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NCT03430011 · BASELINE

Baseline characteristics

Study Evaluating the Safety and Efficacy of JCARH125 in Subjects With Relapsed and/or Refractory Multiple Myeloma · Source last updated 2024-05-24

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
      15
    2. group Id
      BG001
      value
      30
    3. group Id
      BG002
      value
      27
    4. group Id
      BG003
      value
      22
    5. group Id
      BG004
      value
      22
    6. group Id
      BG005
      value
      14
    7. group Id
      BG006
      value
      25
    8. group Id
      BG007
      value
      10
    9. group Id
      BG008
      value
      165
    units
    Participants
groups
  1. description
    JCARH125 IV at dose level 50 x 10\^6 consisting of CD3+CAR+T cells
    id
    BG000
    title
    Phase 1 50 x 10^6 Cells
  2. description
    JCARH125 IV at dose level 150 x 10\^6 consisting of CD3+CAR+T cells
    id
    BG001
    title
    Phase 1 150 x 10^6 Cells
  3. description
    JCARH125 IV at dose level 300 x 10\^6 consisting of CD3+CAR+T cells
    id
    BG002
    title
    Phase 1 300 x 10^6 Cells
  4. description
    JCARH125 IV at dose level 450 x 10\^6 consisting of CD3+CAR+T cells
    id
    BG003
    title
    Phase 1 450 x 10^6 Cells
  5. description
    JCARH125 IV at dose level 600 x 10\^6 consisting of CD3+CAR+T cells
    id
    BG004
    title
    Phase 1 600 x 10^6 Cells
  6. description
    2 doses of 100 mg anakinra administered subcutaneously (SC) for 5 consecutive days + JCARH125 IV at dose level 600 x 10\^6 consisting of CD3+CAR+T cells
    id
    BG005
    title
    Phase 1 Anakinra 600 x 10^6 Cells
  7. description
    JCARH125 IV at dose level 600 x 10\^6 consisting of CD3+CAR+T cells expansion
    id
    BG006
    title
    Phase 2 600 x 10^6 Cells
  8. description
    JCARH125 IV at dose level 600 x 10\^6 consisting of CD3+CAR+T cells in participants previously treated with BCMA-directed anti-myeloma therapy
    id
    BG007
    title
    Phase 2a 600 x 10^6 Cells Anti-BCMA
  9. description
    Total of all reporting groups
    id
    BG008
    title
    Total
measures
  1. 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
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          12
        2. group Id
          BG001
          value
          19
        3. group Id
          BG002
          value
          16
        4. group Id
          BG003
          value
          15
        5. group Id
          BG004
          value
          14
        6. group Id
          BG005
          value
          9
        7. group Id
          BG006
          value
          17
        8. group Id
          BG007
          value
          5
        9. group Id
          BG008
          value
          107
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          11
        3. group Id
          BG002
          value
          11
        4. group Id
          BG003
          value
          7
        5. group Id
          BG004
          value
          8
        6. group Id
          BG005
          value
          5
        7. group Id
          BG006
          value
          8
        8. group Id
          BG007
          value
          5
        9. group Id
          BG008
          value
          58
        title
        >=65 years
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Categorical
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          13
        3. group Id
          BG002
          value
          10
        4. group Id
          BG003
          value
          9
        5. group Id
          BG004
          value
          10
        6. group Id
          BG005
          value
          7
        7. group Id
          BG006
          value
          8
        8. group Id
          BG007
          value
          6
        9. group Id
          BG008
          value
          68
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          10
        2. group Id
          BG001
          value
          17
        3. group Id
          BG002
          value
          17
        4. group Id
          BG003
          value
          13
        5. group Id
          BG004
          value
          12
        6. group Id
          BG005
          value
          7
        7. group Id
          BG006
          value
          17
        8. group Id
          BG007
          value
          4
        9. group Id
          BG008
          value
          97
        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
          1
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          2
        6. group Id
          BG005
          value
          1
        7. group Id
          BG006
          value
          1
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          12
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          13
        2. group Id
          BG001
          value
          25
        3. group Id
          BG002
          value
          25
        4. group Id
          BG003
          value
          19
        5. group Id
          BG004
          value
          20
        6. group Id
          BG005
          value
          12
        7. group Id
          BG006
          value
          24
        8. group Id
          BG007
          value
          7
        9. group Id
          BG008
          value
          145
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          1
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          3
        9. group Id
          BG008
          value
          8
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  4. 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
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          1
        7. group Id
          BG006
          value
          1
        8. group Id
          BG007
          value
          2
        9. group Id
          BG008
          value
          8
        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
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          3
        6. group Id
          BG005
          value
          2
        7. group Id
          BG006
          value
          2
        8. group Id
          BG007
          value
          1
        9. group Id
          BG008
          value
          17
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          9
        2. group Id
          BG001
          value
          22
        3. group Id
          BG002
          value
          23
        4. group Id
          BG003
          value
          16
        5. group Id
          BG004
          value
          16
        6. group Id
          BG005
          value
          9
        7. group Id
          BG006
          value
          20
        8. group Id
          BG007
          value
          4
        9. group Id
          BG008
          value
          119
        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
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          3
        6. group Id
          BG005
          value
          2
        7. group Id
          BG006
          value
          2
        8. group Id
          BG007
          value
          3
        9. group Id
          BG008
          value
          21
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      15
    2. group Id
      BG001
      value
      30
    3. group Id
      BG002
      value
      27
    4. group Id
      BG003
      value
      22
    5. group Id
      BG004
      value
      22
    6. group Id
      BG005
      value
      14
    7. group Id
      BG006
      value
      25
    8. group Id
      BG007
      value
      10
    9. group Id
      BG008
      value
      165
    units
    Participants
groups
  1. description
    JCARH125 IV at dose level 50 x 10\^6 consisting of CD3+CAR+T cells
    id
    BG000
    title
    Phase 1 50 x 10^6 Cells
  2. description
    JCARH125 IV at dose level 150 x 10\^6 consisting of CD3+CAR+T cells
    id
    BG001
    title
    Phase 1 150 x 10^6 Cells
  3. description
    JCARH125 IV at dose level 300 x 10\^6 consisting of CD3+CAR+T cells
    id
    BG002
    title
    Phase 1 300 x 10^6 Cells
  4. description
    JCARH125 IV at dose level 450 x 10\^6 consisting of CD3+CAR+T cells
    id
    BG003
    title
    Phase 1 450 x 10^6 Cells
  5. description
    JCARH125 IV at dose level 600 x 10\^6 consisting of CD3+CAR+T cells
    id
    BG004
    title
    Phase 1 600 x 10^6 Cells
  6. description
    2 doses of 100 mg anakinra administered subcutaneously (SC) for 5 consecutive days + JCARH125 IV at dose level 600 x 10\^6 consisting of CD3+CAR+T cells
    id
    BG005
    title
    Phase 1 Anakinra 600 x 10^6 Cells
  7. description
    JCARH125 IV at dose level 600 x 10\^6 consisting of CD3+CAR+T cells expansion
    id
    BG006
    title
    Phase 2 600 x 10^6 Cells
  8. description
    JCARH125 IV at dose level 600 x 10\^6 consisting of CD3+CAR+T cells in participants previously treated with BCMA-directed anti-myeloma therapy
    id
    BG007
    title
    Phase 2a 600 x 10^6 Cells Anti-BCMA
  9. description
    Total of all reporting groups
    id
    BG008
    title
    Total
measures
  1. 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
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          12
        2. group Id
          BG001
          value
          19
        3. group Id
          BG002
          value
          16
        4. group Id
          BG003
          value
          15
        5. group Id
          BG004
          value
          14
        6. group Id
          BG005
          value
          9
        7. group Id
          BG006
          value
          17
        8. group Id
          BG007
          value
          5
        9. group Id
          BG008
          value
          107
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          11
        3. group Id
          BG002
          value
          11
        4. group Id
          BG003
          value
          7
        5. group Id
          BG004
          value
          8
        6. group Id
          BG005
          value
          5
        7. group Id
          BG006
          value
          8
        8. group Id
          BG007
          value
          5
        9. group Id
          BG008
          value
          58
        title
        >=65 years
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Categorical
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          13
        3. group Id
          BG002
          value
          10
        4. group Id
          BG003
          value
          9
        5. group Id
          BG004
          value
          10
        6. group Id
          BG005
          value
          7
        7. group Id
          BG006
          value
          8
        8. group Id
          BG007
          value
          6
        9. group Id
          BG008
          value
          68
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          10
        2. group Id
          BG001
          value
          17
        3. group Id
          BG002
          value
          17
        4. group Id
          BG003
          value
          13
        5. group Id
          BG004
          value
          12
        6. group Id
          BG005
          value
          7
        7. group Id
          BG006
          value
          17
        8. group Id
          BG007
          value
          4
        9. group Id
          BG008
          value
          97
        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
          1
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          2
        6. group Id
          BG005
          value
          1
        7. group Id
          BG006
          value
          1
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          12
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          13
        2. group Id
          BG001
          value
          25
        3. group Id
          BG002
          value
          25
        4. group Id
          BG003
          value
          19
        5. group Id
          BG004
          value
          20
        6. group Id
          BG005
          value
          12
        7. group Id
          BG006
          value
          24
        8. group Id
          BG007
          value
          7
        9. group Id
          BG008
          value
          145
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          1
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          3
        9. group Id
          BG008
          value
          8
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  4. 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
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          1
        7. group Id
          BG006
          value
          1
        8. group Id
          BG007
          value
          2
        9. group Id
          BG008
          value
          8
        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
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          3
        6. group Id
          BG005
          value
          2
        7. group Id
          BG006
          value
          2
        8. group Id
          BG007
          value
          1
        9. group Id
          BG008
          value
          17
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          9
        2. group Id
          BG001
          value
          22
        3. group Id
          BG002
          value
          23
        4. group Id
          BG003
          value
          16
        5. group Id
          BG004
          value
          16
        6. group Id
          BG005
          value
          9
        7. group Id
          BG006
          value
          20
        8. group Id
          BG007
          value
          4
        9. group Id
          BG008
          value
          119
        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
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          3
        6. group Id
          BG005
          value
          2
        7. group Id
          BG006
          value
          2
        8. group Id
          BG007
          value
          3
        9. group Id
          BG008
          value
          21
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants

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