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NCT00742560 · BASELINE

Baseline characteristics

A Phase 1b/2, Dose-Escalation Study of Elotuzumab (Humanized Anti-CS1 Monoclonal IgG1 Antibody) in Relapsed Multiple Myeloma · Source last updated 2018-01-10

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
      3
    2. group Id
      BG001
      value
      3
    3. group Id
      BG002
      value
      22
    4. group Id
      BG003
      value
      36
    5. group Id
      BG004
      value
      37
    6. group Id
      BG005
      value
      101
    units
    Participants
groups
  1. description
    Elotuzumab 5 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.
    id
    BG000
    title
    Elotuzumab 5 mg/kg + Lenalidomide and Dexamethasone (Phase 1)
  2. description
    Elotuzumab 10 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.
    id
    BG001
    title
    Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone (Phase 1)
  3. description
    Elotuzumab 20 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.
    id
    BG002
    title
    Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone (Phase 1)
  4. description
    Elotuzumab 10 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.
    id
    BG003
    title
    Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone (Phase 2)
  5. description
    Elotuzumab 20 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.
    id
    BG004
    title
    Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone (Phase 2)
  6. description
    Total of all reporting groups
    id
    BG005
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          7.23
          value
          68.3
        2. group Id
          BG001
          spread
          6.94
          value
          64.7
        3. group Id
          BG002
          spread
          10.87
          value
          59.3
        4. group Id
          BG003
          spread
          9.70
          value
          60.6
        5. group Id
          BG004
          spread
          9.76
          value
          63.3
        6. group Id
          BG005
          spread
          9.91
          value
          61.7
    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
          2
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          10
        4. group Id
          BG003
          value
          19
        5. group Id
          BG004
          value
          24
        6. group Id
          BG005
          value
          56
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          12
        4. group Id
          BG003
          value
          17
        5. group Id
          BG004
          value
          13
        6. group Id
          BG005
          value
          45
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
population Description
Safety population: all randomized participants who received at least 1 dose of study drug
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      3
    2. group Id
      BG001
      value
      3
    3. group Id
      BG002
      value
      22
    4. group Id
      BG003
      value
      36
    5. group Id
      BG004
      value
      37
    6. group Id
      BG005
      value
      101
    units
    Participants
groups
  1. description
    Elotuzumab 5 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.
    id
    BG000
    title
    Elotuzumab 5 mg/kg + Lenalidomide and Dexamethasone (Phase 1)
  2. description
    Elotuzumab 10 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.
    id
    BG001
    title
    Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone (Phase 1)
  3. description
    Elotuzumab 20 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.
    id
    BG002
    title
    Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone (Phase 1)
  4. description
    Elotuzumab 10 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.
    id
    BG003
    title
    Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone (Phase 2)
  5. description
    Elotuzumab 20 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.
    id
    BG004
    title
    Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone (Phase 2)
  6. description
    Total of all reporting groups
    id
    BG005
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          7.23
          value
          68.3
        2. group Id
          BG001
          spread
          6.94
          value
          64.7
        3. group Id
          BG002
          spread
          10.87
          value
          59.3
        4. group Id
          BG003
          spread
          9.70
          value
          60.6
        5. group Id
          BG004
          spread
          9.76
          value
          63.3
        6. group Id
          BG005
          spread
          9.91
          value
          61.7
    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
          2
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          10
        4. group Id
          BG003
          value
          19
        5. group Id
          BG004
          value
          24
        6. group Id
          BG005
          value
          56
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          12
        4. group Id
          BG003
          value
          17
        5. group Id
          BG004
          value
          13
        6. group Id
          BG005
          value
          45
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
population Description
Safety population: all randomized participants who received at least 1 dose of study drug

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

Preserved source evidence · Not medical advice