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NCT03361306 · BASELINE

Baseline characteristics

LCI-HEM-MYE-CRD-002: Carfilzomib-Revlimid-Dexamethasone-Elotuzumab in Relapsed/Refractory Multiple Myeloma · Source last updated 2026-03-06

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
      15
    units
    Participants
groups
  1. description
    Induction (4 28-day cycles): Carfilzomib (IV) @ 20 mg/m\^2, Day 1 of Cycle 1; @ 56 mg/m\^2, Day 8,15 of Cycle 1; @ 56 mg/m\^2, Day 1,8,15 of Cycles 2-4 Lenalidomide (Oral) @ 25 mg, once daily at bedtime on Days 1-21 of each cycle (Cycles 1-4) Dexamethasone @ 28 mg orally OR 8 mg IV, once weekly on Day 1,8,15,22 of Cycles 1-2; @28 mg orally OR 8 mg IV on Day 1 of Cycles 3-4 Elotuzumab (IV) @ 10 mg/kg, once weekly on Day 1,8,15,22 of Cycles 1-2; @ 20 mg/kg on Day 1 of Cycles 3-4 Maintenance (28-day cycles): Elotuzumab (IV) @ 20 mg/kg, Day 1 of each cycle (Cycles 1-n) Lenalidomide (Oral) @ 15 mg (or last tolerated dose if \<15 mg), once daily at bedtime on Days 1-21 of each cycle (Cycles 1-n)
    id
    BG000
    title
    KRd-Elotuzumab
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          9
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          6
        title
        >=65 years
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Categorical
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          46
          upper Limit
          74
          value
          64
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Age, Continuous
    unit Of Measure
    years
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          6
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          9
        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
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          15
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          0
        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
          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
          4
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          10
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          1
        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
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          15
      title
      United States
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          6
        title
        0
      2. measurements
        1. group Id
          BG000
          value
          8
        title
        1
      3. measurements
        1. group Id
          BG000
          value
          1
        title
        2
    description
    Measure Description: ECOG Scale of Performance Status, developed by the Eastern Cooperative Oncology Group. (0) subject is fully active, able to carry on all predisease performance without restriction; (1) subject is restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature (e.g., light house work, office work); (2) subject is ambulatory and capable of all self-care but unable to carry out any work activities (up and about more than 50% of waking hours)
    param Type
    COUNT_OF_PARTICIPANTS
    title
    ECOG at Baseline
    unit Of Measure
    Participants
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          7
        title
        Stage I
      2. measurements
        1. group Id
          BG000
          value
          3
        title
        Stage II
      3. measurements
        1. group Id
          BG000
          value
          5
        title
        Stage III
    description
    International Staging System (ISS) - developed by the International Myeloma Working Group (IMWG). Stage I indicates serum beta 2 microglobulin (SB2M)\<3.5 mg/L, serum albumin\>=3.5 g/dL; Stage II indicates SB2M\<3.5 mg/L and serum albumin\<3.5 g/dL, OR SB2M 3.5-5.5 mg/L, irrespective of serum albumin; Stage III indicates SB2M\>5.5 mg/L
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Baseline ISS Stage
    unit Of Measure
    Participants
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          5
        title
        Stage I
      2. measurements
        1. group Id
          BG000
          value
          5
        title
        Stage II
      3. measurements
        1. group Id
          BG000
          value
          5
        title
        Stage III
    description
    Revised International Staging System (R-ISS) - revision developed by the International Myeloma Working Group (IMWG). Stage I indicates serum beta 2 microglobulin (SB2M)\<3.5 mg/L, serum albumin\>=3.5 g/dL, standard risk chromosomal abnormalities (CA) by iFISH, normal LDH; Stage II indicates not R-ISS stage I or stage III; Stage III indicates SB2M\>5.5 mg/L and either high-risk CA by iFISH or high LDH
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Baseline R-ISS Stage
    unit Of Measure
    Participants
  10. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          13
        title
        Prior lenalidomide
      2. measurements
        1. group Id
          BG000
          value
          2
        title
        No prior lenalidomide
    description
    Indicates whether the subject had previously received lenalidomide
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Prior Lenalidomide Exposure
    unit Of Measure
    Participants
  11. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          14
        title
        Prior Bortezomib
      2. measurements
        1. group Id
          BG000
          value
          1
        title
        No Prior Bortezomib
    description
    Indicates whether the subject had previously received bortezomib
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Prior Bortezomib Exposure
    unit Of Measure
    Participants
  12. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          12
        title
        Prior ASCT
      2. measurements
        1. group Id
          BG000
          value
          3
        title
        No Prior ASCT
    description
    Indicates whether the subject had previously undergone autologous stem cell transplant (ASCT)
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Prior ASCT
    unit Of Measure
    Participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      15
    units
    Participants
groups
  1. description
    Induction (4 28-day cycles): Carfilzomib (IV) @ 20 mg/m\^2, Day 1 of Cycle 1; @ 56 mg/m\^2, Day 8,15 of Cycle 1; @ 56 mg/m\^2, Day 1,8,15 of Cycles 2-4 Lenalidomide (Oral) @ 25 mg, once daily at bedtime on Days 1-21 of each cycle (Cycles 1-4) Dexamethasone @ 28 mg orally OR 8 mg IV, once weekly on Day 1,8,15,22 of Cycles 1-2; @28 mg orally OR 8 mg IV on Day 1 of Cycles 3-4 Elotuzumab (IV) @ 10 mg/kg, once weekly on Day 1,8,15,22 of Cycles 1-2; @ 20 mg/kg on Day 1 of Cycles 3-4 Maintenance (28-day cycles): Elotuzumab (IV) @ 20 mg/kg, Day 1 of each cycle (Cycles 1-n) Lenalidomide (Oral) @ 15 mg (or last tolerated dose if \<15 mg), once daily at bedtime on Days 1-21 of each cycle (Cycles 1-n)
    id
    BG000
    title
    KRd-Elotuzumab
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          9
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          6
        title
        >=65 years
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Categorical
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          46
          upper Limit
          74
          value
          64
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Age, Continuous
    unit Of Measure
    years
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          6
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          9
        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
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          15
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          0
        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
          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
          4
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          10
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          1
        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
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          15
      title
      United States
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          6
        title
        0
      2. measurements
        1. group Id
          BG000
          value
          8
        title
        1
      3. measurements
        1. group Id
          BG000
          value
          1
        title
        2
    description
    Measure Description: ECOG Scale of Performance Status, developed by the Eastern Cooperative Oncology Group. (0) subject is fully active, able to carry on all predisease performance without restriction; (1) subject is restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature (e.g., light house work, office work); (2) subject is ambulatory and capable of all self-care but unable to carry out any work activities (up and about more than 50% of waking hours)
    param Type
    COUNT_OF_PARTICIPANTS
    title
    ECOG at Baseline
    unit Of Measure
    Participants
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          7
        title
        Stage I
      2. measurements
        1. group Id
          BG000
          value
          3
        title
        Stage II
      3. measurements
        1. group Id
          BG000
          value
          5
        title
        Stage III
    description
    International Staging System (ISS) - developed by the International Myeloma Working Group (IMWG). Stage I indicates serum beta 2 microglobulin (SB2M)\<3.5 mg/L, serum albumin\>=3.5 g/dL; Stage II indicates SB2M\<3.5 mg/L and serum albumin\<3.5 g/dL, OR SB2M 3.5-5.5 mg/L, irrespective of serum albumin; Stage III indicates SB2M\>5.5 mg/L
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Baseline ISS Stage
    unit Of Measure
    Participants
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          5
        title
        Stage I
      2. measurements
        1. group Id
          BG000
          value
          5
        title
        Stage II
      3. measurements
        1. group Id
          BG000
          value
          5
        title
        Stage III
    description
    Revised International Staging System (R-ISS) - revision developed by the International Myeloma Working Group (IMWG). Stage I indicates serum beta 2 microglobulin (SB2M)\<3.5 mg/L, serum albumin\>=3.5 g/dL, standard risk chromosomal abnormalities (CA) by iFISH, normal LDH; Stage II indicates not R-ISS stage I or stage III; Stage III indicates SB2M\>5.5 mg/L and either high-risk CA by iFISH or high LDH
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Baseline R-ISS Stage
    unit Of Measure
    Participants
  10. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          13
        title
        Prior lenalidomide
      2. measurements
        1. group Id
          BG000
          value
          2
        title
        No prior lenalidomide
    description
    Indicates whether the subject had previously received lenalidomide
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Prior Lenalidomide Exposure
    unit Of Measure
    Participants
  11. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          14
        title
        Prior Bortezomib
      2. measurements
        1. group Id
          BG000
          value
          1
        title
        No Prior Bortezomib
    description
    Indicates whether the subject had previously received bortezomib
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Prior Bortezomib Exposure
    unit Of Measure
    Participants
  12. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          12
        title
        Prior ASCT
      2. measurements
        1. group Id
          BG000
          value
          3
        title
        No Prior ASCT
    description
    Indicates whether the subject had previously undergone autologous stem cell transplant (ASCT)
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Prior ASCT
    unit Of Measure
    Participants

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Preserved source evidence · Not medical advice