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NCT00075829 · BASELINE

Baseline characteristics

Stem Cell Transplantation in Individuals With Multiple Myeloma (BMT CTN 0102) · Source last updated 2021-11-01

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
      436
    2. group Id
      BG001
      value
      189
    3. group Id
      BG002
      value
      48
    4. group Id
      BG003
      value
      37
    5. group Id
      BG004
      value
      710
    units
    Participants
groups
  1. description
    Tandem autologous transplant plus thalidomide/dexamethasone (Thal-Dex) or observation (Obs) for standard risk patients PFS and OS did not differ between the Thal-Dex and the Obs arms and were thus pooled for analysis.
    id
    BG000
    title
    Auto-Auto Standard Risk
  2. description
    Autologous transplant plus non-myeloablative allogeneic transplant for standard risk patients
    id
    BG001
    title
    Auto-Allo Standard Risk
  3. description
    Tandem autologous transplant plus thalidomide/dexamethasone (Thal-Dex) or observation (Obs) for high risk patients PFS and OS did not differ between the Thal-Dex and the Obs arms and were thus pooled for analysis.
    id
    BG002
    title
    Auto-Auto High Risk
  4. description
    Autologous transplant plus non-myeloablative allogeneic transplant for high risk patients
    id
    BG003
    title
    Auto-Allo High Risk
  5. description
    Total of all reporting groups
    id
    BG004
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          22
          upper Limit
          70
          value
          55
        2. group Id
          BG001
          lower Limit
          29
          upper Limit
          68
          value
          53
        3. group Id
          BG002
          lower Limit
          32
          upper Limit
          70
          value
          57
        4. group Id
          BG003
          lower Limit
          32
          upper Limit
          66
          value
          51
        5. group Id
          BG004
          lower Limit
          22
          upper Limit
          68
          value
          53.2
    dispersion Type
    INTER_QUARTILE_RANGE
    param Type
    MEDIAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          176
        2. group Id
          BG001
          value
          78
        3. group Id
          BG002
          value
          21
        4. group Id
          BG003
          value
          16
        5. group Id
          BG004
          value
          291
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          260
        2. group Id
          BG001
          value
          111
        3. group Id
          BG002
          value
          27
        4. group Id
          BG003
          value
          21
        5. group Id
          BG004
          value
          419
        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
          77
        2. group Id
          BG001
          value
          18
        3. group Id
          BG002
          value
          8
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          106
      title
      African American
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          335
        2. group Id
          BG001
          value
          161
        3. group Id
          BG002
          value
          38
        4. group Id
          BG003
          value
          33
        5. group Id
          BG004
          value
          567
      title
      Caucasian
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          24
        2. group Id
          BG001
          value
          10
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          37
      title
      Other
    param Type
    NUMBER
    title
    Race/Ethnicity, Customized
    unit Of Measure
    participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          344
        2. group Id
          BG001
          value
          148
        3. group Id
          BG002
          value
          27
        4. group Id
          BG003
          value
          26
        5. group Id
          BG004
          value
          545
      title
      100 - 90
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          92
        2. group Id
          BG001
          value
          41
        3. group Id
          BG002
          value
          21
        4. group Id
          BG003
          value
          11
        5. group Id
          BG004
          value
          165
      title
      < 90
    description
    Assesses patient self-perceived global quality of life and functioning (excellent, very good, good, fair, poor), where 100 equals perfect quality of life.
    param Type
    NUMBER
    title
    Karnofsky Performance score
    unit Of Measure
    participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          0.004
          upper Limit
          4.0
          value
          2.0
        2. group Id
          BG001
          lower Limit
          0.9
          upper Limit
          4.0
          value
          2.0
        3. group Id
          BG002
          lower Limit
          0.9
          upper Limit
          9.8
          value
          4.4
        4. group Id
          BG003
          lower Limit
          1.2
          upper Limit
          6.6
          value
          3.7
        5. group Id
          BG004
          lower Limit
          0.004
          upper Limit
          9.8
          value
          3.025
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    β-2 Microglobulin
    unit Of Measure
    mg/L
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          142
        2. group Id
          BG001
          value
          59
        3. group Id
          BG002
          value
          10
        4. group Id
          BG003
          value
          9
        5. group Id
          BG004
          value
          220
      title
      Stages I-II
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          294
        2. group Id
          BG001
          value
          130
        3. group Id
          BG002
          value
          38
        4. group Id
          BG003
          value
          28
        5. group Id
          BG004
          value
          490
      title
      Stage III
    description
    The Durie and Salmon classification uses three multiple myeloma stages. Stage I has all of the following: Hemoglobin greater than 10 g/dL, Serum calcium less than 12 mg/dL, Normal bone structure or solitary plasmacytoma on radiographs, and Low M component. Stage II does not fit either Stage I or Stage III. Stage III has one or more of the following: Hemoglobin less than 8.5 g/dL, Serum calcium greater than 12 mg/dL, Advanced lytic bone lesions, and/or Hyper M component.
    param Type
    NUMBER
    title
    Durie-Salmon
    unit Of Measure
    participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          3
          upper Limit
          55
          value
          7
        2. group Id
          BG001
          lower Limit
          4
          upper Limit
          35
          value
          7
        3. group Id
          BG002
          lower Limit
          5
          upper Limit
          22
          value
          7
        4. group Id
          BG003
          lower Limit
          3
          upper Limit
          38
          value
          7
        5. group Id
          BG004
          lower Limit
          3
          upper Limit
          55
          value
          7
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Interval from diagnosis to transplantation
    unit Of Measure
    months
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          41
        2. group Id
          BG001
          value
          24
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          69
      title
      CR
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          65
        2. group Id
          BG001
          value
          22
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          90
      title
      Near CR
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          79
        2. group Id
          BG001
          value
          32
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          7
        5. group Id
          BG004
          value
          119
      title
      Very Good PR
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          158
        2. group Id
          BG001
          value
          76
        3. group Id
          BG002
          value
          21
        4. group Id
          BG003
          value
          14
        5. group Id
          BG004
          value
          269
      title
      PR
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          31
        2. group Id
          BG001
          value
          17
        3. group Id
          BG002
          value
          10
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          61
      title
      MR
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          21
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          4
        5. group Id
          BG004
          value
          37
      title
      SD
    7. categories
      1. measurements
        1. group Id
          BG000
          value
          30
        2. group Id
          BG001
          value
          12
        3. group Id
          BG002
          value
          8
        4. group Id
          BG003
          value
          4
        5. group Id
          BG004
          value
          54
      title
      Not Evaluable
    8. categories
      1. measurements
        1. group Id
          BG000
          value
          11
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          11
      title
      Unknown
    description
    Disease status at time of first autologous transplantation represents the results from initial multiple myeloma therapy received prior to trial enrollment: Complete Response (CR), Partial Response (PR), Minimal Response (MR), Stable Disease (SD)
    param Type
    NUMBER
    title
    Disease status
    unit Of Measure
    participants
population Description
Analysis is based on intention-to-treat data. Primary analysis of the clinical trial focused on patients meeting protocol criteria of standard risk multiple myeloma.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      436
    2. group Id
      BG001
      value
      189
    3. group Id
      BG002
      value
      48
    4. group Id
      BG003
      value
      37
    5. group Id
      BG004
      value
      710
    units
    Participants
groups
  1. description
    Tandem autologous transplant plus thalidomide/dexamethasone (Thal-Dex) or observation (Obs) for standard risk patients PFS and OS did not differ between the Thal-Dex and the Obs arms and were thus pooled for analysis.
    id
    BG000
    title
    Auto-Auto Standard Risk
  2. description
    Autologous transplant plus non-myeloablative allogeneic transplant for standard risk patients
    id
    BG001
    title
    Auto-Allo Standard Risk
  3. description
    Tandem autologous transplant plus thalidomide/dexamethasone (Thal-Dex) or observation (Obs) for high risk patients PFS and OS did not differ between the Thal-Dex and the Obs arms and were thus pooled for analysis.
    id
    BG002
    title
    Auto-Auto High Risk
  4. description
    Autologous transplant plus non-myeloablative allogeneic transplant for high risk patients
    id
    BG003
    title
    Auto-Allo High Risk
  5. description
    Total of all reporting groups
    id
    BG004
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          22
          upper Limit
          70
          value
          55
        2. group Id
          BG001
          lower Limit
          29
          upper Limit
          68
          value
          53
        3. group Id
          BG002
          lower Limit
          32
          upper Limit
          70
          value
          57
        4. group Id
          BG003
          lower Limit
          32
          upper Limit
          66
          value
          51
        5. group Id
          BG004
          lower Limit
          22
          upper Limit
          68
          value
          53.2
    dispersion Type
    INTER_QUARTILE_RANGE
    param Type
    MEDIAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          176
        2. group Id
          BG001
          value
          78
        3. group Id
          BG002
          value
          21
        4. group Id
          BG003
          value
          16
        5. group Id
          BG004
          value
          291
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          260
        2. group Id
          BG001
          value
          111
        3. group Id
          BG002
          value
          27
        4. group Id
          BG003
          value
          21
        5. group Id
          BG004
          value
          419
        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
          77
        2. group Id
          BG001
          value
          18
        3. group Id
          BG002
          value
          8
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          106
      title
      African American
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          335
        2. group Id
          BG001
          value
          161
        3. group Id
          BG002
          value
          38
        4. group Id
          BG003
          value
          33
        5. group Id
          BG004
          value
          567
      title
      Caucasian
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          24
        2. group Id
          BG001
          value
          10
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          37
      title
      Other
    param Type
    NUMBER
    title
    Race/Ethnicity, Customized
    unit Of Measure
    participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          344
        2. group Id
          BG001
          value
          148
        3. group Id
          BG002
          value
          27
        4. group Id
          BG003
          value
          26
        5. group Id
          BG004
          value
          545
      title
      100 - 90
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          92
        2. group Id
          BG001
          value
          41
        3. group Id
          BG002
          value
          21
        4. group Id
          BG003
          value
          11
        5. group Id
          BG004
          value
          165
      title
      < 90
    description
    Assesses patient self-perceived global quality of life and functioning (excellent, very good, good, fair, poor), where 100 equals perfect quality of life.
    param Type
    NUMBER
    title
    Karnofsky Performance score
    unit Of Measure
    participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          0.004
          upper Limit
          4.0
          value
          2.0
        2. group Id
          BG001
          lower Limit
          0.9
          upper Limit
          4.0
          value
          2.0
        3. group Id
          BG002
          lower Limit
          0.9
          upper Limit
          9.8
          value
          4.4
        4. group Id
          BG003
          lower Limit
          1.2
          upper Limit
          6.6
          value
          3.7
        5. group Id
          BG004
          lower Limit
          0.004
          upper Limit
          9.8
          value
          3.025
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    β-2 Microglobulin
    unit Of Measure
    mg/L
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          142
        2. group Id
          BG001
          value
          59
        3. group Id
          BG002
          value
          10
        4. group Id
          BG003
          value
          9
        5. group Id
          BG004
          value
          220
      title
      Stages I-II
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          294
        2. group Id
          BG001
          value
          130
        3. group Id
          BG002
          value
          38
        4. group Id
          BG003
          value
          28
        5. group Id
          BG004
          value
          490
      title
      Stage III
    description
    The Durie and Salmon classification uses three multiple myeloma stages. Stage I has all of the following: Hemoglobin greater than 10 g/dL, Serum calcium less than 12 mg/dL, Normal bone structure or solitary plasmacytoma on radiographs, and Low M component. Stage II does not fit either Stage I or Stage III. Stage III has one or more of the following: Hemoglobin less than 8.5 g/dL, Serum calcium greater than 12 mg/dL, Advanced lytic bone lesions, and/or Hyper M component.
    param Type
    NUMBER
    title
    Durie-Salmon
    unit Of Measure
    participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          3
          upper Limit
          55
          value
          7
        2. group Id
          BG001
          lower Limit
          4
          upper Limit
          35
          value
          7
        3. group Id
          BG002
          lower Limit
          5
          upper Limit
          22
          value
          7
        4. group Id
          BG003
          lower Limit
          3
          upper Limit
          38
          value
          7
        5. group Id
          BG004
          lower Limit
          3
          upper Limit
          55
          value
          7
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Interval from diagnosis to transplantation
    unit Of Measure
    months
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          41
        2. group Id
          BG001
          value
          24
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          69
      title
      CR
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          65
        2. group Id
          BG001
          value
          22
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          90
      title
      Near CR
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          79
        2. group Id
          BG001
          value
          32
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          7
        5. group Id
          BG004
          value
          119
      title
      Very Good PR
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          158
        2. group Id
          BG001
          value
          76
        3. group Id
          BG002
          value
          21
        4. group Id
          BG003
          value
          14
        5. group Id
          BG004
          value
          269
      title
      PR
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          31
        2. group Id
          BG001
          value
          17
        3. group Id
          BG002
          value
          10
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          61
      title
      MR
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          21
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          4
        5. group Id
          BG004
          value
          37
      title
      SD
    7. categories
      1. measurements
        1. group Id
          BG000
          value
          30
        2. group Id
          BG001
          value
          12
        3. group Id
          BG002
          value
          8
        4. group Id
          BG003
          value
          4
        5. group Id
          BG004
          value
          54
      title
      Not Evaluable
    8. categories
      1. measurements
        1. group Id
          BG000
          value
          11
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          11
      title
      Unknown
    description
    Disease status at time of first autologous transplantation represents the results from initial multiple myeloma therapy received prior to trial enrollment: Complete Response (CR), Partial Response (PR), Minimal Response (MR), Stable Disease (SD)
    param Type
    NUMBER
    title
    Disease status
    unit Of Measure
    participants
population Description
Analysis is based on intention-to-treat data. Primary analysis of the clinical trial focused on patients meeting protocol criteria of standard risk multiple myeloma.

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