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NCT05121103 · BASELINE

Baseline characteristics

A Study of the Safety, Tolerability and Effectiveness of EZM0414 (IPN60210) Investigative Product in Participants With Relapsed/Refractory Multiple Myeloma and Relapsed/Refractory Diffuse Large B Cell Lymphoma · Source last updated 2025-06-22

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
      3
    3. group Id
      BG002
      value
      6
    4. group Id
      BG003
      value
      13
    units
    Participants
groups
  1. description
    Participants with t(4;14) R/R MM or non-t(4;14) R/R MM or R/R DLBCL received EZM0414 100 mg tablet orally QD in continuous 28-day cycles (except on Days 2 and 3 of Cycle 1) until consent withdrawal, unacceptable toxicity, disease progression or need for treatment prohibited on this study.
    id
    BG000
    title
    Part 1: EZM0414 100 mg
  2. description
    Participants with t(4;14) R/R MM or non-t(4;14) R/R MM or R/R DLBCL received EZM0414 200 mg tablet orally QD in continuous 28-day cycles (except on Days 2 and 3 of Cycle 1) until consent withdrawal, unacceptable toxicity, disease progression or need for treatment prohibited on this study.
    id
    BG001
    title
    Part 1: EZM0414 200 mg
  3. description
    Participants with t(4;14) R/R MM or non-t(4;14) R/R MM or R/R DLBCL received EZM0414 300 mg tablet orally QD in continuous 28-day cycles (except on Days 2 and 3 of Cycle 1) until consent withdrawal, unacceptable toxicity, disease progression or need for treatment prohibited on this study.
    id
    BG002
    title
    Part 1: EZM0414 300 mg
  4. description
    Total of all reporting groups
    id
    BG003
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          7.42
          value
          61.5
        2. group Id
          BG001
          spread
          6.66
          value
          70.3
        3. group Id
          BG002
          spread
          13.11
          value
          68.0
        4. group Id
          BG003
          spread
          10.29
          value
          66.5
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. calculate Pct
    false
    classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          8
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          5
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. 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
          1
        4. group Id
          BG003
          value
          2
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          5
        4. group Id
          BG003
          value
          10
        title
        Not Hispanic or Latino
      3. 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
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  4. 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
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          3
        title
        Asian
      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
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          2
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          6
        title
        White
      6. 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
        title
        More than one race
      7. 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
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
population Description
The safety population included all participants who received at least 1 dose of the study treatment in Part 1.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      4
    2. group Id
      BG001
      value
      3
    3. group Id
      BG002
      value
      6
    4. group Id
      BG003
      value
      13
    units
    Participants
groups
  1. description
    Participants with t(4;14) R/R MM or non-t(4;14) R/R MM or R/R DLBCL received EZM0414 100 mg tablet orally QD in continuous 28-day cycles (except on Days 2 and 3 of Cycle 1) until consent withdrawal, unacceptable toxicity, disease progression or need for treatment prohibited on this study.
    id
    BG000
    title
    Part 1: EZM0414 100 mg
  2. description
    Participants with t(4;14) R/R MM or non-t(4;14) R/R MM or R/R DLBCL received EZM0414 200 mg tablet orally QD in continuous 28-day cycles (except on Days 2 and 3 of Cycle 1) until consent withdrawal, unacceptable toxicity, disease progression or need for treatment prohibited on this study.
    id
    BG001
    title
    Part 1: EZM0414 200 mg
  3. description
    Participants with t(4;14) R/R MM or non-t(4;14) R/R MM or R/R DLBCL received EZM0414 300 mg tablet orally QD in continuous 28-day cycles (except on Days 2 and 3 of Cycle 1) until consent withdrawal, unacceptable toxicity, disease progression or need for treatment prohibited on this study.
    id
    BG002
    title
    Part 1: EZM0414 300 mg
  4. description
    Total of all reporting groups
    id
    BG003
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          7.42
          value
          61.5
        2. group Id
          BG001
          spread
          6.66
          value
          70.3
        3. group Id
          BG002
          spread
          13.11
          value
          68.0
        4. group Id
          BG003
          spread
          10.29
          value
          66.5
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. calculate Pct
    false
    classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          8
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          5
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. 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
          1
        4. group Id
          BG003
          value
          2
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          5
        4. group Id
          BG003
          value
          10
        title
        Not Hispanic or Latino
      3. 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
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  4. 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
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          3
        title
        Asian
      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
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          2
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          6
        title
        White
      6. 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
        title
        More than one race
      7. 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
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
population Description
The safety population included all participants who received at least 1 dose of the study treatment in Part 1.

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice