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NCT01478581 · FLOW

Participant flow

Study of the Bruton's Tyrosine Kinase Inhibitor in Subjects With Relapsed or Relapsed and Refractory Multiple Myeloma · Source last updated 2020-03-10

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

groups
  1. description
    PCI-32765 420 mg per day PCI-32765
    id
    FG000
    title
    PCI-32765 420 mg Per Day
  2. description
    PCI-32765 560 mg per day, 40 mg dexamethasone (oral) once per week PCI-32765 Dexamethasone
    id
    FG001
    title
    PCI-32765 560 mg Per Day, 40 mg Dexamethasone
  3. description
    PCI-32765 840 mg per day PCI-32765
    id
    FG002
    title
    PCI-32765 840 mg Per Day
  4. description
    PCI-32765 840 mg per day, 40 mg dexamethasone (oral) once per week PCI-32765 Dexamethasone
    id
    FG003
    title
    PCI-32765 840 mg Per Day, 40 mg Dexamethasone
periods
  1. milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        13
      2. group Id
        FG001
        num Subjects
        18
      3. group Id
        FG002
        num Subjects
        18
      4. comment
        Simon 2-stage design - cohort 4 expansion per stage 1 data (≥3 Clinical Benefit Responders observed
        group Id
        FG003
        num Subjects
        43
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        13
      2. group Id
        FG001
        num Subjects
        18
      3. group Id
        FG002
        num Subjects
        18
      4. group Id
        FG003
        num Subjects
        43
      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
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
Simon 2-stage design . Stage 1 -13 subjects enrolled in cohort 1. For cohort 2,3, and 4, up to 18 subjects were enrolled in Stage 1. Cohort 4 was selected for expansion for enrollment of 43 subjects in Stage 2.
Complete source fields
groups
  1. description
    PCI-32765 420 mg per day PCI-32765
    id
    FG000
    title
    PCI-32765 420 mg Per Day
  2. description
    PCI-32765 560 mg per day, 40 mg dexamethasone (oral) once per week PCI-32765 Dexamethasone
    id
    FG001
    title
    PCI-32765 560 mg Per Day, 40 mg Dexamethasone
  3. description
    PCI-32765 840 mg per day PCI-32765
    id
    FG002
    title
    PCI-32765 840 mg Per Day
  4. description
    PCI-32765 840 mg per day, 40 mg dexamethasone (oral) once per week PCI-32765 Dexamethasone
    id
    FG003
    title
    PCI-32765 840 mg Per Day, 40 mg Dexamethasone
periods
  1. milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        13
      2. group Id
        FG001
        num Subjects
        18
      3. group Id
        FG002
        num Subjects
        18
      4. comment
        Simon 2-stage design - cohort 4 expansion per stage 1 data (≥3 Clinical Benefit Responders observed
        group Id
        FG003
        num Subjects
        43
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        13
      2. group Id
        FG001
        num Subjects
        18
      3. group Id
        FG002
        num Subjects
        18
      4. group Id
        FG003
        num Subjects
        43
      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
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
Simon 2-stage design . Stage 1 -13 subjects enrolled in cohort 1. For cohort 2,3, and 4, up to 18 subjects were enrolled in Stage 1. Cohort 4 was selected for expansion for enrollment of 43 subjects in Stage 2.

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice