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NCT01208662 · BASELINE

Baseline characteristics

Randomized Trial of Lenalidomide, Bortezomib, Dexamethasone vs High-Dose Treatment With SCT in MM Patients up to Age 65 · Source last updated 2026-01-22

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
      357
    2. group Id
      BG001
      value
      365
    3. group Id
      BG002
      value
      7
    4. group Id
      BG003
      value
      729
    units
    Participants
groups
  1. description
    All participants received one cycle of lenalidomide (R), bortezomib (V) and dexamethasone (D) and then were randomized. All participants then received two additional RVD cycles, followed by stem-cell collection. RVD Alone participants received five additional RVD cycles. Maintenance in both arms comprised daily lenalidomide 10 mg, escalated to 15 mg if tolerated, until disease progression, unacceptable toxicity, or withdrawal from treatment or study. After finishing protocol-specified treatment, off-study salvage transplantation was recommended but not mandated for RVD Alone participants at relapse. RVD cycle duration=21 days R: 25 mg oral on days 1-14 V: 1.3 mg per square meter of body surface area IV or subcutaneous on days 1, 4, 8, and 11 D: 20 mg oral (cycles 1-3) or 10 mg (cycles 4-8) on days 1, 2, 4, 5, 8, 9, 11, and 12
    id
    BG000
    title
    RVD Alone
  2. description
    All participants received one cycle of lenalidomide (R), bortezomib (V) and dexamethasone (d) and then were randomized. All participants then received two additional RVD cycles, followed by stem-cell collection. RVD plus autologous stem cell transplant (ASCT) participants received high-dose melphalan (200 mg/m2, adjusted for ideal body weight) ASCT and, upon recovery (\~day 60), two additional RVD cycles. Maintenance in both arms comprised daily lenalidomide 10 mg, escalated to 15 mg if tolerated, until disease progression, unacceptable toxicity, or withdrawal from treatment or study. After finishing protocol-specified treatment, RVD plus ASCT participants could undergo a second transplant. RVD cycle duration=21 days R: 25 mg oral on days 1-14 V: 1.3 mg per square meter of body surface area IV or subcutaneous on days 1, 4, 8, and 11 D: 20 mg oral (cycles 1-3) or 10 mg (cycles 4-8) on days 1, 2, 4, 5, 8, 9, 11, and 12
    id
    BG001
    title
    RVD Plus ASCT
  3. description
    Some participants started cycle 1 lenalidomide (R), bortezomib (V) and dexamethasone (D) therapy but were not randomized. RVD cycle duration=21 days R: 25 mg oral on days 1-14 V: 1.3 mg per square meter of body surface area IV or subcutaneous on days 1, 4, 8, and 11 D: 20 mg oral (cycles 1-3) or 10 mg (cycles 4-8) on days 1, 2, 4, 5, 8, 9, 11, and 12
    id
    BG002
    title
    RVD Cycle 1 Only
  4. description
    Total of all reporting groups
    id
    BG003
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          25
          upper Limit
          66
          value
          57
        2. group Id
          BG001
          lower Limit
          30
          upper Limit
          65
          value
          55
        3. group Id
          BG002
          lower Limit
          55
          upper Limit
          65
          value
          59
        4. group Id
          BG003
          lower Limit
          50
          upper Limit
          61
          value
          56
      denoms
      1. counts
        1. group Id
          BG000
          value
          357
        2. group Id
          BG001
          value
          365
        3. group Id
          BG002
          value
          7
        4. group Id
          BG003
          value
          729
        units
        Participants
    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
          155
        2. group Id
          BG001
          value
          150
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          308
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          202
        2. group Id
          BG001
          value
          215
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          421
        title
        Male
      denoms
      1. counts
        1. group Id
          BG000
          value
          357
        2. group Id
          BG001
          value
          365
        3. group Id
          BG002
          value
          7
        4. group Id
          BG003
          value
          729
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          19
        2. group Id
          BG001
          value
          23
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          42
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          336
        2. group Id
          BG001
          value
          332
        3. group Id
          BG002
          value
          7
        4. group Id
          BG003
          value
          675
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          10
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          12
        title
        Unknown or Not Reported
      denoms
      1. counts
        1. group Id
          BG000
          value
          357
        2. group Id
          BG001
          value
          365
        3. group Id
          BG002
          value
          7
        4. group Id
          BG003
          value
          729
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          268
        2. group Id
          BG001
          value
          272
        3. group Id
          BG002
          value
          5
        4. group Id
          BG003
          value
          545
      denoms
      1. counts
        1. group Id
          BG000
          value
          357
        2. group Id
          BG001
          value
          365
        3. group Id
          BG002
          value
          7
        4. group Id
          BG003
          value
          729
        units
        Participants
      title
      White
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          66
        2. group Id
          BG001
          value
          66
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          134
      denoms
      1. counts
        1. group Id
          BG000
          value
          357
        2. group Id
          BG001
          value
          365
        3. group Id
          BG002
          value
          7
        4. group Id
          BG003
          value
          729
        units
        Participants
      title
      Black
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          12
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          20
      denoms
      1. counts
        1. group Id
          BG000
          value
          357
        2. group Id
          BG001
          value
          365
        3. group Id
          BG002
          value
          7
        4. group Id
          BG003
          value
          729
        units
        Participants
      title
      Asian
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          9
        2. group Id
          BG001
          value
          9
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          18
      denoms
      1. counts
        1. group Id
          BG000
          value
          357
        2. group Id
          BG001
          value
          365
        3. group Id
          BG002
          value
          7
        4. group Id
          BG003
          value
          729
        units
        Participants
      title
      Other
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          12
      denoms
      1. counts
        1. group Id
          BG000
          value
          357
        2. group Id
          BG001
          value
          365
        3. group Id
          BG002
          value
          7
        4. group Id
          BG003
          value
          729
        units
        Participants
      title
      Unknown
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          357
        2. group Id
          BG001
          value
          365
        3. group Id
          BG002
          value
          7
        4. group Id
          BG003
          value
          729
      denoms
      1. counts
        1. group Id
          BG000
          value
          357
        2. group Id
          BG001
          value
          365
        3. group Id
          BG002
          value
          7
        4. group Id
          BG003
          value
          729
        units
        Participants
      title
      United States
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          178
        2. group Id
          BG001
          value
          184
        3. group Id
          BG003
          value
          362
      denoms
      1. counts
        1. group Id
          BG000
          value
          357
        2. group Id
          BG001
          value
          365
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          722
        units
        Participants
      title
      I
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          130
        2. group Id
          BG001
          value
          134
        3. group Id
          BG003
          value
          264
      denoms
      1. counts
        1. group Id
          BG000
          value
          357
        2. group Id
          BG001
          value
          365
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          722
        units
        Participants
      title
      II
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          49
        2. group Id
          BG001
          value
          47
        3. group Id
          BG003
          value
          96
      denoms
      1. counts
        1. group Id
          BG000
          value
          357
        2. group Id
          BG001
          value
          365
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          722
        units
        Participants
      title
      III
    description
    The International Staging System (ISS) consists of three stages: stage I, serum beta 2-microglobulin level lower than 3.5 mg per liter and serum albumin level 3.5 g per deciliter or higher; stage II, neither stage I nor III; and stage III, serum beta 2-microglobulin level 5.5 mg per liter or higher. Higher stages indicate more severe disease.
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    ISS Multiple Myeloma staging data collected at randomization and therefore data was not collected for the seven participants who were not randomized.
    title
    ISS Multiple Myeloma Stage
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          66
        2. group Id
          BG001
          value
          66
        3. group Id
          BG003
          value
          132
      denoms
      1. counts
        1. group Id
          BG000
          value
          357
        2. group Id
          BG001
          value
          365
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          722
        units
        Participants
      title
      High risk
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          268
        2. group Id
          BG001
          value
          274
        3. group Id
          BG003
          value
          542
      denoms
      1. counts
        1. group Id
          BG000
          value
          357
        2. group Id
          BG001
          value
          365
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          722
        units
        Participants
      title
      Standard risk
    description
    Cytogenetic risk was based on FISH or karyotype analysis; patients who had a high-risk cytogenetic profile had at least one high-risk abnormality (t\[4;14\], t\[14;16\], or del17p). Patients with standard risk had no high-risk cytogenetic abnormalities.
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    Cytogenetic risk category data collected at randomization and therefore data was not collected for the seven participants who were not randomized.
    title
    Cytogenetic Risk Category
    unit Of Measure
    Participants
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          80
        2. group Id
          BG001
          value
          81
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          162
      denoms
      1. counts
        1. group Id
          BG000
          value
          357
        2. group Id
          BG001
          value
          365
        3. group Id
          BG002
          value
          7
        4. group Id
          BG003
          value
          729
        units
        Participants
      title
      <25
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          141
        2. group Id
          BG001
          value
          127
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          270
      denoms
      1. counts
        1. group Id
          BG000
          value
          357
        2. group Id
          BG001
          value
          365
        3. group Id
          BG002
          value
          7
        4. group Id
          BG003
          value
          729
        units
        Participants
      title
      25 to <30
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          136
        2. group Id
          BG001
          value
          157
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          297
      denoms
      1. counts
        1. group Id
          BG000
          value
          357
        2. group Id
          BG001
          value
          365
        3. group Id
          BG002
          value
          7
        4. group Id
          BG003
          value
          729
        units
        Participants
      title
      >/= 30
    description
    The body-mass index (BMI) is the weight in kilograms divided by the square of the height in meters.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    BMI
    unit Of Measure
    Participants
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          153
        2. group Id
          BG001
          value
          164
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          321
      denoms
      1. counts
        1. group Id
          BG000
          value
          357
        2. group Id
          BG001
          value
          365
        3. group Id
          BG002
          value
          7
        4. group Id
          BG003
          value
          729
        units
        Participants
      title
      0
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          177
        2. group Id
          BG001
          value
          161
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          341
      denoms
      1. counts
        1. group Id
          BG000
          value
          357
        2. group Id
          BG001
          value
          365
        3. group Id
          BG002
          value
          7
        4. group Id
          BG003
          value
          729
        units
        Participants
      title
      1
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          27
        2. group Id
          BG001
          value
          39
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          66
      denoms
      1. counts
        1. group Id
          BG000
          value
          357
        2. group Id
          BG001
          value
          365
        3. group Id
          BG002
          value
          7
        4. group Id
          BG003
          value
          729
        units
        Participants
      title
      2
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
      denoms
      1. counts
        1. group Id
          BG000
          value
          357
        2. group Id
          BG001
          value
          365
        3. group Id
          BG002
          value
          7
        4. group Id
          BG003
          value
          729
        units
        Participants
      title
      Unknown
    description
    Eastern Cooperative Oncology Group (ECOG) Performance Status: (PS0) Fully active, able to carry on all pre-disease performance without restriction (PS1) Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature (PS2) Ambulatory and capable of all self-care but unable to carry out any work activities; Up and about \>50% of waking hours.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    ECOG Performance Status
    unit Of Measure
    Participants
population Description
All enrolled participants.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      357
    2. group Id
      BG001
      value
      365
    3. group Id
      BG002
      value
      7
    4. group Id
      BG003
      value
      729
    units
    Participants
groups
  1. description
    All participants received one cycle of lenalidomide (R), bortezomib (V) and dexamethasone (D) and then were randomized. All participants then received two additional RVD cycles, followed by stem-cell collection. RVD Alone participants received five additional RVD cycles. Maintenance in both arms comprised daily lenalidomide 10 mg, escalated to 15 mg if tolerated, until disease progression, unacceptable toxicity, or withdrawal from treatment or study. After finishing protocol-specified treatment, off-study salvage transplantation was recommended but not mandated for RVD Alone participants at relapse. RVD cycle duration=21 days R: 25 mg oral on days 1-14 V: 1.3 mg per square meter of body surface area IV or subcutaneous on days 1, 4, 8, and 11 D: 20 mg oral (cycles 1-3) or 10 mg (cycles 4-8) on days 1, 2, 4, 5, 8, 9, 11, and 12
    id
    BG000
    title
    RVD Alone
  2. description
    All participants received one cycle of lenalidomide (R), bortezomib (V) and dexamethasone (d) and then were randomized. All participants then received two additional RVD cycles, followed by stem-cell collection. RVD plus autologous stem cell transplant (ASCT) participants received high-dose melphalan (200 mg/m2, adjusted for ideal body weight) ASCT and, upon recovery (\~day 60), two additional RVD cycles. Maintenance in both arms comprised daily lenalidomide 10 mg, escalated to 15 mg if tolerated, until disease progression, unacceptable toxicity, or withdrawal from treatment or study. After finishing protocol-specified treatment, RVD plus ASCT participants could undergo a second transplant. RVD cycle duration=21 days R: 25 mg oral on days 1-14 V: 1.3 mg per square meter of body surface area IV or subcutaneous on days 1, 4, 8, and 11 D: 20 mg oral (cycles 1-3) or 10 mg (cycles 4-8) on days 1, 2, 4, 5, 8, 9, 11, and 12
    id
    BG001
    title
    RVD Plus ASCT
  3. description
    Some participants started cycle 1 lenalidomide (R), bortezomib (V) and dexamethasone (D) therapy but were not randomized. RVD cycle duration=21 days R: 25 mg oral on days 1-14 V: 1.3 mg per square meter of body surface area IV or subcutaneous on days 1, 4, 8, and 11 D: 20 mg oral (cycles 1-3) or 10 mg (cycles 4-8) on days 1, 2, 4, 5, 8, 9, 11, and 12
    id
    BG002
    title
    RVD Cycle 1 Only
  4. description
    Total of all reporting groups
    id
    BG003
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          25
          upper Limit
          66
          value
          57
        2. group Id
          BG001
          lower Limit
          30
          upper Limit
          65
          value
          55
        3. group Id
          BG002
          lower Limit
          55
          upper Limit
          65
          value
          59
        4. group Id
          BG003
          lower Limit
          50
          upper Limit
          61
          value
          56
      denoms
      1. counts
        1. group Id
          BG000
          value
          357
        2. group Id
          BG001
          value
          365
        3. group Id
          BG002
          value
          7
        4. group Id
          BG003
          value
          729
        units
        Participants
    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
          155
        2. group Id
          BG001
          value
          150
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          308
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          202
        2. group Id
          BG001
          value
          215
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          421
        title
        Male
      denoms
      1. counts
        1. group Id
          BG000
          value
          357
        2. group Id
          BG001
          value
          365
        3. group Id
          BG002
          value
          7
        4. group Id
          BG003
          value
          729
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          19
        2. group Id
          BG001
          value
          23
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          42
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          336
        2. group Id
          BG001
          value
          332
        3. group Id
          BG002
          value
          7
        4. group Id
          BG003
          value
          675
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          10
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          12
        title
        Unknown or Not Reported
      denoms
      1. counts
        1. group Id
          BG000
          value
          357
        2. group Id
          BG001
          value
          365
        3. group Id
          BG002
          value
          7
        4. group Id
          BG003
          value
          729
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          268
        2. group Id
          BG001
          value
          272
        3. group Id
          BG002
          value
          5
        4. group Id
          BG003
          value
          545
      denoms
      1. counts
        1. group Id
          BG000
          value
          357
        2. group Id
          BG001
          value
          365
        3. group Id
          BG002
          value
          7
        4. group Id
          BG003
          value
          729
        units
        Participants
      title
      White
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          66
        2. group Id
          BG001
          value
          66
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          134
      denoms
      1. counts
        1. group Id
          BG000
          value
          357
        2. group Id
          BG001
          value
          365
        3. group Id
          BG002
          value
          7
        4. group Id
          BG003
          value
          729
        units
        Participants
      title
      Black
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          12
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          20
      denoms
      1. counts
        1. group Id
          BG000
          value
          357
        2. group Id
          BG001
          value
          365
        3. group Id
          BG002
          value
          7
        4. group Id
          BG003
          value
          729
        units
        Participants
      title
      Asian
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          9
        2. group Id
          BG001
          value
          9
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          18
      denoms
      1. counts
        1. group Id
          BG000
          value
          357
        2. group Id
          BG001
          value
          365
        3. group Id
          BG002
          value
          7
        4. group Id
          BG003
          value
          729
        units
        Participants
      title
      Other
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          12
      denoms
      1. counts
        1. group Id
          BG000
          value
          357
        2. group Id
          BG001
          value
          365
        3. group Id
          BG002
          value
          7
        4. group Id
          BG003
          value
          729
        units
        Participants
      title
      Unknown
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          357
        2. group Id
          BG001
          value
          365
        3. group Id
          BG002
          value
          7
        4. group Id
          BG003
          value
          729
      denoms
      1. counts
        1. group Id
          BG000
          value
          357
        2. group Id
          BG001
          value
          365
        3. group Id
          BG002
          value
          7
        4. group Id
          BG003
          value
          729
        units
        Participants
      title
      United States
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          178
        2. group Id
          BG001
          value
          184
        3. group Id
          BG003
          value
          362
      denoms
      1. counts
        1. group Id
          BG000
          value
          357
        2. group Id
          BG001
          value
          365
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          722
        units
        Participants
      title
      I
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          130
        2. group Id
          BG001
          value
          134
        3. group Id
          BG003
          value
          264
      denoms
      1. counts
        1. group Id
          BG000
          value
          357
        2. group Id
          BG001
          value
          365
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          722
        units
        Participants
      title
      II
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          49
        2. group Id
          BG001
          value
          47
        3. group Id
          BG003
          value
          96
      denoms
      1. counts
        1. group Id
          BG000
          value
          357
        2. group Id
          BG001
          value
          365
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          722
        units
        Participants
      title
      III
    description
    The International Staging System (ISS) consists of three stages: stage I, serum beta 2-microglobulin level lower than 3.5 mg per liter and serum albumin level 3.5 g per deciliter or higher; stage II, neither stage I nor III; and stage III, serum beta 2-microglobulin level 5.5 mg per liter or higher. Higher stages indicate more severe disease.
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    ISS Multiple Myeloma staging data collected at randomization and therefore data was not collected for the seven participants who were not randomized.
    title
    ISS Multiple Myeloma Stage
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          66
        2. group Id
          BG001
          value
          66
        3. group Id
          BG003
          value
          132
      denoms
      1. counts
        1. group Id
          BG000
          value
          357
        2. group Id
          BG001
          value
          365
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          722
        units
        Participants
      title
      High risk
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          268
        2. group Id
          BG001
          value
          274
        3. group Id
          BG003
          value
          542
      denoms
      1. counts
        1. group Id
          BG000
          value
          357
        2. group Id
          BG001
          value
          365
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          722
        units
        Participants
      title
      Standard risk
    description
    Cytogenetic risk was based on FISH or karyotype analysis; patients who had a high-risk cytogenetic profile had at least one high-risk abnormality (t\[4;14\], t\[14;16\], or del17p). Patients with standard risk had no high-risk cytogenetic abnormalities.
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    Cytogenetic risk category data collected at randomization and therefore data was not collected for the seven participants who were not randomized.
    title
    Cytogenetic Risk Category
    unit Of Measure
    Participants
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          80
        2. group Id
          BG001
          value
          81
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          162
      denoms
      1. counts
        1. group Id
          BG000
          value
          357
        2. group Id
          BG001
          value
          365
        3. group Id
          BG002
          value
          7
        4. group Id
          BG003
          value
          729
        units
        Participants
      title
      <25
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          141
        2. group Id
          BG001
          value
          127
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          270
      denoms
      1. counts
        1. group Id
          BG000
          value
          357
        2. group Id
          BG001
          value
          365
        3. group Id
          BG002
          value
          7
        4. group Id
          BG003
          value
          729
        units
        Participants
      title
      25 to <30
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          136
        2. group Id
          BG001
          value
          157
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          297
      denoms
      1. counts
        1. group Id
          BG000
          value
          357
        2. group Id
          BG001
          value
          365
        3. group Id
          BG002
          value
          7
        4. group Id
          BG003
          value
          729
        units
        Participants
      title
      >/= 30
    description
    The body-mass index (BMI) is the weight in kilograms divided by the square of the height in meters.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    BMI
    unit Of Measure
    Participants
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          153
        2. group Id
          BG001
          value
          164
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          321
      denoms
      1. counts
        1. group Id
          BG000
          value
          357
        2. group Id
          BG001
          value
          365
        3. group Id
          BG002
          value
          7
        4. group Id
          BG003
          value
          729
        units
        Participants
      title
      0
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          177
        2. group Id
          BG001
          value
          161
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          341
      denoms
      1. counts
        1. group Id
          BG000
          value
          357
        2. group Id
          BG001
          value
          365
        3. group Id
          BG002
          value
          7
        4. group Id
          BG003
          value
          729
        units
        Participants
      title
      1
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          27
        2. group Id
          BG001
          value
          39
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          66
      denoms
      1. counts
        1. group Id
          BG000
          value
          357
        2. group Id
          BG001
          value
          365
        3. group Id
          BG002
          value
          7
        4. group Id
          BG003
          value
          729
        units
        Participants
      title
      2
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
      denoms
      1. counts
        1. group Id
          BG000
          value
          357
        2. group Id
          BG001
          value
          365
        3. group Id
          BG002
          value
          7
        4. group Id
          BG003
          value
          729
        units
        Participants
      title
      Unknown
    description
    Eastern Cooperative Oncology Group (ECOG) Performance Status: (PS0) Fully active, able to carry on all pre-disease performance without restriction (PS1) Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature (PS2) Ambulatory and capable of all self-care but unable to carry out any work activities; Up and about \>50% of waking hours.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    ECOG Performance Status
    unit Of Measure
    Participants
population Description
All enrolled participants.

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Preserved source evidence · Not medical advice