Skip to content
Triangle logo TriangleGet started
← Full study record

NCT02011113 · BASELINE

Baseline characteristics

Japanese Phase 2 Study to Evaluate the Efficacy and Safety of Pomalidomide in Subjects With Relapsed and Refractory Multiple Myeloma · Source last updated 2016-11-01

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

denoms
  1. counts
    1. group Id
      BG000
      value
      36
    units
    Participants
groups
  1. description
    Pomalidomide: 4 mg oral pomalidomide once daily Days 1-21 of each 28-day cycle Dexamethasone: 40 mg or 20 mg oral dexamethasone once daily on Days 1, 8, 15, 22 of each 28-day cycle
    id
    BG000
    title
    Pomalidomide Plus Dexamethasone
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          43
          upper Limit
          78
          value
          64.5
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          32
      title
      ≤ 75 Years Old
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          4
      title
      > 75 Years Old
    param Type
    NUMBER
    title
    Age, Customized
    unit Of Measure
    participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          20
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          16
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          36
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          0
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          0
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          0
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          0.6
          upper Limit
          21.1
          value
          4.65
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Time from first diagnosis
    unit Of Measure
    years
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          7
      title
      Stage I
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          16
      title
      Stage II
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          13
      title
      Stage III
    description
    Stages are: Stage I: Hemoglobin \> 10 g/dL Serum calcium normal On roentgenogram, normal bone structure or solitary bone plasmacytoma only Low M-component production rates (IgG value \< 5 g/dL, IgA value \< 3 g/dL, Bence Jones protein \< 4 g/24h) Stage II: Overall data as minimally abnormal for stage I, and no single value as abnormal as defined for stage III Stage III: 1 or more of below: Hemoglobin \< 8.5 g/dL Serum calcium \> 12 mg/dL Advanced lytic bone lesions (scale 3) High-M-component production rates (IgG value \> 7 g/dL, IgA value \> 5 g/dL, Bence Jones protein \> 12 g/24h)
    param Type
    NUMBER
    title
    Durie-Salmon Multiple myeloma staging at screening
    unit Of Measure
    participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          17
      title
      0 = (Asymptomatic)
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          16
      title
      1 = (Symptomatic but completely ambulatory)
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          3
      title
      2 = (Ambulatory but unable to work)
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          0
      title
      3 = (Limited self-care)
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          0
      title
      4 = (Completely disabled)
    description
    The ECOG scale is as follows: Grade 0: Fully active, able to carry on all pre-disease activities without restriction; Grade 1: Restricted in physically strenuous activity, ambulatory and able to carry out work of a light nature; Grade 2: Ambulatory and capable of all self-care but unable to work. Up and about more than 50% of waking hours; Grade 3: Capable of only limited self-care, confined to bed or chair \> 50% of waking hours; Grade 4: Completely disabled. Cannot carry on any self-care. Confined to bed or chair.
    param Type
    NUMBER
    title
    Eastern Cooperative Oncology Group Performance Status] (ECOG)
    unit Of Measure
    participants
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          2
          upper Limit
          14
          value
          6.0
    description
    The number of prior chemotherapy regimens for myeloma
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Prior Chemotherapy Regimens
    unit Of Measure
    regimens
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          19
      title
      Yes
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          17
      title
      No
    param Type
    NUMBER
    title
    Prior Stem Cell Transplant for Myeloma
    unit Of Measure
    participants
  10. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          7
      title
      Stage I
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          16
      title
      Stage II
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          13
      title
      Stage III
    description
    Stages are: Stage I: Hemoglobin \> 10 g/dL Serum calcium normal On roentgenogram, normal bone structure or solitary bone plasmacytoma only Low M-component production rates (IgG value \< 5 g/dL, IgA value \< 3 g/dL, Bence Jones protein \< 4 g/24h) Stage II: Overall data as minimally abnormal for stage I, and no single value as abnormal as defined for stage III Stage III: 1 or more of below: Hemoglobin \< 8.5 g/dL Serum calcium \> 12 mg/dL Advanced lytic bone lesions (scale 3) High-M-component production rates (IgG value \> 7 g/dL, IgA value \> 5 g/dL, Bence Jones protein \> 12 g/24h)
    param Type
    NUMBER
    title
    Durie-Salmon Multiple Myeloma staging at screening
    unit Of Measure
    participants
population Description
Safety Population included all participants who received at least one dose of study medication
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      36
    units
    Participants
groups
  1. description
    Pomalidomide: 4 mg oral pomalidomide once daily Days 1-21 of each 28-day cycle Dexamethasone: 40 mg or 20 mg oral dexamethasone once daily on Days 1, 8, 15, 22 of each 28-day cycle
    id
    BG000
    title
    Pomalidomide Plus Dexamethasone
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          43
          upper Limit
          78
          value
          64.5
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          32
      title
      ≤ 75 Years Old
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          4
      title
      > 75 Years Old
    param Type
    NUMBER
    title
    Age, Customized
    unit Of Measure
    participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          20
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          16
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          36
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          0
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          0
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          0
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          0.6
          upper Limit
          21.1
          value
          4.65
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Time from first diagnosis
    unit Of Measure
    years
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          7
      title
      Stage I
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          16
      title
      Stage II
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          13
      title
      Stage III
    description
    Stages are: Stage I: Hemoglobin \> 10 g/dL Serum calcium normal On roentgenogram, normal bone structure or solitary bone plasmacytoma only Low M-component production rates (IgG value \< 5 g/dL, IgA value \< 3 g/dL, Bence Jones protein \< 4 g/24h) Stage II: Overall data as minimally abnormal for stage I, and no single value as abnormal as defined for stage III Stage III: 1 or more of below: Hemoglobin \< 8.5 g/dL Serum calcium \> 12 mg/dL Advanced lytic bone lesions (scale 3) High-M-component production rates (IgG value \> 7 g/dL, IgA value \> 5 g/dL, Bence Jones protein \> 12 g/24h)
    param Type
    NUMBER
    title
    Durie-Salmon Multiple myeloma staging at screening
    unit Of Measure
    participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          17
      title
      0 = (Asymptomatic)
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          16
      title
      1 = (Symptomatic but completely ambulatory)
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          3
      title
      2 = (Ambulatory but unable to work)
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          0
      title
      3 = (Limited self-care)
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          0
      title
      4 = (Completely disabled)
    description
    The ECOG scale is as follows: Grade 0: Fully active, able to carry on all pre-disease activities without restriction; Grade 1: Restricted in physically strenuous activity, ambulatory and able to carry out work of a light nature; Grade 2: Ambulatory and capable of all self-care but unable to work. Up and about more than 50% of waking hours; Grade 3: Capable of only limited self-care, confined to bed or chair \> 50% of waking hours; Grade 4: Completely disabled. Cannot carry on any self-care. Confined to bed or chair.
    param Type
    NUMBER
    title
    Eastern Cooperative Oncology Group Performance Status] (ECOG)
    unit Of Measure
    participants
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          2
          upper Limit
          14
          value
          6.0
    description
    The number of prior chemotherapy regimens for myeloma
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Prior Chemotherapy Regimens
    unit Of Measure
    regimens
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          19
      title
      Yes
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          17
      title
      No
    param Type
    NUMBER
    title
    Prior Stem Cell Transplant for Myeloma
    unit Of Measure
    participants
  10. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          7
      title
      Stage I
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          16
      title
      Stage II
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          13
      title
      Stage III
    description
    Stages are: Stage I: Hemoglobin \> 10 g/dL Serum calcium normal On roentgenogram, normal bone structure or solitary bone plasmacytoma only Low M-component production rates (IgG value \< 5 g/dL, IgA value \< 3 g/dL, Bence Jones protein \< 4 g/24h) Stage II: Overall data as minimally abnormal for stage I, and no single value as abnormal as defined for stage III Stage III: 1 or more of below: Hemoglobin \< 8.5 g/dL Serum calcium \> 12 mg/dL Advanced lytic bone lesions (scale 3) High-M-component production rates (IgG value \> 7 g/dL, IgA value \> 5 g/dL, Bence Jones protein \> 12 g/24h)
    param Type
    NUMBER
    title
    Durie-Salmon Multiple Myeloma staging at screening
    unit Of Measure
    participants
population Description
Safety Population included all participants who received at least one dose of study medication

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

Preserved source evidence · Not medical advice