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NCT00405756 · FLOW

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A Study to Compare MPR With MP in Newly Diagnosed Multiple Myeloma Subjects 65 Years Old or Older. · Source last updated 2017-01-11

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

groups
  1. description
    Double-blind induction therapy with melphalan/prednisone and lenalidomide 10 mg (MPR) for up to 9 cycles, followed by maintenance therapy with single-agent lenalidomide (R) 10mg from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
    id
    FG000
    title
    MPR+R
  2. description
    Double-blind induction therapy with melphalan/prednisone and lenalidomide 10mg (MPR) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
    id
    FG001
    title
    MPR+p
  3. description
    Double-blind induction therapy with melphalan/prednisone and placebo (MPp) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
    id
    FG002
    title
    MPp+p
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        45
      2. group Id
        FG001
        num Subjects
        24
      3. group Id
        FG002
        num Subjects
        18
      type
      Ongoing in Double-blind Treatment
    2. reasons
      1. group Id
        FG000
        num Subjects
        31
      2. group Id
        FG001
        num Subjects
        27
      3. group Id
        FG002
        num Subjects
        12
      type
      Adverse Event
    3. reasons
      1. group Id
        FG000
        num Subjects
        47
      2. group Id
        FG001
        num Subjects
        81
      3. group Id
        FG002
        num Subjects
        102
      type
      Disease Progression
    4. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        4
      3. group Id
        FG002
        num Subjects
        2
      type
      Lack of Efficacy
    5. reasons
      1. group Id
        FG000
        num Subjects
        15
      2. group Id
        FG001
        num Subjects
        9
      3. group Id
        FG002
        num Subjects
        10
      type
      Withdrawal by Subject
    6. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      Lost to Follow-up
    7. reasons
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        4
      3. group Id
        FG002
        num Subjects
        4
      type
      Death
    8. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        2
      type
      Protocol Violation
    9. reasons
      1. group Id
        FG000
        num Subjects
        7
      2. group Id
        FG001
        num Subjects
        4
      3. group Id
        FG002
        num Subjects
        4
      type
      Other
    milestones
    1. achievements
      1. comment
        Intent to treat population of all randomized participants
        group Id
        FG000
        num Subjects
        152
      2. group Id
        FG001
        num Subjects
        153
      3. group Id
        FG002
        num Subjects
        154
      type
      STARTED
    2. achievements
      1. comment
        Participants who took at least one dose of study drug.
        group Id
        FG000
        num Subjects
        150
      2. group Id
        FG001
        num Subjects
        152
      3. group Id
        FG002
        num Subjects
        153
      type
      Safety Population
    3. achievements
      1. comment
        Double-blind Treatment Period had no defined completion.
        group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        152
      2. group Id
        FG001
        num Subjects
        153
      3. group Id
        FG002
        num Subjects
        154
      type
      NOT COMPLETED
    title
    Double-blind Treatment
  2. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        7
      2. group Id
        FG001
        num Subjects
        15
      3. group Id
        FG002
        num Subjects
        25
      type
      Ongoing in Open Label Period
    2. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        7
      type
      Adverse Event
    3. reasons
      1. group Id
        FG000
        num Subjects
        8
      2. group Id
        FG001
        num Subjects
        23
      3. group Id
        FG002
        num Subjects
        26
      type
      Disease Progression
    4. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        3
      type
      Withdrawal by Subject
    5. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        4
      type
      Death
    6. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        7
      type
      Other
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        19
      2. group Id
        FG001
        num Subjects
        47
      3. group Id
        FG002
        num Subjects
        72
      type
      STARTED
    2. achievements
      1. comment
        Participants continue until disease progression or other reason for discontinuing.
        group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        19
      2. group Id
        FG001
        num Subjects
        47
      3. group Id
        FG002
        num Subjects
        72
      type
      NOT COMPLETED
    title
    Open-label Extension
  3. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        52
      2. group Id
        FG001
        num Subjects
        51
      3. group Id
        FG002
        num Subjects
        60
      type
      Ongoing in Follow-up Period
    2. reasons
      1. group Id
        FG000
        num Subjects
        21
      2. group Id
        FG001
        num Subjects
        31
      3. group Id
        FG002
        num Subjects
        24
      type
      Death
    3. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        8
      3. group Id
        FG002
        num Subjects
        4
      type
      Lost to Follow-up
    milestones
    1. achievements
      1. comment
        66 participants from Double-blind and 9 from the Open Label Extension
        group Id
        FG000
        num Subjects
        75
      2. comment
        65 participants from the Double-blind and 25 from the Open Label Extension
        group Id
        FG001
        num Subjects
        90
      3. comment
        52 participants from the Double-blind and 36 from the Open Label Extension
        group Id
        FG002
        num Subjects
        88
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        75
      2. group Id
        FG001
        num Subjects
        90
      3. group Id
        FG002
        num Subjects
        88
      type
      NOT COMPLETED
    title
    Follow-up
pre Assignment Details
Of the 606 subjects screened for this study, 147 failed screening. Reasons for screen failures included: laboratory values not met (45 subjects); diagnostic criteria for measurable multiple myeloma not met (30 subjects); other inclusion/exclusion criteria not met (30 subjects); subject withdrawal of consent (14 subjects); and other (28 subjects).
recruitment Details
Data represents a May 11, 2010 data cut-off. The study is ongoing.
Complete source fields
groups
  1. description
    Double-blind induction therapy with melphalan/prednisone and lenalidomide 10 mg (MPR) for up to 9 cycles, followed by maintenance therapy with single-agent lenalidomide (R) 10mg from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
    id
    FG000
    title
    MPR+R
  2. description
    Double-blind induction therapy with melphalan/prednisone and lenalidomide 10mg (MPR) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
    id
    FG001
    title
    MPR+p
  3. description
    Double-blind induction therapy with melphalan/prednisone and placebo (MPp) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
    id
    FG002
    title
    MPp+p
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        45
      2. group Id
        FG001
        num Subjects
        24
      3. group Id
        FG002
        num Subjects
        18
      type
      Ongoing in Double-blind Treatment
    2. reasons
      1. group Id
        FG000
        num Subjects
        31
      2. group Id
        FG001
        num Subjects
        27
      3. group Id
        FG002
        num Subjects
        12
      type
      Adverse Event
    3. reasons
      1. group Id
        FG000
        num Subjects
        47
      2. group Id
        FG001
        num Subjects
        81
      3. group Id
        FG002
        num Subjects
        102
      type
      Disease Progression
    4. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        4
      3. group Id
        FG002
        num Subjects
        2
      type
      Lack of Efficacy
    5. reasons
      1. group Id
        FG000
        num Subjects
        15
      2. group Id
        FG001
        num Subjects
        9
      3. group Id
        FG002
        num Subjects
        10
      type
      Withdrawal by Subject
    6. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      Lost to Follow-up
    7. reasons
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        4
      3. group Id
        FG002
        num Subjects
        4
      type
      Death
    8. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        2
      type
      Protocol Violation
    9. reasons
      1. group Id
        FG000
        num Subjects
        7
      2. group Id
        FG001
        num Subjects
        4
      3. group Id
        FG002
        num Subjects
        4
      type
      Other
    milestones
    1. achievements
      1. comment
        Intent to treat population of all randomized participants
        group Id
        FG000
        num Subjects
        152
      2. group Id
        FG001
        num Subjects
        153
      3. group Id
        FG002
        num Subjects
        154
      type
      STARTED
    2. achievements
      1. comment
        Participants who took at least one dose of study drug.
        group Id
        FG000
        num Subjects
        150
      2. group Id
        FG001
        num Subjects
        152
      3. group Id
        FG002
        num Subjects
        153
      type
      Safety Population
    3. achievements
      1. comment
        Double-blind Treatment Period had no defined completion.
        group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        152
      2. group Id
        FG001
        num Subjects
        153
      3. group Id
        FG002
        num Subjects
        154
      type
      NOT COMPLETED
    title
    Double-blind Treatment
  2. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        7
      2. group Id
        FG001
        num Subjects
        15
      3. group Id
        FG002
        num Subjects
        25
      type
      Ongoing in Open Label Period
    2. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        7
      type
      Adverse Event
    3. reasons
      1. group Id
        FG000
        num Subjects
        8
      2. group Id
        FG001
        num Subjects
        23
      3. group Id
        FG002
        num Subjects
        26
      type
      Disease Progression
    4. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        3
      type
      Withdrawal by Subject
    5. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        4
      type
      Death
    6. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        7
      type
      Other
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        19
      2. group Id
        FG001
        num Subjects
        47
      3. group Id
        FG002
        num Subjects
        72
      type
      STARTED
    2. achievements
      1. comment
        Participants continue until disease progression or other reason for discontinuing.
        group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        19
      2. group Id
        FG001
        num Subjects
        47
      3. group Id
        FG002
        num Subjects
        72
      type
      NOT COMPLETED
    title
    Open-label Extension
  3. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        52
      2. group Id
        FG001
        num Subjects
        51
      3. group Id
        FG002
        num Subjects
        60
      type
      Ongoing in Follow-up Period
    2. reasons
      1. group Id
        FG000
        num Subjects
        21
      2. group Id
        FG001
        num Subjects
        31
      3. group Id
        FG002
        num Subjects
        24
      type
      Death
    3. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        8
      3. group Id
        FG002
        num Subjects
        4
      type
      Lost to Follow-up
    milestones
    1. achievements
      1. comment
        66 participants from Double-blind and 9 from the Open Label Extension
        group Id
        FG000
        num Subjects
        75
      2. comment
        65 participants from the Double-blind and 25 from the Open Label Extension
        group Id
        FG001
        num Subjects
        90
      3. comment
        52 participants from the Double-blind and 36 from the Open Label Extension
        group Id
        FG002
        num Subjects
        88
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        75
      2. group Id
        FG001
        num Subjects
        90
      3. group Id
        FG002
        num Subjects
        88
      type
      NOT COMPLETED
    title
    Follow-up
pre Assignment Details
Of the 606 subjects screened for this study, 147 failed screening. Reasons for screen failures included: laboratory values not met (45 subjects); diagnostic criteria for measurable multiple myeloma not met (30 subjects); other inclusion/exclusion criteria not met (30 subjects); subject withdrawal of consent (14 subjects); and other (28 subjects).
recruitment Details
Data represents a May 11, 2010 data cut-off. The study is ongoing.

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Preserved source evidence · Not medical advice