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NCT00450814 · BASELINE

Baseline characteristics

Vaccine Therapy With or Without Cyclophosphamide in Treating Patients With Recurrent or Refractory Multiple Myeloma · Source last updated 2019-12-16

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
      3
    2. group Id
      BG001
      value
      3
    3. group Id
      BG002
      value
      3
    4. group Id
      BG003
      value
      3
    5. group Id
      BG004
      value
      3
    6. group Id
      BG005
      value
      6
    7. group Id
      BG006
      value
      3
    8. group Id
      BG007
      value
      3
    9. group Id
      BG008
      value
      2
    10. group Id
      BG009
      value
      15
    11. group Id
      BG010
      value
      44
    units
    Participants
groups
  1. description
    Patients receive 1x10\^6 MV-NIS (TCID50) IV over 1 hour on day 1.
    id
    BG000
    title
    Phase I: Stage 1 (MV-NIS Alone) Dose Level 1
  2. description
    Patients receive 1x10\^7 MV-NIS (TCID50) IV over 1 hour on day 1.
    id
    BG001
    title
    Phase I: Stage 1 (MV-NIS Alone) Dose Level 2
  3. description
    Patients receive 1x10\^8 MV-NIS (TCID50) IV over 1 hour on day 1.
    id
    BG002
    title
    Phase I: Stage 1 (MV-NIS Alone) Dose Level 3
  4. description
    Patients receive 1x10\^9 MV-NIS (TCID50) IV over 1 hour on day 1.
    id
    BG003
    title
    Phase I: Stage 1 (MV-NIS Alone) Dose Level 4
  5. description
    Patients receive 1x10\^10 MV-NIS (TCID50) IV over 1 hour on day 1.
    id
    BG004
    title
    Phase I: Stage 1 (MV-NIS Alone) Dose Level 5
  6. description
    Patients receive 1x10\^11 MV-NIS (TCID50) IV over 1 hour on day 1.
    id
    BG005
    title
    Phase I: Stage 1 (MV-NIS Alone) Dose Level 6
  7. description
    Patients receive 10 mg/kg cyclophosphamide IV over 30 minutes and then (Stage 1 MTD/100=10\^7) MV-NIS (TCID50) IV over 1 hour 2 days later. (Temporarily closed to accrual on 10/13/11)
    id
    BG006
    title
    Phase I: Stage 2 (MV-NIS and Cyclophosphamide) Dose Level 1
  8. description
    Patients receive 10 mg/kg cyclophosphamide IV over 30 minutes and then 3 x 10\^7 MV-NIS (TCID50) IV over 1 hour 2 days later. (Temporarily closed to accrual on 10/13/11)
    id
    BG007
    title
    Phase I: Stage 2 (MV-NIS and Cyclophosphamide) Dose Level 2
  9. description
    Patients receive 10 mg/kg cyclophosphamide IV over 30 minutes and then 9 x 10\^7 MV-NIS (TCID50) IV over 1 hour 2 days later. (Temporarily closed to accrual on 10/13/11)
    id
    BG008
    title
    Phase I: Stage 2 (MV-NIS and Cyclophosphamide) Dose Level 3
  10. description
    Patients receive 650 mg Acetaminophen and 50 mg Benadryl orally 30 minutes prior to MV-NIS then receive MV-NIS IV over 1 hour on day 1.
    id
    BG009
    title
    Phase II (Acetaminophen + Benadryl + MV-NIS)
  11. description
    Total of all reporting groups
    id
    BG010
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          59
          upper Limit
          66
          value
          64
        2. group Id
          BG001
          lower Limit
          57
          upper Limit
          68
          value
          66
        3. group Id
          BG002
          lower Limit
          43
          upper Limit
          74
          value
          51
        4. group Id
          BG003
          lower Limit
          63
          upper Limit
          82
          value
          65
        5. group Id
          BG004
          lower Limit
          56
          upper Limit
          65
          value
          63
        6. group Id
          BG005
          lower Limit
          49
          upper Limit
          65
          value
          59
        7. group Id
          BG006
          lower Limit
          49
          upper Limit
          81
          value
          62
        8. group Id
          BG007
          lower Limit
          59
          upper Limit
          65
          value
          60
        9. group Id
          BG008
          lower Limit
          59
          upper Limit
          71
          value
          65
        10. group Id
          BG009
          lower Limit
          40
          upper Limit
          72
          value
          59
        11. group Id
          BG010
          lower Limit
          40
          upper Limit
          82
          value
          60
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          5
        7. group Id
          BG006
          value
          1
        8. group Id
          BG007
          value
          1
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          4
        11. group Id
          BG010
          value
          18
        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
          1
        5. group Id
          BG004
          value
          2
        6. group Id
          BG005
          value
          1
        7. group Id
          BG006
          value
          2
        8. group Id
          BG007
          value
          2
        9. group Id
          BG008
          value
          2
        10. group Id
          BG009
          value
          11
        11. group Id
          BG010
          value
          26
        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
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          0
        11. group Id
          BG010
          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
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          0
        11. group Id
          BG010
          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
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          0
        11. group Id
          BG010
          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
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          1
        11. group Id
          BG010
          value
          1
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          3
        6. group Id
          BG005
          value
          6
        7. group Id
          BG006
          value
          3
        8. group Id
          BG007
          value
          3
        9. group Id
          BG008
          value
          2
        10. group Id
          BG009
          value
          13
        11. group Id
          BG010
          value
          42
        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
        10. group Id
          BG009
          value
          0
        11. group Id
          BG010
          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
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          1
        11. group Id
          BG010
          value
          1
        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
          1
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          3
        6. group Id
          BG005
          value
          5
        7. group Id
          BG006
          value
          2
        8. group Id
          BG007
          value
          2
        9. group Id
          BG008
          value
          1
        10. group Id
          BG009
          value
          9
        11. group Id
          BG010
          value
          23
        title
        0
      2. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          1
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          1
        9. group Id
          BG008
          value
          1
        10. group Id
          BG009
          value
          5
        11. group Id
          BG010
          value
          15
        title
        1
      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
          0
        7. group Id
          BG006
          value
          1
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          1
        11. group Id
          BG010
          value
          6
        title
        2
    description
    Eastern Cooperative Oncology Group PS Scale: 0)Fully active, able to carry on all pre-disease performance without restriction; 1)Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work; 2)Ambulatory and capable of all selfcare but unable to carry out any work activities. Up and about more than 50% of waking hours; 3)Capable of only limited selfcare, confined to bed or chair more than 50% of waking hours; 4)Completely disabled. Cannot carry on any selfcare. Totally confined to bed or chair.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    ECOG Performance Status
    unit Of Measure
    Participants
population Description
Phase II Cohort A and Phase II Cohort B were combined for this analysis due to accrual terminating early in Cohort B.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      3
    2. group Id
      BG001
      value
      3
    3. group Id
      BG002
      value
      3
    4. group Id
      BG003
      value
      3
    5. group Id
      BG004
      value
      3
    6. group Id
      BG005
      value
      6
    7. group Id
      BG006
      value
      3
    8. group Id
      BG007
      value
      3
    9. group Id
      BG008
      value
      2
    10. group Id
      BG009
      value
      15
    11. group Id
      BG010
      value
      44
    units
    Participants
groups
  1. description
    Patients receive 1x10\^6 MV-NIS (TCID50) IV over 1 hour on day 1.
    id
    BG000
    title
    Phase I: Stage 1 (MV-NIS Alone) Dose Level 1
  2. description
    Patients receive 1x10\^7 MV-NIS (TCID50) IV over 1 hour on day 1.
    id
    BG001
    title
    Phase I: Stage 1 (MV-NIS Alone) Dose Level 2
  3. description
    Patients receive 1x10\^8 MV-NIS (TCID50) IV over 1 hour on day 1.
    id
    BG002
    title
    Phase I: Stage 1 (MV-NIS Alone) Dose Level 3
  4. description
    Patients receive 1x10\^9 MV-NIS (TCID50) IV over 1 hour on day 1.
    id
    BG003
    title
    Phase I: Stage 1 (MV-NIS Alone) Dose Level 4
  5. description
    Patients receive 1x10\^10 MV-NIS (TCID50) IV over 1 hour on day 1.
    id
    BG004
    title
    Phase I: Stage 1 (MV-NIS Alone) Dose Level 5
  6. description
    Patients receive 1x10\^11 MV-NIS (TCID50) IV over 1 hour on day 1.
    id
    BG005
    title
    Phase I: Stage 1 (MV-NIS Alone) Dose Level 6
  7. description
    Patients receive 10 mg/kg cyclophosphamide IV over 30 minutes and then (Stage 1 MTD/100=10\^7) MV-NIS (TCID50) IV over 1 hour 2 days later. (Temporarily closed to accrual on 10/13/11)
    id
    BG006
    title
    Phase I: Stage 2 (MV-NIS and Cyclophosphamide) Dose Level 1
  8. description
    Patients receive 10 mg/kg cyclophosphamide IV over 30 minutes and then 3 x 10\^7 MV-NIS (TCID50) IV over 1 hour 2 days later. (Temporarily closed to accrual on 10/13/11)
    id
    BG007
    title
    Phase I: Stage 2 (MV-NIS and Cyclophosphamide) Dose Level 2
  9. description
    Patients receive 10 mg/kg cyclophosphamide IV over 30 minutes and then 9 x 10\^7 MV-NIS (TCID50) IV over 1 hour 2 days later. (Temporarily closed to accrual on 10/13/11)
    id
    BG008
    title
    Phase I: Stage 2 (MV-NIS and Cyclophosphamide) Dose Level 3
  10. description
    Patients receive 650 mg Acetaminophen and 50 mg Benadryl orally 30 minutes prior to MV-NIS then receive MV-NIS IV over 1 hour on day 1.
    id
    BG009
    title
    Phase II (Acetaminophen + Benadryl + MV-NIS)
  11. description
    Total of all reporting groups
    id
    BG010
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          59
          upper Limit
          66
          value
          64
        2. group Id
          BG001
          lower Limit
          57
          upper Limit
          68
          value
          66
        3. group Id
          BG002
          lower Limit
          43
          upper Limit
          74
          value
          51
        4. group Id
          BG003
          lower Limit
          63
          upper Limit
          82
          value
          65
        5. group Id
          BG004
          lower Limit
          56
          upper Limit
          65
          value
          63
        6. group Id
          BG005
          lower Limit
          49
          upper Limit
          65
          value
          59
        7. group Id
          BG006
          lower Limit
          49
          upper Limit
          81
          value
          62
        8. group Id
          BG007
          lower Limit
          59
          upper Limit
          65
          value
          60
        9. group Id
          BG008
          lower Limit
          59
          upper Limit
          71
          value
          65
        10. group Id
          BG009
          lower Limit
          40
          upper Limit
          72
          value
          59
        11. group Id
          BG010
          lower Limit
          40
          upper Limit
          82
          value
          60
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          5
        7. group Id
          BG006
          value
          1
        8. group Id
          BG007
          value
          1
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          4
        11. group Id
          BG010
          value
          18
        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
          1
        5. group Id
          BG004
          value
          2
        6. group Id
          BG005
          value
          1
        7. group Id
          BG006
          value
          2
        8. group Id
          BG007
          value
          2
        9. group Id
          BG008
          value
          2
        10. group Id
          BG009
          value
          11
        11. group Id
          BG010
          value
          26
        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
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          0
        11. group Id
          BG010
          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
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          0
        11. group Id
          BG010
          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
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          0
        11. group Id
          BG010
          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
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          1
        11. group Id
          BG010
          value
          1
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          3
        6. group Id
          BG005
          value
          6
        7. group Id
          BG006
          value
          3
        8. group Id
          BG007
          value
          3
        9. group Id
          BG008
          value
          2
        10. group Id
          BG009
          value
          13
        11. group Id
          BG010
          value
          42
        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
        10. group Id
          BG009
          value
          0
        11. group Id
          BG010
          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
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          1
        11. group Id
          BG010
          value
          1
        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
          1
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          3
        6. group Id
          BG005
          value
          5
        7. group Id
          BG006
          value
          2
        8. group Id
          BG007
          value
          2
        9. group Id
          BG008
          value
          1
        10. group Id
          BG009
          value
          9
        11. group Id
          BG010
          value
          23
        title
        0
      2. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          1
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          1
        9. group Id
          BG008
          value
          1
        10. group Id
          BG009
          value
          5
        11. group Id
          BG010
          value
          15
        title
        1
      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
          0
        7. group Id
          BG006
          value
          1
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          1
        11. group Id
          BG010
          value
          6
        title
        2
    description
    Eastern Cooperative Oncology Group PS Scale: 0)Fully active, able to carry on all pre-disease performance without restriction; 1)Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work; 2)Ambulatory and capable of all selfcare but unable to carry out any work activities. Up and about more than 50% of waking hours; 3)Capable of only limited selfcare, confined to bed or chair more than 50% of waking hours; 4)Completely disabled. Cannot carry on any selfcare. Totally confined to bed or chair.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    ECOG Performance Status
    unit Of Measure
    Participants
population Description
Phase II Cohort A and Phase II Cohort B were combined for this analysis due to accrual terminating early in Cohort B.

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