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NCT01775553 · BASELINE

Baseline characteristics

Study of High Dose Carfilzomib in Multiple Myeloma Patients Who Have Progressed On Standard Dose Carfilzomib · Source last updated 2017-06-21

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
      13
    units
    Participants
groups
  1. description
    All patients will receive Carfilzomib Carfilzomib: During Cycle 1, patients will receive either 20 mg/m2 on days 1,2 (if the subject has not received carfilzomib as part another clinical trial within the last 4 weeks) or 56 mg/m2 (if the subject is enrolling in the present study after progression of disease on carfilzomib within the last month - for example subjects enrolled in CMAP compassionate use carfilzomib). Thereafter, all subjects will receive 56 mg/m2 for the remaining doses given Cycle 1 Day 8 onwards. Each cycle is 28 days.
    id
    BG000
    title
    Carfilzomib
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          49
          upper Limit
          75
          value
          62.9
    dispersion Type
    FULL_RANGE
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          6
        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
          6
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age >65 years
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          5
      title
      0
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          5
      title
      1
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          3
      title
      2
    description
    The Eastern Cooperative Oncology Group (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
    ECOG Performance Status
    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
          3
      title
      Stage 3
    description
    The International Staging System (ISS): The ISS is based on the assessment of two blood test results: beta 2-microglobulin (ß2-M) and albumin. 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
    COUNT_OF_PARTICIPANTS
    title
    ISS Staging
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          10
      title
      IgG
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          3
      title
      IgA
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          0
      title
      IgM
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          0
      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
          7
      title
      K
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          6
      title
      L
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Light-chain subtype
    unit Of Measure
    Participants
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          7
      title
      Normal
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          6
      title
      Any abnormality
    description
    Fluorescence in situ hybridization (FISH), a molecular cytogenetic technique that tags genetic material with fluorescent molecules. FISH is useful for identifying chromosomes and parts of chromosomes, deciphering chromosome rearrangements, detecting chromosome abnormalities, and detecting and mapping genes.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    FISH
    unit Of Measure
    Participants
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          2
          upper Limit
          10
          value
          7
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Prior therapies since diagnosis
    unit Of Measure
    years
  10. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          2
          upper Limit
          10
          value
          5
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Number of prior regimens
    unit Of Measure
    prior regimens
  11. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          13
      title
      Dexamethasone : Exposed
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          13
      title
      Dexamethasone : Refractory
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          7
      title
      Thalidomide : Exposed
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      title
      Thalidomide : Refractory
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          13
      title
      Lenalidomide : Exposed
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          9
      title
      Lenalidomide : Refractory
    7. categories
      1. measurements
        1. group Id
          BG000
          value
          8
      title
      Pomalidomide : Exposed
    8. categories
      1. measurements
        1. group Id
          BG000
          value
          8
      title
      Pomalidomide : Refractory
    9. categories
      1. measurements
        1. group Id
          BG000
          value
          13
      title
      Bortezomib : Exposed
    10. categories
      1. measurements
        1. group Id
          BG000
          value
          9
      title
      Bortezomib : Refractory
    param Type
    NUMBER
    title
    Prior therapy
    unit Of Measure
    participants
  12. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          7
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Prior Autologous Stem Cell Transplant
    unit Of Measure
    Participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      13
    units
    Participants
groups
  1. description
    All patients will receive Carfilzomib Carfilzomib: During Cycle 1, patients will receive either 20 mg/m2 on days 1,2 (if the subject has not received carfilzomib as part another clinical trial within the last 4 weeks) or 56 mg/m2 (if the subject is enrolling in the present study after progression of disease on carfilzomib within the last month - for example subjects enrolled in CMAP compassionate use carfilzomib). Thereafter, all subjects will receive 56 mg/m2 for the remaining doses given Cycle 1 Day 8 onwards. Each cycle is 28 days.
    id
    BG000
    title
    Carfilzomib
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          49
          upper Limit
          75
          value
          62.9
    dispersion Type
    FULL_RANGE
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          6
        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
          6
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age >65 years
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          5
      title
      0
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          5
      title
      1
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          3
      title
      2
    description
    The Eastern Cooperative Oncology Group (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
    ECOG Performance Status
    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
          3
      title
      Stage 3
    description
    The International Staging System (ISS): The ISS is based on the assessment of two blood test results: beta 2-microglobulin (ß2-M) and albumin. 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
    COUNT_OF_PARTICIPANTS
    title
    ISS Staging
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          10
      title
      IgG
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          3
      title
      IgA
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          0
      title
      IgM
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          0
      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
          7
      title
      K
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          6
      title
      L
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Light-chain subtype
    unit Of Measure
    Participants
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          7
      title
      Normal
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          6
      title
      Any abnormality
    description
    Fluorescence in situ hybridization (FISH), a molecular cytogenetic technique that tags genetic material with fluorescent molecules. FISH is useful for identifying chromosomes and parts of chromosomes, deciphering chromosome rearrangements, detecting chromosome abnormalities, and detecting and mapping genes.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    FISH
    unit Of Measure
    Participants
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          2
          upper Limit
          10
          value
          7
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Prior therapies since diagnosis
    unit Of Measure
    years
  10. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          2
          upper Limit
          10
          value
          5
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Number of prior regimens
    unit Of Measure
    prior regimens
  11. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          13
      title
      Dexamethasone : Exposed
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          13
      title
      Dexamethasone : Refractory
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          7
      title
      Thalidomide : Exposed
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      title
      Thalidomide : Refractory
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          13
      title
      Lenalidomide : Exposed
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          9
      title
      Lenalidomide : Refractory
    7. categories
      1. measurements
        1. group Id
          BG000
          value
          8
      title
      Pomalidomide : Exposed
    8. categories
      1. measurements
        1. group Id
          BG000
          value
          8
      title
      Pomalidomide : Refractory
    9. categories
      1. measurements
        1. group Id
          BG000
          value
          13
      title
      Bortezomib : Exposed
    10. categories
      1. measurements
        1. group Id
          BG000
          value
          9
      title
      Bortezomib : Refractory
    param Type
    NUMBER
    title
    Prior therapy
    unit Of Measure
    participants
  12. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          7
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Prior Autologous Stem Cell Transplant
    unit Of Measure
    Participants

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Preserved source evidence · Not medical advice