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NCT01632150 · BASELINE

Baseline characteristics

Safety Study of Elotuzumab in Combination With Thalidomide and Dexamethasone in Relapsed and/or Refractory Multiple Myeloma · Source last updated 2017-04-14

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
    Participants received thalidomide in 28-day cycles: 50 mg, for the first 2 weeks, escalated to 100 mg for the next 2 weeks and beginning with Cycle 2, to 200 mg once daily. Elotuzumab, 10 mg/kg, was administered as an intravenous infusion weekly for the first 2 cycles and beginning with Cycle 3, every 2 weeks. Dexamethasone, 40 mg, was administered weekly on those weeks when elotuzumab was not administered. On weeks when elotuzumab was also given, participants received dexamethasone as a split dose of 28 mg, 3 to 24 hours before the elotuzumab infusion, and 8 mg intravenously at least 45 minutes before the infusion. Those patients with suboptimal response, defined as evidence of progressive disease between end of Cycle 2 and end of Cycle 4 or inability to achieve partial response or better by end of Cycle 4, also received cyclophosphamide, 50 mg. Cyclophosphamide could not be added beyond Cycle 5.
    id
    BG000
    title
    Thalidomide + Elotuzumab + Dexamethasone + Cyclophosphamide
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          8.47
          value
          64.3
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    Years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          22
      title
      Younger than 65 years
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          12
      title
      65 years and older to younger than 75 years
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          6
      title
      75 years and older
    param Type
    NUMBER
    title
    Age, Customized
    unit Of Measure
    Participants
  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
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          0
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          0
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          40
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          0
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          15
      title
      Immunoglobulin (Ig)G
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          7
      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
      IGD
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          9
      title
      Light chain disease
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          9
      title
      Not reported
    param Type
    NUMBER
    title
    Myeloma type
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          17
      title
      Score 0
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          21
      title
      Score 1
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          2
      title
      Score 2
    description
    ECOG is a 6-item scale used to assess disease progression, daily functioning, appropriate treatment, and prognosis. Performance status is scored on a scale ranging from 0-5, with (best score) 0=fully active and able to carry on all predisease performance without restriction and (worst score) 5=death.
    param Type
    NUMBER
    title
    Eastern Cooperative Oncology Group (ECOG) performance status
    unit Of Measure
    Participants
population Description
All participants who received thalidomide +elotuzumab + dexamethose (40) and had cyclophosphamide added to the regimen (11).
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      40
    units
    Participants
groups
  1. description
    Participants received thalidomide in 28-day cycles: 50 mg, for the first 2 weeks, escalated to 100 mg for the next 2 weeks and beginning with Cycle 2, to 200 mg once daily. Elotuzumab, 10 mg/kg, was administered as an intravenous infusion weekly for the first 2 cycles and beginning with Cycle 3, every 2 weeks. Dexamethasone, 40 mg, was administered weekly on those weeks when elotuzumab was not administered. On weeks when elotuzumab was also given, participants received dexamethasone as a split dose of 28 mg, 3 to 24 hours before the elotuzumab infusion, and 8 mg intravenously at least 45 minutes before the infusion. Those patients with suboptimal response, defined as evidence of progressive disease between end of Cycle 2 and end of Cycle 4 or inability to achieve partial response or better by end of Cycle 4, also received cyclophosphamide, 50 mg. Cyclophosphamide could not be added beyond Cycle 5.
    id
    BG000
    title
    Thalidomide + Elotuzumab + Dexamethasone + Cyclophosphamide
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          8.47
          value
          64.3
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    Years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          22
      title
      Younger than 65 years
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          12
      title
      65 years and older to younger than 75 years
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          6
      title
      75 years and older
    param Type
    NUMBER
    title
    Age, Customized
    unit Of Measure
    Participants
  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
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          0
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          0
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          40
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          0
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          15
      title
      Immunoglobulin (Ig)G
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          7
      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
      IGD
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          9
      title
      Light chain disease
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          9
      title
      Not reported
    param Type
    NUMBER
    title
    Myeloma type
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          17
      title
      Score 0
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          21
      title
      Score 1
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          2
      title
      Score 2
    description
    ECOG is a 6-item scale used to assess disease progression, daily functioning, appropriate treatment, and prognosis. Performance status is scored on a scale ranging from 0-5, with (best score) 0=fully active and able to carry on all predisease performance without restriction and (worst score) 5=death.
    param Type
    NUMBER
    title
    Eastern Cooperative Oncology Group (ECOG) performance status
    unit Of Measure
    Participants
population Description
All participants who received thalidomide +elotuzumab + dexamethose (40) and had cyclophosphamide added to the regimen (11).

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Preserved source evidence · Not medical advice