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NCT01421186 · BASELINE

Baseline characteristics

A Phase 1/2a Study of Human Anti-CD 38 Antibody MOR03087 (MOR202) in Relapsed/Refractory Multiple Myeloma · Source last updated 2021-11-16

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
      31
    2. group Id
      BG001
      value
      4
    3. group Id
      BG002
      value
      18
    4. group Id
      BG003
      value
      21
    5. group Id
      BG004
      value
      17
    6. group Id
      BG005
      value
      91
    units
    Participants
groups
  1. description
    Treatment cycle 28 days, MOR03087 doses applied day 1 \& 15, initial 0.01 mg/kg, max 16 mg/kg
    id
    BG000
    title
    Part A: MOR03087 Biweekly Dose Escalation
  2. description
    Treatment cycle 28 days, MOR03087 doses applied day 1, 8, 15 \& 22 plus extra dose on day 4 of cycle 1, Initial MOR03087 dose 4 mg/kg, max 16 mg/kg
    id
    BG001
    title
    Part B: MOR03087 Weekly Dose Escalation
  3. description
    Treatment cycle 28 days, iv MOR03087 and oral dexamethasone (DEX) applied day 1, 8, 15 \& 22 plus extra dose on day 4 of cycle 1, initial MOR03087 dose 4 mg/kg, max 16 mg/kg. DEX dose 40 mg (≤ 75 years old) or 20 mg (\> 75 years old)
    id
    BG002
    title
    Part C: MOR03087 Plus Dexamethasone
  4. description
    Treatment cycle 28 days, iv MOR03087 and oral dexamethasone (DEX) applied day 1, 8, 15 \& 22 plus extra dose on day 4 of cycle 1, initial MOR03087 dose 8 mg/kg, max 16 mg/kg. DEX dose 40 mg (≤ 75 years old) or 20 mg (\> 75 years old). Pomalidomide was administered to patients orally 4 mg on days 1-21 of the 28-day cycle.
    id
    BG003
    title
    Part D: MOR03087 Plus Pomalidomide + Dexamethasone
  5. description
    Treatment cycle 28 days, iv MOR03087 and oral dexamethasone (DEX) applied day 1, 8, 15 \& 22 plus extra dose on day 4 of cycle 1, initial MOR03087 dose 8 mg/kg, max 16 mg/kg. DEX dose 40 mg (≤ 75 years old) or 20 mg (\> 75 years old). Lenalidomide was administered to patients orally 25 mg on days 1-21 of the 28-day cycle.
    id
    BG004
    title
    Part E: MOR03087 Plus Lenalidomide + Dexamethasone
  6. description
    Total of all reporting groups
    id
    BG005
    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
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          7
        4. group Id
          BG003
          value
          10
        5. group Id
          BG004
          value
          8
        6. group Id
          BG005
          value
          34
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          23
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          11
        4. group Id
          BG003
          value
          11
        5. group Id
          BG004
          value
          9
        6. group Id
          BG005
          value
          57
        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
          12
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          8
        4. group Id
          BG003
          value
          8
        5. group Id
          BG004
          value
          5
        6. group Id
          BG005
          value
          33
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          19
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          10
        4. group Id
          BG003
          value
          13
        5. group Id
          BG004
          value
          12
        6. group Id
          BG005
          value
          58
        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
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        title
        American Indian or Alaska Native
      2. 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
        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
        title
        Native Hawaiian or Other Pacific Islander
      4. 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
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          31
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          18
        4. group Id
          BG003
          value
          21
        5. group Id
          BG004
          value
          17
        6. group Id
          BG005
          value
          91
        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
        title
        More than one race
      7. 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
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (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
          3
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          4
      title
      Austria
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          31
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          15
        4. group Id
          BG003
          value
          20
        5. group Id
          BG004
          value
          17
        6. group Id
          BG005
          value
          87
      title
      Germany
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      31
    2. group Id
      BG001
      value
      4
    3. group Id
      BG002
      value
      18
    4. group Id
      BG003
      value
      21
    5. group Id
      BG004
      value
      17
    6. group Id
      BG005
      value
      91
    units
    Participants
groups
  1. description
    Treatment cycle 28 days, MOR03087 doses applied day 1 \& 15, initial 0.01 mg/kg, max 16 mg/kg
    id
    BG000
    title
    Part A: MOR03087 Biweekly Dose Escalation
  2. description
    Treatment cycle 28 days, MOR03087 doses applied day 1, 8, 15 \& 22 plus extra dose on day 4 of cycle 1, Initial MOR03087 dose 4 mg/kg, max 16 mg/kg
    id
    BG001
    title
    Part B: MOR03087 Weekly Dose Escalation
  3. description
    Treatment cycle 28 days, iv MOR03087 and oral dexamethasone (DEX) applied day 1, 8, 15 \& 22 plus extra dose on day 4 of cycle 1, initial MOR03087 dose 4 mg/kg, max 16 mg/kg. DEX dose 40 mg (≤ 75 years old) or 20 mg (\> 75 years old)
    id
    BG002
    title
    Part C: MOR03087 Plus Dexamethasone
  4. description
    Treatment cycle 28 days, iv MOR03087 and oral dexamethasone (DEX) applied day 1, 8, 15 \& 22 plus extra dose on day 4 of cycle 1, initial MOR03087 dose 8 mg/kg, max 16 mg/kg. DEX dose 40 mg (≤ 75 years old) or 20 mg (\> 75 years old). Pomalidomide was administered to patients orally 4 mg on days 1-21 of the 28-day cycle.
    id
    BG003
    title
    Part D: MOR03087 Plus Pomalidomide + Dexamethasone
  5. description
    Treatment cycle 28 days, iv MOR03087 and oral dexamethasone (DEX) applied day 1, 8, 15 \& 22 plus extra dose on day 4 of cycle 1, initial MOR03087 dose 8 mg/kg, max 16 mg/kg. DEX dose 40 mg (≤ 75 years old) or 20 mg (\> 75 years old). Lenalidomide was administered to patients orally 25 mg on days 1-21 of the 28-day cycle.
    id
    BG004
    title
    Part E: MOR03087 Plus Lenalidomide + Dexamethasone
  6. description
    Total of all reporting groups
    id
    BG005
    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
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          7
        4. group Id
          BG003
          value
          10
        5. group Id
          BG004
          value
          8
        6. group Id
          BG005
          value
          34
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          23
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          11
        4. group Id
          BG003
          value
          11
        5. group Id
          BG004
          value
          9
        6. group Id
          BG005
          value
          57
        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
          12
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          8
        4. group Id
          BG003
          value
          8
        5. group Id
          BG004
          value
          5
        6. group Id
          BG005
          value
          33
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          19
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          10
        4. group Id
          BG003
          value
          13
        5. group Id
          BG004
          value
          12
        6. group Id
          BG005
          value
          58
        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
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        title
        American Indian or Alaska Native
      2. 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
        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
        title
        Native Hawaiian or Other Pacific Islander
      4. 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
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          31
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          18
        4. group Id
          BG003
          value
          21
        5. group Id
          BG004
          value
          17
        6. group Id
          BG005
          value
          91
        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
        title
        More than one race
      7. 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
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (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
          3
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          4
      title
      Austria
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          31
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          15
        4. group Id
          BG003
          value
          20
        5. group Id
          BG004
          value
          17
        6. group Id
          BG005
          value
          87
      title
      Germany
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants

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

Preserved source evidence · Not medical advice