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NCT01239797 · BASELINE

Baseline characteristics

Phase III Study of Lenalidomide and Dexamethasone With or Without Elotuzumab to Treat Relapsed or Refractory Multiple Myeloma · Source last updated 2022-06-01

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
      321
    2. group Id
      BG001
      value
      325
    3. group Id
      BG002
      value
      646
    units
    Participants
groups
  1. description
    Lenalidomide: Capsules, Oral, 25 mg, once daily, on Days 1-21 Repeat every 28 days until participants met criteria for discontinuation of study drug Dexamethasone (Oral): On weeks without Elotuzumab dosing: Tablets, Oral, 40mg Repeat every 28 days until participants met criteria for discontinuation of study drug On weeks with Elotuzumab dosing: Tablets, Oral, 28 mg Repeat every 28 days until participants met criteria for discontinuation of study drug Dexamethasone (IV): On weeks without Elotuzumab dosing: Not Applicable (N/A) On weeks with Elotuzumab dosing: Solution, Intravenous (IV), 8 mg, weekly Repeat every 28 days until participants met criteria for discontinuation of study drug Elotuzumab (BMS-901608; HuLuc63): Solution, IV, 10 mg/kg, weekly, on Days 1, 8, 15, 22 (cycles 1\&2); Days 1 and 15 (cycles 3 and beyond) Repeat every 28 days until participants met criteria for discontinuation of study drug
    id
    BG000
    title
    Lenalidomide + Dexamethasone + Elotuzumab
  2. description
    Lenalidomide: Capsules, Oral, 25 mg, once daily, on Days 1-21 Regimen repeated every 28 days until participants met criteria for discontinuation of study drug Dexamethasone: Tablets, Oral, 40 mg, weekly, on Days 1, 8, 15, 22 Regimen repeated every 28 days until participants met criteria for discontinuation of study drug
    id
    BG001
    title
    Lenalidomide + Dexamethasone
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          9.34
          value
          66.2
        2. group Id
          BG001
          spread
          10.26
          value
          65.3
        3. group Id
          BG002
          spread
          9.81
          value
          65.7
    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
          134
        2. group Id
          BG001
          value
          142
        3. group Id
          BG002
          value
          276
        title
        < 65 years old
      2. measurements
        1. group Id
          BG000
          value
          119
        2. group Id
          BG001
          value
          122
        3. group Id
          BG002
          value
          241
        title
        >= 65 and < 75 years old
      3. measurements
        1. group Id
          BG000
          value
          68
        2. group Id
          BG001
          value
          61
        3. group Id
          BG002
          value
          129
        title
        >= 75 years old
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Customized
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          129
        2. group Id
          BG001
          value
          132
        3. group Id
          BG002
          value
          261
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          192
        2. group Id
          BG001
          value
          193
        3. group Id
          BG002
          value
          385
        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
          5
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          6
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          28
        2. group Id
          BG001
          value
          33
        3. group Id
          BG002
          value
          61
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          288
        2. group Id
          BG001
          value
          291
        3. group Id
          BG002
          value
          579
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          264
        2. group Id
          BG001
          value
          280
        3. group Id
          BG002
          value
          544
        title
        White
      2. measurements
        1. group Id
          BG000
          value
          13
        2. group Id
          BG001
          value
          10
        3. group Id
          BG002
          value
          23
        title
        Black or African American
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        American Indian or Alaska Native
      4. measurements
        1. group Id
          BG000
          value
          33
        2. group Id
          BG001
          value
          31
        3. group Id
          BG002
          value
          64
        title
        Asian
      5. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        title
        Native Hawaiian or Other Pacific Islander
      6. measurements
        1. group Id
          BG000
          value
          9
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          13
        title
        Other
      7. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        title
        Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
population Description
Randomized: all participants randomized to any treatment group
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      321
    2. group Id
      BG001
      value
      325
    3. group Id
      BG002
      value
      646
    units
    Participants
groups
  1. description
    Lenalidomide: Capsules, Oral, 25 mg, once daily, on Days 1-21 Repeat every 28 days until participants met criteria for discontinuation of study drug Dexamethasone (Oral): On weeks without Elotuzumab dosing: Tablets, Oral, 40mg Repeat every 28 days until participants met criteria for discontinuation of study drug On weeks with Elotuzumab dosing: Tablets, Oral, 28 mg Repeat every 28 days until participants met criteria for discontinuation of study drug Dexamethasone (IV): On weeks without Elotuzumab dosing: Not Applicable (N/A) On weeks with Elotuzumab dosing: Solution, Intravenous (IV), 8 mg, weekly Repeat every 28 days until participants met criteria for discontinuation of study drug Elotuzumab (BMS-901608; HuLuc63): Solution, IV, 10 mg/kg, weekly, on Days 1, 8, 15, 22 (cycles 1\&2); Days 1 and 15 (cycles 3 and beyond) Repeat every 28 days until participants met criteria for discontinuation of study drug
    id
    BG000
    title
    Lenalidomide + Dexamethasone + Elotuzumab
  2. description
    Lenalidomide: Capsules, Oral, 25 mg, once daily, on Days 1-21 Regimen repeated every 28 days until participants met criteria for discontinuation of study drug Dexamethasone: Tablets, Oral, 40 mg, weekly, on Days 1, 8, 15, 22 Regimen repeated every 28 days until participants met criteria for discontinuation of study drug
    id
    BG001
    title
    Lenalidomide + Dexamethasone
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          9.34
          value
          66.2
        2. group Id
          BG001
          spread
          10.26
          value
          65.3
        3. group Id
          BG002
          spread
          9.81
          value
          65.7
    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
          134
        2. group Id
          BG001
          value
          142
        3. group Id
          BG002
          value
          276
        title
        < 65 years old
      2. measurements
        1. group Id
          BG000
          value
          119
        2. group Id
          BG001
          value
          122
        3. group Id
          BG002
          value
          241
        title
        >= 65 and < 75 years old
      3. measurements
        1. group Id
          BG000
          value
          68
        2. group Id
          BG001
          value
          61
        3. group Id
          BG002
          value
          129
        title
        >= 75 years old
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Customized
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          129
        2. group Id
          BG001
          value
          132
        3. group Id
          BG002
          value
          261
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          192
        2. group Id
          BG001
          value
          193
        3. group Id
          BG002
          value
          385
        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
          5
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          6
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          28
        2. group Id
          BG001
          value
          33
        3. group Id
          BG002
          value
          61
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          288
        2. group Id
          BG001
          value
          291
        3. group Id
          BG002
          value
          579
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          264
        2. group Id
          BG001
          value
          280
        3. group Id
          BG002
          value
          544
        title
        White
      2. measurements
        1. group Id
          BG000
          value
          13
        2. group Id
          BG001
          value
          10
        3. group Id
          BG002
          value
          23
        title
        Black or African American
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        American Indian or Alaska Native
      4. measurements
        1. group Id
          BG000
          value
          33
        2. group Id
          BG001
          value
          31
        3. group Id
          BG002
          value
          64
        title
        Asian
      5. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        title
        Native Hawaiian or Other Pacific Islander
      6. measurements
        1. group Id
          BG000
          value
          9
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          13
        title
        Other
      7. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        title
        Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
population Description
Randomized: all participants randomized to any treatment group

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice