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NCT01109004 · BASELINE

Baseline characteristics

Stem Cell Transplant With Lenalidomide Maintenance in Patients With Multiple Myeloma (BMT CTN 0702) · Source last updated 2021-12-09

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
      247
    2. group Id
      BG001
      value
      254
    3. group Id
      BG002
      value
      257
    4. group Id
      BG003
      value
      758
    units
    Participants
groups
  1. description
    Initial autologous transplant followed by a second autologous transplant and lenalidomide maintenance Lenalidomide: All patients will undergo a first autologous peripheral blood stem cell (PBSC) transplant with high-dose melphalan (200 mg/m\^2 IV) given on Day -2. Upon recovery from the first transplant patients will receive a second autologous PBSC transplant with the same conditioning regimen as the first transplant. All patients will also receive maintenance lenalidomide which will start after the second transplant. Maintenance therapy with lenalidomide will start at 10 mg daily for 3 months and increase to 15 mg daily. The duration of maintenance will be three years in all treatment arms.
    id
    BG000
    title
    Tandem Auto Transplant
  2. description
    Initial autologous transplant followed by lenalidomide, bortezomib and dexamethasone (RVD) consolidation and lenalidomide maintenance lenalidomide, bortezomib and dexamethasone: All patients will undergo a first autologous peripheral blood stem cell (PBSC) transplant with high-dose melphalan (200 mg/m\^2 IV) given on Day -2. Upon recovery from the first transplant patients will receive consolidation therapy with RVD (lenalidomide 15 mg/day on Days 1-14, dexamethasone 40mg on Days 1, 8 and 15, and bortezomib 1.3mg/m2 on Days 1, 4, 8 and 11 of every 21 day cycle, patients will receive four cycles). All patients will also receive maintenance lenalidomide which will start after consolidation therapy. Maintenance therapy with lenalidomide will start at 10 mg daily for 3 months and increase to 15 mg daily. The duration of maintenance will be three years in all treatment arms.
    id
    BG001
    title
    RVD Consolidation
  3. description
    Initial autologous transplant followed by lenalidomide maintenance Lenalidomide: All patients will undergo a first autologous peripheral blood stem cell (PBSC) transplant with high-dose melphalan (200 mg/m\^2 IV) given on Day -2. Upon recovery from the first transplant patients will receive maintenance with lenalidomide (15 mg daily). Maintenance lenalidomide will start after the first autologous transplant. Maintenance therapy with lenalidomide will start at 10 mg daily for 3 months and increase to 15 mg daily. The duration of maintenance will be three years in all treatment arms.
    id
    BG002
    title
    Lenalidomide Maintenance
  4. description
    Total of all reporting groups
    id
    BG003
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          28
          upper Limit
          70
          value
          56
        2. group Id
          BG001
          lower Limit
          20
          upper Limit
          70
          value
          57
        3. group Id
          BG002
          lower Limit
          30
          upper Limit
          70
          value
          56
        4. group Id
          BG003
          lower Limit
          20
          upper Limit
          70
          value
          56
    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
          100
        2. group Id
          BG001
          value
          108
        3. group Id
          BG002
          value
          96
        4. group Id
          BG003
          value
          304
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          147
        2. group Id
          BG001
          value
          146
        3. group Id
          BG002
          value
          161
        4. group Id
          BG003
          value
          454
        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
          178
        2. group Id
          BG001
          value
          192
        3. group Id
          BG002
          value
          201
        4. group Id
          BG003
          value
          571
        title
        Caucasian
      2. measurements
        1. group Id
          BG000
          value
          50
        2. group Id
          BG001
          value
          39
        3. group Id
          BG002
          value
          41
        4. group Id
          BG003
          value
          130
        title
        African American
      3. measurements
        1. group Id
          BG000
          value
          19
        2. group Id
          BG001
          value
          23
        3. group Id
          BG002
          value
          15
        4. group Id
          BG003
          value
          57
        title
        Multiple/Other/Unknown
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          182
        2. group Id
          BG001
          value
          169
        3. group Id
          BG002
          value
          172
        4. group Id
          BG003
          value
          523
        title
        90 or Greater
      2. measurements
        1. group Id
          BG000
          value
          65
        2. group Id
          BG001
          value
          85
        3. group Id
          BG002
          value
          85
        4. group Id
          BG003
          value
          235
        title
        Less Than 90
    description
    KPS describes patient-perceived global quality of life and functioning on a scale of 0-100. 100: No evidence of disease; 90: Normal activity. Minor signs or symptoms of disease; 80: Normal activity with effort. Some signs or symptoms of disease; 70: Cares for self. Unable to continue normal activity; 60: Needs occasional assistance, but cares for most personal needs; 50: Needs considerable assistance and medical care; 40: Disabled. Needs special care and assistance; 30: Severely disabled. Hospital admission indicated; 20: Very sick. Active supportive therapy needed; 10: Moribund; 0: Dead
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Karnofsky Performance Score (KPS)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          175
        2. group Id
          BG001
          value
          178
        3. group Id
          BG002
          value
          182
        4. group Id
          BG003
          value
          535
        title
        Standard
      2. measurements
        1. group Id
          BG000
          value
          72
        2. group Id
          BG001
          value
          76
        3. group Id
          BG002
          value
          75
        4. group Id
          BG003
          value
          223
        title
        High
    description
    Participants on this study will be stratified for the purposes of statistical analysis into high-risk and standard risk-groups. High-risk multiple myeloma is defined by the presence of high beta-2 microglobulin (\> 5.5mg/L) or the presence of cytogenetic abnormalities including t(4;14), t(14;20), t(14;16), deletion (17p) detected by FISH or standard cytogenetics, deletion 13 detected by standard cytogenetics only or aneuploidy. Participants without cytogenetic analysis available and beta-2 microglobulin ≤ 5.5mg/L or with deletion 13 detected by FISH will be classified as standard-risk disease.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Disease Risk
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          141
        2. group Id
          BG001
          value
          136
        3. group Id
          BG002
          value
          143
        4. group Id
          BG003
          value
          420
        title
        Bortezomib/Lenalidomide/Dexamethasone
      2. measurements
        1. group Id
          BG000
          value
          33
        2. group Id
          BG001
          value
          35
        3. group Id
          BG002
          value
          40
        4. group Id
          BG003
          value
          108
        title
        Bortezomib/Cyclophosphamide/Dexamethasone
      3. measurements
        1. group Id
          BG000
          value
          24
        2. group Id
          BG001
          value
          28
        3. group Id
          BG002
          value
          22
        4. group Id
          BG003
          value
          74
        title
        Lenalidomide/Dexamethasone
      4. measurements
        1. group Id
          BG000
          value
          29
        2. group Id
          BG001
          value
          32
        3. group Id
          BG002
          value
          32
        4. group Id
          BG003
          value
          93
        title
        Bortezomib/Dexamethasone
      5. measurements
        1. group Id
          BG000
          value
          19
        2. group Id
          BG001
          value
          19
        3. group Id
          BG002
          value
          20
        4. group Id
          BG003
          value
          58
        title
        Other
      6. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          5
        title
        Unknown
    description
    Initial therapy administered for the treatment of multiple myeloma
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Initial Therapy
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          2
          upper Limit
          14
          value
          5
        2. group Id
          BG001
          lower Limit
          2
          upper Limit
          12
          value
          5
        3. group Id
          BG002
          lower Limit
          2
          upper Limit
          12
          value
          5
        4. group Id
          BG003
          lower Limit
          2
          upper Limit
          14
          value
          5
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Time from Initial Therapy to Enrollment
    unit Of Measure
    months
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          210
        2. group Id
          BG001
          value
          213
        3. group Id
          BG002
          value
          218
        4. group Id
          BG003
          value
          641
        title
        1
      2. measurements
        1. group Id
          BG000
          value
          31
        2. group Id
          BG001
          value
          36
        3. group Id
          BG002
          value
          37
        4. group Id
          BG003
          value
          104
        title
        2
      3. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          8
        title
        3
      4. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          5
        title
        Unknown
    description
    Lines of therapy is defined as the number of different regimens received prior to study entry.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Number of Lines of Therapy
    unit Of Measure
    Participants
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          21
        2. group Id
          BG001
          value
          26
        3. group Id
          BG002
          value
          23
        4. group Id
          BG003
          value
          70
        title
        Stringent Complete Response
      2. measurements
        1. group Id
          BG000
          value
          22
        2. group Id
          BG001
          value
          19
        3. group Id
          BG002
          value
          24
        4. group Id
          BG003
          value
          65
        title
        Complete Response
      3. measurements
        1. group Id
          BG000
          value
          27
        2. group Id
          BG001
          value
          22
        3. group Id
          BG002
          value
          24
        4. group Id
          BG003
          value
          73
        title
        Near Complete Response
      4. measurements
        1. group Id
          BG000
          value
          52
        2. group Id
          BG001
          value
          53
        3. group Id
          BG002
          value
          43
        4. group Id
          BG003
          value
          148
        title
        Very Good Partial Response
      5. measurements
        1. group Id
          BG000
          value
          106
        2. group Id
          BG001
          value
          108
        3. group Id
          BG002
          value
          123
        4. group Id
          BG003
          value
          337
        title
        Partial Response
      6. measurements
        1. group Id
          BG000
          value
          14
        2. group Id
          BG001
          value
          21
        3. group Id
          BG002
          value
          14
        4. group Id
          BG003
          value
          49
        title
        Stable Disease
      7. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          9
        title
        Progression
      8. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          7
        title
        Not Evaluable
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Disease Status at Enrollment
    unit Of Measure
    Participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      247
    2. group Id
      BG001
      value
      254
    3. group Id
      BG002
      value
      257
    4. group Id
      BG003
      value
      758
    units
    Participants
groups
  1. description
    Initial autologous transplant followed by a second autologous transplant and lenalidomide maintenance Lenalidomide: All patients will undergo a first autologous peripheral blood stem cell (PBSC) transplant with high-dose melphalan (200 mg/m\^2 IV) given on Day -2. Upon recovery from the first transplant patients will receive a second autologous PBSC transplant with the same conditioning regimen as the first transplant. All patients will also receive maintenance lenalidomide which will start after the second transplant. Maintenance therapy with lenalidomide will start at 10 mg daily for 3 months and increase to 15 mg daily. The duration of maintenance will be three years in all treatment arms.
    id
    BG000
    title
    Tandem Auto Transplant
  2. description
    Initial autologous transplant followed by lenalidomide, bortezomib and dexamethasone (RVD) consolidation and lenalidomide maintenance lenalidomide, bortezomib and dexamethasone: All patients will undergo a first autologous peripheral blood stem cell (PBSC) transplant with high-dose melphalan (200 mg/m\^2 IV) given on Day -2. Upon recovery from the first transplant patients will receive consolidation therapy with RVD (lenalidomide 15 mg/day on Days 1-14, dexamethasone 40mg on Days 1, 8 and 15, and bortezomib 1.3mg/m2 on Days 1, 4, 8 and 11 of every 21 day cycle, patients will receive four cycles). All patients will also receive maintenance lenalidomide which will start after consolidation therapy. Maintenance therapy with lenalidomide will start at 10 mg daily for 3 months and increase to 15 mg daily. The duration of maintenance will be three years in all treatment arms.
    id
    BG001
    title
    RVD Consolidation
  3. description
    Initial autologous transplant followed by lenalidomide maintenance Lenalidomide: All patients will undergo a first autologous peripheral blood stem cell (PBSC) transplant with high-dose melphalan (200 mg/m\^2 IV) given on Day -2. Upon recovery from the first transplant patients will receive maintenance with lenalidomide (15 mg daily). Maintenance lenalidomide will start after the first autologous transplant. Maintenance therapy with lenalidomide will start at 10 mg daily for 3 months and increase to 15 mg daily. The duration of maintenance will be three years in all treatment arms.
    id
    BG002
    title
    Lenalidomide Maintenance
  4. description
    Total of all reporting groups
    id
    BG003
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          28
          upper Limit
          70
          value
          56
        2. group Id
          BG001
          lower Limit
          20
          upper Limit
          70
          value
          57
        3. group Id
          BG002
          lower Limit
          30
          upper Limit
          70
          value
          56
        4. group Id
          BG003
          lower Limit
          20
          upper Limit
          70
          value
          56
    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
          100
        2. group Id
          BG001
          value
          108
        3. group Id
          BG002
          value
          96
        4. group Id
          BG003
          value
          304
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          147
        2. group Id
          BG001
          value
          146
        3. group Id
          BG002
          value
          161
        4. group Id
          BG003
          value
          454
        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
          178
        2. group Id
          BG001
          value
          192
        3. group Id
          BG002
          value
          201
        4. group Id
          BG003
          value
          571
        title
        Caucasian
      2. measurements
        1. group Id
          BG000
          value
          50
        2. group Id
          BG001
          value
          39
        3. group Id
          BG002
          value
          41
        4. group Id
          BG003
          value
          130
        title
        African American
      3. measurements
        1. group Id
          BG000
          value
          19
        2. group Id
          BG001
          value
          23
        3. group Id
          BG002
          value
          15
        4. group Id
          BG003
          value
          57
        title
        Multiple/Other/Unknown
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          182
        2. group Id
          BG001
          value
          169
        3. group Id
          BG002
          value
          172
        4. group Id
          BG003
          value
          523
        title
        90 or Greater
      2. measurements
        1. group Id
          BG000
          value
          65
        2. group Id
          BG001
          value
          85
        3. group Id
          BG002
          value
          85
        4. group Id
          BG003
          value
          235
        title
        Less Than 90
    description
    KPS describes patient-perceived global quality of life and functioning on a scale of 0-100. 100: No evidence of disease; 90: Normal activity. Minor signs or symptoms of disease; 80: Normal activity with effort. Some signs or symptoms of disease; 70: Cares for self. Unable to continue normal activity; 60: Needs occasional assistance, but cares for most personal needs; 50: Needs considerable assistance and medical care; 40: Disabled. Needs special care and assistance; 30: Severely disabled. Hospital admission indicated; 20: Very sick. Active supportive therapy needed; 10: Moribund; 0: Dead
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Karnofsky Performance Score (KPS)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          175
        2. group Id
          BG001
          value
          178
        3. group Id
          BG002
          value
          182
        4. group Id
          BG003
          value
          535
        title
        Standard
      2. measurements
        1. group Id
          BG000
          value
          72
        2. group Id
          BG001
          value
          76
        3. group Id
          BG002
          value
          75
        4. group Id
          BG003
          value
          223
        title
        High
    description
    Participants on this study will be stratified for the purposes of statistical analysis into high-risk and standard risk-groups. High-risk multiple myeloma is defined by the presence of high beta-2 microglobulin (\> 5.5mg/L) or the presence of cytogenetic abnormalities including t(4;14), t(14;20), t(14;16), deletion (17p) detected by FISH or standard cytogenetics, deletion 13 detected by standard cytogenetics only or aneuploidy. Participants without cytogenetic analysis available and beta-2 microglobulin ≤ 5.5mg/L or with deletion 13 detected by FISH will be classified as standard-risk disease.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Disease Risk
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          141
        2. group Id
          BG001
          value
          136
        3. group Id
          BG002
          value
          143
        4. group Id
          BG003
          value
          420
        title
        Bortezomib/Lenalidomide/Dexamethasone
      2. measurements
        1. group Id
          BG000
          value
          33
        2. group Id
          BG001
          value
          35
        3. group Id
          BG002
          value
          40
        4. group Id
          BG003
          value
          108
        title
        Bortezomib/Cyclophosphamide/Dexamethasone
      3. measurements
        1. group Id
          BG000
          value
          24
        2. group Id
          BG001
          value
          28
        3. group Id
          BG002
          value
          22
        4. group Id
          BG003
          value
          74
        title
        Lenalidomide/Dexamethasone
      4. measurements
        1. group Id
          BG000
          value
          29
        2. group Id
          BG001
          value
          32
        3. group Id
          BG002
          value
          32
        4. group Id
          BG003
          value
          93
        title
        Bortezomib/Dexamethasone
      5. measurements
        1. group Id
          BG000
          value
          19
        2. group Id
          BG001
          value
          19
        3. group Id
          BG002
          value
          20
        4. group Id
          BG003
          value
          58
        title
        Other
      6. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          5
        title
        Unknown
    description
    Initial therapy administered for the treatment of multiple myeloma
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Initial Therapy
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          2
          upper Limit
          14
          value
          5
        2. group Id
          BG001
          lower Limit
          2
          upper Limit
          12
          value
          5
        3. group Id
          BG002
          lower Limit
          2
          upper Limit
          12
          value
          5
        4. group Id
          BG003
          lower Limit
          2
          upper Limit
          14
          value
          5
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Time from Initial Therapy to Enrollment
    unit Of Measure
    months
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          210
        2. group Id
          BG001
          value
          213
        3. group Id
          BG002
          value
          218
        4. group Id
          BG003
          value
          641
        title
        1
      2. measurements
        1. group Id
          BG000
          value
          31
        2. group Id
          BG001
          value
          36
        3. group Id
          BG002
          value
          37
        4. group Id
          BG003
          value
          104
        title
        2
      3. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          8
        title
        3
      4. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          5
        title
        Unknown
    description
    Lines of therapy is defined as the number of different regimens received prior to study entry.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Number of Lines of Therapy
    unit Of Measure
    Participants
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          21
        2. group Id
          BG001
          value
          26
        3. group Id
          BG002
          value
          23
        4. group Id
          BG003
          value
          70
        title
        Stringent Complete Response
      2. measurements
        1. group Id
          BG000
          value
          22
        2. group Id
          BG001
          value
          19
        3. group Id
          BG002
          value
          24
        4. group Id
          BG003
          value
          65
        title
        Complete Response
      3. measurements
        1. group Id
          BG000
          value
          27
        2. group Id
          BG001
          value
          22
        3. group Id
          BG002
          value
          24
        4. group Id
          BG003
          value
          73
        title
        Near Complete Response
      4. measurements
        1. group Id
          BG000
          value
          52
        2. group Id
          BG001
          value
          53
        3. group Id
          BG002
          value
          43
        4. group Id
          BG003
          value
          148
        title
        Very Good Partial Response
      5. measurements
        1. group Id
          BG000
          value
          106
        2. group Id
          BG001
          value
          108
        3. group Id
          BG002
          value
          123
        4. group Id
          BG003
          value
          337
        title
        Partial Response
      6. measurements
        1. group Id
          BG000
          value
          14
        2. group Id
          BG001
          value
          21
        3. group Id
          BG002
          value
          14
        4. group Id
          BG003
          value
          49
        title
        Stable Disease
      7. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          9
        title
        Progression
      8. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          7
        title
        Not Evaluable
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Disease Status at Enrollment
    unit Of Measure
    Participants

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Preserved source evidence · Not medical advice