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NCT01858558 · BASELINE

Baseline characteristics

Tadalafil and Lenalidomide Maintenance With or Without Activated Marrow Infiltrating Lymphocytes (MILs) in High Risk Myeloma · Source last updated 2020-06-29

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
      70
    2. group Id
      BG001
      value
      31
    3. group Id
      BG002
      value
      101
    units
    Participants
groups
  1. description
    Patients receive activated Marrow Infiltrating Lymphocytes (aMIL) aMIL: On day 0, patients will receive auto transplant followed by Tadalafil and aMIL. At day 60, patients will receive Lenalidomide.
    id
    BG000
    title
    aMIL Arm
  2. description
    Patients do not receive activated Marrow Infiltrating Lymphocytes (aMIL) No aMIL: On day 0, patients will receive auto transplant followed by Tadalafil. At day 60, patients will receive Lenalidomide.
    id
    BG001
    title
    No aMIL
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          35.0
          upper Limit
          74.8
          value
          62.5
        2. group Id
          BG001
          lower Limit
          37.1
          upper Limit
          75.9
          value
          59.0
        3. group Id
          BG002
          lower Limit
          35.0
          upper Limit
          75.9
          value
          61.7
    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
          36
        2. group Id
          BG001
          value
          15
        3. group Id
          BG002
          value
          51
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          34
        2. group Id
          BG001
          value
          16
        3. group Id
          BG002
          value
          50
        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
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
      title
      Asian
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          14
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          22
      title
      Black
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          3
      title
      Other
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          53
        2. group Id
          BG001
          value
          21
        3. group Id
          BG002
          value
          74
      title
      White
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          70
        2. group Id
          BG001
          value
          31
        3. group Id
          BG002
          value
          101
      title
      United States
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          60
        2. group Id
          BG001
          value
          26
        3. group Id
          BG002
          value
          86
        title
        Newly Diagnosed
      2. measurements
        1. group Id
          BG000
          value
          10
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          15
        title
        Relapsed
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Disease Status
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          12
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          16
        title
        High Risk
      2. measurements
        1. group Id
          BG000
          value
          25
        2. group Id
          BG001
          value
          15
        3. group Id
          BG002
          value
          40
        title
        Low Risk
      3. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          10
        title
        N/A
      4. measurements
        1. group Id
          BG000
          value
          25
        2. group Id
          BG001
          value
          10
        3. group Id
          BG002
          value
          35
        title
        Indeterminate
    description
    The Myeloma Prognostic Risk Signature (MyPRS®) (Signal Genetics™) is used to estimate the underlying activity of disease progression in patients diagnosed with active multiple myeloma.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Myeloma Prognostic Risk Signature (MYPRS) Risk Category
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          58
        2. group Id
          BG001
          value
          27
        3. group Id
          BG002
          value
          85
        title
        Not High Risk
      2. measurements
        1. group Id
          BG000
          value
          12
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          16
        title
        High Risk
    description
    The 70-gene Prognostic Risk Score (GEP-70) quantifies the expression of 70 genes commonly altered in multiple myeloma. Primarily prognostic, GEP-70 assesses risk of disease relapse and survival outcomes and is the randomization stratification of the MYPRS multiple myeloma specific gene expression profile risk categories.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    70-gene expression Prognostic Risk Score (GEP-70)
    unit Of Measure
    Participants
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          27
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          34
        title
        0
      2. measurements
        1. group Id
          BG000
          value
          34
        2. group Id
          BG001
          value
          21
        3. group Id
          BG002
          value
          55
        title
        1 or 2
      3. measurements
        1. group Id
          BG000
          value
          9
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          12
        title
        Missing
    description
    ECOG Scoring System 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 self care but unable to carry out any work activities. Up and about more than 50% of waking hours 3. Capable of only limited self care, confined to bed or chair more than 50% of waking hours 4. Completely disabled. Cannot carry on any self care. Totally confined to bed or chair 5. Dead
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Eastern Cooperative Oncology Group (ECOG) Performance Status
    unit Of Measure
    Participants
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          20
        2. group Id
          BG001
          value
          10
        3. group Id
          BG002
          value
          30
        title
        Stage I
      2. measurements
        1. group Id
          BG000
          value
          19
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          26
        title
        Stage II
      3. measurements
        1. group Id
          BG000
          value
          17
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          25
        title
        Stage III
      4. measurements
        1. group Id
          BG000
          value
          14
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          20
        title
        missing
    description
    Prognosticates the severity of multiple myeloma and patient survival based on routinely obtained lab values. Stage I= Serum β2 microglobulin \< 3.5 mg/l; serum albumin ≥ 3.5 g/dl; standard-risk chromosomal abnormalities (CA) and normal lactate dehydrogenase (LDH) Stage II= not stage I or Stage III Stage III= Serum β2 microglobulin ≥ 5.5 mg/L and either high-risk CA by florescent in situ hybridization (FISH) or high LDH
    param Type
    COUNT_OF_PARTICIPANTS
    title
    International Staging System (ISS) Multiple Myeloma Classification
    unit Of Measure
    Participants
  10. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          9
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          9
        title
        IA-IB
      2. measurements
        1. group Id
          BG000
          value
          14
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          21
        title
        IIA-IIB
      3. measurements
        1. group Id
          BG000
          value
          35
        2. group Id
          BG001
          value
          21
        3. group Id
          BG002
          value
          56
        title
        IIIA-IIIB
      4. measurements
        1. group Id
          BG000
          value
          12
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          15
        title
        missing
    description
    demonstrates the correlation between the amount of myeloma and the damage it has caused based on number of bone lesions, anemia, serum calcium levels, and serum and urine light chain levels, and can be measured as myeloma cell mass (myeloma cells in billions/m2)\* . Stage I= low cell mass (600 billion) Stage II= intermediate cell mass (600-1200 billion) Stage III= high cell mass (\>1200 billion) Subcategory: A = normal renal function. B= abnormal renal function
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Salmon Stage multiple myeloma classification
    unit Of Measure
    Participants
  11. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          1
          upper Limit
          6
          value
          1
        2. group Id
          BG001
          lower Limit
          1
          upper Limit
          5
          value
          2
        3. group Id
          BG002
          lower Limit
          1
          upper Limit
          6
          value
          1
    dispersion Type
    INTER_QUARTILE_RANGE
    param Type
    MEDIAN
    title
    Number of Prior Multiple Myeloma Treatments
    unit Of Measure
    prior treatments
  12. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          0.07
          upper Limit
          8.15
          value
          0.53
        2. group Id
          BG001
          lower Limit
          0.38
          upper Limit
          4.80
          value
          0.76
        3. group Id
          BG002
          lower Limit
          0.07
          upper Limit
          8.15
          value
          0.55
    dispersion Type
    INTER_QUARTILE_RANGE
    param Type
    MEDIAN
    title
    Time to Diagnosis
    unit Of Measure
    years
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      70
    2. group Id
      BG001
      value
      31
    3. group Id
      BG002
      value
      101
    units
    Participants
groups
  1. description
    Patients receive activated Marrow Infiltrating Lymphocytes (aMIL) aMIL: On day 0, patients will receive auto transplant followed by Tadalafil and aMIL. At day 60, patients will receive Lenalidomide.
    id
    BG000
    title
    aMIL Arm
  2. description
    Patients do not receive activated Marrow Infiltrating Lymphocytes (aMIL) No aMIL: On day 0, patients will receive auto transplant followed by Tadalafil. At day 60, patients will receive Lenalidomide.
    id
    BG001
    title
    No aMIL
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          35.0
          upper Limit
          74.8
          value
          62.5
        2. group Id
          BG001
          lower Limit
          37.1
          upper Limit
          75.9
          value
          59.0
        3. group Id
          BG002
          lower Limit
          35.0
          upper Limit
          75.9
          value
          61.7
    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
          36
        2. group Id
          BG001
          value
          15
        3. group Id
          BG002
          value
          51
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          34
        2. group Id
          BG001
          value
          16
        3. group Id
          BG002
          value
          50
        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
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
      title
      Asian
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          14
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          22
      title
      Black
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          3
      title
      Other
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          53
        2. group Id
          BG001
          value
          21
        3. group Id
          BG002
          value
          74
      title
      White
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          70
        2. group Id
          BG001
          value
          31
        3. group Id
          BG002
          value
          101
      title
      United States
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          60
        2. group Id
          BG001
          value
          26
        3. group Id
          BG002
          value
          86
        title
        Newly Diagnosed
      2. measurements
        1. group Id
          BG000
          value
          10
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          15
        title
        Relapsed
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Disease Status
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          12
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          16
        title
        High Risk
      2. measurements
        1. group Id
          BG000
          value
          25
        2. group Id
          BG001
          value
          15
        3. group Id
          BG002
          value
          40
        title
        Low Risk
      3. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          10
        title
        N/A
      4. measurements
        1. group Id
          BG000
          value
          25
        2. group Id
          BG001
          value
          10
        3. group Id
          BG002
          value
          35
        title
        Indeterminate
    description
    The Myeloma Prognostic Risk Signature (MyPRS®) (Signal Genetics™) is used to estimate the underlying activity of disease progression in patients diagnosed with active multiple myeloma.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Myeloma Prognostic Risk Signature (MYPRS) Risk Category
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          58
        2. group Id
          BG001
          value
          27
        3. group Id
          BG002
          value
          85
        title
        Not High Risk
      2. measurements
        1. group Id
          BG000
          value
          12
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          16
        title
        High Risk
    description
    The 70-gene Prognostic Risk Score (GEP-70) quantifies the expression of 70 genes commonly altered in multiple myeloma. Primarily prognostic, GEP-70 assesses risk of disease relapse and survival outcomes and is the randomization stratification of the MYPRS multiple myeloma specific gene expression profile risk categories.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    70-gene expression Prognostic Risk Score (GEP-70)
    unit Of Measure
    Participants
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          27
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          34
        title
        0
      2. measurements
        1. group Id
          BG000
          value
          34
        2. group Id
          BG001
          value
          21
        3. group Id
          BG002
          value
          55
        title
        1 or 2
      3. measurements
        1. group Id
          BG000
          value
          9
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          12
        title
        Missing
    description
    ECOG Scoring System 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 self care but unable to carry out any work activities. Up and about more than 50% of waking hours 3. Capable of only limited self care, confined to bed or chair more than 50% of waking hours 4. Completely disabled. Cannot carry on any self care. Totally confined to bed or chair 5. Dead
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Eastern Cooperative Oncology Group (ECOG) Performance Status
    unit Of Measure
    Participants
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          20
        2. group Id
          BG001
          value
          10
        3. group Id
          BG002
          value
          30
        title
        Stage I
      2. measurements
        1. group Id
          BG000
          value
          19
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          26
        title
        Stage II
      3. measurements
        1. group Id
          BG000
          value
          17
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          25
        title
        Stage III
      4. measurements
        1. group Id
          BG000
          value
          14
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          20
        title
        missing
    description
    Prognosticates the severity of multiple myeloma and patient survival based on routinely obtained lab values. Stage I= Serum β2 microglobulin \< 3.5 mg/l; serum albumin ≥ 3.5 g/dl; standard-risk chromosomal abnormalities (CA) and normal lactate dehydrogenase (LDH) Stage II= not stage I or Stage III Stage III= Serum β2 microglobulin ≥ 5.5 mg/L and either high-risk CA by florescent in situ hybridization (FISH) or high LDH
    param Type
    COUNT_OF_PARTICIPANTS
    title
    International Staging System (ISS) Multiple Myeloma Classification
    unit Of Measure
    Participants
  10. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          9
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          9
        title
        IA-IB
      2. measurements
        1. group Id
          BG000
          value
          14
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          21
        title
        IIA-IIB
      3. measurements
        1. group Id
          BG000
          value
          35
        2. group Id
          BG001
          value
          21
        3. group Id
          BG002
          value
          56
        title
        IIIA-IIIB
      4. measurements
        1. group Id
          BG000
          value
          12
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          15
        title
        missing
    description
    demonstrates the correlation between the amount of myeloma and the damage it has caused based on number of bone lesions, anemia, serum calcium levels, and serum and urine light chain levels, and can be measured as myeloma cell mass (myeloma cells in billions/m2)\* . Stage I= low cell mass (600 billion) Stage II= intermediate cell mass (600-1200 billion) Stage III= high cell mass (\>1200 billion) Subcategory: A = normal renal function. B= abnormal renal function
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Salmon Stage multiple myeloma classification
    unit Of Measure
    Participants
  11. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          1
          upper Limit
          6
          value
          1
        2. group Id
          BG001
          lower Limit
          1
          upper Limit
          5
          value
          2
        3. group Id
          BG002
          lower Limit
          1
          upper Limit
          6
          value
          1
    dispersion Type
    INTER_QUARTILE_RANGE
    param Type
    MEDIAN
    title
    Number of Prior Multiple Myeloma Treatments
    unit Of Measure
    prior treatments
  12. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          0.07
          upper Limit
          8.15
          value
          0.53
        2. group Id
          BG001
          lower Limit
          0.38
          upper Limit
          4.80
          value
          0.76
        3. group Id
          BG002
          lower Limit
          0.07
          upper Limit
          8.15
          value
          0.55
    dispersion Type
    INTER_QUARTILE_RANGE
    param Type
    MEDIAN
    title
    Time to Diagnosis
    unit Of Measure
    years

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Preserved source evidence · Not medical advice