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NCT00378209 · FLOW

Participant flow

Bortezomib, Lenalidomide, and Dexamethasone Combination Therapy for Patients With Relapsed or Relapsed and Refractory Multiple Myeloma · Source last updated 2016-11-17

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

groups
  1. description
    Patients were treated for up to 8 21-day cycles with the combination of bortezomib 1.0 mg/m2 IV, days 1, 4, 8, and 11, and oral lenalidomide 15 mg/day, days 1 through 14, with oral dexamethasone 40 mg/day (cycles 1-4) and 20 mg/day (cycles 5-8) on the days of and days after bortezomib dosing (days 1, 2, 4, 5, 8, 9, 11, and 12).Following a protocol amendment , dexamethasone dosing was reduced to 20 mg/day in cycles 1 through 4 and 10 mg/day in cycles 5 through 8. Beyond cycle 8, responding patients and those with stable disease (SD) could receive maintenance therapy until disease progression or unacceptable toxicity. Maintenance therapy comprised bortezomib and lenalidomide at the doses tolerated on completion of cycle 8, with lenalidomide on days 1 through 14 and using an amended schedule of weekly bortezomib (days 1 and 8) and dexamethasone 10 mg on days 1, 2, 8, and 9.
    id
    FG000
    title
    Lenalidomide, Dexamethasone, Bortezomib Combination
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        11
      type
      Progressive disease
    2. reasons
      1. group Id
        FG000
        num Subjects
        3
      type
      Adverse Event
    3. reasons
      1. group Id
        FG000
        num Subjects
        3
      type
      Initiation of non-protocol therapy
    4. reasons
      1. group Id
        FG000
        num Subjects
        3
      type
      Physician Decision
    5. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Death
    6. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Treatment delay
    milestones
    1. achievements
      1. comment
        1 patient who never started treatment was excluded in the analysis.
        group Id
        FG000
        num Subjects
        64
      type
      STARTED
    2. achievements
      1. comment
        This included patients who completed at least 8 cycles of combination therapy with all drugs.
        group Id
        FG000
        num Subjects
        42
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        22
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
Participants screened over a 3 week period.
recruitment Details
65 eligible participants were enrolled from the 6 institutions in the United States between September 2006 and April 2008 and 64 out of 65 received protocol treatment.
Complete source fields
groups
  1. description
    Patients were treated for up to 8 21-day cycles with the combination of bortezomib 1.0 mg/m2 IV, days 1, 4, 8, and 11, and oral lenalidomide 15 mg/day, days 1 through 14, with oral dexamethasone 40 mg/day (cycles 1-4) and 20 mg/day (cycles 5-8) on the days of and days after bortezomib dosing (days 1, 2, 4, 5, 8, 9, 11, and 12).Following a protocol amendment , dexamethasone dosing was reduced to 20 mg/day in cycles 1 through 4 and 10 mg/day in cycles 5 through 8. Beyond cycle 8, responding patients and those with stable disease (SD) could receive maintenance therapy until disease progression or unacceptable toxicity. Maintenance therapy comprised bortezomib and lenalidomide at the doses tolerated on completion of cycle 8, with lenalidomide on days 1 through 14 and using an amended schedule of weekly bortezomib (days 1 and 8) and dexamethasone 10 mg on days 1, 2, 8, and 9.
    id
    FG000
    title
    Lenalidomide, Dexamethasone, Bortezomib Combination
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        11
      type
      Progressive disease
    2. reasons
      1. group Id
        FG000
        num Subjects
        3
      type
      Adverse Event
    3. reasons
      1. group Id
        FG000
        num Subjects
        3
      type
      Initiation of non-protocol therapy
    4. reasons
      1. group Id
        FG000
        num Subjects
        3
      type
      Physician Decision
    5. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Death
    6. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Treatment delay
    milestones
    1. achievements
      1. comment
        1 patient who never started treatment was excluded in the analysis.
        group Id
        FG000
        num Subjects
        64
      type
      STARTED
    2. achievements
      1. comment
        This included patients who completed at least 8 cycles of combination therapy with all drugs.
        group Id
        FG000
        num Subjects
        42
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        22
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
Participants screened over a 3 week period.
recruitment Details
65 eligible participants were enrolled from the 6 institutions in the United States between September 2006 and April 2008 and 64 out of 65 received protocol treatment.

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Preserved source evidence · Not medical advice