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NCT02963493 · BASELINE

Baseline characteristics

A Study of Melphalan Flufenamide (Melflufen) Plus Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma · Source last updated 2022-11-22

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
      157
    units
    Participants
groups
  1. description
    Melphalan flufenamide (melflufen) 40 mg Day 1 and dexamethasone 40 mg (reduced dose for patients 75 years or older) on Days 1, 8, 15 and 22 of each 28-day cycle. Melphalan flufenamide (Melflufen) Dexamethasone
    id
    BG000
    title
    Melphalan Flufenamide (Melflufen) + Dexamethasone
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          78
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          79
        title
        >=65 years
      denoms
      1. counts
        1. group Id
          BG000
          value
          157
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Categorical
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          9.63
          value
          64.7
      denoms
      1. counts
        1. group Id
          BG000
          value
          157
        units
        Participants
    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
          89
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          68
        title
        Male
      denoms
      1. counts
        1. group Id
          BG000
          value
          157
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          5
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          137
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          15
        title
        Unknown or Not Reported
      denoms
      1. counts
        1. group Id
          BG000
          value
          157
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          1
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          1
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          11
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          132
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          12
        title
        Unknown or Not Reported
      denoms
      1. counts
        1. group Id
          BG000
          value
          157
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          69
      denoms
      1. counts
        1. group Id
          BG000
          value
          157
        units
        Participants
      title
      United States
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          23
      denoms
      1. counts
        1. group Id
          BG000
          value
          157
        units
        Participants
      title
      Italy
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          13
      denoms
      1. counts
        1. group Id
          BG000
          value
          157
        units
        Participants
      title
      France
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          52
      denoms
      1. counts
        1. group Id
          BG000
          value
          157
        units
        Participants
      title
      Spain
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          39
        title
        Performance Status 0
      2. measurements
        1. group Id
          BG000
          value
          93
        title
        Performance Status 1
      3. measurements
        1. group Id
          BG000
          value
          24
        title
        Performance Status 2
      4. measurements
        1. group Id
          BG000
          value
          1
        title
        Performance Status 3
      denoms
      1. counts
        1. group Id
          BG000
          value
          157
        units
        Participants
    description
    ECOG Performance Status Categories Status 0: Normal activity, fully active, able to carry on all pre-disease performance without restriction. Status 1: Symptoms, but fully ambulatory, restricted in physically strenuous but ambulatory and able to carry out work of a light or sedentary nature (e.g., light housework, office work). Status 2: Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours. Status 3: Capable of only limited selfcare; confined to bed or chair more than 50% of waking hours.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    ECOG Performance Status
    unit Of Measure
    Participants
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          17.41
          value
          74.3
      denoms
      1. counts
        1. group Id
          BG000
          value
          156
        units
        Participants
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    population Description
    Baseline weight not recorded for one patient
    title
    Weight
    unit Of Measure
    kilograms
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          63
        title
        International Staging System (ISS) Stage I
      2. measurements
        1. group Id
          BG000
          value
          49
        title
        International Staging System (ISS) Stage II
      3. measurements
        1. group Id
          BG000
          value
          39
        title
        International Staging System (ISS) Stage III
      4. measurements
        1. group Id
          BG000
          value
          4
        title
        Unknown
      5. measurements
        1. group Id
          BG000
          value
          2
        title
        Missing
      denoms
      1. counts
        1. group Id
          BG000
          value
          157
        units
        Participants
    description
    International Staging System (ISS) is an assessment of risk factors for multiple myeloma ISS Stage I: Serum B2-microglobulin \< 3.5 mg/L, serum albumin ≥ 3.5 g/dL ISS Stage II: Not ISS Stage I or III ISS Stage III: Serum B 2-microglobulin ≥ 5.5 mg/L
    param Type
    COUNT_OF_PARTICIPANTS
    title
    International Staging System (ISS)
    unit Of Measure
    Participants
  10. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          3.46
          value
          7.0
      denoms
      1. counts
        1. group Id
          BG000
          value
          157
        units
        Participants
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Time since initial diagnosis
    unit Of Measure
    years
  11. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          55
      denoms
      1. counts
        1. group Id
          BG000
          value
          157
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Extramedullary disease at study entry
    unit Of Measure
    Participants
  12. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          33
      denoms
      1. counts
        1. group Id
          BG000
          value
          157
        units
        Participants
      title
      SPEP and UPEP
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          63
      denoms
      1. counts
        1. group Id
          BG000
          value
          157
        units
        Participants
      title
      SPEP only
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          37
      denoms
      1. counts
        1. group Id
          BG000
          value
          157
        units
        Participants
      title
      UPEP only
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          20
      denoms
      1. counts
        1. group Id
          BG000
          value
          157
        units
        Participants
      title
      sFLC only
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          4
      denoms
      1. counts
        1. group Id
          BG000
          value
          157
        units
        Participants
      title
      Unable to determine
    description
    Serum M-protein ≥ 0.5 g/dL (SPEP), urine M-protein ≥ 200 mg/24 hours (UPEP), or serum free light chain (sFLC) assay with FLC ≥ 10 mg/dL (≥ 100 mg/L) and abnormal serum immunoglobulin kappa to lambda FLC ratio.
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    5 patients did not have all assessments completed to adequately categorize
    title
    Type of measurable disease at baseline
    unit Of Measure
    Participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      157
    units
    Participants
groups
  1. description
    Melphalan flufenamide (melflufen) 40 mg Day 1 and dexamethasone 40 mg (reduced dose for patients 75 years or older) on Days 1, 8, 15 and 22 of each 28-day cycle. Melphalan flufenamide (Melflufen) Dexamethasone
    id
    BG000
    title
    Melphalan Flufenamide (Melflufen) + Dexamethasone
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          78
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          79
        title
        >=65 years
      denoms
      1. counts
        1. group Id
          BG000
          value
          157
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Categorical
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          9.63
          value
          64.7
      denoms
      1. counts
        1. group Id
          BG000
          value
          157
        units
        Participants
    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
          89
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          68
        title
        Male
      denoms
      1. counts
        1. group Id
          BG000
          value
          157
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          5
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          137
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          15
        title
        Unknown or Not Reported
      denoms
      1. counts
        1. group Id
          BG000
          value
          157
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          1
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          1
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          11
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          132
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          12
        title
        Unknown or Not Reported
      denoms
      1. counts
        1. group Id
          BG000
          value
          157
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          69
      denoms
      1. counts
        1. group Id
          BG000
          value
          157
        units
        Participants
      title
      United States
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          23
      denoms
      1. counts
        1. group Id
          BG000
          value
          157
        units
        Participants
      title
      Italy
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          13
      denoms
      1. counts
        1. group Id
          BG000
          value
          157
        units
        Participants
      title
      France
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          52
      denoms
      1. counts
        1. group Id
          BG000
          value
          157
        units
        Participants
      title
      Spain
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          39
        title
        Performance Status 0
      2. measurements
        1. group Id
          BG000
          value
          93
        title
        Performance Status 1
      3. measurements
        1. group Id
          BG000
          value
          24
        title
        Performance Status 2
      4. measurements
        1. group Id
          BG000
          value
          1
        title
        Performance Status 3
      denoms
      1. counts
        1. group Id
          BG000
          value
          157
        units
        Participants
    description
    ECOG Performance Status Categories Status 0: Normal activity, fully active, able to carry on all pre-disease performance without restriction. Status 1: Symptoms, but fully ambulatory, restricted in physically strenuous but ambulatory and able to carry out work of a light or sedentary nature (e.g., light housework, office work). Status 2: Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours. Status 3: Capable of only limited selfcare; confined to bed or chair more than 50% of waking hours.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    ECOG Performance Status
    unit Of Measure
    Participants
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          17.41
          value
          74.3
      denoms
      1. counts
        1. group Id
          BG000
          value
          156
        units
        Participants
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    population Description
    Baseline weight not recorded for one patient
    title
    Weight
    unit Of Measure
    kilograms
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          63
        title
        International Staging System (ISS) Stage I
      2. measurements
        1. group Id
          BG000
          value
          49
        title
        International Staging System (ISS) Stage II
      3. measurements
        1. group Id
          BG000
          value
          39
        title
        International Staging System (ISS) Stage III
      4. measurements
        1. group Id
          BG000
          value
          4
        title
        Unknown
      5. measurements
        1. group Id
          BG000
          value
          2
        title
        Missing
      denoms
      1. counts
        1. group Id
          BG000
          value
          157
        units
        Participants
    description
    International Staging System (ISS) is an assessment of risk factors for multiple myeloma ISS Stage I: Serum B2-microglobulin \< 3.5 mg/L, serum albumin ≥ 3.5 g/dL ISS Stage II: Not ISS Stage I or III ISS Stage III: Serum B 2-microglobulin ≥ 5.5 mg/L
    param Type
    COUNT_OF_PARTICIPANTS
    title
    International Staging System (ISS)
    unit Of Measure
    Participants
  10. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          3.46
          value
          7.0
      denoms
      1. counts
        1. group Id
          BG000
          value
          157
        units
        Participants
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Time since initial diagnosis
    unit Of Measure
    years
  11. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          55
      denoms
      1. counts
        1. group Id
          BG000
          value
          157
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Extramedullary disease at study entry
    unit Of Measure
    Participants
  12. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          33
      denoms
      1. counts
        1. group Id
          BG000
          value
          157
        units
        Participants
      title
      SPEP and UPEP
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          63
      denoms
      1. counts
        1. group Id
          BG000
          value
          157
        units
        Participants
      title
      SPEP only
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          37
      denoms
      1. counts
        1. group Id
          BG000
          value
          157
        units
        Participants
      title
      UPEP only
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          20
      denoms
      1. counts
        1. group Id
          BG000
          value
          157
        units
        Participants
      title
      sFLC only
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          4
      denoms
      1. counts
        1. group Id
          BG000
          value
          157
        units
        Participants
      title
      Unable to determine
    description
    Serum M-protein ≥ 0.5 g/dL (SPEP), urine M-protein ≥ 200 mg/24 hours (UPEP), or serum free light chain (sFLC) assay with FLC ≥ 10 mg/dL (≥ 100 mg/L) and abnormal serum immunoglobulin kappa to lambda FLC ratio.
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    5 patients did not have all assessments completed to adequately categorize
    title
    Type of measurable disease at baseline
    unit Of Measure
    Participants

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Preserved source evidence · Not medical advice