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NCT00148317 · BASELINE

Baseline characteristics

Phase II Study of Velcade, Decadron, and Doxil Followed by Cyclophosphamide in Multiple Myeloma · Source last updated 2017-07-18

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
      38
    units
    Participants
groups
  1. description
    Bortezomib, Dexamethasone, Pegylated Liposomal Doxorubicin, Cyclophosphamide: Bortezomib 1.3 mg/m2 days 1, 4, 8, 11 (initial cycles) Dexamethasone 40 mg Days 1-4, 8-11, 15-18 (initial cycles) Doxil 30 mg/m2 Day 4 of subsequent cycles
    id
    BG000
    title
    Treatment Arm (All Patients)
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          27
          upper Limit
          76
          value
          61
    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
          34
      title
      Age <70 years
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          4
      title
      Age > or = 70
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Customized
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          17
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          21
        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
          4
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          34
        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
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          3
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          4
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          26
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          5
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          1.0
          upper Limit
          10.2
          value
          2.05
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Beta-2 Microglubilin
    unit Of Measure
    mg/L
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          2.0
          upper Limit
          4.3
          value
          3.5
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Serum Albumin
    unit Of Measure
    g/dL
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      title
      1a
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          19
      title
      2a
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          17
      title
      3a
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      title
      3b
    description
    The Durie Salmon Staging System was used to assess patients status. Stage 1A is associated with a better outcome \& a low tumor burden, stage 2A with a intermediate outcome and tumor burden, and stage 3A with a worse outcome \& higher tumor burden. Criteria for staging is based on multiple factors including hematology values, disease burden, and renal function. The staging system can be found here: https://www.themmrf.org/multiple-myeloma/prognosis/myeloma-stages/durie-salmon-staging-system/ As assessed by the treating physician, the 1a subject:had active myeloma based on the IMWG criteria.
    param Type
    NUMBER
    title
    Durie Salmon Staging System
    unit Of Measure
    participants
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          18
      title
      I
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          17
      title
      II
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          3
      title
      III
    description
    Measure Description: Stage I ß2-M \< 3.5 mg/dL and albumin =3.5 g/dL Stage II Neither stage I nor stage III Stage III ß2-M ≥ 5.5 mg/L
    param Type
    NUMBER
    title
    International Staging System
    unit Of Measure
    participants
  10. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          10
      title
      trisomy 11
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          7
      title
      hyperdiploidy
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          4
      title
      t (4;14)
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          4
      title
      p53
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      title
      del (17p)
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          5
      title
      t (11;14)
    7. categories
      1. measurements
        1. group Id
          BG000
          value
          2
      title
      t (14;16)
    8. categories
      1. measurements
        1. group Id
          BG000
          value
          16
      title
      none
    description
    Cytogenetic abnormalities were assessed in patients using fluorescence in situ hybridization (FISH), which detects chromosomal abnormalities. Del (17p), t(4;14), and t (14;16) were considered High Risk cytogenetic abnormalities. All other abnormalities were considered standard risk cytogenetics.
    param Type
    NUMBER
    title
    Abnormalities by FISH
    unit Of Measure
    participants
  11. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          21
      title
      lenalidomide + dexamethasone ± BIAXIN
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          8
      title
      Thalidomide + lenalidomide + dexamethasone± BIAXIN
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          3
      title
      Thalidomide + dexamethasone
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          2
      title
      thalidomide only
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          2
      title
      pulsed dexamethasone only
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      title
      melphalan + cyclophosphamide
    7. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      title
      dexamethasone, then single-agent lenalidomide
    param Type
    NUMBER
    title
    Prior induction therapy
    unit Of Measure
    participants
  12. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      title
      Complete Response
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          27
      title
      partial Response
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          10
      title
      Stable Disease
    description
    Best response was noted using the International Myeloma Working Group Guidelines: http://imwg.myeloma.org/international-myeloma-working-group-imwg-uniform-response-criteria-for-multiple-myeloma/
    param Type
    NUMBER
    title
    Best response prior to induction therapy
    unit Of Measure
    participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      38
    units
    Participants
groups
  1. description
    Bortezomib, Dexamethasone, Pegylated Liposomal Doxorubicin, Cyclophosphamide: Bortezomib 1.3 mg/m2 days 1, 4, 8, 11 (initial cycles) Dexamethasone 40 mg Days 1-4, 8-11, 15-18 (initial cycles) Doxil 30 mg/m2 Day 4 of subsequent cycles
    id
    BG000
    title
    Treatment Arm (All Patients)
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          27
          upper Limit
          76
          value
          61
    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
          34
      title
      Age <70 years
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          4
      title
      Age > or = 70
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Customized
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          17
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          21
        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
          4
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          34
        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
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          3
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          4
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          26
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          5
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          1.0
          upper Limit
          10.2
          value
          2.05
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Beta-2 Microglubilin
    unit Of Measure
    mg/L
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          2.0
          upper Limit
          4.3
          value
          3.5
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Serum Albumin
    unit Of Measure
    g/dL
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      title
      1a
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          19
      title
      2a
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          17
      title
      3a
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      title
      3b
    description
    The Durie Salmon Staging System was used to assess patients status. Stage 1A is associated with a better outcome \& a low tumor burden, stage 2A with a intermediate outcome and tumor burden, and stage 3A with a worse outcome \& higher tumor burden. Criteria for staging is based on multiple factors including hematology values, disease burden, and renal function. The staging system can be found here: https://www.themmrf.org/multiple-myeloma/prognosis/myeloma-stages/durie-salmon-staging-system/ As assessed by the treating physician, the 1a subject:had active myeloma based on the IMWG criteria.
    param Type
    NUMBER
    title
    Durie Salmon Staging System
    unit Of Measure
    participants
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          18
      title
      I
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          17
      title
      II
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          3
      title
      III
    description
    Measure Description: Stage I ß2-M \< 3.5 mg/dL and albumin =3.5 g/dL Stage II Neither stage I nor stage III Stage III ß2-M ≥ 5.5 mg/L
    param Type
    NUMBER
    title
    International Staging System
    unit Of Measure
    participants
  10. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          10
      title
      trisomy 11
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          7
      title
      hyperdiploidy
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          4
      title
      t (4;14)
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          4
      title
      p53
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      title
      del (17p)
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          5
      title
      t (11;14)
    7. categories
      1. measurements
        1. group Id
          BG000
          value
          2
      title
      t (14;16)
    8. categories
      1. measurements
        1. group Id
          BG000
          value
          16
      title
      none
    description
    Cytogenetic abnormalities were assessed in patients using fluorescence in situ hybridization (FISH), which detects chromosomal abnormalities. Del (17p), t(4;14), and t (14;16) were considered High Risk cytogenetic abnormalities. All other abnormalities were considered standard risk cytogenetics.
    param Type
    NUMBER
    title
    Abnormalities by FISH
    unit Of Measure
    participants
  11. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          21
      title
      lenalidomide + dexamethasone ± BIAXIN
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          8
      title
      Thalidomide + lenalidomide + dexamethasone± BIAXIN
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          3
      title
      Thalidomide + dexamethasone
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          2
      title
      thalidomide only
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          2
      title
      pulsed dexamethasone only
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      title
      melphalan + cyclophosphamide
    7. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      title
      dexamethasone, then single-agent lenalidomide
    param Type
    NUMBER
    title
    Prior induction therapy
    unit Of Measure
    participants
  12. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      title
      Complete Response
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          27
      title
      partial Response
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          10
      title
      Stable Disease
    description
    Best response was noted using the International Myeloma Working Group Guidelines: http://imwg.myeloma.org/international-myeloma-working-group-imwg-uniform-response-criteria-for-multiple-myeloma/
    param Type
    NUMBER
    title
    Best response prior to induction therapy
    unit Of Measure
    participants

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Preserved source evidence · Not medical advice