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NCT00507442 · BASELINE

Baseline characteristics

Phase 1/2 Study of VELCADE® in Combination With Other Drugs to Treat Previously Untreated Multiple Myeloma Patients · Source last updated 2013-07-26

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
      42
    2. group Id
      BG001
      value
      66
    3. group Id
      BG002
      value
      33
    4. group Id
      BG003
      value
      17
    5. group Id
      BG004
      value
      158
    units
    Participants
groups
  1. description
    VELCADE (bortezomib), dexamethasone, and Revlimid (lenalidomide) Bortezomib: 1.3 mg/m\^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles. Dexamethasone: 40 mg orally \[PO\] on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop. Lenalidomide: 25 mg PO on Days 1 through 14 of a 3-week cycle for 8 cycles, then stop.
    id
    BG000
    title
    V-DR
  2. description
    VELCADE (bortezomib), dexamethasone, cyclophosphamide, Revlimid (lenalidomide) Bortezomib: 1.3 mg/m\^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles. Dexamethasone: 40 mg PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop. Cyclophosphamide: 100 - 500 mg/m\^2 dose PO on Days 1 and 8 of a 3-week cycle for 8 cycles, then stop. Lenalidomide: 15 mg PO on Days 1 through 14 of a 3-week cycle for 8 cycles, then stop.
    id
    BG001
    title
    VDCR
  3. description
    VELCADE (bortezomib), dexamethasone, cyclophosphamide Bortezomib: 1.3 mg/m\^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles. Dexamethasone: 40 mg orally PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop. Cyclophosphamide: 500 mg/m\^2 dose PO on Days 1 and 8 of a 3-week cycle for 8 cycles, then stop.
    id
    BG002
    title
    V-DC
  4. description
    Modified dosing of VELCADE (bortezomib), dexamethasone, cyclophosphamide Bortezomib: 1.3 mg/m\^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles. Dexamethasone: 40 mg PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop. Cyclophosphamide: 500 mg/m\^2 dose PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.
    id
    BG003
    title
    VDC-mod
  5. description
    Total of all reporting groups
    id
    BG004
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          27
        2. group Id
          BG001
          value
          42
        3. group Id
          BG002
          value
          21
        4. group Id
          BG003
          value
          11
        5. group Id
          BG004
          value
          101
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          15
        2. group Id
          BG001
          value
          24
        3. group Id
          BG002
          value
          12
        4. group Id
          BG003
          value
          6
        5. group Id
          BG004
          value
          57
        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
          spread
          8.76
          value
          59.5
        2. group Id
          BG001
          spread
          8.97
          value
          60.9
        3. group Id
          BG002
          spread
          8.32
          value
          61.4
        4. group Id
          BG003
          spread
          9.16
          value
          59.6
        5. group Id
          BG004
          spread
          8.75
          value
          60.5
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age Continuous
    unit Of Measure
    years
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          18
        2. group Id
          BG001
          value
          28
        3. group Id
          BG002
          value
          14
        4. group Id
          BG003
          value
          10
        5. group Id
          BG004
          value
          70
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          24
        2. group Id
          BG001
          value
          38
        3. group Id
          BG002
          value
          19
        4. group Id
          BG003
          value
          7
        5. group Id
          BG004
          value
          88
        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
          42
        2. group Id
          BG001
          value
          66
        3. group Id
          BG002
          value
          33
        4. group Id
          BG003
          value
          17
        5. group Id
          BG004
          value
          158
      title
      United States
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      42
    2. group Id
      BG001
      value
      66
    3. group Id
      BG002
      value
      33
    4. group Id
      BG003
      value
      17
    5. group Id
      BG004
      value
      158
    units
    Participants
groups
  1. description
    VELCADE (bortezomib), dexamethasone, and Revlimid (lenalidomide) Bortezomib: 1.3 mg/m\^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles. Dexamethasone: 40 mg orally \[PO\] on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop. Lenalidomide: 25 mg PO on Days 1 through 14 of a 3-week cycle for 8 cycles, then stop.
    id
    BG000
    title
    V-DR
  2. description
    VELCADE (bortezomib), dexamethasone, cyclophosphamide, Revlimid (lenalidomide) Bortezomib: 1.3 mg/m\^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles. Dexamethasone: 40 mg PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop. Cyclophosphamide: 100 - 500 mg/m\^2 dose PO on Days 1 and 8 of a 3-week cycle for 8 cycles, then stop. Lenalidomide: 15 mg PO on Days 1 through 14 of a 3-week cycle for 8 cycles, then stop.
    id
    BG001
    title
    VDCR
  3. description
    VELCADE (bortezomib), dexamethasone, cyclophosphamide Bortezomib: 1.3 mg/m\^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles. Dexamethasone: 40 mg orally PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop. Cyclophosphamide: 500 mg/m\^2 dose PO on Days 1 and 8 of a 3-week cycle for 8 cycles, then stop.
    id
    BG002
    title
    V-DC
  4. description
    Modified dosing of VELCADE (bortezomib), dexamethasone, cyclophosphamide Bortezomib: 1.3 mg/m\^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles. Dexamethasone: 40 mg PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop. Cyclophosphamide: 500 mg/m\^2 dose PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.
    id
    BG003
    title
    VDC-mod
  5. description
    Total of all reporting groups
    id
    BG004
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          27
        2. group Id
          BG001
          value
          42
        3. group Id
          BG002
          value
          21
        4. group Id
          BG003
          value
          11
        5. group Id
          BG004
          value
          101
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          15
        2. group Id
          BG001
          value
          24
        3. group Id
          BG002
          value
          12
        4. group Id
          BG003
          value
          6
        5. group Id
          BG004
          value
          57
        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
          spread
          8.76
          value
          59.5
        2. group Id
          BG001
          spread
          8.97
          value
          60.9
        3. group Id
          BG002
          spread
          8.32
          value
          61.4
        4. group Id
          BG003
          spread
          9.16
          value
          59.6
        5. group Id
          BG004
          spread
          8.75
          value
          60.5
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age Continuous
    unit Of Measure
    years
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          18
        2. group Id
          BG001
          value
          28
        3. group Id
          BG002
          value
          14
        4. group Id
          BG003
          value
          10
        5. group Id
          BG004
          value
          70
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          24
        2. group Id
          BG001
          value
          38
        3. group Id
          BG002
          value
          19
        4. group Id
          BG003
          value
          7
        5. group Id
          BG004
          value
          88
        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
          42
        2. group Id
          BG001
          value
          66
        3. group Id
          BG002
          value
          33
        4. group Id
          BG003
          value
          17
        5. group Id
          BG004
          value
          158
      title
      United States
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants

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Preserved source evidence · Not medical advice