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NCT02322320 · BASELINE

Baseline characteristics

Continued, Long-Term Follow-Up and Lenalidomide Maintenance Therapy for Patients on BMT CTN 0702 Protocol (BMT CTN 07LT) · Source last updated 2020-05-11

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
      98
    2. group Id
      BG001
      value
      86
    3. group Id
      BG002
      value
      89
    4. group Id
      BG003
      value
      273
    units
    Participants
groups
  1. description
    Initial autologous transplant followed by a second autologous transplant and lenalidomide maintenance Lenalidomide: In BMT CTN 0702, maintenance therapy with lenalidomide started at 10 mg daily for three months and increased to 15 mg daily. The duration of maintenance was three years in all treatment arms. Lenalidomide will be administered initially at the patient's last documented dose prior to discontinuation of BMT CTN 0702 lenalidomide maintenance therapy. Cycle duration is 28 days. Patients will continue lenalidomide until disease progression, or discontinuation due to toxicity, death, or withdrawal from the study.
    id
    BG000
    title
    Tandem Auto Transplant
  2. description
    Initial autologous transplant followed by lenalidomide, bortezomib and dexamethasone (RVD) consolidation and lenalidomide maintenance Lenalidomide: In BMT CTN 0702, maintenance therapy with lenalidomide started at 10 mg daily for three months and increased to 15 mg daily. The duration of maintenance was three years in all treatment arms. Lenalidomide will be administered initially at the patient's last documented dose prior to discontinuation of BMT CTN 0702 lenalidomide maintenance therapy. Cycle duration is 28 days. Patients will continue lenalidomide until disease progression, or discontinuation due to toxicity, death, or withdrawal from the study.
    id
    BG001
    title
    RVD Consolidation
  3. description
    Initial autologous transplant followed by lenalidomide maintenance Lenalidomide: In BMT CTN 0702, maintenance therapy with lenalidomide started at 10 mg daily for three months and increased to 15 mg daily. The duration of maintenance was three years in all treatment arms. Lenalidomide will be administered initially at the patient's last documented dose prior to discontinuation of BMT CTN 0702 lenalidomide maintenance therapy. Cycle duration is 28 days. Patients will continue lenalidomide until disease progression, or discontinuation due to toxicity, death, or withdrawal from the study.
    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
          55
        2. group Id
          BG001
          lower Limit
          28
          upper Limit
          69
          value
          56
        3. group Id
          BG002
          lower Limit
          31
          upper Limit
          66
          value
          57
        4. group Id
          BG003
          lower Limit
          28
          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
          40
        2. group Id
          BG001
          value
          31
        3. group Id
          BG002
          value
          34
        4. group Id
          BG003
          value
          105
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          58
        2. group Id
          BG001
          value
          55
        3. group Id
          BG002
          value
          55
        4. group Id
          BG003
          value
          168
        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
          11
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          18
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          81
        2. group Id
          BG001
          value
          77
        3. group Id
          BG002
          value
          84
        4. group Id
          BG003
          value
          242
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          13
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          11
      title
      Asian
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          22
        2. group Id
          BG001
          value
          10
        3. group Id
          BG002
          value
          16
        4. group Id
          BG003
          value
          48
      title
      Black or African American
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          68
        2. group Id
          BG001
          value
          69
        3. group Id
          BG002
          value
          68
        4. group Id
          BG003
          value
          205
      title
      White
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          3
      title
      Multiracial
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
      title
      Other
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          5
      title
      Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          78
        2. group Id
          BG001
          value
          60
        3. group Id
          BG002
          value
          63
        4. group Id
          BG003
          value
          201
        title
        90-100
      2. measurements
        1. group Id
          BG000
          value
          20
        2. group Id
          BG001
          value
          26
        3. group Id
          BG002
          value
          26
        4. group Id
          BG003
          value
          72
        title
        70-80
    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
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          73
        2. group Id
          BG001
          value
          65
        3. group Id
          BG002
          value
          72
        4. group Id
          BG003
          value
          210
        title
        Standard
      2. measurements
        1. group Id
          BG000
          value
          25
        2. group Id
          BG001
          value
          21
        3. group Id
          BG002
          value
          17
        4. group Id
          BG003
          value
          63
        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
    Diseae Risk at BMT CTN 0702 Enrollment
    unit Of Measure
    Participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      98
    2. group Id
      BG001
      value
      86
    3. group Id
      BG002
      value
      89
    4. group Id
      BG003
      value
      273
    units
    Participants
groups
  1. description
    Initial autologous transplant followed by a second autologous transplant and lenalidomide maintenance Lenalidomide: In BMT CTN 0702, maintenance therapy with lenalidomide started at 10 mg daily for three months and increased to 15 mg daily. The duration of maintenance was three years in all treatment arms. Lenalidomide will be administered initially at the patient's last documented dose prior to discontinuation of BMT CTN 0702 lenalidomide maintenance therapy. Cycle duration is 28 days. Patients will continue lenalidomide until disease progression, or discontinuation due to toxicity, death, or withdrawal from the study.
    id
    BG000
    title
    Tandem Auto Transplant
  2. description
    Initial autologous transplant followed by lenalidomide, bortezomib and dexamethasone (RVD) consolidation and lenalidomide maintenance Lenalidomide: In BMT CTN 0702, maintenance therapy with lenalidomide started at 10 mg daily for three months and increased to 15 mg daily. The duration of maintenance was three years in all treatment arms. Lenalidomide will be administered initially at the patient's last documented dose prior to discontinuation of BMT CTN 0702 lenalidomide maintenance therapy. Cycle duration is 28 days. Patients will continue lenalidomide until disease progression, or discontinuation due to toxicity, death, or withdrawal from the study.
    id
    BG001
    title
    RVD Consolidation
  3. description
    Initial autologous transplant followed by lenalidomide maintenance Lenalidomide: In BMT CTN 0702, maintenance therapy with lenalidomide started at 10 mg daily for three months and increased to 15 mg daily. The duration of maintenance was three years in all treatment arms. Lenalidomide will be administered initially at the patient's last documented dose prior to discontinuation of BMT CTN 0702 lenalidomide maintenance therapy. Cycle duration is 28 days. Patients will continue lenalidomide until disease progression, or discontinuation due to toxicity, death, or withdrawal from the study.
    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
          55
        2. group Id
          BG001
          lower Limit
          28
          upper Limit
          69
          value
          56
        3. group Id
          BG002
          lower Limit
          31
          upper Limit
          66
          value
          57
        4. group Id
          BG003
          lower Limit
          28
          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
          40
        2. group Id
          BG001
          value
          31
        3. group Id
          BG002
          value
          34
        4. group Id
          BG003
          value
          105
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          58
        2. group Id
          BG001
          value
          55
        3. group Id
          BG002
          value
          55
        4. group Id
          BG003
          value
          168
        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
          11
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          18
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          81
        2. group Id
          BG001
          value
          77
        3. group Id
          BG002
          value
          84
        4. group Id
          BG003
          value
          242
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          13
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          11
      title
      Asian
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          22
        2. group Id
          BG001
          value
          10
        3. group Id
          BG002
          value
          16
        4. group Id
          BG003
          value
          48
      title
      Black or African American
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          68
        2. group Id
          BG001
          value
          69
        3. group Id
          BG002
          value
          68
        4. group Id
          BG003
          value
          205
      title
      White
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          3
      title
      Multiracial
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
      title
      Other
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          5
      title
      Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          78
        2. group Id
          BG001
          value
          60
        3. group Id
          BG002
          value
          63
        4. group Id
          BG003
          value
          201
        title
        90-100
      2. measurements
        1. group Id
          BG000
          value
          20
        2. group Id
          BG001
          value
          26
        3. group Id
          BG002
          value
          26
        4. group Id
          BG003
          value
          72
        title
        70-80
    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
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          73
        2. group Id
          BG001
          value
          65
        3. group Id
          BG002
          value
          72
        4. group Id
          BG003
          value
          210
        title
        Standard
      2. measurements
        1. group Id
          BG000
          value
          25
        2. group Id
          BG001
          value
          21
        3. group Id
          BG002
          value
          17
        4. group Id
          BG003
          value
          63
        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
    Diseae Risk at BMT CTN 0702 Enrollment
    unit Of Measure
    Participants

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Preserved source evidence · Not medical advice