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NCT00424047 · FLOW

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A Study of CC-5013 Plus Dexamethasone Versus Dexamethasone Alone in Previously Treated Subjects With Multiple Myeloma · Source last updated 2017-10-19

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

groups
  1. description
    Lenalidomide 25 mg by mouth (PO) daily (QD) on Days 1 to 21 and a matching placebo capsule QD on Days 22 to 28 of each 28-day cycle. Pulse dexamethasone 40mg PO QD on Days 1-4, 9-12, and 17-20 of each 28-day cycle for cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40mg PO QD on Days 1 to 4 every 28 days for the remaining cycles.
    id
    FG000
    title
    Lenalidomide Plus Dexamethasone (Len/Dex)
  2. description
    Placebo PO daily on Days 1 to 28 of each 28 day cycle. Pulse dexamethasone 40mg PO QD on Days 1-4, 9-12, and 17-20 of each 28-day cycle for Cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40mg PO QD for Days 1-4 every 28 days. Participants with documented progressive disease were permitted to crossover to receive lenalidomide at the same doses mentioned. After the study was unblinded in August 2005 participants were given the option to add lenalidomide to their dexamethasone treatment regimen immediately or to add lenalidomide to their dexamethasone therapy at the time of disease progression.
    id
    FG001
    title
    Placebo Plus Dexamethasone
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        18
      2. group Id
        FG001
        num Subjects
        12
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        67
      2. group Id
        FG001
        num Subjects
        122
      type
      Progression of disease
    3. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        3
      type
      Lack of therapeutic effect
    4. reasons
      1. group Id
        FG000
        num Subjects
        23
      2. group Id
        FG001
        num Subjects
        8
      type
      Withdrawal by Subject
    5. reasons
      1. group Id
        FG000
        num Subjects
        11
      2. group Id
        FG001
        num Subjects
        10
      type
      Death
    6. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        1
      type
      Other
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        176
      2. group Id
        FG001
        num Subjects
        175
      type
      STARTED
    2. achievements
      1. comment
        Includes those who took at least one dose of study medication regimen
        group Id
        FG000
        num Subjects
        176
      2. comment
        Includes those who took at least one dose of study medication regimen
        group Id
        FG001
        num Subjects
        175
      type
      Safety Population
    3. achievements
      1. comment
        1 participant excluded because they had no baseline M-protein assessment
        group Id
        FG000
        num Subjects
        175
      2. comment
        4 participants excluded because they had no baseline M-protein assessment
        group Id
        FG001
        num Subjects
        171
      type
      Evaluable Population
    4. achievements
      1. comment
        54 participants ongoing and continuing on lenalidomide/dexamethasone treatment
        group Id
        FG000
        num Subjects
        54
      2. comment
        Ongoing and includes 15 participants who crossed over to lenalidomide/dexamethasone after unblinding
        group Id
        FG001
        num Subjects
        19
      type
      COMPLETED
    5. achievements
      1. group Id
        FG000
        num Subjects
        122
      2. group Id
        FG001
        num Subjects
        156
      type
      NOT COMPLETED
    title
    Blinded Treatment (Up to 03 Aug 2005)
  2. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        22
      2. group Id
        FG001
        num Subjects
        12
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        92
      2. group Id
        FG001
        num Subjects
        128
      type
      Progression of disease
    3. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        3
      type
      Lack of Efficacy
    4. reasons
      1. group Id
        FG000
        num Subjects
        24
      2. group Id
        FG001
        num Subjects
        9
      type
      Withdrawal by Subject
    5. reasons
      1. group Id
        FG000
        num Subjects
        11
      2. group Id
        FG001
        num Subjects
        11
      type
      Death
    6. reasons
      1. group Id
        FG000
        num Subjects
        5
      2. group Id
        FG001
        num Subjects
        4
      type
      Other
    milestones
    1. achievements
      1. comment
        Refers to original treatment group assignment in the study.
        group Id
        FG000
        num Subjects
        176
      2. group Id
        FG001
        num Subjects
        175
      type
      STARTED
    2. achievements
      1. comment
        Participants completed = those continuing on long term Lenalidomide and dexamethasone
        group Id
        FG000
        num Subjects
        21
      2. comment
        Participants completed = those continuing on long term dexamethasone
        group Id
        FG001
        num Subjects
        8
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        155
      2. group Id
        FG001
        num Subjects
        167
      type
      NOT COMPLETED
    title
    On Study at Time of Unblinding
  3. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      type
      Death
    3. reasons
      1. group Id
        FG000
        num Subjects
        12
      2. group Id
        FG001
        num Subjects
        4
      type
      Other
    4. reasons
      1. group Id
        FG000
        num Subjects
        7
      2. group Id
        FG001
        num Subjects
        3
      type
      Progression of Disease
    5. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      type
      Withdrawal by Subject
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        21
      2. comment
        2 participants opted to receive dex alone, 3 crossed over to Len/Dex and 3 added Len at a later date
        group Id
        FG001
        num Subjects
        8
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        21
      2. group Id
        FG001
        num Subjects
        8
      type
      NOT COMPLETED
    title
    Long Term Extension (Up to 25 Jun 2013)
pre Assignment Details
A pre-specified interim analysis revealed a highly significant benefit favoring the lenalidomide/dexamethasone regimen, crossing the pre-specified O'Brien-Fleming superiority boundary. A decision was made to unblind the study allowing those receiving Placebo/dexamethasone to receive the lenalidomide/dexamethasone regimen.
recruitment Details
The study was conducted at 55 sites in Australia, Europe, and Israel. Eligible participants were randomized in a 1:1 ratio to: lenalidomide plus oral pulse high-dose dexamethasone or Placebo plus oral pulse high-dose dexamethasone.
Complete source fields
groups
  1. description
    Lenalidomide 25 mg by mouth (PO) daily (QD) on Days 1 to 21 and a matching placebo capsule QD on Days 22 to 28 of each 28-day cycle. Pulse dexamethasone 40mg PO QD on Days 1-4, 9-12, and 17-20 of each 28-day cycle for cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40mg PO QD on Days 1 to 4 every 28 days for the remaining cycles.
    id
    FG000
    title
    Lenalidomide Plus Dexamethasone (Len/Dex)
  2. description
    Placebo PO daily on Days 1 to 28 of each 28 day cycle. Pulse dexamethasone 40mg PO QD on Days 1-4, 9-12, and 17-20 of each 28-day cycle for Cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40mg PO QD for Days 1-4 every 28 days. Participants with documented progressive disease were permitted to crossover to receive lenalidomide at the same doses mentioned. After the study was unblinded in August 2005 participants were given the option to add lenalidomide to their dexamethasone treatment regimen immediately or to add lenalidomide to their dexamethasone therapy at the time of disease progression.
    id
    FG001
    title
    Placebo Plus Dexamethasone
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        18
      2. group Id
        FG001
        num Subjects
        12
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        67
      2. group Id
        FG001
        num Subjects
        122
      type
      Progression of disease
    3. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        3
      type
      Lack of therapeutic effect
    4. reasons
      1. group Id
        FG000
        num Subjects
        23
      2. group Id
        FG001
        num Subjects
        8
      type
      Withdrawal by Subject
    5. reasons
      1. group Id
        FG000
        num Subjects
        11
      2. group Id
        FG001
        num Subjects
        10
      type
      Death
    6. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        1
      type
      Other
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        176
      2. group Id
        FG001
        num Subjects
        175
      type
      STARTED
    2. achievements
      1. comment
        Includes those who took at least one dose of study medication regimen
        group Id
        FG000
        num Subjects
        176
      2. comment
        Includes those who took at least one dose of study medication regimen
        group Id
        FG001
        num Subjects
        175
      type
      Safety Population
    3. achievements
      1. comment
        1 participant excluded because they had no baseline M-protein assessment
        group Id
        FG000
        num Subjects
        175
      2. comment
        4 participants excluded because they had no baseline M-protein assessment
        group Id
        FG001
        num Subjects
        171
      type
      Evaluable Population
    4. achievements
      1. comment
        54 participants ongoing and continuing on lenalidomide/dexamethasone treatment
        group Id
        FG000
        num Subjects
        54
      2. comment
        Ongoing and includes 15 participants who crossed over to lenalidomide/dexamethasone after unblinding
        group Id
        FG001
        num Subjects
        19
      type
      COMPLETED
    5. achievements
      1. group Id
        FG000
        num Subjects
        122
      2. group Id
        FG001
        num Subjects
        156
      type
      NOT COMPLETED
    title
    Blinded Treatment (Up to 03 Aug 2005)
  2. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        22
      2. group Id
        FG001
        num Subjects
        12
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        92
      2. group Id
        FG001
        num Subjects
        128
      type
      Progression of disease
    3. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        3
      type
      Lack of Efficacy
    4. reasons
      1. group Id
        FG000
        num Subjects
        24
      2. group Id
        FG001
        num Subjects
        9
      type
      Withdrawal by Subject
    5. reasons
      1. group Id
        FG000
        num Subjects
        11
      2. group Id
        FG001
        num Subjects
        11
      type
      Death
    6. reasons
      1. group Id
        FG000
        num Subjects
        5
      2. group Id
        FG001
        num Subjects
        4
      type
      Other
    milestones
    1. achievements
      1. comment
        Refers to original treatment group assignment in the study.
        group Id
        FG000
        num Subjects
        176
      2. group Id
        FG001
        num Subjects
        175
      type
      STARTED
    2. achievements
      1. comment
        Participants completed = those continuing on long term Lenalidomide and dexamethasone
        group Id
        FG000
        num Subjects
        21
      2. comment
        Participants completed = those continuing on long term dexamethasone
        group Id
        FG001
        num Subjects
        8
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        155
      2. group Id
        FG001
        num Subjects
        167
      type
      NOT COMPLETED
    title
    On Study at Time of Unblinding
  3. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      type
      Death
    3. reasons
      1. group Id
        FG000
        num Subjects
        12
      2. group Id
        FG001
        num Subjects
        4
      type
      Other
    4. reasons
      1. group Id
        FG000
        num Subjects
        7
      2. group Id
        FG001
        num Subjects
        3
      type
      Progression of Disease
    5. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      type
      Withdrawal by Subject
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        21
      2. comment
        2 participants opted to receive dex alone, 3 crossed over to Len/Dex and 3 added Len at a later date
        group Id
        FG001
        num Subjects
        8
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        21
      2. group Id
        FG001
        num Subjects
        8
      type
      NOT COMPLETED
    title
    Long Term Extension (Up to 25 Jun 2013)
pre Assignment Details
A pre-specified interim analysis revealed a highly significant benefit favoring the lenalidomide/dexamethasone regimen, crossing the pre-specified O'Brien-Fleming superiority boundary. A decision was made to unblind the study allowing those receiving Placebo/dexamethasone to receive the lenalidomide/dexamethasone regimen.
recruitment Details
The study was conducted at 55 sites in Australia, Europe, and Israel. Eligible participants were randomized in a 1:1 ratio to: lenalidomide plus oral pulse high-dose dexamethasone or Placebo plus oral pulse high-dose dexamethasone.

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Preserved source evidence · Not medical advice