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NCT01572480 · BASELINE

Baseline characteristics

Carfilzomib, Lenalidomide, and Dexamethasone for Smoldering Multiple Myeloma · Source last updated 2026-03-10

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
      55
    units
    Participants
groups
  1. description
    Carfilzomib (intravenous (IV), Days 1, 2, 8, 9, 15, and 16 of the 28-day cycle); Revlimid (by mouth (PO), Days 1-21 of the 28-day cycle; exception: not given on cycle 1 day 1); and Dexamethasone (PO or IV, Days 1, 2, 8, 9, 15, 16, 22, and 23 of the 28-day cycle; exception: not given on cycle 1 day 1) Carfilzomib intravenous (IV) 20-36 mg/m\^2 per dose on days 1, 2, 8, 9, 15, and 16 of each cycle based on arm; until disease progression or unacceptable toxicity. Revlimid by mouth (PO) 25 mg/day, days 1-21 every 28 days of each cycle based on arm; until disease progression or unacceptable toxicity.
    id
    BG000
    title
    All Participants
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          40
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          15
        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
          spread
          8
          value
          60.83
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          24
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          31
        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
          2
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          53
        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
          1
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          15
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          38
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          1
        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
          20
        title
        Northeast
      2. measurements
        1. group Id
          BG000
          value
          28
        title
        Southeast
      3. measurements
        1. group Id
          BG000
          value
          2
        title
        Southwest
      4. measurements
        1. group Id
          BG000
          value
          4
        title
        West
      5. measurements
        1. group Id
          BG000
          value
          1
        title
        Missing
      title
      United States
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Region of Enrollment
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          20
      title
      High Risk
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          27
      title
      Standard Risk
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          7
      title
      Unknown
    description
    High risk cytogenetics was defined as del17p,t(14;16), t(14;20), and 1q gain. These cytogenetic abnormalities identified by fluorescence in situ hybridization (FISH) confer a worse prognosis. Per the International Myeloma Working Group (IMWG), participants with high risk cytogenetics may have impaired response to treatment and worse overall survival (OS).
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Cytogenetic Risk Group
    unit Of Measure
    Participants
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          10
    description
    This trial was for high risk smoldering myeloma participants.These participants were enrolled before the updated definition of multiple myeloma, Myeloma-defining events include ≥60% bone marrow plasmacytosis, serum-free light chain ratio≥100, \&/or\>1 focal lesion on magnetic resonance imaging. Between the time of initial enrollment in 2013, the definition of smoldering myeloma was changed to exclude participants with the listed myeloma defining events. The 10 participants in our cohort of high risk smoldering myeloma would be classified as having "full multiple myeloma" by today's definition.
    param Type
    NUMBER
    title
    Myeloma-defining event per International Myeloma Working Group (IMWG) 2014
    unit Of Measure
    events
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          36
    description
    High-risk is defined by immunoparesis ≥95% aberrant plasma cells on bone marrow aspirate flow cytometry Programa de Estudio y Tratamiento de las Hemopatías Malignas (PETHEMA). This is just one high risk criteria. Neither good nor bad for the participant.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    High-risk Smoldering Multiple Myeloma by Programa de Estudio y Tratamiento de las Hemopatías Maligna
    unit Of Measure
    Participants
  10. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          8
    description
    High-risk is defined by a serum-free light chain ratio of 8 or 0.125 (Mayo Clinic 2008) or 2-3 of the following: serumMprotein \>2 g/dL, involved to uninvolved free light chain ratio \>20, or bone marrow plasmacytosis \>20%. This is just one high risk criteria. Neither good nor bad for the participant.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Number of Participants with High-Risk Smoldering Multiple Myeloma (SMM) by Mayo Clinic 2008
    unit Of Measure
    Participants
  11. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          36
    description
    These participants were enrolled before the updated definition of multiple myeloma, Myeloma-defining events include ≥60% bone marrow plasmacytosis, serum-free light chain ratio ≥100, and/or \>1 focal lesion on magnetic resonance imaging. This is just one high risk criteria. Neither good nor bad for the participant.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Number of Participants with High-Risk Smoldering Multiple Myeloma (SMM) by Mayo Clinic 2018
    unit Of Measure
    Participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      55
    units
    Participants
groups
  1. description
    Carfilzomib (intravenous (IV), Days 1, 2, 8, 9, 15, and 16 of the 28-day cycle); Revlimid (by mouth (PO), Days 1-21 of the 28-day cycle; exception: not given on cycle 1 day 1); and Dexamethasone (PO or IV, Days 1, 2, 8, 9, 15, 16, 22, and 23 of the 28-day cycle; exception: not given on cycle 1 day 1) Carfilzomib intravenous (IV) 20-36 mg/m\^2 per dose on days 1, 2, 8, 9, 15, and 16 of each cycle based on arm; until disease progression or unacceptable toxicity. Revlimid by mouth (PO) 25 mg/day, days 1-21 every 28 days of each cycle based on arm; until disease progression or unacceptable toxicity.
    id
    BG000
    title
    All Participants
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          40
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          15
        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
          spread
          8
          value
          60.83
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          24
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          31
        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
          2
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          53
        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
          1
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          15
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          38
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          1
        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
          20
        title
        Northeast
      2. measurements
        1. group Id
          BG000
          value
          28
        title
        Southeast
      3. measurements
        1. group Id
          BG000
          value
          2
        title
        Southwest
      4. measurements
        1. group Id
          BG000
          value
          4
        title
        West
      5. measurements
        1. group Id
          BG000
          value
          1
        title
        Missing
      title
      United States
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Region of Enrollment
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          20
      title
      High Risk
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          27
      title
      Standard Risk
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          7
      title
      Unknown
    description
    High risk cytogenetics was defined as del17p,t(14;16), t(14;20), and 1q gain. These cytogenetic abnormalities identified by fluorescence in situ hybridization (FISH) confer a worse prognosis. Per the International Myeloma Working Group (IMWG), participants with high risk cytogenetics may have impaired response to treatment and worse overall survival (OS).
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Cytogenetic Risk Group
    unit Of Measure
    Participants
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          10
    description
    This trial was for high risk smoldering myeloma participants.These participants were enrolled before the updated definition of multiple myeloma, Myeloma-defining events include ≥60% bone marrow plasmacytosis, serum-free light chain ratio≥100, \&/or\>1 focal lesion on magnetic resonance imaging. Between the time of initial enrollment in 2013, the definition of smoldering myeloma was changed to exclude participants with the listed myeloma defining events. The 10 participants in our cohort of high risk smoldering myeloma would be classified as having "full multiple myeloma" by today's definition.
    param Type
    NUMBER
    title
    Myeloma-defining event per International Myeloma Working Group (IMWG) 2014
    unit Of Measure
    events
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          36
    description
    High-risk is defined by immunoparesis ≥95% aberrant plasma cells on bone marrow aspirate flow cytometry Programa de Estudio y Tratamiento de las Hemopatías Malignas (PETHEMA). This is just one high risk criteria. Neither good nor bad for the participant.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    High-risk Smoldering Multiple Myeloma by Programa de Estudio y Tratamiento de las Hemopatías Maligna
    unit Of Measure
    Participants
  10. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          8
    description
    High-risk is defined by a serum-free light chain ratio of 8 or 0.125 (Mayo Clinic 2008) or 2-3 of the following: serumMprotein \>2 g/dL, involved to uninvolved free light chain ratio \>20, or bone marrow plasmacytosis \>20%. This is just one high risk criteria. Neither good nor bad for the participant.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Number of Participants with High-Risk Smoldering Multiple Myeloma (SMM) by Mayo Clinic 2008
    unit Of Measure
    Participants
  11. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          36
    description
    These participants were enrolled before the updated definition of multiple myeloma, Myeloma-defining events include ≥60% bone marrow plasmacytosis, serum-free light chain ratio ≥100, and/or \>1 focal lesion on magnetic resonance imaging. This is just one high risk criteria. Neither good nor bad for the participant.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Number of Participants with High-Risk Smoldering Multiple Myeloma (SMM) by Mayo Clinic 2018
    unit Of Measure
    Participants

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Preserved source evidence · Not medical advice