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NCT00985907 · BASELINE

Baseline characteristics

Doxil® + Melphalan + Velcade (DMV) in Relapsed/Refractory Multiple Myeloma · Source last updated 2020-06-17

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
      13
    units
    Participants
groups
  1. description
    Doxil, melphalan, bortezomib: Doxil®: IV over 30-60 min, Day 1 q28d Melphalan: IV over 30 min, Day 1 q28d Velcade®: IV bolus, Day 1, 4, 8, 11 q28d Dose Level 1: Doxil 10 mg/m2, Melphalan 5 mg/m2, Velcade 0.7 mg/m2 Dose Level 2: Doxil 10 mg/m2, Melphalan 10 mg/m2, Velcade 0.7 mg/m2 Dose Level 3: Doxil 20 mg/m2, Melphalan 10 mg/m2, Velcade 0.7 mg/m2 Dose Level 4: Doxil 20 mg/m2, Melphalan 10 mg/m2, Velcade 1.0 mg/m2
    id
    BG000
    title
    Doxil® + Melphalan + Velcade (DMV)
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      title
      30-39 years old
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      title
      40-49 years old
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          6
      title
      50-59 years old
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          3
      title
      60-69 years old
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          2
      title
      70-79 years old
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Customized
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          6
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          7
        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
          4
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          9
        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
          1
        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
          9
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          2
        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
          13
      title
      United States
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
population Description
Arms/Groups are not separated by individual cohorts within Phase 1 as the information was lost when it was transferred from our legacy system. Paper records were lost in a flood. So the participants were only grouped electronically by which phase they were enrolled
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      13
    units
    Participants
groups
  1. description
    Doxil, melphalan, bortezomib: Doxil®: IV over 30-60 min, Day 1 q28d Melphalan: IV over 30 min, Day 1 q28d Velcade®: IV bolus, Day 1, 4, 8, 11 q28d Dose Level 1: Doxil 10 mg/m2, Melphalan 5 mg/m2, Velcade 0.7 mg/m2 Dose Level 2: Doxil 10 mg/m2, Melphalan 10 mg/m2, Velcade 0.7 mg/m2 Dose Level 3: Doxil 20 mg/m2, Melphalan 10 mg/m2, Velcade 0.7 mg/m2 Dose Level 4: Doxil 20 mg/m2, Melphalan 10 mg/m2, Velcade 1.0 mg/m2
    id
    BG000
    title
    Doxil® + Melphalan + Velcade (DMV)
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      title
      30-39 years old
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      title
      40-49 years old
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          6
      title
      50-59 years old
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          3
      title
      60-69 years old
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          2
      title
      70-79 years old
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Customized
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          6
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          7
        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
          4
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          9
        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
          1
        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
          9
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          2
        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
          13
      title
      United States
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
population Description
Arms/Groups are not separated by individual cohorts within Phase 1 as the information was lost when it was transferred from our legacy system. Paper records were lost in a flood. So the participants were only grouped electronically by which phase they were enrolled

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

Preserved source evidence · Not medical advice