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NCT03246529 · BASELINE

Baseline characteristics

A Phase III, Safety, Tolerability and Efficacy of Combination Treatment of BL-8040 and Granulocyte Colony Stimulating Factor (G-CSF) as Compared to Placebo and G-CSF for the Mobilization of Hematopoietic Stem Cells for Autologous Transplantation in Subjects With Multiple Myeloma (MM) · Source last updated 2026-01-15

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
      12
    2. group Id
      BG001
      value
      80
    3. group Id
      BG002
      value
      42
    4. group Id
      BG003
      value
      134
    units
    Participants
groups
  1. description
    Part 1 (lead-in) period. G-CSF given one time daily s.c. for 5-8 days (Day 1 up to 8) at doses of approximately 10 µg/kg/day but not more than 15 µg/kg/day. BL-8040 1.25 mg/kg s.c. on Day 4 (and Day 6, if needed). First apheresis on Day 5 with up to 3 additional procedures possible until Day 8, as needed.
    id
    BG000
    title
    BL-8040 + G-CSF Part 1
  2. description
    Part 2: randomized, double-blinded, placebo controlled period. G-CSF given one time daily s.c. for 5-8 days (Day 1 up to 8) at doses of approximately 10 µg/kg/day but not more than 15 µg/kg/day. BL-8040 1.25 mg/kg s.c. on Day 4 (and Day 6, if needed). First apheresis on Day 5 with up to 3 additional procedures possible until Day 8, as needed.
    id
    BG001
    title
    BL-8040 + G-CSF Part 2
  3. description
    Part 2: randomized, double-blinded, placebo controlled period. G-CSF given one time daily s.c. for 5-8 days (Day 1 up to 8) at doses of approximately 10 µg/kg/day but not more than 15 µg/kg/day. Placebo s.c. on Day 4 (and Day 6, if needed). First apheresis on Day 5 with up to 3 additional procedures possible until Day 8, as needed.
    id
    BG002
    title
    Placebo + G-CSF Part 2
  4. description
    Total of all reporting groups
    id
    BG003
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          4.8
          value
          63.3
        2. group Id
          BG001
          spread
          9.4
          value
          60.4
        3. group Id
          BG002
          spread
          9.6
          value
          59.2
        4. group Id
          BG003
          spread
          9.1
          value
          60.5
    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
          5
        2. group Id
          BG001
          value
          25
        3. group Id
          BG002
          value
          18
        4. group Id
          BG003
          value
          48
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          55
        3. group Id
          BG002
          value
          24
        4. group Id
          BG003
          value
          86
        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
          2
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          12
      title
      African American
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          9
        2. group Id
          BG001
          value
          65
        3. group Id
          BG002
          value
          40
        4. group Id
          BG003
          value
          114
      title
      Caucasian
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
      title
      Not reported
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
      title
      African
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          2
      title
      Asian
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
      title
      Hispanic origin
    7. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          2
      title
      Unknown
    8. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
      title
      Not Specified
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          10
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          16
      title
      Hungary
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          12
        2. group Id
          BG001
          value
          52
        3. group Id
          BG002
          value
          26
        4. group Id
          BG003
          value
          90
      title
      United States
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          9
        3. group Id
          BG002
          value
          8
        4. group Id
          BG003
          value
          17
      title
      Italy
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          3
      title
      Germany
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          8
      title
      Spain
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Region of Enrollment
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          54
        3. group Id
          BG002
          value
          28
        4. group Id
          BG003
          value
          89
      title
      Bortezomib
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          1
      title
      Cisplatin
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          9
      title
      Cyclophosphamide
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          1
      title
      Daratumumab 0 - 1 2.4%
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          1
      title
      Doxorubicin
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          1
      title
      Etoposide
    7. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
      title
      Ixazomib
    8. categories
      1. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          9
      title
      Kyprolis
    9. categories
      1. measurements
        1. group Id
          BG000
          value
          12
        2. group Id
          BG001
          value
          57
        3. group Id
          BG002
          value
          28
        4. group Id
          BG003
          value
          97
      title
      Lenalidomide
    10. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          1
      title
      Melphalan
    11. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          2
      title
      Pomalidomide
    12. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          18
        3. group Id
          BG002
          value
          12
        4. group Id
          BG003
          value
          30
      title
      Thalidomide
    description
    Treatment Indicated for Multiple Myeloma Before Study Initiation
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Treatment Indicated for Multiple Myeloma Before Study Initiation
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          31
        3. group Id
          BG002
          value
          10
        4. group Id
          BG003
          value
          41
        title
        PR (Partial Response)
      2. measurements
        1. group Id
          BG000
          value
          9
        2. group Id
          BG001
          value
          33
        3. group Id
          BG002
          value
          23
        4. group Id
          BG003
          value
          65
        title
        VGPR (Very Good Partial Response)
      3. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          12
        3. group Id
          BG002
          value
          7
        4. group Id
          BG003
          value
          21
        title
        CR (Complete Response)
      4. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          7
        title
        sCR (Stringent Complete Response)
    description
    Response criteria for the purposes of the study was defined in accordance with the International Myeloma Working Group (IMWG) Uniform Response Criteria.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    IMWG Classification at Screening
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          0.9
          value
          4.6
        2. group Id
          BG001
          spread
          11.1
          value
          6.5
        3. group Id
          BG002
          spread
          6.9
          value
          6.4
        4. group Id
          BG003
          spread
          9.4
          value
          6.3
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Months from MM Diagnosis to Study Consent
    unit Of Measure
    months
population Description
Part 1: Full analysis set - all enrolled subjects. Part 2: ITT analysis set: all randomized subjects. According to the treatment group to which they were originally randomized.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      12
    2. group Id
      BG001
      value
      80
    3. group Id
      BG002
      value
      42
    4. group Id
      BG003
      value
      134
    units
    Participants
groups
  1. description
    Part 1 (lead-in) period. G-CSF given one time daily s.c. for 5-8 days (Day 1 up to 8) at doses of approximately 10 µg/kg/day but not more than 15 µg/kg/day. BL-8040 1.25 mg/kg s.c. on Day 4 (and Day 6, if needed). First apheresis on Day 5 with up to 3 additional procedures possible until Day 8, as needed.
    id
    BG000
    title
    BL-8040 + G-CSF Part 1
  2. description
    Part 2: randomized, double-blinded, placebo controlled period. G-CSF given one time daily s.c. for 5-8 days (Day 1 up to 8) at doses of approximately 10 µg/kg/day but not more than 15 µg/kg/day. BL-8040 1.25 mg/kg s.c. on Day 4 (and Day 6, if needed). First apheresis on Day 5 with up to 3 additional procedures possible until Day 8, as needed.
    id
    BG001
    title
    BL-8040 + G-CSF Part 2
  3. description
    Part 2: randomized, double-blinded, placebo controlled period. G-CSF given one time daily s.c. for 5-8 days (Day 1 up to 8) at doses of approximately 10 µg/kg/day but not more than 15 µg/kg/day. Placebo s.c. on Day 4 (and Day 6, if needed). First apheresis on Day 5 with up to 3 additional procedures possible until Day 8, as needed.
    id
    BG002
    title
    Placebo + G-CSF Part 2
  4. description
    Total of all reporting groups
    id
    BG003
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          4.8
          value
          63.3
        2. group Id
          BG001
          spread
          9.4
          value
          60.4
        3. group Id
          BG002
          spread
          9.6
          value
          59.2
        4. group Id
          BG003
          spread
          9.1
          value
          60.5
    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
          5
        2. group Id
          BG001
          value
          25
        3. group Id
          BG002
          value
          18
        4. group Id
          BG003
          value
          48
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          55
        3. group Id
          BG002
          value
          24
        4. group Id
          BG003
          value
          86
        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
          2
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          12
      title
      African American
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          9
        2. group Id
          BG001
          value
          65
        3. group Id
          BG002
          value
          40
        4. group Id
          BG003
          value
          114
      title
      Caucasian
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
      title
      Not reported
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
      title
      African
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          2
      title
      Asian
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
      title
      Hispanic origin
    7. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          2
      title
      Unknown
    8. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
      title
      Not Specified
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          10
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          16
      title
      Hungary
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          12
        2. group Id
          BG001
          value
          52
        3. group Id
          BG002
          value
          26
        4. group Id
          BG003
          value
          90
      title
      United States
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          9
        3. group Id
          BG002
          value
          8
        4. group Id
          BG003
          value
          17
      title
      Italy
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          3
      title
      Germany
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          8
      title
      Spain
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Region of Enrollment
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          54
        3. group Id
          BG002
          value
          28
        4. group Id
          BG003
          value
          89
      title
      Bortezomib
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          1
      title
      Cisplatin
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          9
      title
      Cyclophosphamide
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          1
      title
      Daratumumab 0 - 1 2.4%
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          1
      title
      Doxorubicin
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          1
      title
      Etoposide
    7. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
      title
      Ixazomib
    8. categories
      1. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          9
      title
      Kyprolis
    9. categories
      1. measurements
        1. group Id
          BG000
          value
          12
        2. group Id
          BG001
          value
          57
        3. group Id
          BG002
          value
          28
        4. group Id
          BG003
          value
          97
      title
      Lenalidomide
    10. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          1
      title
      Melphalan
    11. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          2
      title
      Pomalidomide
    12. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          18
        3. group Id
          BG002
          value
          12
        4. group Id
          BG003
          value
          30
      title
      Thalidomide
    description
    Treatment Indicated for Multiple Myeloma Before Study Initiation
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Treatment Indicated for Multiple Myeloma Before Study Initiation
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          31
        3. group Id
          BG002
          value
          10
        4. group Id
          BG003
          value
          41
        title
        PR (Partial Response)
      2. measurements
        1. group Id
          BG000
          value
          9
        2. group Id
          BG001
          value
          33
        3. group Id
          BG002
          value
          23
        4. group Id
          BG003
          value
          65
        title
        VGPR (Very Good Partial Response)
      3. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          12
        3. group Id
          BG002
          value
          7
        4. group Id
          BG003
          value
          21
        title
        CR (Complete Response)
      4. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          7
        title
        sCR (Stringent Complete Response)
    description
    Response criteria for the purposes of the study was defined in accordance with the International Myeloma Working Group (IMWG) Uniform Response Criteria.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    IMWG Classification at Screening
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          0.9
          value
          4.6
        2. group Id
          BG001
          spread
          11.1
          value
          6.5
        3. group Id
          BG002
          spread
          6.9
          value
          6.4
        4. group Id
          BG003
          spread
          9.4
          value
          6.3
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Months from MM Diagnosis to Study Consent
    unit Of Measure
    months
population Description
Part 1: Full analysis set - all enrolled subjects. Part 2: ITT analysis set: all randomized subjects. According to the treatment group to which they were originally randomized.

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Preserved source evidence · Not medical advice