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NCT01653418 · BASELINE

Baseline characteristics

Phase II Study of V-BEAM Conditioning Regimen Prior to Second Autologous Stem Cell Transplantation · Source last updated 2014-10-15

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
      10
    units
    Participants
groups
  1. description
    Bortezomib IV or SC (1.3mg/m2) on Days -6, -3, +1 and +4 Carmustine IV (300mg/m2) on Day -7 Etoposide IV twice daily (100 mg/m2) on Days -6, -5, -4, and -3 Cytarabine IV twice daily (100 mg/m2) on Days -6, -5, -4, and -3 Melphalan IV (140 mg/m2) on Day-2 Stem cell infusion on Day 0
    id
    BG000
    title
    V-BEAM + Stem Cell Infusion
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          48
          upper Limit
          69
          value
          64.5
    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
          5
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          5
        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
          10
      title
      United States
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
      title
      Stage I
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          3
      title
      Stage IIA
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          7
      title
      Stage IIIA
    description
    STAGE I * Hemoglobin \>10g/dL * Serum calcium normal or \<10.5mg/dL * Bone x-ray, normal bone structure (scale 0), or solitary bone plasmacytoma only * Low M-component production rates IgG value \<5g/dL; IgA value \<3g/dL * Urine light chain M-component on electrophoresis \<4g/24h STAGE II -Neither Stage I or Stage III STAGE III * Hemoglobin \<8.5g/dL * Serum calcium \>12mg/dL * Advanced lytic bone lesions (scale 3) -High M-component production rates IgG value \>7g/dL IgA value \>5g/dL- Bence Jones protein \>12g/24h SUBCLASS -A: relatively normal renal function (serum creatinine) \<2.0 mg/dL
    param Type
    NUMBER
    title
    Durie-Salmon Stage of Myeloma on Diagnosis
    unit Of Measure
    participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          2
      title
      Stage I
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          5
      title
      Stage II
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          2
      title
      Stage III
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      title
      Unknown
    description
    STAGE I -Serum beta-2 microglobulin is less than 3.5 (mg/L) and the albumin level is above 3.5 (g/L) STAGE II -Neither stage I or III STAGE III -Serum beta-2 microglobulin is greater than 5.5
    param Type
    NUMBER
    title
    International Staging System (ISS) Stage of Myeloma on Diagnosis
    unit Of Measure
    participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          3
      title
      IgG
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          5
      title
      IgA
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          2
      title
      Light chain only
    description
    Antibodies typically consist of 2 heavy chains and 2 light chains. There are 5 kinds of heavy chains termed IgG, IgA, IgM, IgD, and IgE; and 2 distinct types of light chain, termed kappa and lambda. In myeloma, all the abnormal plasma cells make the same antibody. Therefore the myeloma can be classified by the type of light and heavy chains produced, such as IgG kappa, IgG lambda, IgA kappa, or IgA lambda, etc. Occasionally, the malignant plasma cells make only the light chain component of the antibody. These patients are said to have "light chain myeloma."
    param Type
    NUMBER
    title
    Monoclonal Protein Type
    unit Of Measure
    participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          17
          upper Limit
          97
          value
          29
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Time to Progression from First Transplant
    unit Of Measure
    months
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          27
          upper Limit
          118
          value
          42
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Time from Diagnosis to V-BEAM transplant
    unit Of Measure
    months
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          3
          upper Limit
          6
          value
          4
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Number of Prior Therapies (including prior transplant)
    unit Of Measure
    prior therapies
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      10
    units
    Participants
groups
  1. description
    Bortezomib IV or SC (1.3mg/m2) on Days -6, -3, +1 and +4 Carmustine IV (300mg/m2) on Day -7 Etoposide IV twice daily (100 mg/m2) on Days -6, -5, -4, and -3 Cytarabine IV twice daily (100 mg/m2) on Days -6, -5, -4, and -3 Melphalan IV (140 mg/m2) on Day-2 Stem cell infusion on Day 0
    id
    BG000
    title
    V-BEAM + Stem Cell Infusion
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          48
          upper Limit
          69
          value
          64.5
    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
          5
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          5
        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
          10
      title
      United States
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
      title
      Stage I
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          3
      title
      Stage IIA
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          7
      title
      Stage IIIA
    description
    STAGE I * Hemoglobin \>10g/dL * Serum calcium normal or \<10.5mg/dL * Bone x-ray, normal bone structure (scale 0), or solitary bone plasmacytoma only * Low M-component production rates IgG value \<5g/dL; IgA value \<3g/dL * Urine light chain M-component on electrophoresis \<4g/24h STAGE II -Neither Stage I or Stage III STAGE III * Hemoglobin \<8.5g/dL * Serum calcium \>12mg/dL * Advanced lytic bone lesions (scale 3) -High M-component production rates IgG value \>7g/dL IgA value \>5g/dL- Bence Jones protein \>12g/24h SUBCLASS -A: relatively normal renal function (serum creatinine) \<2.0 mg/dL
    param Type
    NUMBER
    title
    Durie-Salmon Stage of Myeloma on Diagnosis
    unit Of Measure
    participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          2
      title
      Stage I
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          5
      title
      Stage II
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          2
      title
      Stage III
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      title
      Unknown
    description
    STAGE I -Serum beta-2 microglobulin is less than 3.5 (mg/L) and the albumin level is above 3.5 (g/L) STAGE II -Neither stage I or III STAGE III -Serum beta-2 microglobulin is greater than 5.5
    param Type
    NUMBER
    title
    International Staging System (ISS) Stage of Myeloma on Diagnosis
    unit Of Measure
    participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          3
      title
      IgG
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          5
      title
      IgA
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          2
      title
      Light chain only
    description
    Antibodies typically consist of 2 heavy chains and 2 light chains. There are 5 kinds of heavy chains termed IgG, IgA, IgM, IgD, and IgE; and 2 distinct types of light chain, termed kappa and lambda. In myeloma, all the abnormal plasma cells make the same antibody. Therefore the myeloma can be classified by the type of light and heavy chains produced, such as IgG kappa, IgG lambda, IgA kappa, or IgA lambda, etc. Occasionally, the malignant plasma cells make only the light chain component of the antibody. These patients are said to have "light chain myeloma."
    param Type
    NUMBER
    title
    Monoclonal Protein Type
    unit Of Measure
    participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          17
          upper Limit
          97
          value
          29
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Time to Progression from First Transplant
    unit Of Measure
    months
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          27
          upper Limit
          118
          value
          42
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Time from Diagnosis to V-BEAM transplant
    unit Of Measure
    months
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          3
          upper Limit
          6
          value
          4
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Number of Prior Therapies (including prior transplant)
    unit Of Measure
    prior therapies

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Preserved source evidence · Not medical advice