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NCT02603887 · BASELINE

Baseline characteristics

Pembrolizumab in Treating Patients With Intermediate or High-Risk Smoldering Multiple Myeloma · Source last updated 2026-07-17

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
      13
    units
    Participants
groups
  1. description
    Pembrolizumab 200 mg, 30 minute IV infusion every 21 days up to 24 cycles if equal or higher than minor response and without serious adverse events after 8 cycles
    id
    BG000
    title
    Treatment (Pembrolizumab)
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          5
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          8
        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
          59
          upper Limit
          71
          value
          68
    dispersion Type
    INTER_QUARTILE_RANGE
    param Type
    MEDIAN
    title
    Age, Continuous
    unit Of Measure
    years
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          5
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          8
        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
          13
        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
          0
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          12
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        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
          13
      title
      United States
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          11.95
          upper Limit
          13.95
          value
          12.4
      title
      Hemoglobin
    2. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          0.8
          upper Limit
          3.15
          value
          1.9
      title
      Serum paraprotein
    description
    Measure Description: Laboratory exams including hemoglobin, calcium, creatinine, serum paraprotein, bence jones urine protein, kappa and lambda free light chain, free light chain ratio, involved:uninvolved ratio, B2 microglobulin, LDH and bone marrow biopsy plasma cell percentage, needed to assess properly a patient with plasma cell dyscrasia
    dispersion Type
    INTER_QUARTILE_RANGE
    param Type
    MEDIAN
    title
    Myeloma related labs
    unit Of Measure
    gm/dL
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          8.7
          upper Limit
          9.55
          value
          9.3
      title
      Calcium
    2. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          0.79
          upper Limit
          1.04
          value
          .88
      title
      Creatinine
    description
    Measure Description: Laboratory exams including hemoglobin, calcium, creatinine, serum paraprotein, bence jones urine protein, kappa and lambda free light chain, free light chain ratio, involved:uninvolved ratio, B2 microglobulin, LDH and bone marrow biopsy plasma cell percentage, needed to assess properly a patient with plasma cell dyscrasia
    dispersion Type
    INTER_QUARTILE_RANGE
    param Type
    MEDIAN
    title
    Myeloma related labs
    unit Of Measure
    mg/dL
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          1.75
          upper Limit
          2.3
          value
          1.9
      title
      B2 microglobulin
    2. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          18.18
          upper Limit
          277.48
          value
          127.04
      title
      Kappa free light chain
    3. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          6.74
          upper Limit
          14.59
          value
          8.08
      title
      Lambda free light chain
    description
    Measure Description: Laboratory exams including hemoglobin, calcium, creatinine, serum paraprotein, bence jones urine protein, kappa and lambda free light chain, free light chain ratio, involved:uninvolved ratio, B2 microglobulin, LDH and bone marrow biopsy plasma cell percentage, needed to assess properly a patient with plasma cell dyscrasia
    dispersion Type
    INTER_QUARTILE_RANGE
    param Type
    MEDIAN
    title
    Myeloma related labs
    unit Of Measure
    mg/L
  10. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          349.5
          upper Limit
          488
          value
          439
    dispersion Type
    INTER_QUARTILE_RANGE
    param Type
    MEDIAN
    title
    Myeloma related lab Lactate dehydrogenase
    unit Of Measure
    u/L
  11. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          17.5
          upper Limit
          45
          value
          30
    dispersion Type
    INTER_QUARTILE_RANGE
    param Type
    MEDIAN
    title
    Myeloma related lab Bone marrow biopsy plasma cells
    unit Of Measure
    percentage of plasma cells
  12. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          0
          upper Limit
          30.5
          value
          6
    dispersion Type
    INTER_QUARTILE_RANGE
    param Type
    MEDIAN
    title
    Myeloma related lab Bence Jones urine protein
    unit Of Measure
    mg/day
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      13
    units
    Participants
groups
  1. description
    Pembrolizumab 200 mg, 30 minute IV infusion every 21 days up to 24 cycles if equal or higher than minor response and without serious adverse events after 8 cycles
    id
    BG000
    title
    Treatment (Pembrolizumab)
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          5
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          8
        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
          59
          upper Limit
          71
          value
          68
    dispersion Type
    INTER_QUARTILE_RANGE
    param Type
    MEDIAN
    title
    Age, Continuous
    unit Of Measure
    years
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          5
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          8
        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
          13
        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
          0
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          12
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        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
          13
      title
      United States
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          11.95
          upper Limit
          13.95
          value
          12.4
      title
      Hemoglobin
    2. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          0.8
          upper Limit
          3.15
          value
          1.9
      title
      Serum paraprotein
    description
    Measure Description: Laboratory exams including hemoglobin, calcium, creatinine, serum paraprotein, bence jones urine protein, kappa and lambda free light chain, free light chain ratio, involved:uninvolved ratio, B2 microglobulin, LDH and bone marrow biopsy plasma cell percentage, needed to assess properly a patient with plasma cell dyscrasia
    dispersion Type
    INTER_QUARTILE_RANGE
    param Type
    MEDIAN
    title
    Myeloma related labs
    unit Of Measure
    gm/dL
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          8.7
          upper Limit
          9.55
          value
          9.3
      title
      Calcium
    2. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          0.79
          upper Limit
          1.04
          value
          .88
      title
      Creatinine
    description
    Measure Description: Laboratory exams including hemoglobin, calcium, creatinine, serum paraprotein, bence jones urine protein, kappa and lambda free light chain, free light chain ratio, involved:uninvolved ratio, B2 microglobulin, LDH and bone marrow biopsy plasma cell percentage, needed to assess properly a patient with plasma cell dyscrasia
    dispersion Type
    INTER_QUARTILE_RANGE
    param Type
    MEDIAN
    title
    Myeloma related labs
    unit Of Measure
    mg/dL
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          1.75
          upper Limit
          2.3
          value
          1.9
      title
      B2 microglobulin
    2. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          18.18
          upper Limit
          277.48
          value
          127.04
      title
      Kappa free light chain
    3. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          6.74
          upper Limit
          14.59
          value
          8.08
      title
      Lambda free light chain
    description
    Measure Description: Laboratory exams including hemoglobin, calcium, creatinine, serum paraprotein, bence jones urine protein, kappa and lambda free light chain, free light chain ratio, involved:uninvolved ratio, B2 microglobulin, LDH and bone marrow biopsy plasma cell percentage, needed to assess properly a patient with plasma cell dyscrasia
    dispersion Type
    INTER_QUARTILE_RANGE
    param Type
    MEDIAN
    title
    Myeloma related labs
    unit Of Measure
    mg/L
  10. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          349.5
          upper Limit
          488
          value
          439
    dispersion Type
    INTER_QUARTILE_RANGE
    param Type
    MEDIAN
    title
    Myeloma related lab Lactate dehydrogenase
    unit Of Measure
    u/L
  11. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          17.5
          upper Limit
          45
          value
          30
    dispersion Type
    INTER_QUARTILE_RANGE
    param Type
    MEDIAN
    title
    Myeloma related lab Bone marrow biopsy plasma cells
    unit Of Measure
    percentage of plasma cells
  12. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          0
          upper Limit
          30.5
          value
          6
    dispersion Type
    INTER_QUARTILE_RANGE
    param Type
    MEDIAN
    title
    Myeloma related lab Bence Jones urine protein
    unit Of Measure
    mg/day

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Preserved source evidence · Not medical advice