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NCT00325416 · BASELINE

Baseline characteristics

Study of Melphalan and Topotecan (MT) Followed by Autologous Stem Cell Rescue in Patients With Multiple Myeloma. · Source last updated 2018-03-14

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
      109
    2. group Id
      BG001
      value
      68
    3. group Id
      BG002
      value
      177
    units
    Participants
groups
  1. description
    Participants 18 - 60 years of age. Intensive-Dose Melphalan and Topotecan (MT) followed by Stem Cell transplant. melphalan: (Days -4,-3,-2) 50 mg/m\^2/day IV over 30 minutes (total dose 150 mg/m\^2) topotecan (TPT): Phase I Dose Escalation: Level 1 - 20 mg/m\^2; Level 2 - 30 mg/m\^2; Level 4 - 54 mg/m\^2; Level 5 - 72 mg/m\^2; Level 6 - 96 mg/m\^2; Level 7 - 127.8 mg/m\^2; Level 8 - 170.1 mg/m\^2 Phase II: Treatment at maximum tolerated dose (MTD) Autologous Stem Cell Rescue: Day 0
    id
    BG000
    title
    Age Group A - Melphalan and Topotecan Plus Stem Cell Rescue
  2. description
    Participants 61 years of age or older. Intensive-Dose Melphalan and Topotecan (MT) followed by Stem Cell transplant. melphalan: (Days -4,-3,-2) 50 mg/m\^2/day IV over 30 minutes (total dose 150 mg/m\^2) topotecan (TPT): Phase I Dose Escalation: Level 1 - 20 mg/m\^2; Level 2 - 30 mg/m\^2; Level 4 - 54 mg/m\^2; Level 5 - 72 mg/m\^2; Level 6 - 96 mg/m\^2; Level 7 - 127.8 mg/m\^2; Level 8 - 170.1 mg/m\^2 Phase II: Treatment at maximum tolerated dose (MTD) Autologous Stem Cell Rescue: Day 0
    id
    BG001
    title
    Age Group B - Melphalan and Topotecan Plus Stem Cell Rescue
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          32
          upper Limit
          60
          value
          46
        2. group Id
          BG001
          lower Limit
          61
          upper Limit
          76
          value
          68.5
        3. group Id
          BG002
          lower Limit
          32
          upper Limit
          76
          value
          54
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. 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
          109
        2. group Id
          BG001
          value
          10
        3. group Id
          BG002
          value
          119
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          58
        3. group Id
          BG002
          value
          58
        title
        >=65 years
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Categorical
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          39
        2. group Id
          BG001
          value
          29
        3. group Id
          BG002
          value
          68
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          70
        2. group Id
          BG001
          value
          39
        3. group Id
          BG002
          value
          109
        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
          109
        2. group Id
          BG001
          value
          68
        3. group Id
          BG002
          value
          177
      title
      United States
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
population Description
Participants: 177 included in Baseline; 129 included in Phase I Maximum Tolerated Dose Outcome; 51 Phase II participants with responsive disease prior to transplant were re-evaluated for the Overall Response Rate; 79 treated in Phase II and evaluable at time of analysis are included in the Event Free Survival and Overall Survival Outcome Measures.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      109
    2. group Id
      BG001
      value
      68
    3. group Id
      BG002
      value
      177
    units
    Participants
groups
  1. description
    Participants 18 - 60 years of age. Intensive-Dose Melphalan and Topotecan (MT) followed by Stem Cell transplant. melphalan: (Days -4,-3,-2) 50 mg/m\^2/day IV over 30 minutes (total dose 150 mg/m\^2) topotecan (TPT): Phase I Dose Escalation: Level 1 - 20 mg/m\^2; Level 2 - 30 mg/m\^2; Level 4 - 54 mg/m\^2; Level 5 - 72 mg/m\^2; Level 6 - 96 mg/m\^2; Level 7 - 127.8 mg/m\^2; Level 8 - 170.1 mg/m\^2 Phase II: Treatment at maximum tolerated dose (MTD) Autologous Stem Cell Rescue: Day 0
    id
    BG000
    title
    Age Group A - Melphalan and Topotecan Plus Stem Cell Rescue
  2. description
    Participants 61 years of age or older. Intensive-Dose Melphalan and Topotecan (MT) followed by Stem Cell transplant. melphalan: (Days -4,-3,-2) 50 mg/m\^2/day IV over 30 minutes (total dose 150 mg/m\^2) topotecan (TPT): Phase I Dose Escalation: Level 1 - 20 mg/m\^2; Level 2 - 30 mg/m\^2; Level 4 - 54 mg/m\^2; Level 5 - 72 mg/m\^2; Level 6 - 96 mg/m\^2; Level 7 - 127.8 mg/m\^2; Level 8 - 170.1 mg/m\^2 Phase II: Treatment at maximum tolerated dose (MTD) Autologous Stem Cell Rescue: Day 0
    id
    BG001
    title
    Age Group B - Melphalan and Topotecan Plus Stem Cell Rescue
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          32
          upper Limit
          60
          value
          46
        2. group Id
          BG001
          lower Limit
          61
          upper Limit
          76
          value
          68.5
        3. group Id
          BG002
          lower Limit
          32
          upper Limit
          76
          value
          54
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. 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
          109
        2. group Id
          BG001
          value
          10
        3. group Id
          BG002
          value
          119
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          58
        3. group Id
          BG002
          value
          58
        title
        >=65 years
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Categorical
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          39
        2. group Id
          BG001
          value
          29
        3. group Id
          BG002
          value
          68
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          70
        2. group Id
          BG001
          value
          39
        3. group Id
          BG002
          value
          109
        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
          109
        2. group Id
          BG001
          value
          68
        3. group Id
          BG002
          value
          177
      title
      United States
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
population Description
Participants: 177 included in Baseline; 129 included in Phase I Maximum Tolerated Dose Outcome; 51 Phase II participants with responsive disease prior to transplant were re-evaluated for the Overall Response Rate; 79 treated in Phase II and evaluable at time of analysis are included in the Event Free Survival and Overall Survival Outcome Measures.

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

Preserved source evidence · Not medical advice