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NCT02990338 · BASELINE

Baseline characteristics

Multinational Clinical Study Comparing Isatuximab, Pomalidomide, and Dexamethasone to Pomalidomide and Dexamethasone in Refractory or Relapsed and Refractory Multiple Myeloma Patients · Source last updated 2025-01-17

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
      153
    2. group Id
      BG001
      value
      154
    3. group Id
      BG002
      value
      307
    units
    Participants
groups
  1. description
    Participants received pomalidomide 4 mg PO on Days 1 to 21 of each 28-day treatment cycle plus dexamethasone 40 mg (participants \>= 75 years of age received 20 mg dexamethasone) PO on Days 1, 8, 15 and 22 of each 28-day treatment cycle until disease progression or unacceptable toxicity or participant's wish to discontinue study treatment, or any other reason, whichever comes first (maximum exposure: 306.6 weeks).
    id
    BG000
    title
    Pd (Pomalidomide + Dexamethasone)
  2. description
    Participants received isatuximab 10 mg/kg IV infusion on Days 1, 8, 15, and 22 at Cycle 1, and then on Days 1 and 15 of subsequent cycles plus pomalidomide 4 mg PO on Days 1 to 21 of each 28-day treatment cycle and dexamethasone 40 mg (participants \>= 75 years of age received 20 mg dexamethasone), PO or IV on Day 1, 8, 15, 22 of each 28-day treatment cycle until disease progression or unacceptable toxicity or participant's wish to discontinue study treatment, or any other reason, whichever comes first (maximum exposure: 311.0 weeks).
    id
    BG001
    title
    IPd (Isatuximab + Pomalidomide + Dexamethasone)
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          9.5
          value
          65.2
        2. group Id
          BG001
          spread
          9.1
          value
          66.6
        3. group Id
          BG002
          spread
          9.3
          value
          65.9
    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
          83
        2. group Id
          BG001
          value
          65
        3. group Id
          BG002
          value
          148
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          70
        2. group Id
          BG001
          value
          89
        3. group Id
          BG002
          value
          159
        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
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          15
        2. group Id
          BG001
          value
          21
        3. group Id
          BG002
          value
          36
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          3
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          4
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          126
        2. group Id
          BG001
          value
          118
        3. group Id
          BG002
          value
          244
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          12
        3. group Id
          BG002
          value
          20
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
population Description
Analysis was performed on randomized population which included all participants with a signed informed consent and have been allocated a randomization number by the IRT, regardless of whether the participants was treated or not.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      153
    2. group Id
      BG001
      value
      154
    3. group Id
      BG002
      value
      307
    units
    Participants
groups
  1. description
    Participants received pomalidomide 4 mg PO on Days 1 to 21 of each 28-day treatment cycle plus dexamethasone 40 mg (participants \>= 75 years of age received 20 mg dexamethasone) PO on Days 1, 8, 15 and 22 of each 28-day treatment cycle until disease progression or unacceptable toxicity or participant's wish to discontinue study treatment, or any other reason, whichever comes first (maximum exposure: 306.6 weeks).
    id
    BG000
    title
    Pd (Pomalidomide + Dexamethasone)
  2. description
    Participants received isatuximab 10 mg/kg IV infusion on Days 1, 8, 15, and 22 at Cycle 1, and then on Days 1 and 15 of subsequent cycles plus pomalidomide 4 mg PO on Days 1 to 21 of each 28-day treatment cycle and dexamethasone 40 mg (participants \>= 75 years of age received 20 mg dexamethasone), PO or IV on Day 1, 8, 15, 22 of each 28-day treatment cycle until disease progression or unacceptable toxicity or participant's wish to discontinue study treatment, or any other reason, whichever comes first (maximum exposure: 311.0 weeks).
    id
    BG001
    title
    IPd (Isatuximab + Pomalidomide + Dexamethasone)
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          9.5
          value
          65.2
        2. group Id
          BG001
          spread
          9.1
          value
          66.6
        3. group Id
          BG002
          spread
          9.3
          value
          65.9
    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
          83
        2. group Id
          BG001
          value
          65
        3. group Id
          BG002
          value
          148
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          70
        2. group Id
          BG001
          value
          89
        3. group Id
          BG002
          value
          159
        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
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          15
        2. group Id
          BG001
          value
          21
        3. group Id
          BG002
          value
          36
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          3
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          4
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          126
        2. group Id
          BG001
          value
          118
        3. group Id
          BG002
          value
          244
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          12
        3. group Id
          BG002
          value
          20
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
population Description
Analysis was performed on randomized population which included all participants with a signed informed consent and have been allocated a randomization number by the IRT, regardless of whether the participants was treated or not.

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice