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NCT01160484 · BASELINE

Baseline characteristics

Pegylated Liposomal Doxorubicin, Bortezomib, Dexamethasone and Lenalidomide for Relapsed/Refractory Multiple Myeloma · Source last updated 2015-05-04

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
      40
    units
    Participants
groups
  1. description
    Dose schematic of Dexamethasone + Bortezomib + Pegylated Liposomal Doxorubicin + Lenalidomide (DVD-R) Therapy: Per 28 Day Cycle, patients will received drug in the following order, dosing and schedule: 1\) Dexamethasone- 40 mg intravenous infusion (IV) on Days 1, 4, 8 and 11; 2) Bortezomib- 1.0 mg/m2 infused over 3 to 5 seconds followed by a standard saline flush on Days 1, 4, 8 and 11; 3) Pegylated Liposomal Doxorubicin- 4.0 mg/m2 IV as a 90 minute infusion on Day 1 of Cycle 1 and subsequent doses may be administered over 30 to 60 minutes on Days 4, 8 and 11 of Cycle 1 and on Days 1, 4, 8, and 11 of each subsequent cycle; and 4) Lenalidomide- 10 mg PO on days 1-14
    id
    BG000
    title
    DVD-R Single Arm
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          13
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          27
        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
          lower Limit
          34
          upper Limit
          86
          value
          71
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Age, Continuous
    unit Of Measure
    years
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          15
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          25
        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
          16
      title
      I (beta 2 microglobulin(B2M )<3.5 +Albumin ≥3.5)
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          14
      title
      II (B2M 3.5 +albumin < 3.5; or B2M 3.5-5.5)
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          10
      title
      III (B2M >5.5)
    param Type
    NUMBER
    title
    International Staging System (ISS); stage (N)
    unit Of Measure
    participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          0.0
          upper Limit
          7.0
          value
          2.05
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Serum M-protein
    unit Of Measure
    g/dL
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          0.0
          upper Limit
          7162.0
          value
          261.1
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Urine-M protein
    unit Of Measure
    mg/dL
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          0.6
          upper Limit
          3.4
          value
          1.0
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Serum creatinine
    unit Of Measure
    mg/dL
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          1
          upper Limit
          17
          value
          3
    dispersion Type
    FULL_RANGE
    param Type
    MEAN
    title
    Prior treatments
    unit Of Measure
    number of treatments
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          33
      title
      Bortezomib (BTZ)
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          20
      title
      Alkylating agents
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          15
      title
      PLD or Doxorubucin
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          15
      title
      Thalidomide
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          19
      title
      Lenalidomide (LEN)
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          35
      title
      Glucocorticoids
    7. categories
      1. measurements
        1. group Id
          BG000
          value
          7
      title
      HDAC inhibitors (panobinostat/romidepsin)
    8. categories
      1. measurements
        1. group Id
          BG000
          value
          5
      title
      Transplant (autologous)
    9. categories
      1. measurements
        1. group Id
          BG000
          value
          11
      title
      Other
    10. categories
      1. measurements
        1. group Id
          BG000
          value
          17
      title
      PLD+btz+dexamethasone (dex)
    11. categories
      1. measurements
        1. group Id
          BG000
          value
          10
      title
      PLD+btz+dex and len+ glucocorticoids
    param Type
    NUMBER
    title
    Total Number of prior lines of treatment
    unit Of Measure
    number of treatments
population Description
The estimated number of participants will allow to determine whether the true rate of response to DVD-R is at least 50%, at the one-sided alpha-level of 0.05 and having at least 85% power
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      40
    units
    Participants
groups
  1. description
    Dose schematic of Dexamethasone + Bortezomib + Pegylated Liposomal Doxorubicin + Lenalidomide (DVD-R) Therapy: Per 28 Day Cycle, patients will received drug in the following order, dosing and schedule: 1\) Dexamethasone- 40 mg intravenous infusion (IV) on Days 1, 4, 8 and 11; 2) Bortezomib- 1.0 mg/m2 infused over 3 to 5 seconds followed by a standard saline flush on Days 1, 4, 8 and 11; 3) Pegylated Liposomal Doxorubicin- 4.0 mg/m2 IV as a 90 minute infusion on Day 1 of Cycle 1 and subsequent doses may be administered over 30 to 60 minutes on Days 4, 8 and 11 of Cycle 1 and on Days 1, 4, 8, and 11 of each subsequent cycle; and 4) Lenalidomide- 10 mg PO on days 1-14
    id
    BG000
    title
    DVD-R Single Arm
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          13
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          27
        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
          lower Limit
          34
          upper Limit
          86
          value
          71
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Age, Continuous
    unit Of Measure
    years
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          15
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          25
        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
          16
      title
      I (beta 2 microglobulin(B2M )<3.5 +Albumin ≥3.5)
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          14
      title
      II (B2M 3.5 +albumin < 3.5; or B2M 3.5-5.5)
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          10
      title
      III (B2M >5.5)
    param Type
    NUMBER
    title
    International Staging System (ISS); stage (N)
    unit Of Measure
    participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          0.0
          upper Limit
          7.0
          value
          2.05
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Serum M-protein
    unit Of Measure
    g/dL
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          0.0
          upper Limit
          7162.0
          value
          261.1
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Urine-M protein
    unit Of Measure
    mg/dL
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          0.6
          upper Limit
          3.4
          value
          1.0
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Serum creatinine
    unit Of Measure
    mg/dL
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          1
          upper Limit
          17
          value
          3
    dispersion Type
    FULL_RANGE
    param Type
    MEAN
    title
    Prior treatments
    unit Of Measure
    number of treatments
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          33
      title
      Bortezomib (BTZ)
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          20
      title
      Alkylating agents
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          15
      title
      PLD or Doxorubucin
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          15
      title
      Thalidomide
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          19
      title
      Lenalidomide (LEN)
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          35
      title
      Glucocorticoids
    7. categories
      1. measurements
        1. group Id
          BG000
          value
          7
      title
      HDAC inhibitors (panobinostat/romidepsin)
    8. categories
      1. measurements
        1. group Id
          BG000
          value
          5
      title
      Transplant (autologous)
    9. categories
      1. measurements
        1. group Id
          BG000
          value
          11
      title
      Other
    10. categories
      1. measurements
        1. group Id
          BG000
          value
          17
      title
      PLD+btz+dexamethasone (dex)
    11. categories
      1. measurements
        1. group Id
          BG000
          value
          10
      title
      PLD+btz+dex and len+ glucocorticoids
    param Type
    NUMBER
    title
    Total Number of prior lines of treatment
    unit Of Measure
    number of treatments
population Description
The estimated number of participants will allow to determine whether the true rate of response to DVD-R is at least 50%, at the one-sided alpha-level of 0.05 and having at least 85% power

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

Preserved source evidence · Not medical advice