NCT04484623 · 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
- 155
- group Id
- BG001
- value
- 147
- group Id
- BG002
- value
- 302
- units
- Participants
- groups
- description
- Participants with Relapsed/Refractory Multiple Myeloma (RRMM) received intravenous (IV) infusion of 2.5 milligram (mg)/kilogram (kg) belantamab mafodotin on Day 1 of Cycle 1 and 1.9 mg/kg on Day 1 of Cycle 2 onwards in each 28-day cycle, in combination with oral 4 mg per day Pomalidomide capsule on Days 1 to 21 of each 28-day cycle; and oral 40 mg per day Dexamethasone tablet on Days 1, 8, 15, and 22 of each 28-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, initiation of another anti-myeloma therapy or end of study, whichever occurs first.
- id
- BG000
- title
- Belantamab Mafodotin+Pomalidomide+Dexamethasone
- description
- Participants with RRMM received oral 4 mg per day Pomalidomide capsule on Days 1 to 14 of each 21-day cycle, in combination with subcutaneous (SC) injection of 1.3 mg/meter\^2(m\^2) Bortezomib on Days 1, 4, 8, 11, of each 21-day cycle for Cycles 1 through 8, and on Days 1, 8, of each 21-day cycle for Cycles 9+, and oral 20 mg Dexamethasone tablet on Days 1, 2, 4, 5, 8, 9, 11, 12, of each 21-day cycle for Cycles 1 through 8 and then on Days 1, 2, 8, 9, every 3 Weeks (Q3W) from Cycles 9 onwards until disease progression, death, unacceptable toxicity, withdrawal of consent, initiation of another anti-myeloma therapy or end of study, whichever occurs first.
- id
- BG001
- title
- Pomalidomide+Bortezomib+Dexamethasone
- description
- Total of all reporting groups
- id
- BG002
- title
- Total
- measures
- classes
- categories
- measurements
- group Id
- BG000
- spread
- 8.56
- value
- 65.5
- group Id
- BG001
- spread
- 10.03
- value
- 66.7
- group Id
- BG002
- spread
- 9.31
- value
- 66.1
- dispersion Type
- STANDARD_DEVIATION
- param Type
- MEAN
- title
- Age, Continuous
- unit Of Measure
- YEARS
- classes
- categories
- measurements
- group Id
- BG000
- value
- 56
- group Id
- BG001
- value
- 65
- group Id
- BG002
- value
- 121
- title
- Female
- measurements
- group Id
- BG000
- value
- 99
- group Id
- BG001
- value
- 82
- group Id
- BG002
- value
- 181
- title
- Male
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Sex: Female, Male
- unit Of Measure
- Participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 133
- group Id
- BG001
- value
- 127
- group Id
- BG002
- value
- 260
- title
- White
- categories
- measurements
- group Id
- BG000
- value
- 22
- group Id
- BG001
- value
- 20
- group Id
- BG002
- value
- 42
- title
- Others
- description
- Race categories (Asian, native Hawaiian OR other pacific islander, and mixed race where 0\<n\<11) are combined into 'Others' category to maintain participant confidentiality and privacy as the study is evaluating a rare disease.
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Race/Ethnicity, Customized
- unit Of Measure
- Participants
Complete source fields
- denoms
- counts
- group Id
- BG000
- value
- 155
- group Id
- BG001
- value
- 147
- group Id
- BG002
- value
- 302
- units
- Participants
- groups
- description
- Participants with Relapsed/Refractory Multiple Myeloma (RRMM) received intravenous (IV) infusion of 2.5 milligram (mg)/kilogram (kg) belantamab mafodotin on Day 1 of Cycle 1 and 1.9 mg/kg on Day 1 of Cycle 2 onwards in each 28-day cycle, in combination with oral 4 mg per day Pomalidomide capsule on Days 1 to 21 of each 28-day cycle; and oral 40 mg per day Dexamethasone tablet on Days 1, 8, 15, and 22 of each 28-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, initiation of another anti-myeloma therapy or end of study, whichever occurs first.
- id
- BG000
- title
- Belantamab Mafodotin+Pomalidomide+Dexamethasone
- description
- Participants with RRMM received oral 4 mg per day Pomalidomide capsule on Days 1 to 14 of each 21-day cycle, in combination with subcutaneous (SC) injection of 1.3 mg/meter\^2(m\^2) Bortezomib on Days 1, 4, 8, 11, of each 21-day cycle for Cycles 1 through 8, and on Days 1, 8, of each 21-day cycle for Cycles 9+, and oral 20 mg Dexamethasone tablet on Days 1, 2, 4, 5, 8, 9, 11, 12, of each 21-day cycle for Cycles 1 through 8 and then on Days 1, 2, 8, 9, every 3 Weeks (Q3W) from Cycles 9 onwards until disease progression, death, unacceptable toxicity, withdrawal of consent, initiation of another anti-myeloma therapy or end of study, whichever occurs first.
- id
- BG001
- title
- Pomalidomide+Bortezomib+Dexamethasone
- description
- Total of all reporting groups
- id
- BG002
- title
- Total
- measures
- classes
- categories
- measurements
- group Id
- BG000
- spread
- 8.56
- value
- 65.5
- group Id
- BG001
- spread
- 10.03
- value
- 66.7
- group Id
- BG002
- spread
- 9.31
- value
- 66.1
- dispersion Type
- STANDARD_DEVIATION
- param Type
- MEAN
- title
- Age, Continuous
- unit Of Measure
- YEARS
- classes
- categories
- measurements
- group Id
- BG000
- value
- 56
- group Id
- BG001
- value
- 65
- group Id
- BG002
- value
- 121
- title
- Female
- measurements
- group Id
- BG000
- value
- 99
- group Id
- BG001
- value
- 82
- group Id
- BG002
- value
- 181
- title
- Male
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Sex: Female, Male
- unit Of Measure
- Participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 133
- group Id
- BG001
- value
- 127
- group Id
- BG002
- value
- 260
- title
- White
- categories
- measurements
- group Id
- BG000
- value
- 22
- group Id
- BG001
- value
- 20
- group Id
- BG002
- value
- 42
- title
- Others
- description
- Race categories (Asian, native Hawaiian OR other pacific islander, and mixed race where 0\<n\<11) are combined into 'Others' category to maintain participant confidentiality and privacy as the study is evaluating a rare disease.
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Race/Ethnicity, Customized
- unit Of Measure
- Participants
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Preserved source evidence · Not medical advice
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