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NCT01063907 · BASELINE

Baseline characteristics

A Study of KW-2478 in Combination With Bortezomib in Subjects With Relapsed and/or Refractory Multiple Myeloma · Source last updated 2024-04-25

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
      95
    units
    Participants
groups
  1. description
    The target population in both Phase 1 and 2 were adults (≥18 years) of either gender with a confirmed history of MM by IMWG criteria had relapsed or failed to respond to 1-3 prior MM regimens with an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 and a life expectancy ≥ 3 months. Subjects had to have disease that could be evaluated by serum or urinary levels of M protein or serum free light chains in the absence of measurable M protein in serum or urine. For Phase 1, the design was a standard 3+3 study of KW-2478 (130 or 175 mg/m\^2) and Bortezomib(1.0 or 1.3 mg/m\^2) on Days 1, 4, 8, and 11 of a 21-day cycle utilizing four dose-escalation cohorts (overall N=15). The Phase 2 portion of the study enrolled 80 subjects to determine the preliminary efficacy of KW 2478 and Bortezomib at the RP2D (KW-2478 175 mg/m\^2 / Bortezomib 1.3 mg/m\^2).
    id
    BG000
    title
    KW-2478 and Bortezomib
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          9.3
          value
          64.3
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          41
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          54
        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
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          22
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          8
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          61
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          4
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          18
      title
      United States
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          20
      title
      Philippines
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          57
      title
      United Kingdom
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          0.27
          value
          1.87
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Body Surface Area (BSA)
    unit Of Measure
    m^2
population Description
A total of up to 101 male and female subjects at least 18 years of age with a confirmed diagnosis of MM, who failed at least 1 and no more than 3 prior chemotherapy regimens and met other inclusion criteria and none of exclusion criteria, were to be enrolled in this study over a period of 22 months (up to 24 subject in P1 and 77 subjects in P2).
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      95
    units
    Participants
groups
  1. description
    The target population in both Phase 1 and 2 were adults (≥18 years) of either gender with a confirmed history of MM by IMWG criteria had relapsed or failed to respond to 1-3 prior MM regimens with an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 and a life expectancy ≥ 3 months. Subjects had to have disease that could be evaluated by serum or urinary levels of M protein or serum free light chains in the absence of measurable M protein in serum or urine. For Phase 1, the design was a standard 3+3 study of KW-2478 (130 or 175 mg/m\^2) and Bortezomib(1.0 or 1.3 mg/m\^2) on Days 1, 4, 8, and 11 of a 21-day cycle utilizing four dose-escalation cohorts (overall N=15). The Phase 2 portion of the study enrolled 80 subjects to determine the preliminary efficacy of KW 2478 and Bortezomib at the RP2D (KW-2478 175 mg/m\^2 / Bortezomib 1.3 mg/m\^2).
    id
    BG000
    title
    KW-2478 and Bortezomib
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          9.3
          value
          64.3
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          41
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          54
        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
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          22
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          8
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          61
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          4
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          18
      title
      United States
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          20
      title
      Philippines
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          57
      title
      United Kingdom
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          0.27
          value
          1.87
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Body Surface Area (BSA)
    unit Of Measure
    m^2
population Description
A total of up to 101 male and female subjects at least 18 years of age with a confirmed diagnosis of MM, who failed at least 1 and no more than 3 prior chemotherapy regimens and met other inclusion criteria and none of exclusion criteria, were to be enrolled in this study over a period of 22 months (up to 24 subject in P1 and 77 subjects in P2).

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Preserved source evidence · Not medical advice