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NCT01712789 · BASELINE

Baseline characteristics

Evaluation of Safety of Pomalidomide in Combination With Dexamethasone (Low Dose) in Patients With Refractory or Relapsed and Refractory Multiple Myeloma · Source last updated 2022-01-10

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
      682
    units
    Participants
groups
  1. description
    Participants received 4 mg pomalidomide (POM) by mouth (PO) on Days 1 to 21 of each 28-day treatment cycle and low dose dexamethasone (LD-Dex) PO at the starting dose of 40 mg/day (≤ 75 years old) or 20 mg/day (\> 75 years old) on Days 1, 8, 15 and 22 of a 28-day cycle until the documentation of confirmed progressive disease (PD), intolerable toxicity, death, withdrawal of participation in the study/consent, lost to follow-up, or as long as they benefited from therapy according to the opinion of the responsible study investigator.
    id
    BG000
    title
    Pomalidomide Plus Low Dose Dexamethasone (LD-Dex)
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          9.10
          value
          65.4
    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
          301
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          381
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          52
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          626
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          4
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        title
        Asian
      2. measurements
        1. group Id
          BG000
          value
          4
        title
        Black or African American
      3. measurements
        1. group Id
          BG000
          value
          669
        title
        White
      4. measurements
        1. group Id
          BG000
          value
          2
        title
        Other
      5. measurements
        1. group Id
          BG000
          value
          4
        title
        Missing
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          295
        title
        0 = Fully active, no restrictions
      2. measurements
        1. group Id
          BG000
          value
          319
        title
        1 = Restricted activity but ambulatory
      3. measurements
        1. group Id
          BG000
          value
          67
        title
        2 = Ambulatory and capable of all self-care
      4. measurements
        1. group Id
          BG000
          value
          1
        title
        3 = Limited self-care
      5. measurements
        1. group Id
          BG000
          value
          0
        title
        4 = Completely disabled
    description
    ECOG performance status is used to describe a patient's level of functioning in terms of their ability to care for themselves, daily activity, and physical ability (walking, working, etc.). The scale ranges from 0 to 5: 0 = Fully active, no restrictions; 1 = Restricted activity but ambulatory, able to carry out work of a light nature; 2 = Ambulatory and capable of all self-care but unable to carry out work activities; 3 = Limited self-care, confined to bed or chair more than 50% of waking hours; 4 = Completely disabled, no self-care, confined to bed or chair; 5 = Dead
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Eastern Cooperative Oncology Group (ECOG) Performance Status
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          3.649
          value
          6.15
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Time since diagnosis
    unit Of Measure
    Years
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          4.713
          value
          5.48
    description
    This test measures the amount of a protein called beta-2 microglobulin (B2M) in the blood.
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Beta 2 Microglobulin
    unit Of Measure
    mg/L
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          364
        title
        Kappa
      2. measurements
        1. group Id
          BG000
          value
          230
        title
        Lambda
      3. measurements
        1. group Id
          BG000
          value
          16
        title
        No Serum Light chain Type Detected
      4. measurements
        1. group Id
          BG000
          value
          72
        title
        Test Not Performed
    description
    Light chains are proteins made by plasma cells and make immunoglobulins (antibodies). Immunoglobulins help protect the body against illness and infections. Immunoglobulins are formed when light chains link up with heavy chains, another type of protein. There are two types of light chains: lambda and kappa light chains. A free light chains test measures the amount of lambda and kappa free light chains in the blood. If the amount of free light chains is higher or lower than normal, it can mean you have a disorder of the plasma cells.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Serum Light Chain Type
    unit Of Measure
    Participants
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          145
        title
        Immunoglobulin A (IgA)
      2. measurements
        1. group Id
          BG000
          value
          5
        title
        Immunoglobulin D (IgD)
      3. measurements
        1. group Id
          BG000
          value
          0
        title
        Immunoglobulin E (IgE)
      4. measurements
        1. group Id
          BG000
          value
          388
        title
        Immunoglobulin G (IgG)
      5. measurements
        1. group Id
          BG000
          value
          4
        title
        Immunoglobulin M (IgM)
      6. measurements
        1. group Id
          BG000
          value
          68
        title
        No serum heavy chain type detected
      7. measurements
        1. group Id
          BG000
          value
          72
        title
        Test not performed
    description
    Immunoglobulins help protect the body against illness and infections. Immunoglobulins are formed when light chains link up with heavy chains, another type of protein.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Serum Heavy Chain Type
    unit Of Measure
    Participants
  10. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          12
        title
        < 30 mL/min
      2. measurements
        1. group Id
          BG000
          value
          57
        title
        30 - < 45 mL/min
      3. measurements
        1. group Id
          BG000
          value
          168
        title
        45 - < 60 mL/min
      4. measurements
        1. group Id
          BG000
          value
          190
        title
        60 - < 80 mL/min
      5. measurements
        1. group Id
          BG000
          value
          250
        title
        ≥ 80 mL/min
      6. measurements
        1. group Id
          BG000
          value
          5
        title
        Missing
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Renal Function (Cockcroft Gault Creatinine Clearance)
    unit Of Measure
    Participants
  11. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          0.231
          value
          2.43
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Corrected Serum Calcium
    unit Of Measure
    mmol/L
population Description
The intent to treat (ITT) population was defined as all enrolled participants (participants who received an interactive voice response system (IVRS) enrollment date) regardless of whether they received any investigational product (IP) or not.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      682
    units
    Participants
groups
  1. description
    Participants received 4 mg pomalidomide (POM) by mouth (PO) on Days 1 to 21 of each 28-day treatment cycle and low dose dexamethasone (LD-Dex) PO at the starting dose of 40 mg/day (≤ 75 years old) or 20 mg/day (\> 75 years old) on Days 1, 8, 15 and 22 of a 28-day cycle until the documentation of confirmed progressive disease (PD), intolerable toxicity, death, withdrawal of participation in the study/consent, lost to follow-up, or as long as they benefited from therapy according to the opinion of the responsible study investigator.
    id
    BG000
    title
    Pomalidomide Plus Low Dose Dexamethasone (LD-Dex)
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          9.10
          value
          65.4
    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
          301
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          381
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          52
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          626
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          4
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        title
        Asian
      2. measurements
        1. group Id
          BG000
          value
          4
        title
        Black or African American
      3. measurements
        1. group Id
          BG000
          value
          669
        title
        White
      4. measurements
        1. group Id
          BG000
          value
          2
        title
        Other
      5. measurements
        1. group Id
          BG000
          value
          4
        title
        Missing
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          295
        title
        0 = Fully active, no restrictions
      2. measurements
        1. group Id
          BG000
          value
          319
        title
        1 = Restricted activity but ambulatory
      3. measurements
        1. group Id
          BG000
          value
          67
        title
        2 = Ambulatory and capable of all self-care
      4. measurements
        1. group Id
          BG000
          value
          1
        title
        3 = Limited self-care
      5. measurements
        1. group Id
          BG000
          value
          0
        title
        4 = Completely disabled
    description
    ECOG performance status is used to describe a patient's level of functioning in terms of their ability to care for themselves, daily activity, and physical ability (walking, working, etc.). The scale ranges from 0 to 5: 0 = Fully active, no restrictions; 1 = Restricted activity but ambulatory, able to carry out work of a light nature; 2 = Ambulatory and capable of all self-care but unable to carry out work activities; 3 = Limited self-care, confined to bed or chair more than 50% of waking hours; 4 = Completely disabled, no self-care, confined to bed or chair; 5 = Dead
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Eastern Cooperative Oncology Group (ECOG) Performance Status
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          3.649
          value
          6.15
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Time since diagnosis
    unit Of Measure
    Years
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          4.713
          value
          5.48
    description
    This test measures the amount of a protein called beta-2 microglobulin (B2M) in the blood.
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Beta 2 Microglobulin
    unit Of Measure
    mg/L
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          364
        title
        Kappa
      2. measurements
        1. group Id
          BG000
          value
          230
        title
        Lambda
      3. measurements
        1. group Id
          BG000
          value
          16
        title
        No Serum Light chain Type Detected
      4. measurements
        1. group Id
          BG000
          value
          72
        title
        Test Not Performed
    description
    Light chains are proteins made by plasma cells and make immunoglobulins (antibodies). Immunoglobulins help protect the body against illness and infections. Immunoglobulins are formed when light chains link up with heavy chains, another type of protein. There are two types of light chains: lambda and kappa light chains. A free light chains test measures the amount of lambda and kappa free light chains in the blood. If the amount of free light chains is higher or lower than normal, it can mean you have a disorder of the plasma cells.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Serum Light Chain Type
    unit Of Measure
    Participants
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          145
        title
        Immunoglobulin A (IgA)
      2. measurements
        1. group Id
          BG000
          value
          5
        title
        Immunoglobulin D (IgD)
      3. measurements
        1. group Id
          BG000
          value
          0
        title
        Immunoglobulin E (IgE)
      4. measurements
        1. group Id
          BG000
          value
          388
        title
        Immunoglobulin G (IgG)
      5. measurements
        1. group Id
          BG000
          value
          4
        title
        Immunoglobulin M (IgM)
      6. measurements
        1. group Id
          BG000
          value
          68
        title
        No serum heavy chain type detected
      7. measurements
        1. group Id
          BG000
          value
          72
        title
        Test not performed
    description
    Immunoglobulins help protect the body against illness and infections. Immunoglobulins are formed when light chains link up with heavy chains, another type of protein.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Serum Heavy Chain Type
    unit Of Measure
    Participants
  10. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          12
        title
        < 30 mL/min
      2. measurements
        1. group Id
          BG000
          value
          57
        title
        30 - < 45 mL/min
      3. measurements
        1. group Id
          BG000
          value
          168
        title
        45 - < 60 mL/min
      4. measurements
        1. group Id
          BG000
          value
          190
        title
        60 - < 80 mL/min
      5. measurements
        1. group Id
          BG000
          value
          250
        title
        ≥ 80 mL/min
      6. measurements
        1. group Id
          BG000
          value
          5
        title
        Missing
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Renal Function (Cockcroft Gault Creatinine Clearance)
    unit Of Measure
    Participants
  11. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          0.231
          value
          2.43
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Corrected Serum Calcium
    unit Of Measure
    mmol/L
population Description
The intent to treat (ITT) population was defined as all enrolled participants (participants who received an interactive voice response system (IVRS) enrollment date) regardless of whether they received any investigational product (IP) or not.

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

Preserved source evidence · Not medical advice