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NCT01827137 · BASELINE

Baseline characteristics

WT1 Vaccine Treatment of Patients With Multiple Myeloma After Autologous Stem Cell Transplantation · Source last updated 2024-09-19

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
      19
    units
    Participants
groups
  1. description
    Galinpepimut-S (GPS) vaccinations are started 12-22 days following autologous stem cell transplantation (ASCT). GPS and Montanide (in a 1 mL emulsion) are administered subcutaneously (s.c.) Q2W on weeks 0, 2, 4, 6, 8, and 10. GM-CSF (70 μg) are administered s.c. one to two days before and on the day of GPS/Montanide administration. Participants whose disease has not progressed and who are clinically stable (no active infection with fevers and no cardiovascular/respiratory compromise) may receive up to 6 additional monthly vaccinations. The use of post-ASCT maintenance therapy is allowed starting 3 months after ASCT. Galinpepimut-S: Galinpepimut-S admixed with the adjuvant Montanide following specified schedule GM-CSF: subcutaneous injection Montanide: adjuvant lenalidomide: optional post-ASCT therapy bortezomib: optional post-ASCT therapy
    id
    BG000
    title
    Galinpepimut-S + Montanide + GM-CSF
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          46
          upper Limit
          72
          value
          61.3
    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
          11
        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
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          12
        title
        IgG
      2. measurements
        1. group Id
          BG000
          value
          4
        title
        IgA
      3. measurements
        1. group Id
          BG000
          value
          3
        title
        Light chain
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Type of myeloma
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          1
          upper Limit
          3
          value
          2
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Prior therapies
    unit Of Measure
    number of therapies
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          18
        title
        Lenalidomide alone or in combination
      2. measurements
        1. group Id
          BG000
          value
          1
        title
        Other (bortezomib)
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Post ASCT therapy
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          17
        title
        1
      2. measurements
        1. group Id
          BG000
          value
          2
        title
        2
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Prior ASCT
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          15
        title
        High risk
      2. measurements
        1. group Id
          BG000
          value
          4
        title
        Average risk
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Cytogenetics at diagnosis
    unit Of Measure
    Participants
population Description
Analysis set
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      19
    units
    Participants
groups
  1. description
    Galinpepimut-S (GPS) vaccinations are started 12-22 days following autologous stem cell transplantation (ASCT). GPS and Montanide (in a 1 mL emulsion) are administered subcutaneously (s.c.) Q2W on weeks 0, 2, 4, 6, 8, and 10. GM-CSF (70 μg) are administered s.c. one to two days before and on the day of GPS/Montanide administration. Participants whose disease has not progressed and who are clinically stable (no active infection with fevers and no cardiovascular/respiratory compromise) may receive up to 6 additional monthly vaccinations. The use of post-ASCT maintenance therapy is allowed starting 3 months after ASCT. Galinpepimut-S: Galinpepimut-S admixed with the adjuvant Montanide following specified schedule GM-CSF: subcutaneous injection Montanide: adjuvant lenalidomide: optional post-ASCT therapy bortezomib: optional post-ASCT therapy
    id
    BG000
    title
    Galinpepimut-S + Montanide + GM-CSF
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          46
          upper Limit
          72
          value
          61.3
    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
          11
        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
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          12
        title
        IgG
      2. measurements
        1. group Id
          BG000
          value
          4
        title
        IgA
      3. measurements
        1. group Id
          BG000
          value
          3
        title
        Light chain
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Type of myeloma
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          1
          upper Limit
          3
          value
          2
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Prior therapies
    unit Of Measure
    number of therapies
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          18
        title
        Lenalidomide alone or in combination
      2. measurements
        1. group Id
          BG000
          value
          1
        title
        Other (bortezomib)
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Post ASCT therapy
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          17
        title
        1
      2. measurements
        1. group Id
          BG000
          value
          2
        title
        2
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Prior ASCT
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          15
        title
        High risk
      2. measurements
        1. group Id
          BG000
          value
          4
        title
        Average risk
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Cytogenetics at diagnosis
    unit Of Measure
    Participants
population Description
Analysis set

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Preserved source evidence · Not medical advice