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NCT04843579 · BASELINE

Baseline characteristics

Treatment of Selinexor in Combination With Clarithromycin, Pomalidomide and Dexamethasone for Relapsed Refractory Multiple Myeloma Patients · Source last updated 2023-10-25

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
      4
    units
    Participants
groups
  1. description
    Selinexor • Given orally at a dose of 60 mg on days 1, 8, and 15 of a 28-day cycle. Dexamethasone * Given orally at a dose of 40 mg on days 1, 8, 15 and 22 of a 28-day cycle. * Subjects will receive a prescription for dexamethasone 4 mg tablets (generic). Clarithromycin * Given orally at a dose of 500 mg twice a day on days 1-28 of a 28-day cycle. * Subjects will receive a prescription for clarithromycin 250 or 500 mg tablets (generic) for oral administration. Pomalidomide * Given orally at a dose of 4 mg daily on days 1-21 of a 28-day cycle. * Subjects will receive a 21-day supply of pomalidomide 1, 2, 3, or 4 mg capsules for oral administration for each treatment cycle. Selinexor: Given as 60 mg oral capsule Clarithromycin: Given as 500 mg oral capsule Pomalidomide: Given as 4 mg oral capsule Dexamethasone: Given as 40 mg oral capsule
    id
    BG000
    title
    Selinexor, Clarithromycin, Pomalidomide and Dexamethasone (ClaSPd)
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          2
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          2
        title
        >=65 years
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Categorical
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          3
        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
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          4
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          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
          BG000
          value
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          0
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          1
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          3
        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
          value
          4
      title
      United States
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      4
    units
    Participants
groups
  1. description
    Selinexor • Given orally at a dose of 60 mg on days 1, 8, and 15 of a 28-day cycle. Dexamethasone * Given orally at a dose of 40 mg on days 1, 8, 15 and 22 of a 28-day cycle. * Subjects will receive a prescription for dexamethasone 4 mg tablets (generic). Clarithromycin * Given orally at a dose of 500 mg twice a day on days 1-28 of a 28-day cycle. * Subjects will receive a prescription for clarithromycin 250 or 500 mg tablets (generic) for oral administration. Pomalidomide * Given orally at a dose of 4 mg daily on days 1-21 of a 28-day cycle. * Subjects will receive a 21-day supply of pomalidomide 1, 2, 3, or 4 mg capsules for oral administration for each treatment cycle. Selinexor: Given as 60 mg oral capsule Clarithromycin: Given as 500 mg oral capsule Pomalidomide: Given as 4 mg oral capsule Dexamethasone: Given as 40 mg oral capsule
    id
    BG000
    title
    Selinexor, Clarithromycin, Pomalidomide and Dexamethasone (ClaSPd)
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          2
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          2
        title
        >=65 years
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Categorical
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          3
        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
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          4
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          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
          BG000
          value
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          0
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          1
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          3
        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
          value
          4
      title
      United States
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants

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

Preserved source evidence · Not medical advice