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NCT01169337 · BASELINE

Baseline characteristics

Lenalidomide or Observation in Treating Patients With Asymptomatic High-Risk Smoldering Multiple Myeloma · Source last updated 2026-08-04

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
      44
    2. group Id
      BG001
      value
      90
    3. group Id
      BG002
      value
      92
    4. group Id
      BG003
      value
      226
    units
    Participants
groups
  1. description
    Patients receive lenalidomide PO QD on days 1-21. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
    id
    BG000
    title
    Arm A (Lenalidomide; Phase II)
  2. description
    Patients receive lenalidomide PO QD on days 1-21. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
    id
    BG001
    title
    Arm A (Lenalidomide; Phase III)
  3. description
    Patients undergo observation until progression to symptomatic myeloma.
    id
    BG002
    title
    Arm B (Observation; Phase III)
  4. description
    Total of all reporting groups
    id
    BG003
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          36
          upper Limit
          83
          value
          62
        2. group Id
          BG001
          lower Limit
          31
          upper Limit
          82
          value
          63
        3. group Id
          BG002
          lower Limit
          33
          upper Limit
          96
          value
          64
        4. group Id
          BG003
          lower Limit
          31
          upper Limit
          86
          value
          64
    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
          24
        2. group Id
          BG001
          value
          48
        3. group Id
          BG002
          value
          46
        4. group Id
          BG003
          value
          118
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          20
        2. group Id
          BG001
          value
          42
        3. group Id
          BG002
          value
          46
        4. group Id
          BG003
          value
          108
        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
          0
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          6
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          43
        2. group Id
          BG001
          value
          81
        3. group Id
          BG002
          value
          81
        4. group Id
          BG003
          value
          205
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          7
        4. group Id
          BG003
          value
          15
        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
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          2
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          12
        3. group Id
          BG002
          value
          19
        4. group Id
          BG003
          value
          37
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          37
        2. group Id
          BG001
          value
          72
        3. group Id
          BG002
          value
          68
        4. group Id
          BG003
          value
          177
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          10
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
population Description
All registered patients in phase II portion and randomized patients in phase III portion
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      44
    2. group Id
      BG001
      value
      90
    3. group Id
      BG002
      value
      92
    4. group Id
      BG003
      value
      226
    units
    Participants
groups
  1. description
    Patients receive lenalidomide PO QD on days 1-21. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
    id
    BG000
    title
    Arm A (Lenalidomide; Phase II)
  2. description
    Patients receive lenalidomide PO QD on days 1-21. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
    id
    BG001
    title
    Arm A (Lenalidomide; Phase III)
  3. description
    Patients undergo observation until progression to symptomatic myeloma.
    id
    BG002
    title
    Arm B (Observation; Phase III)
  4. description
    Total of all reporting groups
    id
    BG003
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          36
          upper Limit
          83
          value
          62
        2. group Id
          BG001
          lower Limit
          31
          upper Limit
          82
          value
          63
        3. group Id
          BG002
          lower Limit
          33
          upper Limit
          96
          value
          64
        4. group Id
          BG003
          lower Limit
          31
          upper Limit
          86
          value
          64
    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
          24
        2. group Id
          BG001
          value
          48
        3. group Id
          BG002
          value
          46
        4. group Id
          BG003
          value
          118
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          20
        2. group Id
          BG001
          value
          42
        3. group Id
          BG002
          value
          46
        4. group Id
          BG003
          value
          108
        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
          0
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          6
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          43
        2. group Id
          BG001
          value
          81
        3. group Id
          BG002
          value
          81
        4. group Id
          BG003
          value
          205
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          7
        4. group Id
          BG003
          value
          15
        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
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          2
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          12
        3. group Id
          BG002
          value
          19
        4. group Id
          BG003
          value
          37
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          37
        2. group Id
          BG001
          value
          72
        3. group Id
          BG002
          value
          68
        4. group Id
          BG003
          value
          177
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          10
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
population Description
All registered patients in phase II portion and randomized patients in phase III portion

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Preserved source evidence · Not medical advice