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NCT01311687 · BASELINE

Baseline characteristics

A Phase 3, Multicenter, Randomized, Open-Label Study to Compare the Efficacy and Safety of Pomalidomide in Combination With Low-Dose Dexamethasone Versus High-Dose Dexamethasone in Subjects With Refractory Multiple Myeloma or Relapsed and Refractory Multiple Myeloma and Companion Study · Source last updated 2018-10-24

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
      302
    2. group Id
      BG001
      value
      153
    3. group Id
      BG002
      value
      455
    units
    Participants
groups
  1. description
    Participants received 4 mg pomalidomide administered by mouth on Days 1-21 of each 28-day treatment cycle and 40 mg dexamethasone (participants \> 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1, 8, 15, and 22 of a 28-day cycle until disease progression.
    id
    BG000
    title
    Pomalidomide Plus Low-Dose Dexamethasone
  2. description
    Participants received 40 mg dexamethasone (participants \> 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1 through 4, 9 through 12, and 17 through 20 of a 28-day cycle until disease progression.
    id
    BG001
    title
    High-Dose Dexamethasone
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          9.33
          value
          63.6
        2. group Id
          BG001
          spread
          9.56
          value
          63.7
        3. group Id
          BG002
          spread
          9.40
          value
          63.6
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          278
        2. group Id
          BG001
          value
          141
        3. group Id
          BG002
          value
          419
        title
        ≤ 75 Years Old
      2. measurements
        1. group Id
          BG000
          value
          24
        2. group Id
          BG001
          value
          12
        3. group Id
          BG002
          value
          36
        title
        > 75 Years Old
    description
    Stratification Factor 1
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Customized
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          121
        2. group Id
          BG001
          value
          66
        3. group Id
          BG002
          value
          187
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          181
        2. group Id
          BG001
          value
          87
        3. group Id
          BG002
          value
          268
        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
          27
        2. group Id
          BG001
          value
          14
        3. group Id
          BG002
          value
          41
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          228
        2. group Id
          BG001
          value
          104
        3. group Id
          BG002
          value
          332
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          47
        2. group Id
          BG001
          value
          35
        3. group Id
          BG002
          value
          82
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          4
        title
        Asian
      2. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          7
        title
        Black or African American
      3. measurements
        1. group Id
          BG000
          value
          244
        2. group Id
          BG001
          value
          113
        3. group Id
          BG002
          value
          357
        title
        White
      4. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          4
        title
        Other
      5. measurements
        1. group Id
          BG000
          value
          48
        2. group Id
          BG001
          value
          35
        3. group Id
          BG002
          value
          83
        title
        Not collected
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          302
        2. group Id
          BG001
          value
          153
        3. group Id
          BG002
          value
          455
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Participants with Prior Anti-Myeloma (MM) Therapies
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          4.02
          value
          6.2
        2. group Id
          BG001
          spread
          3.63
          value
          6.5
        3. group Id
          BG002
          spread
          3.89
          value
          6.3
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Time from First Pathologic Diagnosis
    unit Of Measure
    years
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          249
        2. group Id
          BG001
          value
          125
        3. group Id
          BG002
          value
          374
        title
        Disease Population Group 1
      2. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          13
        title
        Disease Population Group 2
      3. measurements
        1. group Id
          BG000
          value
          45
        2. group Id
          BG001
          value
          23
        3. group Id
          BG002
          value
          68
        title
        Disease Population Group 3
    description
    Disease Population Group 1 is defined as refractory patients who have progressed on or within 60 days of both lenalidomide and bortezomib based treatments. Disease Population Group 2 is defined as relapsed and refractory patients who achieved at least a partial response (PR) and progressed within 6 months after stopping treatment with lenalidomide and/or bortezomib. Disease Population Group 3 is defined as refractory/intolerant patients who developed intolerance/toxicity after a minimum of 2 cycles of bortezomib.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Stratification Factor 2: Disease Population
    unit Of Measure
    Participants
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          17
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          25
        title
        2 Prior Anti-MM Therapies
      2. measurements
        1. group Id
          BG000
          value
          285
        2. group Id
          BG001
          value
          145
        3. group Id
          BG002
          value
          430
        title
        > 2 Prior Anti-MM Therapies
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Stratification Factor 3: Number of Prior Anti-MM Therapies
    unit Of Measure
    Participants
  10. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          81
        2. group Id
          BG001
          value
          36
        3. group Id
          BG002
          value
          117
        title
        Stage I
      2. measurements
        1. group Id
          BG000
          value
          115
        2. group Id
          BG001
          value
          56
        3. group Id
          BG002
          value
          171
        title
        Stage II
      3. measurements
        1. group Id
          BG000
          value
          92
        2. group Id
          BG001
          value
          53
        3. group Id
          BG002
          value
          145
        title
        Stage III
      4. measurements
        1. group Id
          BG000
          value
          14
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          22
        title
        Missing
    description
    The International Staging System divides myeloma into 3 stages based only on the serum beta-2 microglobulin and serum albumin levels. Stage I: Serum beta-2 microglobulin is less than 3.5 (mg/L) and the albumin level is above 3.5 (g/L); Stage II: Neither stage I or III, meaning that either: ◾ The beta-2 microglobulin level is between 3.5 and 5.5 (with any albumin level), OR ◾ The albumin is below 3.5 while the beta-2 microglobulin is less than 3.5 Stage III: Serum beta-2 microglobulin is greater than 5.5.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Multiple Myeloma Stage before Study Entry
    unit Of Measure
    Participants
population Description
Intent-to-treat population (all participants who were randomized, regardless of whether they received study treatment or not)
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      302
    2. group Id
      BG001
      value
      153
    3. group Id
      BG002
      value
      455
    units
    Participants
groups
  1. description
    Participants received 4 mg pomalidomide administered by mouth on Days 1-21 of each 28-day treatment cycle and 40 mg dexamethasone (participants \> 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1, 8, 15, and 22 of a 28-day cycle until disease progression.
    id
    BG000
    title
    Pomalidomide Plus Low-Dose Dexamethasone
  2. description
    Participants received 40 mg dexamethasone (participants \> 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1 through 4, 9 through 12, and 17 through 20 of a 28-day cycle until disease progression.
    id
    BG001
    title
    High-Dose Dexamethasone
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          9.33
          value
          63.6
        2. group Id
          BG001
          spread
          9.56
          value
          63.7
        3. group Id
          BG002
          spread
          9.40
          value
          63.6
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          278
        2. group Id
          BG001
          value
          141
        3. group Id
          BG002
          value
          419
        title
        ≤ 75 Years Old
      2. measurements
        1. group Id
          BG000
          value
          24
        2. group Id
          BG001
          value
          12
        3. group Id
          BG002
          value
          36
        title
        > 75 Years Old
    description
    Stratification Factor 1
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Customized
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          121
        2. group Id
          BG001
          value
          66
        3. group Id
          BG002
          value
          187
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          181
        2. group Id
          BG001
          value
          87
        3. group Id
          BG002
          value
          268
        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
          27
        2. group Id
          BG001
          value
          14
        3. group Id
          BG002
          value
          41
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          228
        2. group Id
          BG001
          value
          104
        3. group Id
          BG002
          value
          332
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          47
        2. group Id
          BG001
          value
          35
        3. group Id
          BG002
          value
          82
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          4
        title
        Asian
      2. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          7
        title
        Black or African American
      3. measurements
        1. group Id
          BG000
          value
          244
        2. group Id
          BG001
          value
          113
        3. group Id
          BG002
          value
          357
        title
        White
      4. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          4
        title
        Other
      5. measurements
        1. group Id
          BG000
          value
          48
        2. group Id
          BG001
          value
          35
        3. group Id
          BG002
          value
          83
        title
        Not collected
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          302
        2. group Id
          BG001
          value
          153
        3. group Id
          BG002
          value
          455
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Participants with Prior Anti-Myeloma (MM) Therapies
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          4.02
          value
          6.2
        2. group Id
          BG001
          spread
          3.63
          value
          6.5
        3. group Id
          BG002
          spread
          3.89
          value
          6.3
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Time from First Pathologic Diagnosis
    unit Of Measure
    years
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          249
        2. group Id
          BG001
          value
          125
        3. group Id
          BG002
          value
          374
        title
        Disease Population Group 1
      2. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          13
        title
        Disease Population Group 2
      3. measurements
        1. group Id
          BG000
          value
          45
        2. group Id
          BG001
          value
          23
        3. group Id
          BG002
          value
          68
        title
        Disease Population Group 3
    description
    Disease Population Group 1 is defined as refractory patients who have progressed on or within 60 days of both lenalidomide and bortezomib based treatments. Disease Population Group 2 is defined as relapsed and refractory patients who achieved at least a partial response (PR) and progressed within 6 months after stopping treatment with lenalidomide and/or bortezomib. Disease Population Group 3 is defined as refractory/intolerant patients who developed intolerance/toxicity after a minimum of 2 cycles of bortezomib.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Stratification Factor 2: Disease Population
    unit Of Measure
    Participants
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          17
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          25
        title
        2 Prior Anti-MM Therapies
      2. measurements
        1. group Id
          BG000
          value
          285
        2. group Id
          BG001
          value
          145
        3. group Id
          BG002
          value
          430
        title
        > 2 Prior Anti-MM Therapies
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Stratification Factor 3: Number of Prior Anti-MM Therapies
    unit Of Measure
    Participants
  10. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          81
        2. group Id
          BG001
          value
          36
        3. group Id
          BG002
          value
          117
        title
        Stage I
      2. measurements
        1. group Id
          BG000
          value
          115
        2. group Id
          BG001
          value
          56
        3. group Id
          BG002
          value
          171
        title
        Stage II
      3. measurements
        1. group Id
          BG000
          value
          92
        2. group Id
          BG001
          value
          53
        3. group Id
          BG002
          value
          145
        title
        Stage III
      4. measurements
        1. group Id
          BG000
          value
          14
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          22
        title
        Missing
    description
    The International Staging System divides myeloma into 3 stages based only on the serum beta-2 microglobulin and serum albumin levels. Stage I: Serum beta-2 microglobulin is less than 3.5 (mg/L) and the albumin level is above 3.5 (g/L); Stage II: Neither stage I or III, meaning that either: ◾ The beta-2 microglobulin level is between 3.5 and 5.5 (with any albumin level), OR ◾ The albumin is below 3.5 while the beta-2 microglobulin is less than 3.5 Stage III: Serum beta-2 microglobulin is greater than 5.5.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Multiple Myeloma Stage before Study Entry
    unit Of Measure
    Participants
population Description
Intent-to-treat population (all participants who were randomized, regardless of whether they received study treatment or not)

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Preserved source evidence · Not medical advice