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NCT03512353 · BASELINE

Baseline characteristics

A Study of Carfilzomib Plus Dexamethasone in Adults With Relapsed or Refractory Multiple Myeloma at US Community Oncology Centers · Source last updated 2021-01-08

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
      6
    units
    Participants
groups
  1. description
    Participants received carfilzomib administered as an intravenous (IV) infusion twice-weekly for up to six 28-day cycles followed by once-weekly for another six 28-day cycles. The carfilzomib dose was 20 mg/m² on days 1 and 2 of cycle 1, 56 mg/m² for the remaining days of cycle 1 (days 8, 9, 15, and 16) and then on days 1, 2, 8, 9, 15, and 16 of each cycle for cycles 2 to 6, and 70 mg/m² on days 1, 8, and 15 of each cycle for cycles 7 to 12. Participants also received dexamethasone either orally or by IV infusion at a dose of 20 mg once daily on days 1, 2, 8, 9, 15, 16, 22, and 23 of cycles 1 to 6 and at a dose 40 mg once daily on days 1, 8, 15 of cycles 7 to 12.
    id
    BG000
    title
    Carfilzomib Plus Dexamethasone
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          10.2
          value
          62.5
    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
          4
        title
        18 - 64 years
      2. measurements
        1. group Id
          BG000
          value
          1
        title
        65 - 74 years
      3. measurements
        1. group Id
          BG000
          value
          1
        title
        ≥ 75 years
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Customized
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          4
        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
          0
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          6
        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
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        title
        Black or African American
      2. measurements
        1. group Id
          BG000
          value
          5
        title
        White
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          5
        title
        0 (Fully active)
      2. measurements
        1. group Id
          BG000
          value
          1
        title
        1 (Restricted but ambulatory)
      3. measurements
        1. group Id
          BG000
          value
          0
        title
        2 (Ambulatory but unable to work)
    description
    A scale to assess a patient's disease status. 0 = Fully active, able to carry out all pre-disease performance without restriction; 1. = Restricted in physically strenuous activity, ambulatory and able to carry out work of a light nature; 2. = Ambulatory and capable of all self-care, unable to carry out any work activities. Up and about \> 50% of waking hours; 3. = Capable of only limited self-care, confined to bed or chair \> 50% of waking hours; 4. = Completely disabled, confined to bed or chair; 5. = Dead.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Eastern Cooperative Oncology Group (ECOG) Performance Scale
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        title
        1 prior regimen
      2. measurements
        1. group Id
          BG000
          value
          1
        title
        2 prior regimens
      3. measurements
        1. group Id
          BG000
          value
          1
        title
        3 prior regimens
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Number of Prior Treatment Regimens
    unit Of Measure
    Participants
population Description
The full analysis set includes all enrolled participants who received at least 1 dose of any study treatment (ie, carfilzomib or dexamethasone).
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      6
    units
    Participants
groups
  1. description
    Participants received carfilzomib administered as an intravenous (IV) infusion twice-weekly for up to six 28-day cycles followed by once-weekly for another six 28-day cycles. The carfilzomib dose was 20 mg/m² on days 1 and 2 of cycle 1, 56 mg/m² for the remaining days of cycle 1 (days 8, 9, 15, and 16) and then on days 1, 2, 8, 9, 15, and 16 of each cycle for cycles 2 to 6, and 70 mg/m² on days 1, 8, and 15 of each cycle for cycles 7 to 12. Participants also received dexamethasone either orally or by IV infusion at a dose of 20 mg once daily on days 1, 2, 8, 9, 15, 16, 22, and 23 of cycles 1 to 6 and at a dose 40 mg once daily on days 1, 8, 15 of cycles 7 to 12.
    id
    BG000
    title
    Carfilzomib Plus Dexamethasone
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          10.2
          value
          62.5
    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
          4
        title
        18 - 64 years
      2. measurements
        1. group Id
          BG000
          value
          1
        title
        65 - 74 years
      3. measurements
        1. group Id
          BG000
          value
          1
        title
        ≥ 75 years
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Customized
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          4
        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
          0
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          6
        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
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        title
        Black or African American
      2. measurements
        1. group Id
          BG000
          value
          5
        title
        White
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          5
        title
        0 (Fully active)
      2. measurements
        1. group Id
          BG000
          value
          1
        title
        1 (Restricted but ambulatory)
      3. measurements
        1. group Id
          BG000
          value
          0
        title
        2 (Ambulatory but unable to work)
    description
    A scale to assess a patient's disease status. 0 = Fully active, able to carry out all pre-disease performance without restriction; 1. = Restricted in physically strenuous activity, ambulatory and able to carry out work of a light nature; 2. = Ambulatory and capable of all self-care, unable to carry out any work activities. Up and about \> 50% of waking hours; 3. = Capable of only limited self-care, confined to bed or chair \> 50% of waking hours; 4. = Completely disabled, confined to bed or chair; 5. = Dead.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Eastern Cooperative Oncology Group (ECOG) Performance Scale
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        title
        1 prior regimen
      2. measurements
        1. group Id
          BG000
          value
          1
        title
        2 prior regimens
      3. measurements
        1. group Id
          BG000
          value
          1
        title
        3 prior regimens
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Number of Prior Treatment Regimens
    unit Of Measure
    Participants
population Description
The full analysis set includes all enrolled participants who received at least 1 dose of any study treatment (ie, carfilzomib or dexamethasone).

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

Preserved source evidence · Not medical advice