Skip to content
Triangle logo TriangleGet started
← Full study record

NCT02412878 · BASELINE

Baseline characteristics

Once-weekly Versus Twice-weekly Carfilzomib in Combination With Dexamethasone in Adults With Relapsed and Refractory Multiple Myeloma · Source last updated 2022-09-23

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
      238
    2. group Id
      BG001
      value
      240
    3. group Id
      BG002
      value
      478
    units
    Participants
groups
  1. description
    Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 2, 8, 9, 15, and 16 of each 28-day cycle (20 mg/m² on days 1 and 2 of cycle 1 and 27 mg/m² thereafter). Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
    id
    BG000
    title
    Twice-weekly Carfilzomib 20/27 mg/m² + Dexamethasone
  2. description
    Participants received carfilzomib administered by IV infusion on days 1, 8, and 15 of each 28-day cycle (20 mg/m² on day 1 of cycle 1 and 70 mg/m² thereafter). Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
    id
    BG001
    title
    Once-weekly Carfilzomib 20/70 mg/m² + Dexamethasone
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          35
          upper Limit
          83
          value
          66.0
        2. group Id
          BG001
          lower Limit
          39
          upper Limit
          85
          value
          66.0
        3. group Id
          BG002
          lower Limit
          35
          upper Limit
          85
          value
          66.0
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          104
        2. group Id
          BG001
          value
          104
        3. group Id
          BG002
          value
          208
        title
        18 - 64 years
      2. measurements
        1. group Id
          BG000
          value
          102
        2. group Id
          BG001
          value
          90
        3. group Id
          BG002
          value
          192
        title
        65 - 74 years
      3. measurements
        1. group Id
          BG000
          value
          32
        2. group Id
          BG001
          value
          45
        3. group Id
          BG002
          value
          77
        title
        75 - 84 years
      4. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        title
        ≥ 85 years
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Customized
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          110
        2. group Id
          BG001
          value
          108
        3. group Id
          BG002
          value
          218
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          128
        2. group Id
          BG001
          value
          132
        3. group Id
          BG002
          value
          260
        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
          2
        3. group Id
          BG002
          value
          7
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          226
        2. group Id
          BG001
          value
          235
        3. group Id
          BG002
          value
          461
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          10
        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
          15
        2. group Id
          BG001
          value
          30
        3. group Id
          BG002
          value
          45
        title
        Asian
      2. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          5
        title
        Black or African American
      3. measurements
        1. group Id
          BG000
          value
          202
        2. group Id
          BG001
          value
          200
        3. group Id
          BG002
          value
          402
        title
        White
      4. measurements
        1. group Id
          BG000
          value
          9
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          13
        title
        Other
      5. measurements
        1. group Id
          BG000
          value
          10
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          13
        title
        Missing
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          118
        2. group Id
          BG001
          value
          118
        3. group Id
          BG002
          value
          236
        title
        0 (Fully active)
      2. measurements
        1. group Id
          BG000
          value
          120
        2. group Id
          BG001
          value
          121
        3. group Id
          BG002
          value
          241
        title
        1 (Restrictive but ambulatory)
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        title
        2 (Ambulatory but unable to work)
    description
    A scale to assess a patient's disease status. 0 = Fully active, able to carry out all pre-disease performance without restriction; 1 = Restricted in physically strenuous activity, ambulatory and able to carry out work of a light nature; 2 = Ambulatory and capable of all self-care, unable to carry out any work activities. Up and about \> 50% of waking hours; 3 = Capable of only limited self-care, confined to bed or chair \> 50% of waking hours; 4 = Completely disabled, confined to bed or chair; 5 = Dead.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Eastern Cooperative Oncology Group (ECOG) Performance Status
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          100
        2. group Id
          BG001
          value
          100
        3. group Id
          BG002
          value
          200
        title
        Stage 1
      2. measurements
        1. group Id
          BG000
          value
          138
        2. group Id
          BG001
          value
          140
        3. group Id
          BG002
          value
          278
        title
        Stage 2 or 3
    description
    The International Staging System (ISS) for myeloma was published by the International Myeloma Working Group: * Stage I: β2-microglobulin (β2M) \< 3.5 mg/L, albumin \>= 3.5 g/dL * Stage II: β2M \< 3.5 mg/L and albumin \< 3.5 g/dL; or β2M 3.5 mg/L - 5.5 mg/L irrespective of the serum albumin * Stage III: β2M ≥ 5.5 mg/L
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Stratification Factor: International Staging System (ISS) stage
    unit Of Measure
    Participants
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          88
        2. group Id
          BG001
          value
          88
        3. group Id
          BG002
          value
          176
        title
        Yes
      2. measurements
        1. group Id
          BG000
          value
          150
        2. group Id
          BG001
          value
          152
        3. group Id
          BG002
          value
          302
        title
        No
    description
    Participants were classified as refractory to bortezomib in prior regimens if the data collected on prior multiple myeloma therapy indicated that any of the following criteria were met: 1. Best Response to any regimen containing bortezomib was stable disease or progressive disease. 2. Reason bortezomib was stopped was progression in any regimen. 3. Date of relapse/progression was after start date and within 60 days after stop date of bortezomib in any regimen.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Stratification Factor: Refractory to Bortezomib Treatment
    unit Of Measure
    Participants
population Description
The intention-to-treat population consisted of all randomly assigned participants.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      238
    2. group Id
      BG001
      value
      240
    3. group Id
      BG002
      value
      478
    units
    Participants
groups
  1. description
    Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 2, 8, 9, 15, and 16 of each 28-day cycle (20 mg/m² on days 1 and 2 of cycle 1 and 27 mg/m² thereafter). Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
    id
    BG000
    title
    Twice-weekly Carfilzomib 20/27 mg/m² + Dexamethasone
  2. description
    Participants received carfilzomib administered by IV infusion on days 1, 8, and 15 of each 28-day cycle (20 mg/m² on day 1 of cycle 1 and 70 mg/m² thereafter). Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
    id
    BG001
    title
    Once-weekly Carfilzomib 20/70 mg/m² + Dexamethasone
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          35
          upper Limit
          83
          value
          66.0
        2. group Id
          BG001
          lower Limit
          39
          upper Limit
          85
          value
          66.0
        3. group Id
          BG002
          lower Limit
          35
          upper Limit
          85
          value
          66.0
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          104
        2. group Id
          BG001
          value
          104
        3. group Id
          BG002
          value
          208
        title
        18 - 64 years
      2. measurements
        1. group Id
          BG000
          value
          102
        2. group Id
          BG001
          value
          90
        3. group Id
          BG002
          value
          192
        title
        65 - 74 years
      3. measurements
        1. group Id
          BG000
          value
          32
        2. group Id
          BG001
          value
          45
        3. group Id
          BG002
          value
          77
        title
        75 - 84 years
      4. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        title
        ≥ 85 years
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Customized
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          110
        2. group Id
          BG001
          value
          108
        3. group Id
          BG002
          value
          218
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          128
        2. group Id
          BG001
          value
          132
        3. group Id
          BG002
          value
          260
        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
          2
        3. group Id
          BG002
          value
          7
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          226
        2. group Id
          BG001
          value
          235
        3. group Id
          BG002
          value
          461
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          10
        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
          15
        2. group Id
          BG001
          value
          30
        3. group Id
          BG002
          value
          45
        title
        Asian
      2. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          5
        title
        Black or African American
      3. measurements
        1. group Id
          BG000
          value
          202
        2. group Id
          BG001
          value
          200
        3. group Id
          BG002
          value
          402
        title
        White
      4. measurements
        1. group Id
          BG000
          value
          9
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          13
        title
        Other
      5. measurements
        1. group Id
          BG000
          value
          10
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          13
        title
        Missing
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          118
        2. group Id
          BG001
          value
          118
        3. group Id
          BG002
          value
          236
        title
        0 (Fully active)
      2. measurements
        1. group Id
          BG000
          value
          120
        2. group Id
          BG001
          value
          121
        3. group Id
          BG002
          value
          241
        title
        1 (Restrictive but ambulatory)
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        title
        2 (Ambulatory but unable to work)
    description
    A scale to assess a patient's disease status. 0 = Fully active, able to carry out all pre-disease performance without restriction; 1 = Restricted in physically strenuous activity, ambulatory and able to carry out work of a light nature; 2 = Ambulatory and capable of all self-care, unable to carry out any work activities. Up and about \> 50% of waking hours; 3 = Capable of only limited self-care, confined to bed or chair \> 50% of waking hours; 4 = Completely disabled, confined to bed or chair; 5 = Dead.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Eastern Cooperative Oncology Group (ECOG) Performance Status
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          100
        2. group Id
          BG001
          value
          100
        3. group Id
          BG002
          value
          200
        title
        Stage 1
      2. measurements
        1. group Id
          BG000
          value
          138
        2. group Id
          BG001
          value
          140
        3. group Id
          BG002
          value
          278
        title
        Stage 2 or 3
    description
    The International Staging System (ISS) for myeloma was published by the International Myeloma Working Group: * Stage I: β2-microglobulin (β2M) \< 3.5 mg/L, albumin \>= 3.5 g/dL * Stage II: β2M \< 3.5 mg/L and albumin \< 3.5 g/dL; or β2M 3.5 mg/L - 5.5 mg/L irrespective of the serum albumin * Stage III: β2M ≥ 5.5 mg/L
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Stratification Factor: International Staging System (ISS) stage
    unit Of Measure
    Participants
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          88
        2. group Id
          BG001
          value
          88
        3. group Id
          BG002
          value
          176
        title
        Yes
      2. measurements
        1. group Id
          BG000
          value
          150
        2. group Id
          BG001
          value
          152
        3. group Id
          BG002
          value
          302
        title
        No
    description
    Participants were classified as refractory to bortezomib in prior regimens if the data collected on prior multiple myeloma therapy indicated that any of the following criteria were met: 1. Best Response to any regimen containing bortezomib was stable disease or progressive disease. 2. Reason bortezomib was stopped was progression in any regimen. 3. Date of relapse/progression was after start date and within 60 days after stop date of bortezomib in any regimen.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Stratification Factor: Refractory to Bortezomib Treatment
    unit Of Measure
    Participants
population Description
The intention-to-treat population consisted of all randomly assigned participants.

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

Preserved source evidence · Not medical advice