Skip to content
Triangle logo TriangleGet started
← Full study record

NCT01605032 · BASELINE

Baseline characteristics

Busulfan, Melphalan, and Bortezomib Before First-Line Stem Cell Transplant in Treating Patients With Multiple Myeloma · Source last updated 2020-08-20

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
      19
    units
    Participants
groups
  1. description
    CONDITIONING: Patients receive busulfan IV over 3 hours on days -6 to -3, melphalan IV over 20 minutes on day -2, and bortezomib IV over 3-5 seconds on days -6, -3, 1, and 4. TRANSPLANT: Patients undergo autologous PBSCT on day 0. Busulfan: Given IV Melphalan: Given IV Bortezomib: Given IV Autologous Hematopoietic Stem Cell Transplantation: Undergo autologous PBSCT Peripheral Blood Stem Cell Transplantation: Undergo autologous PBSCT
    id
    BG000
    title
    Treatment (Busulfan, Melphalan, Bortezomib, Autologous PBSCT)
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          32
          upper Limit
          70
          value
          55
      denoms
      1. counts
        1. group Id
          BG000
          value
          19
        units
        Participants
    dispersion Type
    INTER_QUARTILE_RANGE
    param Type
    MEDIAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          6
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          13
        title
        Male
      denoms
      1. counts
        1. group Id
          BG000
          value
          19
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. denoms
      1. counts
        1. group Id
          BG000
          value
          0
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    Race and Ethnicity were not collected from any participant.
    title
    Race and Ethnicity Not Collected
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          4
      denoms
      1. counts
        1. group Id
          BG000
          value
          19
        units
        Participants
      title
      Stage 1
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          7
      denoms
      1. counts
        1. group Id
          BG000
          value
          19
        units
        Participants
      title
      Stage 2
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          5
      denoms
      1. counts
        1. group Id
          BG000
          value
          19
        units
        Participants
      title
      Stage 3
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          3
      denoms
      1. counts
        1. group Id
          BG000
          value
          19
        units
        Participants
      title
      Stage unkown
    description
    The international staging system (ISS) was used to stage the patients. * Stage I: Serum beta-2 microglobulin \< 3.5 mg/L and serum albumin ≥3.5 g/dL - Good outcome * Stage II: Not stage I or stage III - Slightly worse outcome * Stage III: Serum beta-2 microglobulin ≥ 5.5 mg/L - Worse outcome For 16 of them ISS was available at initial diagnosis.
    param Type
    NUMBER
    title
    ISS stage at diagnosis
    unit Of Measure
    participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          2
      denoms
      1. counts
        1. group Id
          BG000
          value
          19
        units
        Participants
      title
      High risk
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          2
      denoms
      1. counts
        1. group Id
          BG000
          value
          19
        units
        Participants
      title
      Intermediate risk
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          6
      denoms
      1. counts
        1. group Id
          BG000
          value
          19
        units
        Participants
      title
      Standard risk
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          10
      denoms
      1. counts
        1. group Id
          BG000
          value
          19
        units
        Participants
      title
      Unknown
    param Type
    NUMBER
    title
    Cytogenetics/FISH at diagnosis
    unit Of Measure
    participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          17
      denoms
      1. counts
        1. group Id
          BG000
          value
          19
        units
        Participants
      title
      Bortezomib-containing regimen
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          7
      denoms
      1. counts
        1. group Id
          BG000
          value
          19
        units
        Participants
      title
      Immunomodulatory agent-containing regimen
    param Type
    NUMBER
    title
    Previous treatment
    unit Of Measure
    participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      denoms
      1. counts
        1. group Id
          BG000
          value
          19
        units
        Participants
      title
      Complete response
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          2
      denoms
      1. counts
        1. group Id
          BG000
          value
          19
        units
        Participants
      title
      Very Good partial response
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          10
      denoms
      1. counts
        1. group Id
          BG000
          value
          19
        units
        Participants
      title
      Partial response
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          5
      denoms
      1. counts
        1. group Id
          BG000
          value
          19
        units
        Participants
      title
      Stable disease
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      denoms
      1. counts
        1. group Id
          BG000
          value
          19
        units
        Participants
      title
      Progressive disease
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Response before ASCT
    unit Of Measure
    Participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      19
    units
    Participants
groups
  1. description
    CONDITIONING: Patients receive busulfan IV over 3 hours on days -6 to -3, melphalan IV over 20 minutes on day -2, and bortezomib IV over 3-5 seconds on days -6, -3, 1, and 4. TRANSPLANT: Patients undergo autologous PBSCT on day 0. Busulfan: Given IV Melphalan: Given IV Bortezomib: Given IV Autologous Hematopoietic Stem Cell Transplantation: Undergo autologous PBSCT Peripheral Blood Stem Cell Transplantation: Undergo autologous PBSCT
    id
    BG000
    title
    Treatment (Busulfan, Melphalan, Bortezomib, Autologous PBSCT)
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          32
          upper Limit
          70
          value
          55
      denoms
      1. counts
        1. group Id
          BG000
          value
          19
        units
        Participants
    dispersion Type
    INTER_QUARTILE_RANGE
    param Type
    MEDIAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          6
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          13
        title
        Male
      denoms
      1. counts
        1. group Id
          BG000
          value
          19
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. denoms
      1. counts
        1. group Id
          BG000
          value
          0
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    Race and Ethnicity were not collected from any participant.
    title
    Race and Ethnicity Not Collected
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          4
      denoms
      1. counts
        1. group Id
          BG000
          value
          19
        units
        Participants
      title
      Stage 1
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          7
      denoms
      1. counts
        1. group Id
          BG000
          value
          19
        units
        Participants
      title
      Stage 2
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          5
      denoms
      1. counts
        1. group Id
          BG000
          value
          19
        units
        Participants
      title
      Stage 3
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          3
      denoms
      1. counts
        1. group Id
          BG000
          value
          19
        units
        Participants
      title
      Stage unkown
    description
    The international staging system (ISS) was used to stage the patients. * Stage I: Serum beta-2 microglobulin \< 3.5 mg/L and serum albumin ≥3.5 g/dL - Good outcome * Stage II: Not stage I or stage III - Slightly worse outcome * Stage III: Serum beta-2 microglobulin ≥ 5.5 mg/L - Worse outcome For 16 of them ISS was available at initial diagnosis.
    param Type
    NUMBER
    title
    ISS stage at diagnosis
    unit Of Measure
    participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          2
      denoms
      1. counts
        1. group Id
          BG000
          value
          19
        units
        Participants
      title
      High risk
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          2
      denoms
      1. counts
        1. group Id
          BG000
          value
          19
        units
        Participants
      title
      Intermediate risk
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          6
      denoms
      1. counts
        1. group Id
          BG000
          value
          19
        units
        Participants
      title
      Standard risk
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          10
      denoms
      1. counts
        1. group Id
          BG000
          value
          19
        units
        Participants
      title
      Unknown
    param Type
    NUMBER
    title
    Cytogenetics/FISH at diagnosis
    unit Of Measure
    participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          17
      denoms
      1. counts
        1. group Id
          BG000
          value
          19
        units
        Participants
      title
      Bortezomib-containing regimen
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          7
      denoms
      1. counts
        1. group Id
          BG000
          value
          19
        units
        Participants
      title
      Immunomodulatory agent-containing regimen
    param Type
    NUMBER
    title
    Previous treatment
    unit Of Measure
    participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      denoms
      1. counts
        1. group Id
          BG000
          value
          19
        units
        Participants
      title
      Complete response
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          2
      denoms
      1. counts
        1. group Id
          BG000
          value
          19
        units
        Participants
      title
      Very Good partial response
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          10
      denoms
      1. counts
        1. group Id
          BG000
          value
          19
        units
        Participants
      title
      Partial response
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          5
      denoms
      1. counts
        1. group Id
          BG000
          value
          19
        units
        Participants
      title
      Stable disease
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      denoms
      1. counts
        1. group Id
          BG000
          value
          19
        units
        Participants
      title
      Progressive disease
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Response before ASCT
    unit Of Measure
    Participants

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

Preserved source evidence · Not medical advice