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NCT00075881 · FLOW

Participant flow

Bortezomib in Treating Patients With Newly Diagnosed Multiple Myeloma · Source last updated 2014-06-02

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

groups
  1. description
    Induction treatment: PS-341 1.3 mg/m2 IV push days 1, 4, 8, and 11. As per the PS-341 package insert, there should be at least 72 hours between each PS-341 dose. Repeat cycles every 3 weeks for a total of 8 cycles. Maintenance treatment: PS-341 1.3 mg/m2 IV push days 1 and 15. Reinduction treatment: PS-341 1.3 mg/m2 IV push days 1, 4, 8, and 11. As per the PS-341 package insert, there should be at least 72 hours between each PS-341 dose.
    id
    FG000
    title
    PS-341
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        18
      type
      Lack of Efficacy
    2. reasons
      1. group Id
        FG000
        num Subjects
        7
      type
      Adverse Event
    3. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Death
    4. reasons
      1. group Id
        FG000
        num Subjects
        2
      type
      Withdrawal by Subject
    5. reasons
      1. group Id
        FG000
        num Subjects
        4
      type
      Protocol Violation
    6. reasons
      1. group Id
        FG000
        num Subjects
        3
      type
      other complicating disease
    7. reasons
      1. group Id
        FG000
        num Subjects
        4
      type
      other
    8. reasons
      1. group Id
        FG000
        num Subjects
        2
      type
      missing data
    9. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Ineligible
    10. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      never start protocol therapy
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        44
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        43
      type
      Eligible
    3. achievements
      1. group Id
        FG000
        num Subjects
        42
      type
      Treated
    4. achievements
      1. group Id
        FG000
        num Subjects
        42
      type
      Induction Treatment
    5. achievements
      1. group Id
        FG000
        num Subjects
        15
      type
      Maintenance Treatment
    6. achievements
      1. group Id
        FG000
        num Subjects
        7
      type
      Reinduction Treatment
    7. achievements
      1. group Id
        FG000
        num Subjects
        1
      type
      COMPLETED
    8. achievements
      1. group Id
        FG000
        num Subjects
        43
      type
      NOT COMPLETED
    title
    Overall Study
recruitment Details
The study was activated on January 16, 2004 and terminated on March 7, 2005 after 44 patients had enrolled. Accrual rate was 3 patients per month, slower than expected rate (6 patients per month)
Complete source fields
groups
  1. description
    Induction treatment: PS-341 1.3 mg/m2 IV push days 1, 4, 8, and 11. As per the PS-341 package insert, there should be at least 72 hours between each PS-341 dose. Repeat cycles every 3 weeks for a total of 8 cycles. Maintenance treatment: PS-341 1.3 mg/m2 IV push days 1 and 15. Reinduction treatment: PS-341 1.3 mg/m2 IV push days 1, 4, 8, and 11. As per the PS-341 package insert, there should be at least 72 hours between each PS-341 dose.
    id
    FG000
    title
    PS-341
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        18
      type
      Lack of Efficacy
    2. reasons
      1. group Id
        FG000
        num Subjects
        7
      type
      Adverse Event
    3. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Death
    4. reasons
      1. group Id
        FG000
        num Subjects
        2
      type
      Withdrawal by Subject
    5. reasons
      1. group Id
        FG000
        num Subjects
        4
      type
      Protocol Violation
    6. reasons
      1. group Id
        FG000
        num Subjects
        3
      type
      other complicating disease
    7. reasons
      1. group Id
        FG000
        num Subjects
        4
      type
      other
    8. reasons
      1. group Id
        FG000
        num Subjects
        2
      type
      missing data
    9. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Ineligible
    10. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      never start protocol therapy
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        44
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        43
      type
      Eligible
    3. achievements
      1. group Id
        FG000
        num Subjects
        42
      type
      Treated
    4. achievements
      1. group Id
        FG000
        num Subjects
        42
      type
      Induction Treatment
    5. achievements
      1. group Id
        FG000
        num Subjects
        15
      type
      Maintenance Treatment
    6. achievements
      1. group Id
        FG000
        num Subjects
        7
      type
      Reinduction Treatment
    7. achievements
      1. group Id
        FG000
        num Subjects
        1
      type
      COMPLETED
    8. achievements
      1. group Id
        FG000
        num Subjects
        43
      type
      NOT COMPLETED
    title
    Overall Study
recruitment Details
The study was activated on January 16, 2004 and terminated on March 7, 2005 after 44 patients had enrolled. Accrual rate was 3 patients per month, slower than expected rate (6 patients per month)

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Preserved source evidence · Not medical advice