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NCT05288062 · BASELINE

Baseline characteristics

Immunomodulatory Drugs (Lenalidomide With or Without Pomalidomide) in Combination With a Corticosteroid Drug (Dexamethasone) for the Treatment of Multiple Myeloma · Source last updated 2025-08-20

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
      0
    2. group Id
      BG001
      value
      5
    3. group Id
      BG002
      value
      10
    4. group Id
      BG003
      value
      0
    5. group Id
      BG004
      value
      15
    units
    Participants
groups
  1. description
    Patients with smoldering multiple myeloma receive lenalidomide PO QD alone on days 1-14 OR in combination with dexamethasone PO QD on days 1, 8 and 15. Treatment for cycle 1 continues for 21 days in the absence of disease progression or unacceptable toxicity. Patients then receive lenalidomide PO QD on days 1-21 alone or in combination with dexamethasone PO QD on days 1, 8, 15, and 22, or in combination with another drug. Treatment repeats every 28 days for up to 5 cycles in the absence of disease progression or unacceptable toxicity. Bone Marrow Biopsy: Undergo bone marrow aspirate/biopsy Dexamethasone: Given orally Lenalidomide: Given orally
    id
    BG000
    title
    Cohort A (Lenalidomide, Dexamethasone)
  2. description
    Patients with newly diagnosed multiple myeloma receive treatment as in Cohort A. Bone Marrow Biopsy: Undergo bone marrow aspirate/biopsy Dexamethasone: Given orally Lenalidomide: Given orally
    id
    BG001
    title
    Cohort B (Lenalidomide, Dexamethasone)
  3. description
    Patients with relapsed or refractory multiple myeloma receive lenalidomide PO QD on days 1-14 in combination with dexamethasone PO QD on days 1, 8 and 15 OR pomalidomide PO QD on days 1-21 in combination with dexamethasone PO QD on days 1, 8 and 15. Treatment for cycle 1 continues for 21 days in the absence of disease progression or unacceptable toxicity. Patients then receive lenalidomide PO QD on days 1-21 in combination with dexamethasone PO QD on days 1, 8, 15, and 22 OR pomalidomide PO QD on days 1-21 in combination with dexamethasone PO QD on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 5 cycles in the absence of disease progression or unacceptable toxicity. Bone Marrow Biopsy: Undergo bone marrow aspirate/biopsy Dexamethasone: Given orally Lenalidomide: Given orally Pomalidomide: Given orally
    id
    BG002
    title
    Cohort C (Lenalidomide, Dexamethasone, Pomalidomide)
  4. description
    Patients with relapsed multiple myeloma after lenalidomide maintenance receive treatment as in Cohort C. Bone Marrow Biopsy: Undergo bone marrow aspirate/biopsy Dexamethasone: Given orally Lenalidomide: Given orally Pomalidomide: Given orally
    id
    BG003
    title
    Cohort D (Lenalidomide, Dexamethasone, Pomalidomide)
  5. description
    Total of all reporting groups
    id
    BG004
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG001
          spread
          15.2
          value
          61.4
        2. group Id
          BG002
          spread
          12.1
          value
          69.9
        3. group Id
          BG004
          spread
          13.3
          value
          67.1
    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
          0
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          5
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          7
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          10
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG001
          value
          1
        2. group Id
          BG002
          value
          1
        3. group Id
          BG004
          value
          2
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG001
          value
          4
        2. group Id
          BG002
          value
          9
        3. group Id
          BG004
          value
          13
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG001
          value
          0
        2. group Id
          BG002
          value
          0
        3. group Id
          BG004
          value
          0
        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
          BG001
          value
          0
        2. group Id
          BG002
          value
          0
        3. group Id
          BG004
          value
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG001
          value
          1
        2. group Id
          BG002
          value
          0
        3. group Id
          BG004
          value
          1
        title
        Asian
      3. measurements
        1. group Id
          BG001
          value
          0
        2. group Id
          BG002
          value
          0
        3. group Id
          BG004
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG001
          value
          0
        2. group Id
          BG002
          value
          1
        3. group Id
          BG004
          value
          1
        title
        Black or African American
      5. measurements
        1. group Id
          BG001
          value
          3
        2. group Id
          BG002
          value
          9
        3. group Id
          BG004
          value
          12
        title
        White
      6. measurements
        1. group Id
          BG001
          value
          0
        2. group Id
          BG002
          value
          0
        3. group Id
          BG004
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG001
          value
          1
        2. group Id
          BG002
          value
          0
        3. group Id
          BG004
          value
          1
        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
          BG001
          value
          5
        2. group Id
          BG002
          value
          10
        3. group Id
          BG004
          value
          15
      title
      United States
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
population Description
Only patients that completed the study were included in analysis
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      0
    2. group Id
      BG001
      value
      5
    3. group Id
      BG002
      value
      10
    4. group Id
      BG003
      value
      0
    5. group Id
      BG004
      value
      15
    units
    Participants
groups
  1. description
    Patients with smoldering multiple myeloma receive lenalidomide PO QD alone on days 1-14 OR in combination with dexamethasone PO QD on days 1, 8 and 15. Treatment for cycle 1 continues for 21 days in the absence of disease progression or unacceptable toxicity. Patients then receive lenalidomide PO QD on days 1-21 alone or in combination with dexamethasone PO QD on days 1, 8, 15, and 22, or in combination with another drug. Treatment repeats every 28 days for up to 5 cycles in the absence of disease progression or unacceptable toxicity. Bone Marrow Biopsy: Undergo bone marrow aspirate/biopsy Dexamethasone: Given orally Lenalidomide: Given orally
    id
    BG000
    title
    Cohort A (Lenalidomide, Dexamethasone)
  2. description
    Patients with newly diagnosed multiple myeloma receive treatment as in Cohort A. Bone Marrow Biopsy: Undergo bone marrow aspirate/biopsy Dexamethasone: Given orally Lenalidomide: Given orally
    id
    BG001
    title
    Cohort B (Lenalidomide, Dexamethasone)
  3. description
    Patients with relapsed or refractory multiple myeloma receive lenalidomide PO QD on days 1-14 in combination with dexamethasone PO QD on days 1, 8 and 15 OR pomalidomide PO QD on days 1-21 in combination with dexamethasone PO QD on days 1, 8 and 15. Treatment for cycle 1 continues for 21 days in the absence of disease progression or unacceptable toxicity. Patients then receive lenalidomide PO QD on days 1-21 in combination with dexamethasone PO QD on days 1, 8, 15, and 22 OR pomalidomide PO QD on days 1-21 in combination with dexamethasone PO QD on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 5 cycles in the absence of disease progression or unacceptable toxicity. Bone Marrow Biopsy: Undergo bone marrow aspirate/biopsy Dexamethasone: Given orally Lenalidomide: Given orally Pomalidomide: Given orally
    id
    BG002
    title
    Cohort C (Lenalidomide, Dexamethasone, Pomalidomide)
  4. description
    Patients with relapsed multiple myeloma after lenalidomide maintenance receive treatment as in Cohort C. Bone Marrow Biopsy: Undergo bone marrow aspirate/biopsy Dexamethasone: Given orally Lenalidomide: Given orally Pomalidomide: Given orally
    id
    BG003
    title
    Cohort D (Lenalidomide, Dexamethasone, Pomalidomide)
  5. description
    Total of all reporting groups
    id
    BG004
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG001
          spread
          15.2
          value
          61.4
        2. group Id
          BG002
          spread
          12.1
          value
          69.9
        3. group Id
          BG004
          spread
          13.3
          value
          67.1
    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
          0
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          5
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          7
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          10
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG001
          value
          1
        2. group Id
          BG002
          value
          1
        3. group Id
          BG004
          value
          2
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG001
          value
          4
        2. group Id
          BG002
          value
          9
        3. group Id
          BG004
          value
          13
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG001
          value
          0
        2. group Id
          BG002
          value
          0
        3. group Id
          BG004
          value
          0
        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
          BG001
          value
          0
        2. group Id
          BG002
          value
          0
        3. group Id
          BG004
          value
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG001
          value
          1
        2. group Id
          BG002
          value
          0
        3. group Id
          BG004
          value
          1
        title
        Asian
      3. measurements
        1. group Id
          BG001
          value
          0
        2. group Id
          BG002
          value
          0
        3. group Id
          BG004
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG001
          value
          0
        2. group Id
          BG002
          value
          1
        3. group Id
          BG004
          value
          1
        title
        Black or African American
      5. measurements
        1. group Id
          BG001
          value
          3
        2. group Id
          BG002
          value
          9
        3. group Id
          BG004
          value
          12
        title
        White
      6. measurements
        1. group Id
          BG001
          value
          0
        2. group Id
          BG002
          value
          0
        3. group Id
          BG004
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG001
          value
          1
        2. group Id
          BG002
          value
          0
        3. group Id
          BG004
          value
          1
        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
          BG001
          value
          5
        2. group Id
          BG002
          value
          10
        3. group Id
          BG004
          value
          15
      title
      United States
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
population Description
Only patients that completed the study were included in analysis

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

Preserved source evidence · Not medical advice