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NCT00972959 · BASELINE

Baseline characteristics

Effect of Combination of Bortezomib/Dexamethasone/Zoledronic Acid on Bone Disease in Patients With Multiple Myeloma Relapsed After 1-3 Prior Lines of Therapy · Source last updated 2014-08-05

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
      17
    units
    Participants
groups
  1. description
    For this study, Velcade will be administered at the standard dose of 1.3 mg/m2, iv, bolus, on days 1, 4, 8 and 11 of a 21-day cycle. Dexamethasone will be administered at a dose of 12 mg/m2 p.o., on days 1-2, 4-5, 8-9 and 11-12 of the same cycle. Zoledronic acid will be administered at a dose of 4 mg, iv (15-minute infusion), every 28 days for up to 8 cycles, and then every 28 days for the next 18 months Bortezomib: 1.3 mg/m2, iv, bolus, on days 1, 4, 8 and 11 of a 21-day cycle for up to 8 chemotherapy cycles Zoledronic Acid: 4 mg, iv, at a 15 min infusion, Day 1 of every cycle for up to 8 cycles, and then every 28 days for the next 18 months Dexamethasone: 12 mg/m2 p.o. on days 1-2, 4-5, 8-9 and 11-12 of a 21-day cycle for up to 8 chemotherapy cycles
    id
    BG000
    title
    Bortezomib/Dexamethasone/Zoledronic Acid
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          5
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          12
        title
        >=65 years
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Categorical
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          10
        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
          17
      title
      Greece
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          -3.8
          upper Limit
          2.88
          value
          -0.29
      title
      Lumbar spine (L1-L4)
    2. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          -3.91
          upper Limit
          0.55
          value
          -2.83
      title
      Femoral neck (FN)
    description
    Bone Mineral Density of the lumbar spine (L1-L4, anteroposterior view) and femoral neck (FN) was measured by Dual Energy X-Absorptiometry scan (DEXA-scan) using a Hologic QDR-1000 scanner
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    BMD
    unit Of Measure
    T-score
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          0.3
          upper Limit
          2.1
          value
          0.6
      title
      CTX
    2. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          0.1
          upper Limit
          14
          value
          5.1
      title
      OC
    description
    Bone remodelling was studied by the measurement of the following serum bone metabolism parameters indices using an enzyme-linked immunosorbent assay (ELISA): i) bone resorption marker C-terminal cross-linking telopeptide of collagen type I (CTX) and ii) bone formation marker \[osteocalcin (OC)\].
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Bone remodelling
    unit Of Measure
    ng/ml
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          17
    description
    Skeletal survey was measured using conventional radiography \[imaging of the whole skeleton (skull, cervical spine, thoracic spine, lumbar spine, pelvis, humeri, femoral bones)\].
    param Type
    NUMBER
    title
    Skeletal survey for osteolytic lesions/fractures
    unit Of Measure
    participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          3
          upper Limit
          10
          value
          5
    description
    Bone pain was measured with the use of the Visual Analogue Scale. The visual analogue scale or visual analog scale (VAS) is a psychometric response scale which can be used in questionnaires. It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. The VAS for Bone Pain was constructed as follows: None Mild Moderate Severe Worst possible 1,2 3,4 5,6 7,8 9,10 Lower values are considered to be of a better outcome, higher values are considered to be of a worst outcome.
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Bone pain
    unit Of Measure
    units on a scale
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          4.5
          upper Limit
          34
          value
          15.8
    description
    Bone remodelling was studied by the measurement of the following serum bone metabolism parameters indices using an enzyme-linked immunosorbent assay (ELISA) bone formation marker \[bone-specific alkaline phosphatase (bALP)\].
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Bone remodelling
    unit Of Measure
    U/L
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      17
    units
    Participants
groups
  1. description
    For this study, Velcade will be administered at the standard dose of 1.3 mg/m2, iv, bolus, on days 1, 4, 8 and 11 of a 21-day cycle. Dexamethasone will be administered at a dose of 12 mg/m2 p.o., on days 1-2, 4-5, 8-9 and 11-12 of the same cycle. Zoledronic acid will be administered at a dose of 4 mg, iv (15-minute infusion), every 28 days for up to 8 cycles, and then every 28 days for the next 18 months Bortezomib: 1.3 mg/m2, iv, bolus, on days 1, 4, 8 and 11 of a 21-day cycle for up to 8 chemotherapy cycles Zoledronic Acid: 4 mg, iv, at a 15 min infusion, Day 1 of every cycle for up to 8 cycles, and then every 28 days for the next 18 months Dexamethasone: 12 mg/m2 p.o. on days 1-2, 4-5, 8-9 and 11-12 of a 21-day cycle for up to 8 chemotherapy cycles
    id
    BG000
    title
    Bortezomib/Dexamethasone/Zoledronic Acid
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          5
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          12
        title
        >=65 years
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Categorical
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          10
        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
          17
      title
      Greece
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          -3.8
          upper Limit
          2.88
          value
          -0.29
      title
      Lumbar spine (L1-L4)
    2. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          -3.91
          upper Limit
          0.55
          value
          -2.83
      title
      Femoral neck (FN)
    description
    Bone Mineral Density of the lumbar spine (L1-L4, anteroposterior view) and femoral neck (FN) was measured by Dual Energy X-Absorptiometry scan (DEXA-scan) using a Hologic QDR-1000 scanner
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    BMD
    unit Of Measure
    T-score
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          0.3
          upper Limit
          2.1
          value
          0.6
      title
      CTX
    2. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          0.1
          upper Limit
          14
          value
          5.1
      title
      OC
    description
    Bone remodelling was studied by the measurement of the following serum bone metabolism parameters indices using an enzyme-linked immunosorbent assay (ELISA): i) bone resorption marker C-terminal cross-linking telopeptide of collagen type I (CTX) and ii) bone formation marker \[osteocalcin (OC)\].
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Bone remodelling
    unit Of Measure
    ng/ml
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          17
    description
    Skeletal survey was measured using conventional radiography \[imaging of the whole skeleton (skull, cervical spine, thoracic spine, lumbar spine, pelvis, humeri, femoral bones)\].
    param Type
    NUMBER
    title
    Skeletal survey for osteolytic lesions/fractures
    unit Of Measure
    participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          3
          upper Limit
          10
          value
          5
    description
    Bone pain was measured with the use of the Visual Analogue Scale. The visual analogue scale or visual analog scale (VAS) is a psychometric response scale which can be used in questionnaires. It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. The VAS for Bone Pain was constructed as follows: None Mild Moderate Severe Worst possible 1,2 3,4 5,6 7,8 9,10 Lower values are considered to be of a better outcome, higher values are considered to be of a worst outcome.
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Bone pain
    unit Of Measure
    units on a scale
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          4.5
          upper Limit
          34
          value
          15.8
    description
    Bone remodelling was studied by the measurement of the following serum bone metabolism parameters indices using an enzyme-linked immunosorbent assay (ELISA) bone formation marker \[bone-specific alkaline phosphatase (bALP)\].
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Bone remodelling
    unit Of Measure
    U/L

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

Preserved source evidence · Not medical advice