5. group Id
        FG004
        num Subjects
        4
      6. group Id
        FG005
        num Subjects
        3
      7. group Id
        FG006
        num Subjects
        10
      8. group Id
        FG007
        num Subjects
        4
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        4
      4. group Id
        FG003
        num Subjects
        3
      5. group Id
        FG004
        num Subjects
        2
      6. group Id
        FG005
        num Subjects
        3
      7. group Id
        FG006
        num Subjects
        6
      8. group Id
        FG007
        num Subjects
        2
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      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
        2
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        4
      8. group Id
        FG007
        num Subjects
        2
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
The Intention-to-treat (ITT) population included all subjects who were enrolled in the study and received at least 1 dose of BT062 and who had any post-Baseline evaluations or data. One subject did not have at least one post-injection assessment of the treatment response and was excluded from both the ITT and PP populations (n = 34).

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Preserved source evidence · Not medical advice