NCT04484623 · FLOW
Participant flow
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- 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
- FG000
- 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
- FG001
- title
- Pomalidomide+Bortezomib+Dexamethasone
- periods
- drop Withdraws
- reasons
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 1
- type
- Lost to Follow-up
- reasons
- group Id
- FG000
- num Subjects
- 1
- group Id
- FG001
- num Subjects
- 0
- type
- Protocol Deviation
- reasons
- group Id
- FG000
- num Subjects
- 1
- group Id
- FG001
- num Subjects
- 0
- type
- Physician Decision
- reasons
- group Id
- FG000
- num Subjects
- 11
- group Id
- FG001
- num Subjects
- 8
- type
- Withdrawal by Subject
- reasons
- group Id
- FG000
- num Subjects
- 94
- group Id
- FG001
- num Subjects
- 84
- type
- Ongoing
- milestones
- achievements
- group Id
- FG000
- num Subjects
- 155
- group Id
- FG001
- num Subjects
- 147
- comment
- Intent-to-Treat (ITT) Population included of all randomized participants whether or not randomized treatment was administered.
- type
- STARTED
- achievements
- group Id
- FG000
- num Subjects
- 150
- group Id
- FG001
- num Subjects
- 145
- comment
- All randomized participants who received at least 1 dose of study intervention (any component).
- type
- Safety Population
- achievements
- comment
- Note: Participants who died following randomization whilst on study, including 1 participant who died prior to dosing.
- group Id
- FG000
- num Subjects
- 48
- comment
- Note: Participants who died following randomization whilst on study, including 1 participant who died prior to dosing.
- group Id
- FG001
- num Subjects
- 54
- comment
- Note: Participants who died following randomization whilst on study, were considered to have completed the study.
- type
- COMPLETED
- achievements
- group Id
- FG000
- num Subjects
- 107
- group Id
- FG001
- num Subjects
- 93
- type
- NOT COMPLETED
- title
- Overall Study
- pre Assignment Details
- The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Complete source fields
- 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
- FG000
- 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
- FG001
- title
- Pomalidomide+Bortezomib+Dexamethasone
- periods
- drop Withdraws
- reasons
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 1
- type
- Lost to Follow-up
- reasons
- group Id
- FG000
- num Subjects
- 1
- group Id
- FG001
- num Subjects
- 0
- type
- Protocol Deviation
- reasons
- group Id
- FG000
- num Subjects
- 1
- group Id
- FG001
- num Subjects
- 0
- type
- Physician Decision
- reasons
- group Id
- FG000
- num Subjects
- 11
- group Id
- FG001
- num Subjects
- 8
- type
- Withdrawal by Subject
- reasons
- group Id
- FG000
- num Subjects
- 94
- group Id
- FG001
- num Subjects
- 84
- type
- Ongoing
- milestones
- achievements
- group Id
- FG000
- num Subjects
- 155
- group Id
- FG001
- num Subjects
- 147
- comment
- Intent-to-Treat (ITT) Population included of all randomized participants whether or not randomized treatment was administered.
- type
- STARTED
- achievements
- group Id
- FG000
- num Subjects
- 150
- group Id
- FG001
- num Subjects
- 145
- comment
- All randomized participants who received at least 1 dose of study intervention (any component).
- type
- Safety Population
- achievements
- comment
- Note: Participants who died following randomization whilst on study, including 1 participant who died prior to dosing.
- group Id
- FG000
- num Subjects
- 48
- comment
- Note: Participants who died following randomization whilst on study, including 1 participant who died prior to dosing.
- group Id
- FG001
- num Subjects
- 54
- comment
- Note: Participants who died following randomization whilst on study, were considered to have completed the study.
- type
- COMPLETED
- achievements
- group Id
- FG000
- num Subjects
- 107
- group Id
- FG001
- num Subjects
- 93
- type
- NOT COMPLETED
- title
- Overall Study
- pre Assignment Details
- The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice
Triangle