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NCT00750815 · BASELINE

Baseline characteristics

Cyclophosphamide, VELCADE, DOXIL, and Dexamethasone, (CVDD) in Newly Diagnosed Patients With Multiple Myeloma (MM) · Source last updated 2014-01-20

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
      12
    2. group Id
      BG001
      value
      46
    3. group Id
      BG002
      value
      58
    units
    Participants
groups
  1. description
    Dose of Cyclophosphamide depended on how many patients we had treated: * Dose Level 1: Cyclophosphamide 250 mg /m\^2 IV Day 1; VELCADE, 1.0 mg/m\^2 IV days 1,4,8, and 11; DOXIL 30 mg/m\^2 Day 4; Dexamethasone 20 mg orally daily on days 1-2,4-5,8-9,11-12 * Dose Level 2: Cyclophosphamide 500 mg /m\^2 IV Day 1; VELCADE, 1.0 mg/m\^2 IV days 1,4,8, and 11; DOXIL 30 mg/m\^2 Day 4; Dexamethasone 20 mg orally daily on days 1-2,4-5,8-9,11-12 * Dose Level 3: Cyclophosphamide 750 mg /m\^2 IV Day 1; VELCADE, 1.0 mg/m\^2 IV days 1,4,8, and 11; DOXIL 30 mg/m\^2 Day 4; Dexamethasone 20 mg orally daily on days 1-2,4-5,8-9,11-12 * Dose Level 4: Cyclophosphamide 750 mg /m\^2 IV Day 1; VELCADE, 1.3 mg/m\^2 IV days 1,4,8, and 11; DOXIL 30 mg/m\^2 Day 4; Dexamethasone 20 mg orally daily on days 1-2,4-5,8-9,11-12
    id
    BG000
    title
    A. Phase I - Dose Escalation
  2. description
    Participants received Cyclophosphamide and VELCADE at the MPD at the same schedule of the Phase I study. Pegylated doxorubicin and Dexamethasone were given at the same doses and schedule as the Phase I part of study.
    id
    BG001
    title
    B. Phase II - Maximum Planned Dose (MPD)
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          34
        3. group Id
          BG002
          value
          42
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          12
        3. group Id
          BG002
          value
          16
        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
          lower Limit
          46
          upper Limit
          77
          value
          58.75
        2. group Id
          BG001
          lower Limit
          25
          upper Limit
          75
          value
          57
        3. group Id
          BG002
          lower Limit
          25
          upper Limit
          77
          value
          57
    dispersion Type
    FULL_RANGE
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          20
        3. group Id
          BG002
          value
          24
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          26
        3. group Id
          BG002
          value
          34
        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
          12
        2. group Id
          BG001
          value
          46
        3. group Id
          BG002
          value
          58
      title
      United States
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
population Description
Overall Survival by disease risk stratification: 54 participants with cytogenetics and fluorescence in situ hybridisation (FISH) results available for risk stratification. All other measures: 58 Participants.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      12
    2. group Id
      BG001
      value
      46
    3. group Id
      BG002
      value
      58
    units
    Participants
groups
  1. description
    Dose of Cyclophosphamide depended on how many patients we had treated: * Dose Level 1: Cyclophosphamide 250 mg /m\^2 IV Day 1; VELCADE, 1.0 mg/m\^2 IV days 1,4,8, and 11; DOXIL 30 mg/m\^2 Day 4; Dexamethasone 20 mg orally daily on days 1-2,4-5,8-9,11-12 * Dose Level 2: Cyclophosphamide 500 mg /m\^2 IV Day 1; VELCADE, 1.0 mg/m\^2 IV days 1,4,8, and 11; DOXIL 30 mg/m\^2 Day 4; Dexamethasone 20 mg orally daily on days 1-2,4-5,8-9,11-12 * Dose Level 3: Cyclophosphamide 750 mg /m\^2 IV Day 1; VELCADE, 1.0 mg/m\^2 IV days 1,4,8, and 11; DOXIL 30 mg/m\^2 Day 4; Dexamethasone 20 mg orally daily on days 1-2,4-5,8-9,11-12 * Dose Level 4: Cyclophosphamide 750 mg /m\^2 IV Day 1; VELCADE, 1.3 mg/m\^2 IV days 1,4,8, and 11; DOXIL 30 mg/m\^2 Day 4; Dexamethasone 20 mg orally daily on days 1-2,4-5,8-9,11-12
    id
    BG000
    title
    A. Phase I - Dose Escalation
  2. description
    Participants received Cyclophosphamide and VELCADE at the MPD at the same schedule of the Phase I study. Pegylated doxorubicin and Dexamethasone were given at the same doses and schedule as the Phase I part of study.
    id
    BG001
    title
    B. Phase II - Maximum Planned Dose (MPD)
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          34
        3. group Id
          BG002
          value
          42
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          12
        3. group Id
          BG002
          value
          16
        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
          lower Limit
          46
          upper Limit
          77
          value
          58.75
        2. group Id
          BG001
          lower Limit
          25
          upper Limit
          75
          value
          57
        3. group Id
          BG002
          lower Limit
          25
          upper Limit
          77
          value
          57
    dispersion Type
    FULL_RANGE
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          20
        3. group Id
          BG002
          value
          24
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          26
        3. group Id
          BG002
          value
          34
        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
          12
        2. group Id
          BG001
          value
          46
        3. group Id
          BG002
          value
          58
      title
      United States
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
population Description
Overall Survival by disease risk stratification: 54 participants with cytogenetics and fluorescence in situ hybridisation (FISH) results available for risk stratification. All other measures: 58 Participants.

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

Preserved source evidence · Not medical advice