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NCT01897714 · BASELINE

Baseline characteristics

Safety and Efficacy of Melflufen and Dexamethasone in Relapsed and/or Relapsed-Refractory Multiple Myeloma Patients · Source last updated 2020-10-23

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
      4
    2. group Id
      BG001
      value
      7
    3. group Id
      BG002
      value
      6
    4. group Id
      BG003
      value
      6
    5. group Id
      BG004
      value
      45
    6. group Id
      BG005
      value
      13
    7. group Id
      BG006
      value
      81
    units
    Participants
groups
  1. description
    Patients were treated with 15 mg melflufen as IV infusion on Day 1 and 40 mg dexamethasone oral tablet or IV infusion on Days 1, 8 and 15 of each 21-day treatment cycle. Patients could continue receiving treatment for up to 8 cycles or until they experienced unacceptable toxicity, disease progression, withdrew consent, and/or the study drug was discontinued at the discretion of the Investigator.
    id
    BG000
    title
    Phase I: Melflufen 15 mg + Dexamethasone
  2. description
    Patients were treated with 25 mg melflufen as IV infusion on Day 1 and 40 mg dexamethasone oral tablet or IV infusion on Days 1, 8 and 15 of each 21-day treatment cycle. Patients could continue receiving treatment for up to 8 cycles or until they experienced unacceptable toxicity, disease progression, withdrew consent, and/or the study drug was discontinued at the discretion of the Investigator.
    id
    BG001
    title
    Phase I: Melflufen 25 mg + Dexamethasone
  3. description
    Patients were treated with 40 mg melflufen as IV infusion on Day 1 and 40 mg dexamethasone oral tablet or IV infusion on Days 1, 8 and 15 of each 21-day treatment cycle. Patients could continue receiving treatment for up to 8 cycles or until they experienced unacceptable toxicity, disease progression, withdrew consent, and/or the study drug was discontinued at the discretion of the Investigator.
    id
    BG002
    title
    Phase I: Melflufen 40 mg + Dexamethasone
  4. description
    Patients were treated with 55 mg melflufen as IV infusion on Day 1 and 40 mg dexamethasone oral tablet or IV infusion on Days 1, 8 and 15 of each 21-day treatment cycle. Patients could continue receiving treatment for up to 8 cycles or until they experienced unacceptable toxicity, disease progression, withdrew consent, and/or the study drug was discontinued at the discretion of the Investigator.
    id
    BG003
    title
    Phase I: Melflufen 55 mg + Dexamethasone
  5. description
    Patients were treated with 40 mg melflufen as IV infusion on Day 1 and 40 mg dexamethasone oral tablet or IV infusion on Days 1, 8 and 15 of each 21-day or 28-day treatment cycle. Patients could continue receiving treatment for up to 8 cycles or until they experienced unacceptable toxicity, disease progression, withdrew consent, and/or the study drug was discontinued at the discretion of the Investigator. In Protocol amendment 4, the cycle of melflufen was increased from 21 to 28 days. For any patients on the 28-day treatment schedule, an additional dose of 40 mg dexamethasone was administered on Day 22 of each cycle.
    id
    BG004
    title
    Phase I + II: Melflufen 40 mg + Dexamethasone
  6. description
    Patients were treated with 40 mg melflufen as IV infusion on Day 1 of each 28-day treatment cycle. Dexamethasone was not administered as an antitumor compound. However, all patients were treated with 8 mg dexamethasone as an antiemetic on Days 1 and 2, and an optional 4 mg dexamethasone as an antiemetic on Days 3 and 4 of the same 28-day cycle, unless the Investigator decided to switch a patient to a combination regimen. Patients could continue receiving treatment for up to 8 cycles or until they experienced unacceptable toxicity, disease progression, withdrew consent, and/or the study drug was discontinued at the discretion of the Investigator.
    id
    BG005
    title
    Phase II: Melflufen 40 mg (Single Agent)
  7. description
    Total of all reporting groups
    id
    BG006
    title
    Total
measures
  1. calculate Pct
    false
    classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG006
          value
          0
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          2
        5. group Id
          BG006
          value
          9
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          4
        5. group Id
          BG006
          value
          14
        title
        >=65 years
      denoms
      1. counts
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          6
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          23
        units
        Participants
      title
      Phase I
    2. categories
      1. measurements
        1. group Id
          BG004
          value
          0
        2. group Id
          BG005
          value
          0
        3. group Id
          BG006
          value
          0
        title
        <=18 years
      2. measurements
        1. group Id
          BG004
          value
          20
        2. group Id
          BG005
          value
          8
        3. group Id
          BG006
          value
          28
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG004
          value
          25
        2. group Id
          BG005
          value
          5
        3. group Id
          BG006
          value
          30
        title
        >=65 years
      denoms
      1. counts
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          45
        6. group Id
          BG005
          value
          13
        7. group Id
          BG006
          value
          58
        units
        Participants
      title
      Phase II
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    6 patients from the Phase I: Melflufen 40 mg + Dexamethasone arm were transferred to Phase I + II: Melflufen 40 mg + Dexamethasone arm. All arms for the baseline analysis were not mutually exclusive (mutually exclusive patients = 75).
    title
    Age, Categorical
    unit Of Measure
    Participants
  2. calculate Pct
    false
    classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          3
        5. group Id
          BG006
          value
          11
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          3
        5. group Id
          BG006
          value
          12
        title
        Male
      denoms
      1. counts
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          6
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          23
        units
        Participants
      title
      Phase I
    2. categories
      1. measurements
        1. group Id
          BG004
          value
          15
        2. group Id
          BG005
          value
          5
        3. group Id
          BG006
          value
          20
        title
        Female
      2. measurements
        1. group Id
          BG004
          value
          30
        2. group Id
          BG005
          value
          8
        3. group Id
          BG006
          value
          38
        title
        Male
      denoms
      1. counts
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          45
        6. group Id
          BG005
          value
          13
        7. group Id
          BG006
          value
          58
        units
        Participants
      title
      Phase II
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    6 patients from the Phase I: Melflufen 40 mg + Dexamethasone arm were transferred to Phase I + II: Melflufen 40 mg + Dexamethasone arm. All arms for the baseline analysis were not mutually exclusive (mutually exclusive patients = 75).
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. calculate Pct
    false
    classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG006
          value
          2
        title
        Black or African American
      2. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          6
        5. group Id
          BG006
          value
          21
        title
        Caucasian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG006
          value
          0
        title
        Not collected as per local laws
      denoms
      1. counts
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          6
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          23
        units
        Participants
      title
      Phase I
    2. categories
      1. measurements
        1. group Id
          BG004
          value
          3
        2. group Id
          BG005
          value
          3
        3. group Id
          BG006
          value
          6
        title
        Black or African American
      2. measurements
        1. group Id
          BG004
          value
          41
        2. group Id
          BG005
          value
          10
        3. group Id
          BG006
          value
          51
        title
        Caucasian
      3. measurements
        1. group Id
          BG004
          value
          1
        2. group Id
          BG005
          value
          0
        3. group Id
          BG006
          value
          1
        title
        Not collected as per local laws
      denoms
      1. counts
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          45
        6. group Id
          BG005
          value
          13
        7. group Id
          BG006
          value
          58
        units
        Participants
      title
      Phase II
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    6 patients from the Phase I: Melflufen 40 mg + Dexamethasone arm were transferred to Phase I + II: Melflufen 40 mg + Dexamethasone arm. All arms for the baseline analysis were not mutually exclusive (mutually exclusive patients = 75).
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  4. calculate Pct
    false
    classes
    1. 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
          0
        5. group Id
          BG006
          value
          1
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          5
        4. group Id
          BG003
          value
          5
        5. group Id
          BG006
          value
          20
        title
        Not Hispanic or Latino
      3. 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
        5. group Id
          BG006
          value
          2
        title
        Not collected as per local laws
      denoms
      1. counts
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          6
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          23
        units
        Participants
      title
      Phase I
    2. categories
      1. measurements
        1. group Id
          BG004
          value
          1
        2. group Id
          BG005
          value
          0
        3. group Id
          BG006
          value
          1
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG004
          value
          37
        2. group Id
          BG005
          value
          12
        3. group Id
          BG006
          value
          49
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG004
          value
          7
        2. group Id
          BG005
          value
          1
        3. group Id
          BG006
          value
          8
        title
        Not collected as per local laws
      denoms
      1. counts
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          45
        6. group Id
          BG005
          value
          13
        7. group Id
          BG006
          value
          58
        units
        Participants
      title
      Phase II
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    6 patients from the Phase I: Melflufen 40 mg + Dexamethasone arm were transferred to Phase I + II: Melflufen 40 mg + Dexamethasone arm. All arms for the baseline analysis were not mutually exclusive (mutually exclusive patients = 75).
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
population Description
The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      4
    2. group Id
      BG001
      value
      7
    3. group Id
      BG002
      value
      6
    4. group Id
      BG003
      value
      6
    5. group Id
      BG004
      value
      45
    6. group Id
      BG005
      value
      13
    7. group Id
      BG006
      value
      81
    units
    Participants
groups
  1. description
    Patients were treated with 15 mg melflufen as IV infusion on Day 1 and 40 mg dexamethasone oral tablet or IV infusion on Days 1, 8 and 15 of each 21-day treatment cycle. Patients could continue receiving treatment for up to 8 cycles or until they experienced unacceptable toxicity, disease progression, withdrew consent, and/or the study drug was discontinued at the discretion of the Investigator.
    id
    BG000
    title
    Phase I: Melflufen 15 mg + Dexamethasone
  2. description
    Patients were treated with 25 mg melflufen as IV infusion on Day 1 and 40 mg dexamethasone oral tablet or IV infusion on Days 1, 8 and 15 of each 21-day treatment cycle. Patients could continue receiving treatment for up to 8 cycles or until they experienced unacceptable toxicity, disease progression, withdrew consent, and/or the study drug was discontinued at the discretion of the Investigator.
    id
    BG001
    title
    Phase I: Melflufen 25 mg + Dexamethasone
  3. description
    Patients were treated with 40 mg melflufen as IV infusion on Day 1 and 40 mg dexamethasone oral tablet or IV infusion on Days 1, 8 and 15 of each 21-day treatment cycle. Patients could continue receiving treatment for up to 8 cycles or until they experienced unacceptable toxicity, disease progression, withdrew consent, and/or the study drug was discontinued at the discretion of the Investigator.
    id
    BG002
    title
    Phase I: Melflufen 40 mg + Dexamethasone
  4. description
    Patients were treated with 55 mg melflufen as IV infusion on Day 1 and 40 mg dexamethasone oral tablet or IV infusion on Days 1, 8 and 15 of each 21-day treatment cycle. Patients could continue receiving treatment for up to 8 cycles or until they experienced unacceptable toxicity, disease progression, withdrew consent, and/or the study drug was discontinued at the discretion of the Investigator.
    id
    BG003
    title
    Phase I: Melflufen 55 mg + Dexamethasone
  5. description
    Patients were treated with 40 mg melflufen as IV infusion on Day 1 and 40 mg dexamethasone oral tablet or IV infusion on Days 1, 8 and 15 of each 21-day or 28-day treatment cycle. Patients could continue receiving treatment for up to 8 cycles or until they experienced unacceptable toxicity, disease progression, withdrew consent, and/or the study drug was discontinued at the discretion of the Investigator. In Protocol amendment 4, the cycle of melflufen was increased from 21 to 28 days. For any patients on the 28-day treatment schedule, an additional dose of 40 mg dexamethasone was administered on Day 22 of each cycle.
    id
    BG004
    title
    Phase I + II: Melflufen 40 mg + Dexamethasone
  6. description
    Patients were treated with 40 mg melflufen as IV infusion on Day 1 of each 28-day treatment cycle. Dexamethasone was not administered as an antitumor compound. However, all patients were treated with 8 mg dexamethasone as an antiemetic on Days 1 and 2, and an optional 4 mg dexamethasone as an antiemetic on Days 3 and 4 of the same 28-day cycle, unless the Investigator decided to switch a patient to a combination regimen. Patients could continue receiving treatment for up to 8 cycles or until they experienced unacceptable toxicity, disease progression, withdrew consent, and/or the study drug was discontinued at the discretion of the Investigator.
    id
    BG005
    title
    Phase II: Melflufen 40 mg (Single Agent)
  7. description
    Total of all reporting groups
    id
    BG006
    title
    Total
measures
  1. calculate Pct
    false
    classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG006
          value
          0
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          2
        5. group Id
          BG006
          value
          9
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          4
        5. group Id
          BG006
          value
          14
        title
        >=65 years
      denoms
      1. counts
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          6
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          23
        units
        Participants
      title
      Phase I
    2. categories
      1. measurements
        1. group Id
          BG004
          value
          0
        2. group Id
          BG005
          value
          0
        3. group Id
          BG006
          value
          0
        title
        <=18 years
      2. measurements
        1. group Id
          BG004
          value
          20
        2. group Id
          BG005
          value
          8
        3. group Id
          BG006
          value
          28
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG004
          value
          25
        2. group Id
          BG005
          value
          5
        3. group Id
          BG006
          value
          30
        title
        >=65 years
      denoms
      1. counts
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          45
        6. group Id
          BG005
          value
          13
        7. group Id
          BG006
          value
          58
        units
        Participants
      title
      Phase II
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    6 patients from the Phase I: Melflufen 40 mg + Dexamethasone arm were transferred to Phase I + II: Melflufen 40 mg + Dexamethasone arm. All arms for the baseline analysis were not mutually exclusive (mutually exclusive patients = 75).
    title
    Age, Categorical
    unit Of Measure
    Participants
  2. calculate Pct
    false
    classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          3
        5. group Id
          BG006
          value
          11
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          3
        5. group Id
          BG006
          value
          12
        title
        Male
      denoms
      1. counts
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          6
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          23
        units
        Participants
      title
      Phase I
    2. categories
      1. measurements
        1. group Id
          BG004
          value
          15
        2. group Id
          BG005
          value
          5
        3. group Id
          BG006
          value
          20
        title
        Female
      2. measurements
        1. group Id
          BG004
          value
          30
        2. group Id
          BG005
          value
          8
        3. group Id
          BG006
          value
          38
        title
        Male
      denoms
      1. counts
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          45
        6. group Id
          BG005
          value
          13
        7. group Id
          BG006
          value
          58
        units
        Participants
      title
      Phase II
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    6 patients from the Phase I: Melflufen 40 mg + Dexamethasone arm were transferred to Phase I + II: Melflufen 40 mg + Dexamethasone arm. All arms for the baseline analysis were not mutually exclusive (mutually exclusive patients = 75).
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. calculate Pct
    false
    classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG006
          value
          2
        title
        Black or African American
      2. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          6
        5. group Id
          BG006
          value
          21
        title
        Caucasian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG006
          value
          0
        title
        Not collected as per local laws
      denoms
      1. counts
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          6
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          23
        units
        Participants
      title
      Phase I
    2. categories
      1. measurements
        1. group Id
          BG004
          value
          3
        2. group Id
          BG005
          value
          3
        3. group Id
          BG006
          value
          6
        title
        Black or African American
      2. measurements
        1. group Id
          BG004
          value
          41
        2. group Id
          BG005
          value
          10
        3. group Id
          BG006
          value
          51
        title
        Caucasian
      3. measurements
        1. group Id
          BG004
          value
          1
        2. group Id
          BG005
          value
          0
        3. group Id
          BG006
          value
          1
        title
        Not collected as per local laws
      denoms
      1. counts
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          45
        6. group Id
          BG005
          value
          13
        7. group Id
          BG006
          value
          58
        units
        Participants
      title
      Phase II
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    6 patients from the Phase I: Melflufen 40 mg + Dexamethasone arm were transferred to Phase I + II: Melflufen 40 mg + Dexamethasone arm. All arms for the baseline analysis were not mutually exclusive (mutually exclusive patients = 75).
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  4. calculate Pct
    false
    classes
    1. 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
          0
        5. group Id
          BG006
          value
          1
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          5
        4. group Id
          BG003
          value
          5
        5. group Id
          BG006
          value
          20
        title
        Not Hispanic or Latino
      3. 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
        5. group Id
          BG006
          value
          2
        title
        Not collected as per local laws
      denoms
      1. counts
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          6
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          23
        units
        Participants
      title
      Phase I
    2. categories
      1. measurements
        1. group Id
          BG004
          value
          1
        2. group Id
          BG005
          value
          0
        3. group Id
          BG006
          value
          1
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG004
          value
          37
        2. group Id
          BG005
          value
          12
        3. group Id
          BG006
          value
          49
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG004
          value
          7
        2. group Id
          BG005
          value
          1
        3. group Id
          BG006
          value
          8
        title
        Not collected as per local laws
      denoms
      1. counts
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          45
        6. group Id
          BG005
          value
          13
        7. group Id
          BG006
          value
          58
        units
        Participants
      title
      Phase II
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    6 patients from the Phase I: Melflufen 40 mg + Dexamethasone arm were transferred to Phase I + II: Melflufen 40 mg + Dexamethasone arm. All arms for the baseline analysis were not mutually exclusive (mutually exclusive patients = 75).
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
population Description
The Safety Analysis Set included all patients who received at least 1 dose, or part thereof, of study drug.

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