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NCT01782963 · BASELINE

Baseline characteristics

Lenalidomide/Bortezomib/Dexamethasone for Multiple Myeloma (MM) · Source last updated 2018-10-31

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
      50
    units
    Participants
groups
  1. description
    Induction (Cycles 1-9): Lenalidomide orally, days 1-21. Bortezomib injection, days 1, 8, 15, 22. Dexamethasone orally, days 1, 2, 8, 9, 15, 16, 22, 23 (for subjects 75 years of age or younger), or Dexamethasone orally days 1, 8, 15, 22 (for subjects greater than 75 years of age) Consolidation (cycles 10-15): Lenalidomide po daily (1-21). Bortezomib sc on days 1, 15 Lenalidomide Bortezomib Dexamethasone
    id
    BG000
    title
    Treatment Arm
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          65
          upper Limit
          91
          value
          73
    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
          27
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          23
        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
          42
        title
        White
      2. measurements
        1. group Id
          BG000
          value
          2
        title
        Black or African-American
      3. measurements
        1. group Id
          BG000
          value
          3
        title
        Asian
      4. measurements
        1. group Id
          BG000
          value
          3
        title
        Other
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          50
      title
      United States
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Region of Enrollment
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          19
        title
        I
      2. measurements
        1. group Id
          BG000
          value
          17
        title
        II
      3. measurements
        1. group Id
          BG000
          value
          14
        title
        III
    description
    International Staging System for Multiple Myeloma, divides multiple myeloma into three categories with III representing more advanced disease and I less advanced disease Stage I : * Serum beta-2 microglobulin is less than 3.5 mg/L * AND Albumin level is 3.5 g/dL or greater * AND Cytogenetics are considered "not high risk" * AND Lactate dehydrogenase (LDH) levels are normal Stage II: Not stage I or stage II Stage III: * Serum beta-2 microglobulin is 5.5 (mg/L) or greater * AND Cytogenetics are considered "high-risk" * AND/OR LDH levels are high
    param Type
    COUNT_OF_PARTICIPANTS
    title
    ISS Stage at Diagnosis
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          16
        title
        I
      2. measurements
        1. group Id
          BG000
          value
          16
        title
        II
      3. measurements
        1. group Id
          BG000
          value
          18
        title
        III
    description
    Stage III represents more advanced disease and stage I less advanced. Stage I: * Hemoglobin value 10 g/dL * Serum calcium value normal or =12 mg/dL * Bone x-ray, normal bone structure (scale 0) or solitary bone plasmacytoma only * Low M-component production rate (IgG value \<5 g/dL; IgA value \<3 g/dL; Bence Jones protein \<4 g/24 hr) Stage II: Neither stage I nor stage III Stage III: On or more of the following: * Hemoglobin value 12 mg/dL * Advanced lytic bone lesions (scale 3) * High M-component production rate - IgG value \>7 g/dL; IgA value\>5 g/dL; Bence Jones protein \>12 g/24 h
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Durie-Salmon Stage
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          25
        title
        0
      2. measurements
        1. group Id
          BG000
          value
          18
        title
        1
      3. measurements
        1. group Id
          BG000
          value
          7
        title
        2
      4. measurements
        1. group Id
          BG000
          value
          0
        title
        3
      5. measurements
        1. group Id
          BG000
          value
          0
        title
        4
      6. measurements
        1. group Id
          BG000
          value
          0
        title
        5
    description
    The Eastern Cooperative Oncology Group (ECOG) Performance Status Score * 0: Asymptomatic (Fully active, no restrictions in self care) * 1: Symptomatic but completely ambulatory (Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature) * 2: Symptomatic, \<50% time in bed during the day (Ambulatory and capable of all self care but unable to carry out any work activities) * 3: Symptomatic, \>50% time in bed during waking hours (Capable of only limited self-care) * 4: Bedbound (Completely disabled. Cannot carry on any self-care) * 5: Death
    param Type
    COUNT_OF_PARTICIPANTS
    title
    ECOG Performance Status
    unit Of Measure
    Participants
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          6
        title
        Yes
      2. measurements
        1. group Id
          BG000
          value
          42
        title
        No
      3. measurements
        1. group Id
          BG000
          value
          2
        title
        Unknown
    description
    Cytogenetics risk is determined by doing a genetic analysis of the participants bone marrow. The participants chromosomes are assessed for things like translocations (rearrangement of non-homologous chromosomes) or deletions (part of the genetic sequence is lost). Participants were considered high-risk if they had certain specific genetic changes. Translocations are noted as t(chromosome 1; chromosome 2) where the two chromosomes represent which non homologous chromosomes swapped genetic material. The high-risk cytogenetics included a deletion on chromosome 17, t(4;14), t(14;16), and t(14;20).
    param Type
    COUNT_OF_PARTICIPANTS
    title
    High-Risk Cytogenetics
    unit Of Measure
    Participants
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          34
        title
        IgG
      2. measurements
        1. group Id
          BG000
          value
          9
        title
        IgA
      3. measurements
        1. group Id
          BG000
          value
          5
        title
        Light-chain only
      4. measurements
        1. group Id
          BG000
          value
          2
        title
        Unknown
    description
    The serum heavy/light chain immunoassay quantifies the light chain types of each immunoglobulin (Ig) class based on a sample of the participants blood. Typical antibodies consist of two Ig heavy chains connected to two Ig light chains. When the plasma cells become cancerous, it can result in an increase in monoclonal immunoglobulin in the blood serum. This is used as a measure of the tumor load. The information below gives which specific monoclonal immunoglobulin was detected.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Serum Heavy/Light Chain
    unit Of Measure
    Participants
  10. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          18
          upper Limit
          45
          value
          28
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Body Mass Index (BMI)
    unit Of Measure
    Kg/m^2
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      50
    units
    Participants
groups
  1. description
    Induction (Cycles 1-9): Lenalidomide orally, days 1-21. Bortezomib injection, days 1, 8, 15, 22. Dexamethasone orally, days 1, 2, 8, 9, 15, 16, 22, 23 (for subjects 75 years of age or younger), or Dexamethasone orally days 1, 8, 15, 22 (for subjects greater than 75 years of age) Consolidation (cycles 10-15): Lenalidomide po daily (1-21). Bortezomib sc on days 1, 15 Lenalidomide Bortezomib Dexamethasone
    id
    BG000
    title
    Treatment Arm
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          65
          upper Limit
          91
          value
          73
    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
          27
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          23
        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
          42
        title
        White
      2. measurements
        1. group Id
          BG000
          value
          2
        title
        Black or African-American
      3. measurements
        1. group Id
          BG000
          value
          3
        title
        Asian
      4. measurements
        1. group Id
          BG000
          value
          3
        title
        Other
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          50
      title
      United States
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Region of Enrollment
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          19
        title
        I
      2. measurements
        1. group Id
          BG000
          value
          17
        title
        II
      3. measurements
        1. group Id
          BG000
          value
          14
        title
        III
    description
    International Staging System for Multiple Myeloma, divides multiple myeloma into three categories with III representing more advanced disease and I less advanced disease Stage I : * Serum beta-2 microglobulin is less than 3.5 mg/L * AND Albumin level is 3.5 g/dL or greater * AND Cytogenetics are considered "not high risk" * AND Lactate dehydrogenase (LDH) levels are normal Stage II: Not stage I or stage II Stage III: * Serum beta-2 microglobulin is 5.5 (mg/L) or greater * AND Cytogenetics are considered "high-risk" * AND/OR LDH levels are high
    param Type
    COUNT_OF_PARTICIPANTS
    title
    ISS Stage at Diagnosis
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          16
        title
        I
      2. measurements
        1. group Id
          BG000
          value
          16
        title
        II
      3. measurements
        1. group Id
          BG000
          value
          18
        title
        III
    description
    Stage III represents more advanced disease and stage I less advanced. Stage I: * Hemoglobin value 10 g/dL * Serum calcium value normal or =12 mg/dL * Bone x-ray, normal bone structure (scale 0) or solitary bone plasmacytoma only * Low M-component production rate (IgG value \<5 g/dL; IgA value \<3 g/dL; Bence Jones protein \<4 g/24 hr) Stage II: Neither stage I nor stage III Stage III: On or more of the following: * Hemoglobin value 12 mg/dL * Advanced lytic bone lesions (scale 3) * High M-component production rate - IgG value \>7 g/dL; IgA value\>5 g/dL; Bence Jones protein \>12 g/24 h
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Durie-Salmon Stage
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          25
        title
        0
      2. measurements
        1. group Id
          BG000
          value
          18
        title
        1
      3. measurements
        1. group Id
          BG000
          value
          7
        title
        2
      4. measurements
        1. group Id
          BG000
          value
          0
        title
        3
      5. measurements
        1. group Id
          BG000
          value
          0
        title
        4
      6. measurements
        1. group Id
          BG000
          value
          0
        title
        5
    description
    The Eastern Cooperative Oncology Group (ECOG) Performance Status Score * 0: Asymptomatic (Fully active, no restrictions in self care) * 1: Symptomatic but completely ambulatory (Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature) * 2: Symptomatic, \<50% time in bed during the day (Ambulatory and capable of all self care but unable to carry out any work activities) * 3: Symptomatic, \>50% time in bed during waking hours (Capable of only limited self-care) * 4: Bedbound (Completely disabled. Cannot carry on any self-care) * 5: Death
    param Type
    COUNT_OF_PARTICIPANTS
    title
    ECOG Performance Status
    unit Of Measure
    Participants
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          6
        title
        Yes
      2. measurements
        1. group Id
          BG000
          value
          42
        title
        No
      3. measurements
        1. group Id
          BG000
          value
          2
        title
        Unknown
    description
    Cytogenetics risk is determined by doing a genetic analysis of the participants bone marrow. The participants chromosomes are assessed for things like translocations (rearrangement of non-homologous chromosomes) or deletions (part of the genetic sequence is lost). Participants were considered high-risk if they had certain specific genetic changes. Translocations are noted as t(chromosome 1; chromosome 2) where the two chromosomes represent which non homologous chromosomes swapped genetic material. The high-risk cytogenetics included a deletion on chromosome 17, t(4;14), t(14;16), and t(14;20).
    param Type
    COUNT_OF_PARTICIPANTS
    title
    High-Risk Cytogenetics
    unit Of Measure
    Participants
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          34
        title
        IgG
      2. measurements
        1. group Id
          BG000
          value
          9
        title
        IgA
      3. measurements
        1. group Id
          BG000
          value
          5
        title
        Light-chain only
      4. measurements
        1. group Id
          BG000
          value
          2
        title
        Unknown
    description
    The serum heavy/light chain immunoassay quantifies the light chain types of each immunoglobulin (Ig) class based on a sample of the participants blood. Typical antibodies consist of two Ig heavy chains connected to two Ig light chains. When the plasma cells become cancerous, it can result in an increase in monoclonal immunoglobulin in the blood serum. This is used as a measure of the tumor load. The information below gives which specific monoclonal immunoglobulin was detected.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Serum Heavy/Light Chain
    unit Of Measure
    Participants
  10. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          18
          upper Limit
          45
          value
          28
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Body Mass Index (BMI)
    unit Of Measure
    Kg/m^2

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Preserved source evidence · Not medical advice