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NCT01478048 · BASELINE

Baseline characteristics

Study of Bortezomib and Dexamethasone With or Without Elotuzumab to Treat Relapsed or Refractory Multiple Myeloma · Source last updated 2018-05-21

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
      77
    2. group Id
      BG001
      value
      75
    3. group Id
      BG002
      value
      152
    units
    Participants
groups
  1. description
    Elotuzumab: Solution; Intravenous (IV); 10 mg/kg; (Cycles 1 \& 2: Days 1, 8 \& 15; Cycles 3-8: Days 1 \& 11; Cycle 9+: Days 1 \& 15); Until participant meets criteria for discontinuation of drug Bortezomib: Solution; IV; 1.3 mg/m\^2; (Cycles 1 - 8: Days 1, 4, 8, 11; Cycles 9+: Days 1, 8, 15); Until criteria met for discontinuation of drug. Days of Elotuzumab infusion: Dexamethasone (8mg IV + 8mg Oral) administered. Other days Dexamethasone 20 mg Oral administered Dexamethasone: Tablets; 20 mg; (Cycles 1\& 2: once daily on Days 2, 4, 5, 8, 9, 11; Cycles 3-8: once daily on Days 2, 4, 5, 9, 12; Cycles 9+: once daily on Days 2, 8, 9, 16); Until criteria met for discontinuation. Dexamethasone: Tablets; 8 mg; (Cycles 1\& 2: Days 1, 8, 15; Cycles 3-8: Days 1 \&11; Cycles 9+; Days 1 \& 15); Until criteria met for discontinuation of drug. Dexamethasone: Solution; IV; 8 mg; (Cycles 1\& 2: Days 1, 8, 15; Cycles 3-8: Days 1 \&11; Cycles 9+; Days 1 \& 15); Until criteria met for discontinuation
    id
    BG000
    title
    Elotuzumab + Bortezomib + Dexamethasone
  2. description
    Bortezomib: Solution; IV; 1.3 mg/m\^2; (Cycles 1 - 8: Days 1, 4, 8, 11; Cycles 9+: Days 1, 8, 15); Until criteria met for discontinuation of study drug. Dexamethasone: Tablets; 20 mg; (Cycles 1-8 once daily on Days 1, 2, 4, 5, 8, 9, 11, 12; Cycles 9+ once daily on Days 1, 2, 8, 9, 15, 16); Until criteria is met for discontinuation of study drug
    id
    BG001
    title
    Bortezomib + Dexamethasone
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          9.48
          value
          65.4
        2. group Id
          BG001
          spread
          10.34
          value
          65.1
        3. group Id
          BG002
          spread
          9.88
          value
          65.3
    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
          34
        2. group Id
          BG001
          value
          33
        3. group Id
          BG002
          value
          67
      title
      < 65 years
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          28
        2. group Id
          BG001
          value
          28
        3. group Id
          BG002
          value
          56
      title
      ≥65 and <75 years
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          15
        2. group Id
          BG001
          value
          14
        3. group Id
          BG002
          value
          29
      title
      >= 75 years
    description
    Less than (\<); Greater than, equal to (≥).
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Customized
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          35
        2. group Id
          BG001
          value
          38
        3. group Id
          BG002
          value
          73
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          42
        2. group Id
          BG001
          value
          37
        3. group Id
          BG002
          value
          79
        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
          25
        2. group Id
          BG001
          value
          23
        3. group Id
          BG002
          value
          48
      title
      United States
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          34
        2. group Id
          BG001
          value
          32
        3. group Id
          BG002
          value
          66
      title
      Italy
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          10
        2. group Id
          BG001
          value
          11
        3. group Id
          BG002
          value
          21
      title
      France
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          9
        3. group Id
          BG002
          value
          17
      title
      Spain
    description
    Number of participants enrolled, by country, were summarized.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Region of Enrollment
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          38
        2. group Id
          BG001
          value
          37
        3. group Id
          BG002
          value
          75
      title
      Yes
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          39
        2. group Id
          BG001
          value
          38
        3. group Id
          BG002
          value
          77
      title
      No
    description
    Categories presented as they were at randomization based on information collected via the Interactive Voice Recognition System (IVRS) system.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Prior Protease Inhibitor Use
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          55
        2. group Id
          BG001
          value
          54
        3. group Id
          BG002
          value
          109
      title
      Yes
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          22
        2. group Id
          BG001
          value
          21
        3. group Id
          BG002
          value
          43
      title
      No
    description
    An allele is any one of a series of 2 or more different genes that may be on a specific chromosome. Categories presented as they were at randomization based on information collected via the Interactive Voice Recognition System (IVRS) system.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Presence of At Least 1 FcγRIIIa V allele
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          55
        2. group Id
          BG001
          value
          51
        3. group Id
          BG002
          value
          106
      title
      1 line of prior therapy
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          22
        2. group Id
          BG001
          value
          24
        3. group Id
          BG002
          value
          46
      title
      2 or 3 lines of prior therapy
    description
    Categories presented as they were at randomization based on information collected via the Interactive Voice Recognition System (IVRS) system.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Number of Prior Lines of Therapy
    unit Of Measure
    Participants
population Description
All enrolled participants who were randomized to a treatment arm were summarized.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      77
    2. group Id
      BG001
      value
      75
    3. group Id
      BG002
      value
      152
    units
    Participants
groups
  1. description
    Elotuzumab: Solution; Intravenous (IV); 10 mg/kg; (Cycles 1 \& 2: Days 1, 8 \& 15; Cycles 3-8: Days 1 \& 11; Cycle 9+: Days 1 \& 15); Until participant meets criteria for discontinuation of drug Bortezomib: Solution; IV; 1.3 mg/m\^2; (Cycles 1 - 8: Days 1, 4, 8, 11; Cycles 9+: Days 1, 8, 15); Until criteria met for discontinuation of drug. Days of Elotuzumab infusion: Dexamethasone (8mg IV + 8mg Oral) administered. Other days Dexamethasone 20 mg Oral administered Dexamethasone: Tablets; 20 mg; (Cycles 1\& 2: once daily on Days 2, 4, 5, 8, 9, 11; Cycles 3-8: once daily on Days 2, 4, 5, 9, 12; Cycles 9+: once daily on Days 2, 8, 9, 16); Until criteria met for discontinuation. Dexamethasone: Tablets; 8 mg; (Cycles 1\& 2: Days 1, 8, 15; Cycles 3-8: Days 1 \&11; Cycles 9+; Days 1 \& 15); Until criteria met for discontinuation of drug. Dexamethasone: Solution; IV; 8 mg; (Cycles 1\& 2: Days 1, 8, 15; Cycles 3-8: Days 1 \&11; Cycles 9+; Days 1 \& 15); Until criteria met for discontinuation
    id
    BG000
    title
    Elotuzumab + Bortezomib + Dexamethasone
  2. description
    Bortezomib: Solution; IV; 1.3 mg/m\^2; (Cycles 1 - 8: Days 1, 4, 8, 11; Cycles 9+: Days 1, 8, 15); Until criteria met for discontinuation of study drug. Dexamethasone: Tablets; 20 mg; (Cycles 1-8 once daily on Days 1, 2, 4, 5, 8, 9, 11, 12; Cycles 9+ once daily on Days 1, 2, 8, 9, 15, 16); Until criteria is met for discontinuation of study drug
    id
    BG001
    title
    Bortezomib + Dexamethasone
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          9.48
          value
          65.4
        2. group Id
          BG001
          spread
          10.34
          value
          65.1
        3. group Id
          BG002
          spread
          9.88
          value
          65.3
    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
          34
        2. group Id
          BG001
          value
          33
        3. group Id
          BG002
          value
          67
      title
      < 65 years
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          28
        2. group Id
          BG001
          value
          28
        3. group Id
          BG002
          value
          56
      title
      ≥65 and <75 years
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          15
        2. group Id
          BG001
          value
          14
        3. group Id
          BG002
          value
          29
      title
      >= 75 years
    description
    Less than (\<); Greater than, equal to (≥).
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Customized
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          35
        2. group Id
          BG001
          value
          38
        3. group Id
          BG002
          value
          73
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          42
        2. group Id
          BG001
          value
          37
        3. group Id
          BG002
          value
          79
        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
          25
        2. group Id
          BG001
          value
          23
        3. group Id
          BG002
          value
          48
      title
      United States
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          34
        2. group Id
          BG001
          value
          32
        3. group Id
          BG002
          value
          66
      title
      Italy
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          10
        2. group Id
          BG001
          value
          11
        3. group Id
          BG002
          value
          21
      title
      France
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          9
        3. group Id
          BG002
          value
          17
      title
      Spain
    description
    Number of participants enrolled, by country, were summarized.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Region of Enrollment
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          38
        2. group Id
          BG001
          value
          37
        3. group Id
          BG002
          value
          75
      title
      Yes
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          39
        2. group Id
          BG001
          value
          38
        3. group Id
          BG002
          value
          77
      title
      No
    description
    Categories presented as they were at randomization based on information collected via the Interactive Voice Recognition System (IVRS) system.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Prior Protease Inhibitor Use
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          55
        2. group Id
          BG001
          value
          54
        3. group Id
          BG002
          value
          109
      title
      Yes
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          22
        2. group Id
          BG001
          value
          21
        3. group Id
          BG002
          value
          43
      title
      No
    description
    An allele is any one of a series of 2 or more different genes that may be on a specific chromosome. Categories presented as they were at randomization based on information collected via the Interactive Voice Recognition System (IVRS) system.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Presence of At Least 1 FcγRIIIa V allele
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          55
        2. group Id
          BG001
          value
          51
        3. group Id
          BG002
          value
          106
      title
      1 line of prior therapy
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          22
        2. group Id
          BG001
          value
          24
        3. group Id
          BG002
          value
          46
      title
      2 or 3 lines of prior therapy
    description
    Categories presented as they were at randomization based on information collected via the Interactive Voice Recognition System (IVRS) system.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Number of Prior Lines of Therapy
    unit Of Measure
    Participants
population Description
All enrolled participants who were randomized to a treatment arm were summarized.

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Preserved source evidence · Not medical advice