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NCT01651039 · BASELINE

Baseline characteristics

Phase II, Single-Center, Oral Panobinostat in Combination With Lenalidomide and Dexamethasone in Multiple Myeloma (MM) · Source last updated 2018-04-09

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
      27
    units
    Participants
groups
  1. description
    All patients will receive oral panobinostat, lenalidomide and dexamethasone as per protocol. Panobinostat, Lenalidomide and Dexamethasone: Each cycle is 28 days. Panobinostat will be given 20 mg: Days 1,3,5,15,17,19. Lenalidomide will be given 25 mg: Days 1-21. Dexamethasone will be given for patients 75 years old and younger a dose of 40 mg on Days 1, 8 and 15. Dexamethasone will be given for patients older than 75 years old, 20 mg on Days 1, 8 and 15.
    id
    BG000
    title
    Panobinostat, Lenalidomide and Dexamethasone
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          51
          upper Limit
          75
          value
          64
    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
          11
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          16
        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
          14
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age >65 years
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          16
      title
      0
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          11
      title
      1
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          0
      title
      2
    description
    ECOG measures level of functioning in terms of daily living abilities: 0 - Fully active, able to carry on all pre-disease performance without restriction 1. \- Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work 2. \- Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours
    param Type
    COUNT_OF_PARTICIPANTS
    title
    The Eastern Cooperative Oncology Group (ECOG) Performance
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          5
      title
      Stage 1
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          5
      title
      Stage 2
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          5
      title
      Stage 3
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          12
      title
      missing
    description
    The International Staging System (ISS) for Multiple Myeloma Stage 1 ß2-M \< 3.5 mg/dL and albumin =3.5 g/dL Stage 2 Neither stage 1 nor stage 3 Stage 3 ß2-M ≥ 5.5 mg/L
    param Type
    COUNT_OF_PARTICIPANTS
    title
    ISS Staging
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          14
      title
      IgG
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          8
      title
      IgA
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      title
      IgM
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          4
      title
      None
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Immunoglobulin subtype
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          2
      title
      Normal
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          22
      title
      Any abnormality
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          17
      title
      Any high risk abnormality
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          5
      title
      del(17p)
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          12
      title
      chr1 amplification
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          4
      title
      t(4;14)
    7. categories
      1. measurements
        1. group Id
          BG000
          value
          5
      title
      del(13q)
    8. categories
      1. measurements
        1. group Id
          BG000
          value
          5
      title
      t(11;14)
    param Type
    COUNT_OF_PARTICIPANTS
    title
    FISH
    unit Of Measure
    Participants
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          1.6
          upper Limit
          12.4
          value
          4
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Median time since diagnosis
    unit Of Measure
    years
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          1
          upper Limit
          10
          value
          3
    description
    Number of years participant was on any prior regimens
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Prior regimens
    unit Of Measure
    years
  10. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          1
          upper Limit
          10
          value
          3
    description
    The number of prior treatments the participants had received prior to baseline visit
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Prior therapy
    unit Of Measure
    regimens
  11. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          27
      title
      Dexamethasone
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          6
      title
      Thalidomide
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          27
      title
      Lenalidomide
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          10
      title
      Pomalidomide
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          27
      title
      Bortezomib
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          8
      title
      Carfilzomib
    7. categories
      1. measurements
        1. group Id
          BG000
          value
          20
      title
      Autologous stem cell transplant
    description
    The number of participants that received any of the following chemo drugs
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Prior Therapy, Exposed
    unit Of Measure
    Participants
  12. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          19
      title
      Dexamethasone
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          2
      title
      Thalidomide
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          22
      title
      Lenalidomide
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          19
      title
      Pomalidomide
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          14
      title
      Bortezomib
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          7
      title
      Carfilzomib
    description
    The number of participants that received any of the following chemo drugs and relapsed from it.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Prior therapy, Refractory
    unit Of Measure
    Participants
population Description
27 out of the 32 subjects are evaluable because the 5 patients either did not complete cycle 1, or enrolled but never dosed.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      27
    units
    Participants
groups
  1. description
    All patients will receive oral panobinostat, lenalidomide and dexamethasone as per protocol. Panobinostat, Lenalidomide and Dexamethasone: Each cycle is 28 days. Panobinostat will be given 20 mg: Days 1,3,5,15,17,19. Lenalidomide will be given 25 mg: Days 1-21. Dexamethasone will be given for patients 75 years old and younger a dose of 40 mg on Days 1, 8 and 15. Dexamethasone will be given for patients older than 75 years old, 20 mg on Days 1, 8 and 15.
    id
    BG000
    title
    Panobinostat, Lenalidomide and Dexamethasone
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          51
          upper Limit
          75
          value
          64
    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
          11
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          16
        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
          14
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age >65 years
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          16
      title
      0
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          11
      title
      1
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          0
      title
      2
    description
    ECOG measures level of functioning in terms of daily living abilities: 0 - Fully active, able to carry on all pre-disease performance without restriction 1. \- Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work 2. \- Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours
    param Type
    COUNT_OF_PARTICIPANTS
    title
    The Eastern Cooperative Oncology Group (ECOG) Performance
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          5
      title
      Stage 1
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          5
      title
      Stage 2
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          5
      title
      Stage 3
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          12
      title
      missing
    description
    The International Staging System (ISS) for Multiple Myeloma Stage 1 ß2-M \< 3.5 mg/dL and albumin =3.5 g/dL Stage 2 Neither stage 1 nor stage 3 Stage 3 ß2-M ≥ 5.5 mg/L
    param Type
    COUNT_OF_PARTICIPANTS
    title
    ISS Staging
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          14
      title
      IgG
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          8
      title
      IgA
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      title
      IgM
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          4
      title
      None
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Immunoglobulin subtype
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          2
      title
      Normal
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          22
      title
      Any abnormality
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          17
      title
      Any high risk abnormality
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          5
      title
      del(17p)
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          12
      title
      chr1 amplification
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          4
      title
      t(4;14)
    7. categories
      1. measurements
        1. group Id
          BG000
          value
          5
      title
      del(13q)
    8. categories
      1. measurements
        1. group Id
          BG000
          value
          5
      title
      t(11;14)
    param Type
    COUNT_OF_PARTICIPANTS
    title
    FISH
    unit Of Measure
    Participants
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          1.6
          upper Limit
          12.4
          value
          4
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Median time since diagnosis
    unit Of Measure
    years
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          1
          upper Limit
          10
          value
          3
    description
    Number of years participant was on any prior regimens
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Prior regimens
    unit Of Measure
    years
  10. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          1
          upper Limit
          10
          value
          3
    description
    The number of prior treatments the participants had received prior to baseline visit
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Prior therapy
    unit Of Measure
    regimens
  11. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          27
      title
      Dexamethasone
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          6
      title
      Thalidomide
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          27
      title
      Lenalidomide
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          10
      title
      Pomalidomide
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          27
      title
      Bortezomib
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          8
      title
      Carfilzomib
    7. categories
      1. measurements
        1. group Id
          BG000
          value
          20
      title
      Autologous stem cell transplant
    description
    The number of participants that received any of the following chemo drugs
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Prior Therapy, Exposed
    unit Of Measure
    Participants
  12. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          19
      title
      Dexamethasone
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          2
      title
      Thalidomide
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          22
      title
      Lenalidomide
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          19
      title
      Pomalidomide
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          14
      title
      Bortezomib
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          7
      title
      Carfilzomib
    description
    The number of participants that received any of the following chemo drugs and relapsed from it.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Prior therapy, Refractory
    unit Of Measure
    Participants
population Description
27 out of the 32 subjects are evaluable because the 5 patients either did not complete cycle 1, or enrolled but never dosed.

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Preserved source evidence · Not medical advice