NCT02541383 · BASELINE
Baseline characteristics
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- denoms
- counts
- group Id
- BG000
- value
- 114
- group Id
- BG001
- value
- 85
- group Id
- BG002
- value
- 215
- group Id
- BG003
- value
- 213
- group Id
- BG004
- value
- 229
- group Id
- BG005
- value
- 229
- group Id
- BG006
- value
- 1085
- units
- Participants
- groups
- description
- Bortezomib (VELCADE), Thalidomide, and Dexamethasone (VTD), not re-randomized in maintenance phase
- id
- BG000
- title
- VTd Only
- description
- Daratumumab in combination with Bortezomib (VELCADE), Thalidomide, and Dexamethasone (VTD), not re-randomized in maintenance phase
- id
- BG001
- title
- DVTd Only
- description
- Bortezomib (VELCADE), Thalidomide, and Dexamethasone (VTD) re-randomized to observation
- id
- BG002
- title
- VTd-OBS
- description
- Bortezomib (VELCADE), Thalidomide, and Dexamethasone (VTD) re-randomized to daratumumab monotherapy
- id
- BG003
- title
- VTd-DARA
- description
- Daratumumab in combination with Bortezomib (VELCADE), Thalidomide, and Dexamethasone (VTD) re-randomized to observation
- id
- BG004
- title
- DVTd-OBS
- description
- Daratumumab in combination with Bortezomib (VELCADE), Thalidomide, and Dexamethasone (VTD) re-randomized to daratumumab monotherapy
- id
- BG005
- title
- DVTd-DARA
- description
- Total of all reporting groups
- id
- BG006
- title
- Total
- measures
- classes
- categories
- measurements
- group Id
- BG000
- spread
- 6.36
- value
- 57.7
- group Id
- BG001
- spread
- 7.5
- value
- 57.8
- group Id
- BG002
- spread
- 6.96
- value
- 56
- group Id
- BG003
- spread
- 7.38
- value
- 56.3
- group Id
- BG004
- spread
- 6.83
- value
- 56.8
- group Id
- BG005
- spread
- 6.79
- value
- 56.4
- group Id
- BG006
- spread
- 6.98
- value
- 56.6
- denoms
- counts
- group Id
- BG000
- value
- 114
- group Id
- BG001
- value
- 85
- group Id
- BG002
- value
- 215
- group Id
- BG003
- value
- 213
- group Id
- BG004
- value
- 229
- group Id
- BG005
- value
- 229
- group Id
- BG006
- value
- 1085
- units
- Participants
- dispersion Type
- STANDARD_DEVIATION
- param Type
- MEAN
- title
- Age, Continuous
- unit Of Measure
- years
- classes
- categories
- measurements
- group Id
- BG000
- value
- 42
- group Id
- BG001
- value
- 37
- group Id
- BG002
- value
- 94
- group Id
- BG003
- value
- 87
- group Id
- BG004
- value
- 96
- group Id
- BG005
- value
- 94
- group Id
- BG006
- value
- 450
- title
- Female
- measurements
- group Id
- BG000
- value
- 72
- group Id
- BG001
- value
- 48
- group Id
- BG002
- value
- 121
- group Id
- BG003
- value
- 126
- group Id
- BG004
- value
- 133
- group Id
- BG005
- value
- 135
- group Id
- BG006
- value
- 635
- title
- Male
- denoms
- counts
- group Id
- BG000
- value
- 114
- group Id
- BG001
- value
- 85
- group Id
- BG002
- value
- 215
- group Id
- BG003
- value
- 213
- group Id
- BG004
- value
- 229
- group Id
- BG005
- value
- 229
- group Id
- BG006
- value
- 1085
- units
- Participants
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Sex: Female, Male
- unit Of Measure
- Participants
- classes
- categories
- measurements
- group Id
- BG006
- value
- 0
- denoms
- counts
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 0
- group Id
- BG004
- value
- 0
- group Id
- BG005
- value
- 0
- group Id
- BG006
- value
- 0
- units
- Participants
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Race and Ethnicity were not collected from any participant.
- title
- Race and Ethnicity Not Collected
- unit Of Measure
- Participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 15
- group Id
- BG001
- value
- 5
- group Id
- BG002
- value
- 11
- group Id
- BG003
- value
- 18
- group Id
- BG004
- value
- 23
- group Id
- BG005
- value
- 17
- group Id
- BG006
- value
- 89
- denoms
- counts
- group Id
- BG000
- value
- 114
- group Id
- BG001
- value
- 85
- group Id
- BG002
- value
- 215
- group Id
- BG003
- value
- 213
- group Id
- BG004
- value
- 229
- group Id
- BG005
- value
- 229
- group Id
- BG006
- value
- 1085
- units
- Participants
- title
- BELGIUM
- categories
- measurements
- group Id
- BG000
- value
- 70
- group Id
- BG001
- value
- 64
- group Id
- BG002
- value
- 191
- group Id
- BG003
- value
- 169
- group Id
- BG004
- value
- 177
- group Id
- BG005
- value
- 183
- group Id
- BG006
- value
- 854
- denoms
- counts
- group Id
- BG000
- value
- 114
- group Id
- BG001
- value
- 85
- group Id
- BG002
- value
- 215
- group Id
- BG003
- value
- 213
- group Id
- BG004
- value
- 229
- group Id
- BG005
- value
- 229
- group Id
- BG006
- value
- 1085
- units
- Participants
- title
- FRANCE
- categories
- measurements
- group Id
- BG000
- value
- 29
- group Id
- BG001
- value
- 16
- group Id
- BG002
- value
- 13
- group Id
- BG003
- value
- 26
- group Id
- BG004
- value
- 29
- group Id
- BG005
- value
- 29
- group Id
- BG006
- value
- 142
- denoms
- counts
- group Id
- BG000
- value
- 114
- group Id
- BG001
- value
- 85
- group Id
- BG002
- value
- 215
- group Id
- BG003
- value
- 213
- group Id
- BG004
- value
- 229
- group Id
- BG005
- value
- 229
- group Id
- BG006
- value
- 1085
- units
- Participants
- title
- NETHERLANDS
- param Type
- NUMBER
- title
- Region of Enrollment
- unit Of Measure
- participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 47
- group Id
- BG001
- value
- 25
- group Id
- BG002
- value
- 88
- group Id
- BG003
- value
- 93
- group Id
- BG004
- value
- 83
- group Id
- BG005
- value
- 96
- group Id
- BG006
- value
- 432
- denoms
- counts
- group Id
- BG000
- value
- 114
- group Id
- BG001
- value
- 85
- group Id
- BG002
- value
- 215
- group Id
- BG003
- value
- 213
- group Id
- BG004
- value
- 229
- group Id
- BG005
- value
- 229
- group Id
- BG006
- value
- 1085
- units
- Participants
- title
- I
- categories
- measurements
- group Id
- BG000
- value
- 52
- group Id
- BG001
- value
- 41
- group Id
- BG002
- value
- 96
- group Id
- BG003
- value
- 85
- group Id
- BG004
- value
- 118
- group Id
- BG005
- value
- 96
- group Id
- BG006
- value
- 488
- denoms
- counts
- group Id
- BG000
- value
- 114
- group Id
- BG001
- value
- 85
- group Id
- BG002
- value
- 215
- group Id
- BG003
- value
- 213
- group Id
- BG004
- value
- 229
- group Id
- BG005
- value
- 229
- group Id
- BG006
- value
- 1085
- units
- Participants
- title
- II
- categories
- measurements
- group Id
- BG000
- value
- 15
- group Id
- BG001
- value
- 19
- group Id
- BG002
- value
- 31
- group Id
- BG003
- value
- 35
- group Id
- BG004
- value
- 28
- group Id
- BG005
- value
- 37
- group Id
- BG006
- value
- 165
- denoms
- counts
- group Id
- BG000
- value
- 114
- group Id
- BG001
- value
- 85
- group Id
- BG002
- value
- 215
- group Id
- BG003
- value
- 213
- group Id
- BG004
- value
- 229
- group Id
- BG005
- value
- 229
- group Id
- BG006
- value
- 1085
- units
- Participants
- title
- III
- description
- The International Staging System (ISS) for Multiple Myeloma was established by the International Myeloma Working Group (IMWG) in 2005. Sβ2M = Serum β2 microglobulin. Stage I is defined by Sβ2M \< 3.5 mg/L and serum albumin ≥ 3.5 g/dL - Stage II is defined by Sβ2M \< 3.5 mg/L and serum albumin \< 3.5 g/dL; or β2M ≥ 3.5 mg/L and \< 5.5 mg/L, irrespective of serum albumin - Stage III is defined by Sβ2M ≥ 5.5 mg/L Stage I is considered to have a better prognosis and stage III a worse prognosis.
- param Type
- NUMBER
- title
- Baseline ISS Stage
- unit Of Measure
- participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 1
- group Id
- BG001
- value
- 2
- group Id
- BG002
- value
- 10
- group Id
- BG003
- value
- 8
- group Id
- BG004
- value
- 5
- group Id
- BG005
- value
- 5
- group Id
- BG006
- value
- 31
- denoms
- counts
- group Id
- BG000
- value
- 114
- group Id
- BG001
- value
- 85
- group Id
- BG002
- value
- 215
- group Id
- BG003
- value
- 213
- group Id
- BG004
- value
- 229
- group Id
- BG005
- value
- 229
- group Id
- BG006
- value
- 1085
- units
- Participants
- title
- Biclonal
- categories
- measurements
- group Id
- BG000
- value
- 15
- group Id
- BG001
- value
- 14
- group Id
- BG002
- value
- 46
- group Id
- BG003
- value
- 43
- group Id
- BG004
- value
- 36
- group Id
- BG005
- value
- 37
- group Id
- BG006
- value
- 191
- denoms
- counts
- group Id
- BG000
- value
- 114
- group Id
- BG001
- value
- 85
- group Id
- BG002
- value
- 215
- group Id
- BG003
- value
- 213
- group Id
- BG004
- value
- 229
- group Id
- BG005
- value
- 229
- group Id
- BG006
- value
- 1085
- units
- Participants
- title
- IgA
- categories
- measurements
- group Id
- BG000
- value
- 3
- group Id
- BG001
- value
- 1
- group Id
- BG002
- value
- 3
- group Id
- BG003
- value
- 7
- group Id
- BG004
- value
- 2
- group Id
- BG005
- value
- 2
- group Id
- BG006
- value
- 18
- denoms
- counts
- group Id
- BG000
- value
- 114
- group Id
- BG001
- value
- 85
- group Id
- BG002
- value
- 215
- group Id
- BG003
- value
- 213
- group Id
- BG004
- value
- 229
- group Id
- BG005
- value
- 229
- group Id
- BG006
- value
- 1085
- units
- Participants
- title
- IgD
- categories
- measurements
- group Id
- BG000
- value
- 79
- group Id
- BG001
- value
- 54
- group Id
- BG002
- value
- 126
- group Id
- BG003
- value
- 128
- group Id
- BG004
- value
- 159
- group Id
- BG005
- value
- 138
- group Id
- BG006
- value
- 684
- denoms
- counts
- group Id
- BG000
- value
- 114
- group Id
- BG001
- value
- 85
- group Id
- BG002
- value
- 215
- group Id
- BG003
- value
- 213
- group Id
- BG004
- value
- 229
- group Id
- BG005
- value
- 229
- group Id
- BG006
- value
- 1085
- units
- Participants
- title
- IgG
- categories
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 1
- group Id
- BG003
- value
- 1
- group Id
- BG004
- value
- 0
- group Id
- BG005
- value
- 1
- group Id
- BG006
- value
- 3
- denoms
- counts
- group Id
- BG000
- value
- 114
- group Id
- BG001
- value
- 85
- group Id
- BG002
- value
- 215
- group Id
- BG003
- value
- 213
- group Id
- BG004
- value
- 229
- group Id
- BG005
- value
- 229
- group Id
- BG006
- value
- 1085
- units
- Participants
- title
- IgM
- categories
- measurements
- group Id
- BG000
- value
- 11
- group Id
- BG001
- value
- 9
- group Id
- BG002
- value
- 17
- group Id
- BG003
- value
- 18
- group Id
- BG004
- value
- 17
- group Id
- BG005
- value
- 27
- group Id
- BG006
- value
- 99
- denoms
- counts
- group Id
- BG000
- value
- 114
- group Id
- BG001
- value
- 85
- group Id
- BG002
- value
- 215
- group Id
- BG003
- value
- 213
- group Id
- BG004
- value
- 229
- group Id
- BG005
- value
- 229
- group Id
- BG006
- value
- 1085
- units
- Participants
- title
- Kappa
- categories
- measurements
- group Id
- BG000
- value
- 3
- group Id
- BG001
- value
- 5
- group Id
- BG002
- value
- 10
- group Id
- BG003
- value
- 7
- group Id
- BG004
- value
- 8
- group Id
- BG005
- value
- 17
- group Id
- BG006
- value
- 50
- denoms
- counts
- group Id
- BG000
- value
- 114
- group Id
- BG001
- value
- 85
- group Id
- BG002
- value
- 215
- group Id
- BG003
- value
- 213
- group Id
- BG004
- value
- 229
- group Id
- BG005
- value
- 229
- group Id
- BG006
- value
- 1085
- units
- Participants
- title
- Lambda
- categories
- measurements
- group Id
- BG000
- value
- 2
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 2
- group Id
- BG003
- value
- 1
- group Id
- BG004
- value
- 2
- group Id
- BG005
- value
- 2
- group Id
- BG006
- value
- 9
- denoms
- counts
- group Id
- BG000
- value
- 114
- group Id
- BG001
- value
- 85
- group Id
- BG002
- value
- 215
- group Id
- BG003
- value
- 213
- group Id
- BG004
- value
- 229
- group Id
- BG005
- value
- 229
- group Id
- BG006
- value
- 1085
- units
- Participants
- title
- Negative immunofixation
- description
- Multiple myeloma has different types of monoclonal proteins. These types are based on the immunoglobulin (protein) produced by the myeloma cell and they are identified by immunofixation method. The five types of heavy protein chains are G, A, D, E, and M. The two types of light protein chains are kappa (κ) and lambda (λ). The myeloma cells may secrete heavy and light protein chains (i.e. IgG Kappa) but also only light protein chains. Row "Biclonal" = the myeloma cells (plasmocytes) produce two immunoglobulins with heavy chains - Row "negative immunofixation" = absence of monoclonal proteins
- param Type
- NUMBER
- title
- Baseline Type of Myeloma
- unit Of Measure
- participants
- classes
- categories
- measurements
- group Id
- BG000
- spread
- 2.65
- value
- 1.6
- group Id
- BG001
- spread
- 0.96
- value
- 1.3
- group Id
- BG002
- spread
- 0.86
- value
- 1.2
- group Id
- BG003
- spread
- 0.87
- value
- 1.2
- group Id
- BG004
- spread
- 1.08
- value
- 1.2
- group Id
- BG005
- spread
- 0.95
- value
- 1.2
- group Id
- BG006
- spread
- 1.25
- value
- 1.2
- denoms
- counts
- group Id
- BG000
- value
- 114
- group Id
- BG001
- value
- 85
- group Id
- BG002
- value
- 215
- group Id
- BG003
- value
- 213
- group Id
- BG004
- value
- 229
- group Id
- BG005
- value
- 229
- group Id
- BG006
- value
- 1085
- units
- Participants
- dispersion Type
- STANDARD_DEVIATION
- param Type
- MEAN
- title
- Time since initial diagnosis to randomization (months)
- unit Of Measure
- months
- classes
- categories
- measurements
- group Id
- BG000
- value
- 100
- group Id
- BG001
- value
- 76
- group Id
- BG002
- value
- 197
- group Id
- BG003
- value
- 194
- group Id
- BG004
- value
- 203
- group Id
- BG005
- value
- 208
- group Id
- BG006
- value
- 978
- denoms
- counts
- group Id
- BG000
- value
- 114
- group Id
- BG001
- value
- 85
- group Id
- BG002
- value
- 215
- group Id
- BG003
- value
- 213
- group Id
- BG004
- value
- 229
- group Id
- BG005
- value
- 229
- group Id
- BG006
- value
- 1085
- units
- Participants
- title
- No
- categories
- measurements
- group Id
- BG000
- value
- 14
- group Id
- BG001
- value
- 9
- group Id
- BG002
- value
- 18
- group Id
- BG003
- value
- 17
- group Id
- BG004
- value
- 25
- group Id
- BG005
- value
- 19
- group Id
- BG006
- value
- 102
- denoms
- counts
- group Id
- BG000
- value
- 114
- group Id
- BG001
- value
- 85
- group Id
- BG002
- value
- 215
- group Id
- BG003
- value
- 213
- group Id
- BG004
- value
- 229
- group Id
- BG005
- value
- 229
- group Id
- BG006
- value
- 1085
- units
- Participants
- title
- Yes
- categories
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 2
- group Id
- BG004
- value
- 1
- group Id
- BG005
- value
- 2
- group Id
- BG006
- value
- 5
- denoms
- counts
- group Id
- BG000
- value
- 114
- group Id
- BG001
- value
- 85
- group Id
- BG002
- value
- 215
- group Id
- BG003
- value
- 213
- group Id
- BG004
- value
- 229
- group Id
- BG005
- value
- 229
- group Id
- BG006
- value
- 1085
- units
- Participants
- title
- Missing
- param Type
- NUMBER
- title
- Presence of diffuse myeloma-related osteopenia
- unit Of Measure
- participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 3
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 3
- group Id
- BG003
- value
- 3
- group Id
- BG004
- value
- 4
- group Id
- BG005
- value
- 6
- group Id
- BG006
- value
- 19
- denoms
- counts
- group Id
- BG000
- value
- 114
- group Id
- BG001
- value
- 85
- group Id
- BG002
- value
- 215
- group Id
- BG003
- value
- 213
- group Id
- BG004
- value
- 229
- group Id
- BG005
- value
- 229
- group Id
- BG006
- value
- 1085
- units
- Participants
- title
- No
- categories
- measurements
- group Id
- BG000
- value
- 111
- group Id
- BG001
- value
- 85
- group Id
- BG002
- value
- 212
- group Id
- BG003
- value
- 210
- group Id
- BG004
- value
- 225
- group Id
- BG005
- value
- 223
- group Id
- BG006
- value
- 1066
- denoms
- counts
- group Id
- BG000
- value
- 114
- group Id
- BG001
- value
- 85
- group Id
- BG002
- value
- 215
- group Id
- BG003
- value
- 213
- group Id
- BG004
- value
- 229
- group Id
- BG005
- value
- 229
- group Id
- BG006
- value
- 1085
- units
- Participants
- title
- Yes
- param Type
- NUMBER
- title
- Presence of evaluable bone marrow assessment
- unit Of Measure
- participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 30
- group Id
- BG001
- value
- 28
- group Id
- BG002
- value
- 62
- group Id
- BG003
- value
- 63
- group Id
- BG004
- value
- 62
- group Id
- BG005
- value
- 46
- group Id
- BG006
- value
- 291
- denoms
- counts
- group Id
- BG000
- value
- 114
- group Id
- BG001
- value
- 85
- group Id
- BG002
- value
- 215
- group Id
- BG003
- value
- 213
- group Id
- BG004
- value
- 229
- group Id
- BG005
- value
- 229
- group Id
- BG006
- value
- 1085
- units
- Participants
- title
- Hypercellular
- categories
- measurements
- group Id
- BG000
- value
- 1
- group Id
- BG001
- value
- 3
- group Id
- BG002
- value
- 8
- group Id
- BG003
- value
- 8
- group Id
- BG004
- value
- 6
- group Id
- BG005
- value
- 8
- group Id
- BG006
- value
- 34
- denoms
- counts
- group Id
- BG000
- value
- 114
- group Id
- BG001
- value
- 85
- group Id
- BG002
- value
- 215
- group Id
- BG003
- value
- 213
- group Id
- BG004
- value
- 229
- group Id
- BG005
- value
- 229
- group Id
- BG006
- value
- 1085
- units
- Participants
- title
- Indeterminate
- categories
- measurements
- group Id
- BG000
- value
- 24
- group Id
- BG001
- value
- 19
- group Id
- BG002
- value
- 50
- group Id
- BG003
- value
- 42
- group Id
- BG004
- value
- 41
- group Id
- BG005
- value
- 47
- group Id
- BG006
- value
- 223
- denoms
- counts
- group Id
- BG000
- value
- 114
- group Id
- BG001
- value
- 85
- group Id
- BG002
- value
- 215
- group Id
- BG003
- value
- 213
- group Id
- BG004
- value
- 229
- group Id
- BG005
- value
- 229
- group Id
- BG006
- value
- 1085
- units
- Participants
- title
- Moderately cellular
- categories
- measurements
- group Id
- BG000
- value
- 52
- group Id
- BG001
- value
- 31
- group Id
- BG002
- value
- 78
- group Id
- BG003
- value
- 93
- group Id
- BG004
- value
- 101
- group Id
- BG005
- value
- 112
- group Id
- BG006
- value
- 467
- denoms
- counts
- group Id
- BG000
- value
- 114
- group Id
- BG001
- value
- 85
- group Id
- BG002
- value
- 215
- group Id
- BG003
- value
- 213
- group Id
- BG004
- value
- 229
- group Id
- BG005
- value
- 229
- group Id
- BG006
- value
- 1085
- units
- Participants
- title
- Normocellular
- categories
- measurements
- group Id
- BG000
- value
- 5
- group Id
- BG001
- value
- 3
- group Id
- BG002
- value
- 13
- group Id
- BG003
- value
- 5
- group Id
- BG004
- value
- 14
- group Id
- BG005
- value
- 10
- group Id
- BG006
- value
- 50
- denoms
- counts
- group Id
- BG000
- value
- 114
- group Id
- BG001
- value
- 85
- group Id
- BG002
- value
- 215
- group Id
- BG003
- value
- 213
- group Id
- BG004
- value
- 229
- group Id
- BG005
- value
- 229
- group Id
- BG006
- value
- 1085
- units
- Participants
- title
- Severely acellular
- categories
- measurements
- group Id
- BG000
- value
- 2
- group Id
- BG001
- value
- 1
- group Id
- BG002
- value
- 4
- group Id
- BG003
- value
- 2
- group Id
- BG004
- value
- 5
- group Id
- BG005
- value
- 6
- group Id
- BG006
- value
- 20
- denoms
- counts
- group Id
- BG000
- value
- 114
- group Id
- BG001
- value
- 85
- group Id
- BG002
- value
- 215
- group Id
- BG003
- value
- 213
- group Id
- BG004
- value
- 229
- group Id
- BG005
- value
- 229
- group Id
- BG006
- value
- 1085
- units
- Participants
- title
- Missing
- description
- A sample of bone marrow aspirate was analyzed to count the cells and assess the cellular richness
- param Type
- NUMBER
- title
- Bone marrow cellularity
- unit Of Measure
- participants
Complete source fields
- denoms
- counts
- group Id
- BG000
- value
- 114
- group Id
- BG001
- value
- 85
- group Id
- BG002
- value
- 215
- group Id
- BG003
- value
- 213
- group Id
- BG004
- value
- 229
- group Id
- BG005
- value
- 229
- group Id
- BG006
- value
- 1085
- units
- Participants
- groups
- description
- Bortezomib (VELCADE), Thalidomide, and Dexamethasone (VTD), not re-randomized in maintenance phase
- id
- BG000
- title
- VTd Only
- description
- Daratumumab in combination with Bortezomib (VELCADE), Thalidomide, and Dexamethasone (VTD), not re-randomized in maintenance phase
- id
- BG001
- title
- DVTd Only
- description
- Bortezomib (VELCADE), Thalidomide, and Dexamethasone (VTD) re-randomized to observation
- id
- BG002
- title
- VTd-OBS
- description
- Bortezomib (VELCADE), Thalidomide, and Dexamethasone (VTD) re-randomized to daratumumab monotherapy
- id
- BG003
- title
- VTd-DARA
- description
- Daratumumab in combination with Bortezomib (VELCADE), Thalidomide, and Dexamethasone (VTD) re-randomized to observation
- id
- BG004
- title
- DVTd-OBS
- description
- Daratumumab in combination with Bortezomib (VELCADE), Thalidomide, and Dexamethasone (VTD) re-randomized to daratumumab monotherapy
- id
- BG005
- title
- DVTd-DARA
- description
- Total of all reporting groups
- id
- BG006
- title
- Total
- measures
- classes
- categories
- measurements
- group Id
- BG000
- spread
- 6.36
- value
- 57.7
- group Id
- BG001
- spread
- 7.5
- value
- 57.8
- group Id
- BG002
- spread
- 6.96
- value
- 56
- group Id
- BG003
- spread
- 7.38
- value
- 56.3
- group Id
- BG004
- spread
- 6.83
- value
- 56.8
- group Id
- BG005
- spread
- 6.79
- value
- 56.4
- group Id
- BG006
- spread
- 6.98
- value
- 56.6
- denoms
- counts
- group Id
- BG000
- value
- 114
- group Id
- BG001
- value
- 85
- group Id
- BG002
- value
- 215
- group Id
- BG003
- value
- 213
- group Id
- BG004
- value
- 229
- group Id
- BG005
- value
- 229
- group Id
- BG006
- value
- 1085
- units
- Participants
- dispersion Type
- STANDARD_DEVIATION
- param Type
- MEAN
- title
- Age, Continuous
- unit Of Measure
- years
- classes
- categories
- measurements
- group Id
- BG000
- value
- 42
- group Id
- BG001
- value
- 37
- group Id
- BG002
- value
- 94
- group Id
- BG003
- value
- 87
- group Id
- BG004
- value
- 96
- group Id
- BG005
- value
- 94
- group Id
- BG006
- value
- 450
- title
- Female
- measurements
- group Id
- BG000
- value
- 72
- group Id
- BG001
- value
- 48
- group Id
- BG002
- value
- 121
- group Id
- BG003
- value
- 126
- group Id
- BG004
- value
- 133
- group Id
- BG005
- value
- 135
- group Id
- BG006
- value
- 635
- title
- Male
- denoms
- counts
- group Id
- BG000
- value
- 114
- group Id
- BG001
- value
- 85
- group Id
- BG002
- value
- 215
- group Id
- BG003
- value
- 213
- group Id
- BG004
- value
- 229
- group Id
- BG005
- value
- 229
- group Id
- BG006
- value
- 1085
- units
- Participants
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Sex: Female, Male
- unit Of Measure
- Participants
- classes
- categories
- measurements
- group Id
- BG006
- value
- 0
- denoms
- counts
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 0
- group Id
- BG004
- value
- 0
- group Id
- BG005
- value
- 0
- group Id
- BG006
- value
- 0
- units
- Participants
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Race and Ethnicity were not collected from any participant.
- title
- Race and Ethnicity Not Collected
- unit Of Measure
- Participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 15
- group Id
- BG001
- value
- 5
- group Id
- BG002
- value
- 11
- group Id
- BG003
- value
- 18
- group Id
- BG004
- value
- 23
- group Id
- BG005
- value
- 17
- group Id
- BG006
- value
- 89
- denoms
- counts
- group Id
- BG000
- value
- 114
- group Id
- BG001
- value
- 85
- group Id
- BG002
- value
- 215
- group Id
- BG003
- value
- 213
- group Id
- BG004
- value
- 229
- group Id
- BG005
- value
- 229
- group Id
- BG006
- value
- 1085
- units
- Participants
- title
- BELGIUM
- categories
- measurements
- group Id
- BG000
- value
- 70
- group Id
- BG001
- value
- 64
- group Id
- BG002
- value
- 191
- group Id
- BG003
- value
- 169
- group Id
- BG004
- value
- 177
- group Id
- BG005
- value
- 183
- group Id
- BG006
- value
- 854
- denoms
- counts
- group Id
- BG000
- value
- 114
- group Id
- BG001
- value
- 85
- group Id
- BG002
- value
- 215
- group Id
- BG003
- value
- 213
- group Id
- BG004
- value
- 229
- group Id
- BG005
- value
- 229
- group Id
- BG006
- value
- 1085
- units
- Participants
- title
- FRANCE
- categories
- measurements
- group Id
- BG000
- value
- 29
- group Id
- BG001
- value
- 16
- group Id
- BG002
- value
- 13
- group Id
- BG003
- value
- 26
- group Id
- BG004
- value
- 29
- group Id
- BG005
- value
- 29
- group Id
- BG006
- value
- 142
- denoms
- counts
- group Id
- BG000
- value
- 114
- group Id
- BG001
- value
- 85
- group Id
- BG002
- value
- 215
- group Id
- BG003
- value
- 213
- group Id
- BG004
- value
- 229
- group Id
- BG005
- value
- 229
- group Id
- BG006
- value
- 1085
- units
- Participants
- title
- NETHERLANDS
- param Type
- NUMBER
- title
- Region of Enrollment
- unit Of Measure
- participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 47
- group Id
- BG001
- value
- 25
- group Id
- BG002
- value
- 88
- group Id
- BG003
- value
- 93
- group Id
- BG004
- value
- 83
- group Id
- BG005
- value
- 96
- group Id
- BG006
- value
- 432
- denoms
- counts
- group Id
- BG000
- value
- 114
- group Id
- BG001
- value
- 85
- group Id
- BG002
- value
- 215
- group Id
- BG003
- value
- 213
- group Id
- BG004
- value
- 229
- group Id
- BG005
- value
- 229
- group Id
- BG006
- value
- 1085
- units
- Participants
- title
- I
- categories
- measurements
- group Id
- BG000
- value
- 52
- group Id
- BG001
- value
- 41
- group Id
- BG002
- value
- 96
- group Id
- BG003
- value
- 85
- group Id
- BG004
- value
- 118
- group Id
- BG005
- value
- 96
- group Id
- BG006
- value
- 488
- denoms
- counts
- group Id
- BG000
- value
- 114
- group Id
- BG001
- value
- 85
- group Id
- BG002
- value
- 215
- group Id
- BG003
- value
- 213
- group Id
- BG004
- value
- 229
- group Id
- BG005
- value
- 229
- group Id
- BG006
- value
- 1085
- units
- Participants
- title
- II
- categories
- measurements
- group Id
- BG000
- value
- 15
- group Id
- BG001
- value
- 19
- group Id
- BG002
- value
- 31
- group Id
- BG003
- value
- 35
- group Id
- BG004
- value
- 28
- group Id
- BG005
- value
- 37
- group Id
- BG006
- value
- 165
- denoms
- counts
- group Id
- BG000
- value
- 114
- group Id
- BG001
- value
- 85
- group Id
- BG002
- value
- 215
- group Id
- BG003
- value
- 213
- group Id
- BG004
- value
- 229
- group Id
- BG005
- value
- 229
- group Id
- BG006
- value
- 1085
- units
- Participants
- title
- III
- description
- The International Staging System (ISS) for Multiple Myeloma was established by the International Myeloma Working Group (IMWG) in 2005. Sβ2M = Serum β2 microglobulin. Stage I is defined by Sβ2M \< 3.5 mg/L and serum albumin ≥ 3.5 g/dL - Stage II is defined by Sβ2M \< 3.5 mg/L and serum albumin \< 3.5 g/dL; or β2M ≥ 3.5 mg/L and \< 5.5 mg/L, irrespective of serum albumin - Stage III is defined by Sβ2M ≥ 5.5 mg/L Stage I is considered to have a better prognosis and stage III a worse prognosis.
- param Type
- NUMBER
- title
- Baseline ISS Stage
- unit Of Measure
- participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 1
- group Id
- BG001
- value
- 2
- group Id
- BG002
- value
- 10
- group Id
- BG003
- value
- 8
- group Id
- BG004
- value
- 5
- group Id
- BG005
- value
- 5
- group Id
- BG006
- value
- 31
- denoms
- counts
- group Id
- BG000
- value
- 114
- group Id
- BG001
- value
- 85
- group Id
- BG002
- value
- 215
- group Id
- BG003
- value
- 213
- group Id
- BG004
- value
- 229
- group Id
- BG005
- value
- 229
- group Id
- BG006
- value
- 1085
- units
- Participants
- title
- Biclonal
- categories
- measurements
- group Id
- BG000
- value
- 15
- group Id
- BG001
- value
- 14
- group Id
- BG002
- value
- 46
- group Id
- BG003
- value
- 43
- group Id
- BG004
- value
- 36
- group Id
- BG005
- value
- 37
- group Id
- BG006
- value
- 191
- denoms
- counts
- group Id
- BG000
- value
- 114
- group Id
- BG001
- value
- 85
- group Id
- BG002
- value
- 215
- group Id
- BG003
- value
- 213
- group Id
- BG004
- value
- 229
- group Id
- BG005
- value
- 229
- group Id
- BG006
- value
- 1085
- units
- Participants
- title
- IgA
- categories
- measurements
- group Id
- BG000
- value
- 3
- group Id
- BG001
- value
- 1
- group Id
- BG002
- value
- 3
- group Id
- BG003
- value
- 7
- group Id
- BG004
- value
- 2
- group Id
- BG005
- value
- 2
- group Id
- BG006
- value
- 18
- denoms
- counts
- group Id
- BG000
- value
- 114
- group Id
- BG001
- value
- 85
- group Id
- BG002
- value
- 215
- group Id
- BG003
- value
- 213
- group Id
- BG004
- value
- 229
- group Id
- BG005
- value
- 229
- group Id
- BG006
- value
- 1085
- units
- Participants
- title
- IgD
- categories
- measurements
- group Id
- BG000
- value
- 79
- group Id
- BG001
- value
- 54
- group Id
- BG002
- value
- 126
- group Id
- BG003
- value
- 128
- group Id
- BG004
- value
- 159
- group Id
- BG005
- value
- 138
- group Id
- BG006
- value
- 684
- denoms
- counts
- group Id
- BG000
- value
- 114
- group Id
- BG001
- value
- 85
- group Id
- BG002
- value
- 215
- group Id
- BG003
- value
- 213
- group Id
- BG004
- value
- 229
- group Id
- BG005
- value
- 229
- group Id
- BG006
- value
- 1085
- units
- Participants
- title
- IgG
- categories
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 1
- group Id
- BG003
- value
- 1
- group Id
- BG004
- value
- 0
- group Id
- BG005
- value
- 1
- group Id
- BG006
- value
- 3
- denoms
- counts
- group Id
- BG000
- value
- 114
- group Id
- BG001
- value
- 85
- group Id
- BG002
- value
- 215
- group Id
- BG003
- value
- 213
- group Id
- BG004
- value
- 229
- group Id
- BG005
- value
- 229
- group Id
- BG006
- value
- 1085
- units
- Participants
- title
- IgM
- categories
- measurements
- group Id
- BG000
- value
- 11
- group Id
- BG001
- value
- 9
- group Id
- BG002
- value
- 17
- group Id
- BG003
- value
- 18
- group Id
- BG004
- value
- 17
- group Id
- BG005
- value
- 27
- group Id
- BG006
- value
- 99
- denoms
- counts
- group Id
- BG000
- value
- 114
- group Id
- BG001
- value
- 85
- group Id
- BG002
- value
- 215
- group Id
- BG003
- value
- 213
- group Id
- BG004
- value
- 229
- group Id
- BG005
- value
- 229
- group Id
- BG006
- value
- 1085
- units
- Participants
- title
- Kappa
- categories
- measurements
- group Id
- BG000
- value
- 3
- group Id
- BG001
- value
- 5
- group Id
- BG002
- value
- 10
- group Id
- BG003
- value
- 7
- group Id
- BG004
- value
- 8
- group Id
- BG005
- value
- 17
- group Id
- BG006
- value
- 50
- denoms
- counts
- group Id
- BG000
- value
- 114
- group Id
- BG001
- value
- 85
- group Id
- BG002
- value
- 215
- group Id
- BG003
- value
- 213
- group Id
- BG004
- value
- 229
- group Id
- BG005
- value
- 229
- group Id
- BG006
- value
- 1085
- units
- Participants
- title
- Lambda
- categories
- measurements
- group Id
- BG000
- value
- 2
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 2
- group Id
- BG003
- value
- 1
- group Id
- BG004
- value
- 2
- group Id
- BG005
- value
- 2
- group Id
- BG006
- value
- 9
- denoms
- counts
- group Id
- BG000
- value
- 114
- group Id
- BG001
- value
- 85
- group Id
- BG002
- value
- 215
- group Id
- BG003
- value
- 213
- group Id
- BG004
- value
- 229
- group Id
- BG005
- value
- 229
- group Id
- BG006
- value
- 1085
- units
- Participants
- title
- Negative immunofixation
- description
- Multiple myeloma has different types of monoclonal proteins. These types are based on the immunoglobulin (protein) produced by the myeloma cell and they are identified by immunofixation method. The five types of heavy protein chains are G, A, D, E, and M. The two types of light protein chains are kappa (κ) and lambda (λ). The myeloma cells may secrete heavy and light protein chains (i.e. IgG Kappa) but also only light protein chains. Row "Biclonal" = the myeloma cells (plasmocytes) produce two immunoglobulins with heavy chains - Row "negative immunofixation" = absence of monoclonal proteins
- param Type
- NUMBER
- title
- Baseline Type of Myeloma
- unit Of Measure
- participants
- classes
- categories
- measurements
- group Id
- BG000
- spread
- 2.65
- value
- 1.6
- group Id
- BG001
- spread
- 0.96
- value
- 1.3
- group Id
- BG002
- spread
- 0.86
- value
- 1.2
- group Id
- BG003
- spread
- 0.87
- value
- 1.2
- group Id
- BG004
- spread
- 1.08
- value
- 1.2
- group Id
- BG005
- spread
- 0.95
- value
- 1.2
- group Id
- BG006
- spread
- 1.25
- value
- 1.2
- denoms
- counts
- group Id
- BG000
- value
- 114
- group Id
- BG001
- value
- 85
- group Id
- BG002
- value
- 215
- group Id
- BG003
- value
- 213
- group Id
- BG004
- value
- 229
- group Id
- BG005
- value
- 229
- group Id
- BG006
- value
- 1085
- units
- Participants
- dispersion Type
- STANDARD_DEVIATION
- param Type
- MEAN
- title
- Time since initial diagnosis to randomization (months)
- unit Of Measure
- months
- classes
- categories
- measurements
- group Id
- BG000
- value
- 100
- group Id
- BG001
- value
- 76
- group Id
- BG002
- value
- 197
- group Id
- BG003
- value
- 194
- group Id
- BG004
- value
- 203
- group Id
- BG005
- value
- 208
- group Id
- BG006
- value
- 978
- denoms
- counts
- group Id
- BG000
- value
- 114
- group Id
- BG001
- value
- 85
- group Id
- BG002
- value
- 215
- group Id
- BG003
- value
- 213
- group Id
- BG004
- value
- 229
- group Id
- BG005
- value
- 229
- group Id
- BG006
- value
- 1085
- units
- Participants
- title
- No
- categories
- measurements
- group Id
- BG000
- value
- 14
- group Id
- BG001
- value
- 9
- group Id
- BG002
- value
- 18
- group Id
- BG003
- value
- 17
- group Id
- BG004
- value
- 25
- group Id
- BG005
- value
- 19
- group Id
- BG006
- value
- 102
- denoms
- counts
- group Id
- BG000
- value
- 114
- group Id
- BG001
- value
- 85
- group Id
- BG002
- value
- 215
- group Id
- BG003
- value
- 213
- group Id
- BG004
- value
- 229
- group Id
- BG005
- value
- 229
- group Id
- BG006
- value
- 1085
- units
- Participants
- title
- Yes
- categories
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 2
- group Id
- BG004
- value
- 1
- group Id
- BG005
- value
- 2
- group Id
- BG006
- value
- 5
- denoms
- counts
- group Id
- BG000
- value
- 114
- group Id
- BG001
- value
- 85
- group Id
- BG002
- value
- 215
- group Id
- BG003
- value
- 213
- group Id
- BG004
- value
- 229
- group Id
- BG005
- value
- 229
- group Id
- BG006
- value
- 1085
- units
- Participants
- title
- Missing
- param Type
- NUMBER
- title
- Presence of diffuse myeloma-related osteopenia
- unit Of Measure
- participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 3
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 3
- group Id
- BG003
- value
- 3
- group Id
- BG004
- value
- 4
- group Id
- BG005
- value
- 6
- group Id
- BG006
- value
- 19
- denoms
- counts
- group Id
- BG000
- value
- 114
- group Id
- BG001
- value
- 85
- group Id
- BG002
- value
- 215
- group Id
- BG003
- value
- 213
- group Id
- BG004
- value
- 229
- group Id
- BG005
- value
- 229
- group Id
- BG006
- value
- 1085
- units
- Participants
- title
- No
- categories
- measurements
- group Id
- BG000
- value
- 111
- group Id
- BG001
- value
- 85
- group Id
- BG002
- value
- 212
- group Id
- BG003
- value
- 210
- group Id
- BG004
- value
- 225
- group Id
- BG005
- value
- 223
- group Id
- BG006
- value
- 1066
- denoms
- counts
- group Id
- BG000
- value
- 114
- group Id
- BG001
- value
- 85
- group Id
- BG002
- value
- 215
- group Id
- BG003
- value
- 213
- group Id
- BG004
- value
- 229
- group Id
- BG005
- value
- 229
- group Id
- BG006
- value
- 1085
- units
- Participants
- title
- Yes
- param Type
- NUMBER
- title
- Presence of evaluable bone marrow assessment
- unit Of Measure
- participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 30
- group Id
- BG001
- value
- 28
- group Id
- BG002
- value
- 62
- group Id
- BG003
- value
- 63
- group Id
- BG004
- value
- 62
- group Id
- BG005
- value
- 46
- group Id
- BG006
- value
- 291
- denoms
- counts
- group Id
- BG000
- value
- 114
- group Id
- BG001
- value
- 85
- group Id
- BG002
- value
- 215
- group Id
- BG003
- value
- 213
- group Id
- BG004
- value
- 229
- group Id
- BG005
- value
- 229
- group Id
- BG006
- value
- 1085
- units
- Participants
- title
- Hypercellular
- categories
- measurements
- group Id
- BG000
- value
- 1
- group Id
- BG001
- value
- 3
- group Id
- BG002
- value
- 8
- group Id
- BG003
- value
- 8
- group Id
- BG004
- value
- 6
- group Id
- BG005
- value
- 8
- group Id
- BG006
- value
- 34
- denoms
- counts
- group Id
- BG000
- value
- 114
- group Id
- BG001
- value
- 85
- group Id
- BG002
- value
- 215
- group Id
- BG003
- value
- 213
- group Id
- BG004
- value
- 229
- group Id
- BG005
- value
- 229
- group Id
- BG006
- value
- 1085
- units
- Participants
- title
- Indeterminate
- categories
- measurements
- group Id
- BG000
- value
- 24
- group Id
- BG001
- value
- 19
- group Id
- BG002
- value
- 50
- group Id
- BG003
- value
- 42
- group Id
- BG004
- value
- 41
- group Id
- BG005
- value
- 47
- group Id
- BG006
- value
- 223
- denoms
- counts
- group Id
- BG000
- value
- 114
- group Id
- BG001
- value
- 85
- group Id
- BG002
- value
- 215
- group Id
- BG003
- value
- 213
- group Id
- BG004
- value
- 229
- group Id
- BG005
- value
- 229
- group Id
- BG006
- value
- 1085
- units
- Participants
- title
- Moderately cellular
- categories
- measurements
- group Id
- BG000
- value
- 52
- group Id
- BG001
- value
- 31
- group Id
- BG002
- value
- 78
- group Id
- BG003
- value
- 93
- group Id
- BG004
- value
- 101
- group Id
- BG005
- value
- 112
- group Id
- BG006
- value
- 467
- denoms
- counts
- group Id
- BG000
- value
- 114
- group Id
- BG001
- value
- 85
- group Id
- BG002
- value
- 215
- group Id
- BG003
- value
- 213
- group Id
- BG004
- value
- 229
- group Id
- BG005
- value
- 229
- group Id
- BG006
- value
- 1085
- units
- Participants
- title
- Normocellular
- categories
- measurements
- group Id
- BG000
- value
- 5
- group Id
- BG001
- value
- 3
- group Id
- BG002
- value
- 13
- group Id
- BG003
- value
- 5
- group Id
- BG004
- value
- 14
- group Id
- BG005
- value
- 10
- group Id
- BG006
- value
- 50
- denoms
- counts
- group Id
- BG000
- value
- 114
- group Id
- BG001
- value
- 85
- group Id
- BG002
- value
- 215
- group Id
- BG003
- value
- 213
- group Id
- BG004
- value
- 229
- group Id
- BG005
- value
- 229
- group Id
- BG006
- value
- 1085
- units
- Participants
- title
- Severely acellular
- categories
- measurements
- group Id
- BG000
- value
- 2
- group Id
- BG001
- value
- 1
- group Id
- BG002
- value
- 4
- group Id
- BG003
- value
- 2
- group Id
- BG004
- value
- 5
- group Id
- BG005
- value
- 6
- group Id
- BG006
- value
- 20
- denoms
- counts
- group Id
- BG000
- value
- 114
- group Id
- BG001
- value
- 85
- group Id
- BG002
- value
- 215
- group Id
- BG003
- value
- 213
- group Id
- BG004
- value
- 229
- group Id
- BG005
- value
- 229
- group Id
- BG006
- value
- 1085
- units
- Participants
- title
- Missing
- description
- A sample of bone marrow aspirate was analyzed to count the cells and assess the cellular richness
- param Type
- NUMBER
- title
- Bone marrow cellularity
- unit Of Measure
- participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice
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