Skip to content
Triangle logo TriangleGet started
← Full study record

NCT00689936 · BASELINE

Baseline characteristics

Study to Determine Efficacy and Safety of Lenalidomide Plus Low-dose Dexamethasone Versus Melphalan, Prednisone, Thalidomide in Patients With Previously Untreated Multiple Myeloma · Source last updated 2019-11-20

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
      535
    2. group Id
      BG001
      value
      541
    3. group Id
      BG002
      value
      547
    4. group Id
      BG003
      value
      1623
    units
    Participants
groups
  1. description
    Participants ≤ 75 years old received 25 mg lenalidomide (R) administered by mouth (PO) on days 1 to 21 of each 28-day cycle plus 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants \> 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone at the same schedule. Participants with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity.
    id
    BG000
    title
    Lenalidomide and Low-Dose Dexamethasone (Rd)
  2. description
    Participants ≤ 75 years old received 25 mg lenalidomide (R) PO on days 1 to 21 of each 28-day treatment cycle 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless progressive disease (PD) or intolerable toxicity occurred. Those \> 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Those with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day (QOD) on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity.
    id
    BG001
    title
    Lenalidomide and Dexamethasone Rd18
  3. description
    Participants received melphalan (M) 0.25 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred. Participants with moderate to severe renal insufficiency received melphalan (M) 0.10-0.125 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 100-200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred.
    id
    BG002
    title
    Melphalan + Prednisone + Thalidomide (MPT)
  4. description
    Total of all reporting groups
    id
    BG003
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          6.57
          value
          73.2
        2. group Id
          BG001
          spread
          6.50
          value
          72.9
        3. group Id
          BG002
          spread
          6.32
          value
          73.1
        4. group Id
          BG003
          spread
          6.46
          value
          73.1
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          241
        2. group Id
          BG001
          value
          268
        3. group Id
          BG002
          value
          260
        4. group Id
          BG003
          value
          769
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          294
        2. group Id
          BG001
          value
          273
        3. group Id
          BG002
          value
          287
        4. group Id
          BG003
          value
          854
        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
          40
        2. group Id
          BG001
          value
          43
        3. group Id
          BG002
          value
          44
        4. group Id
          BG003
          value
          127
      title
      Asian
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          9
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          5
        4. group Id
          BG003
          value
          20
      title
      Black or African American
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          2
      title
      Native Hawaiian or other Pacific Islanders
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          474
        2. group Id
          BG001
          value
          480
        3. group Id
          BG002
          value
          491
        4. group Id
          BG003
          value
          1445
      title
      White or Caucasian
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          11
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          20
      title
      Other, Miscellaneous
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          9
      title
      Undisclosed
    param Type
    NUMBER
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          37
        2. group Id
          BG001
          value
          33
        3. group Id
          BG002
          value
          36
        4. group Id
          BG003
          value
          106
      title
      Hispanic or Latino
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          493
        2. group Id
          BG001
          value
          505
        3. group Id
          BG002
          value
          508
        4. group Id
          BG003
          value
          1506
      title
      Not Hispanic or Latino
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          11
      title
      Undisclosed
    param Type
    NUMBER
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          106
        2. group Id
          BG001
          value
          106
        3. group Id
          BG002
          value
          103
        4. group Id
          BG003
          value
          315
      title
      Stage I
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          227
        2. group Id
          BG001
          value
          229
        3. group Id
          BG002
          value
          225
        4. group Id
          BG003
          value
          681
      title
      Stage II
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          202
        2. group Id
          BG001
          value
          206
        3. group Id
          BG002
          value
          219
        4. group Id
          BG003
          value
          627
      title
      Stage III
    description
    International Staging System (ISS) is used as a staging system for multiple myeloma and divides myeloma into 3 stages based only on the serum beta-2 microglobulin and serum albumin levels. Higher stages represent more advanced disease.
    param Type
    NUMBER
    title
    International Staging System (ISS)
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          155
        2. group Id
          BG001
          value
          163
        3. group Id
          BG002
          value
          156
        4. group Id
          BG003
          value
          474
      title
      0 (fully active)
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          257
        2. group Id
          BG001
          value
          263
        3. group Id
          BG002
          value
          275
        4. group Id
          BG003
          value
          795
      title
      1 (restrictive but ambulatory)
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          119
        2. group Id
          BG001
          value
          113
        3. group Id
          BG002
          value
          111
        4. group Id
          BG003
          value
          343
      title
      2 (ambulatory but unable to work)
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          6
      title
      3-4 (limited self-care, completely disabled)
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          5
      title
      Missing
    description
    Eastern Cooperative Oncology Group (ECOG) Performance Status is used to assess the progress of disease in a patient, how the disease affects the daily living abilities of the patient, and determine appropriate treatment and prognosis.
    param Type
    NUMBER
    title
    Eastern Cooperative Oncology Group (ECOG) Performance Status
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          269
        2. group Id
          BG001
          value
          280
        3. group Id
          BG002
          value
          285
        4. group Id
          BG003
          value
          834
      title
      >=60 ml/min
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          266
        2. group Id
          BG001
          value
          261
        3. group Id
          BG002
          value
          261
        4. group Id
          BG003
          value
          788
      title
      <60 ml/min
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          1
      title
      Missing
    param Type
    NUMBER
    title
    Creatinine clearance
    unit Of Measure
    Participants
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          224
        2. group Id
          BG001
          value
          224
        3. group Id
          BG002
          value
          234
        4. group Id
          BG003
          value
          682
      title
      >5.5 mg/L
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          309
        2. group Id
          BG001
          value
          316
        3. group Id
          BG002
          value
          312
        4. group Id
          BG003
          value
          937
      title
      <=5.5 mg/L
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          4
      title
      Missing
    param Type
    NUMBER
    title
    Beta2 Microglobulin
    unit Of Measure
    Participants
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          192
        2. group Id
          BG001
          value
          209
        3. group Id
          BG002
          value
          223
        4. group Id
          BG003
          value
          624
      title
      <=35 g/L
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          343
        2. group Id
          BG001
          value
          331
        3. group Id
          BG002
          value
          324
        4. group Id
          BG003
          value
          998
      title
      > 35 g/L
    3. 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
      title
      Missing
    param Type
    NUMBER
    title
    Albumin
    unit Of Measure
    Participants
  10. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          448
        2. group Id
          BG001
          value
          442
        3. group Id
          BG002
          value
          434
        4. group Id
          BG003
          value
          1324
      title
      <200 U/L
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          86
        2. group Id
          BG001
          value
          99
        3. group Id
          BG002
          value
          112
        4. group Id
          BG003
          value
          297
      title
      >=200 U/L
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          2
      title
      Missing
    param Type
    NUMBER
    title
    Lactic Dehydrogenase
    unit Of Measure
    Participants
  11. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          138
        2. group Id
          BG001
          value
          142
        3. group Id
          BG002
          value
          123
        4. group Id
          BG003
          value
          403
      title
      Immunoglobulin A
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          8
        4. group Id
          BG003
          value
          21
      title
      Immunoglobulin A and Immunoglobulin G
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          1
      title
      Immunoglobulin A and Immunoglobulin M
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          15
      title
      Immunoglobulin D
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          334
        2. group Id
          BG001
          value
          331
        3. group Id
          BG002
          value
          350
        4. group Id
          BG003
          value
          1015
      title
      Immunoglobulin G
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          5
      title
      Immunoglobulin M
    7. categories
      1. measurements
        1. group Id
          BG000
          value
          49
        2. group Id
          BG001
          value
          54
        3. group Id
          BG002
          value
          60
        4. group Id
          BG003
          value
          163
      title
      Not available (includes light-chain disease)
    param Type
    NUMBER
    title
    Multiple Myeloma Subtype
    unit Of Measure
    Participants
  12. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          170
        2. group Id
          BG001
          value
          185
        3. group Id
          BG002
          value
          189
        4. group Id
          BG003
          value
          544
      title
      Adverse Risk
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          112
        2. group Id
          BG001
          value
          103
        3. group Id
          BG002
          value
          102
        4. group Id
          BG003
          value
          317
      title
      Favorable Hyperdiploidy
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          148
        2. group Id
          BG001
          value
          131
        3. group Id
          BG002
          value
          141
        4. group Id
          BG003
          value
          420
      title
      Normal
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          38
        2. group Id
          BG001
          value
          56
        3. group Id
          BG002
          value
          40
        4. group Id
          BG003
          value
          134
      title
      Uncertain Risk
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          34
        2. group Id
          BG001
          value
          35
        3. group Id
          BG002
          value
          44
        4. group Id
          BG003
          value
          113
      title
      Not evaluable
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          33
        2. group Id
          BG001
          value
          31
        3. group Id
          BG002
          value
          31
        4. group Id
          BG003
          value
          95
      title
      Missing
    description
    Cytogenetic risk categories are mutually exclusive. Definitions: Adverse risk category: t(4:14), t(14:16), del (13q) or monosomy 13, del (17p), 1q gain; Non-adverse risk categories include favorable hyperdiploidy: t(11:14), gains of 5/9/15; normal: a normal result, gains other than 5/9/15, IgH deletion, and uncertain risk: probes used for analysis cannot place participant in any risk categories. Not evaluable: no specimen received, test failure or insufficient number of cells available for analysis.
    param Type
    NUMBER
    title
    Cytogenetic Risk
    unit Of Measure
    Participants
population Description
Intent to Treat (ITT) population includes all participants who were randomized, independent of whether they received study treatment or not
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      535
    2. group Id
      BG001
      value
      541
    3. group Id
      BG002
      value
      547
    4. group Id
      BG003
      value
      1623
    units
    Participants
groups
  1. description
    Participants ≤ 75 years old received 25 mg lenalidomide (R) administered by mouth (PO) on days 1 to 21 of each 28-day cycle plus 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants \> 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone at the same schedule. Participants with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity.
    id
    BG000
    title
    Lenalidomide and Low-Dose Dexamethasone (Rd)
  2. description
    Participants ≤ 75 years old received 25 mg lenalidomide (R) PO on days 1 to 21 of each 28-day treatment cycle 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless progressive disease (PD) or intolerable toxicity occurred. Those \> 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Those with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day (QOD) on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity.
    id
    BG001
    title
    Lenalidomide and Dexamethasone Rd18
  3. description
    Participants received melphalan (M) 0.25 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred. Participants with moderate to severe renal insufficiency received melphalan (M) 0.10-0.125 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 100-200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred.
    id
    BG002
    title
    Melphalan + Prednisone + Thalidomide (MPT)
  4. description
    Total of all reporting groups
    id
    BG003
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          6.57
          value
          73.2
        2. group Id
          BG001
          spread
          6.50
          value
          72.9
        3. group Id
          BG002
          spread
          6.32
          value
          73.1
        4. group Id
          BG003
          spread
          6.46
          value
          73.1
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          241
        2. group Id
          BG001
          value
          268
        3. group Id
          BG002
          value
          260
        4. group Id
          BG003
          value
          769
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          294
        2. group Id
          BG001
          value
          273
        3. group Id
          BG002
          value
          287
        4. group Id
          BG003
          value
          854
        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
          40
        2. group Id
          BG001
          value
          43
        3. group Id
          BG002
          value
          44
        4. group Id
          BG003
          value
          127
      title
      Asian
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          9
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          5
        4. group Id
          BG003
          value
          20
      title
      Black or African American
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          2
      title
      Native Hawaiian or other Pacific Islanders
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          474
        2. group Id
          BG001
          value
          480
        3. group Id
          BG002
          value
          491
        4. group Id
          BG003
          value
          1445
      title
      White or Caucasian
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          11
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          20
      title
      Other, Miscellaneous
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          9
      title
      Undisclosed
    param Type
    NUMBER
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          37
        2. group Id
          BG001
          value
          33
        3. group Id
          BG002
          value
          36
        4. group Id
          BG003
          value
          106
      title
      Hispanic or Latino
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          493
        2. group Id
          BG001
          value
          505
        3. group Id
          BG002
          value
          508
        4. group Id
          BG003
          value
          1506
      title
      Not Hispanic or Latino
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          11
      title
      Undisclosed
    param Type
    NUMBER
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          106
        2. group Id
          BG001
          value
          106
        3. group Id
          BG002
          value
          103
        4. group Id
          BG003
          value
          315
      title
      Stage I
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          227
        2. group Id
          BG001
          value
          229
        3. group Id
          BG002
          value
          225
        4. group Id
          BG003
          value
          681
      title
      Stage II
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          202
        2. group Id
          BG001
          value
          206
        3. group Id
          BG002
          value
          219
        4. group Id
          BG003
          value
          627
      title
      Stage III
    description
    International Staging System (ISS) is used as a staging system for multiple myeloma and divides myeloma into 3 stages based only on the serum beta-2 microglobulin and serum albumin levels. Higher stages represent more advanced disease.
    param Type
    NUMBER
    title
    International Staging System (ISS)
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          155
        2. group Id
          BG001
          value
          163
        3. group Id
          BG002
          value
          156
        4. group Id
          BG003
          value
          474
      title
      0 (fully active)
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          257
        2. group Id
          BG001
          value
          263
        3. group Id
          BG002
          value
          275
        4. group Id
          BG003
          value
          795
      title
      1 (restrictive but ambulatory)
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          119
        2. group Id
          BG001
          value
          113
        3. group Id
          BG002
          value
          111
        4. group Id
          BG003
          value
          343
      title
      2 (ambulatory but unable to work)
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          6
      title
      3-4 (limited self-care, completely disabled)
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          5
      title
      Missing
    description
    Eastern Cooperative Oncology Group (ECOG) Performance Status is used to assess the progress of disease in a patient, how the disease affects the daily living abilities of the patient, and determine appropriate treatment and prognosis.
    param Type
    NUMBER
    title
    Eastern Cooperative Oncology Group (ECOG) Performance Status
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          269
        2. group Id
          BG001
          value
          280
        3. group Id
          BG002
          value
          285
        4. group Id
          BG003
          value
          834
      title
      >=60 ml/min
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          266
        2. group Id
          BG001
          value
          261
        3. group Id
          BG002
          value
          261
        4. group Id
          BG003
          value
          788
      title
      <60 ml/min
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          1
      title
      Missing
    param Type
    NUMBER
    title
    Creatinine clearance
    unit Of Measure
    Participants
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          224
        2. group Id
          BG001
          value
          224
        3. group Id
          BG002
          value
          234
        4. group Id
          BG003
          value
          682
      title
      >5.5 mg/L
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          309
        2. group Id
          BG001
          value
          316
        3. group Id
          BG002
          value
          312
        4. group Id
          BG003
          value
          937
      title
      <=5.5 mg/L
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          4
      title
      Missing
    param Type
    NUMBER
    title
    Beta2 Microglobulin
    unit Of Measure
    Participants
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          192
        2. group Id
          BG001
          value
          209
        3. group Id
          BG002
          value
          223
        4. group Id
          BG003
          value
          624
      title
      <=35 g/L
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          343
        2. group Id
          BG001
          value
          331
        3. group Id
          BG002
          value
          324
        4. group Id
          BG003
          value
          998
      title
      > 35 g/L
    3. 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
      title
      Missing
    param Type
    NUMBER
    title
    Albumin
    unit Of Measure
    Participants
  10. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          448
        2. group Id
          BG001
          value
          442
        3. group Id
          BG002
          value
          434
        4. group Id
          BG003
          value
          1324
      title
      <200 U/L
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          86
        2. group Id
          BG001
          value
          99
        3. group Id
          BG002
          value
          112
        4. group Id
          BG003
          value
          297
      title
      >=200 U/L
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          2
      title
      Missing
    param Type
    NUMBER
    title
    Lactic Dehydrogenase
    unit Of Measure
    Participants
  11. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          138
        2. group Id
          BG001
          value
          142
        3. group Id
          BG002
          value
          123
        4. group Id
          BG003
          value
          403
      title
      Immunoglobulin A
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          8
        4. group Id
          BG003
          value
          21
      title
      Immunoglobulin A and Immunoglobulin G
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          1
      title
      Immunoglobulin A and Immunoglobulin M
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          15
      title
      Immunoglobulin D
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          334
        2. group Id
          BG001
          value
          331
        3. group Id
          BG002
          value
          350
        4. group Id
          BG003
          value
          1015
      title
      Immunoglobulin G
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          5
      title
      Immunoglobulin M
    7. categories
      1. measurements
        1. group Id
          BG000
          value
          49
        2. group Id
          BG001
          value
          54
        3. group Id
          BG002
          value
          60
        4. group Id
          BG003
          value
          163
      title
      Not available (includes light-chain disease)
    param Type
    NUMBER
    title
    Multiple Myeloma Subtype
    unit Of Measure
    Participants
  12. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          170
        2. group Id
          BG001
          value
          185
        3. group Id
          BG002
          value
          189
        4. group Id
          BG003
          value
          544
      title
      Adverse Risk
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          112
        2. group Id
          BG001
          value
          103
        3. group Id
          BG002
          value
          102
        4. group Id
          BG003
          value
          317
      title
      Favorable Hyperdiploidy
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          148
        2. group Id
          BG001
          value
          131
        3. group Id
          BG002
          value
          141
        4. group Id
          BG003
          value
          420
      title
      Normal
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          38
        2. group Id
          BG001
          value
          56
        3. group Id
          BG002
          value
          40
        4. group Id
          BG003
          value
          134
      title
      Uncertain Risk
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          34
        2. group Id
          BG001
          value
          35
        3. group Id
          BG002
          value
          44
        4. group Id
          BG003
          value
          113
      title
      Not evaluable
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          33
        2. group Id
          BG001
          value
          31
        3. group Id
          BG002
          value
          31
        4. group Id
          BG003
          value
          95
      title
      Missing
    description
    Cytogenetic risk categories are mutually exclusive. Definitions: Adverse risk category: t(4:14), t(14:16), del (13q) or monosomy 13, del (17p), 1q gain; Non-adverse risk categories include favorable hyperdiploidy: t(11:14), gains of 5/9/15; normal: a normal result, gains other than 5/9/15, IgH deletion, and uncertain risk: probes used for analysis cannot place participant in any risk categories. Not evaluable: no specimen received, test failure or insufficient number of cells available for analysis.
    param Type
    NUMBER
    title
    Cytogenetic Risk
    unit Of Measure
    Participants
population Description
Intent to Treat (ITT) population includes all participants who were randomized, independent of whether they received study treatment or not

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice