NCT03512353 · FLOW
Participant flow
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- groups
- description
- Participants received carfilzomib administered as an intravenous (IV) infusion twice-weekly for up to six 28-day cycles followed by once-weekly for another six 28-day cycles. The carfilzomib dose was 20 mg/m² on days 1 and 2 of cycle 1, 56 mg/m² for the remaining days of cycle 1 (days 8, 9, 15, and 16) and then on days 1, 2, 8, 9, 15, and 16 of each cycle for cycles 2 to 6, and 70 mg/m² on days 1, 8, and 15 of each cycle for cycles 7 to 12. Participants also received dexamethasone either orally or by IV infusion at a dose of 20 mg once daily on days 1, 2, 8, 9, 15, 16, 22, and 23 of cycles 1 to 6 and at a dose 40 mg once daily on days 1, 8, 15 of cycles 7 to 12.
- id
- FG000
- title
- Carfilzomib Plus Dexamethasone
- periods
- drop Withdraws
- reasons
- group Id
- FG000
- num Subjects
- 3
- type
- Sponsor Decision
- reasons
- group Id
- FG000
- num Subjects
- 1
- type
- Death
- milestones
- achievements
- group Id
- FG000
- num Subjects
- 7
- type
- STARTED
- achievements
- group Id
- FG000
- num Subjects
- 6
- type
- Received Treatment
- achievements
- group Id
- FG000
- num Subjects
- 3
- comment
- Study completion is defined as participants who received 12 cycles of treatment and completed the safety follow-up visit.
- type
- COMPLETED
- achievements
- group Id
- FG000
- num Subjects
- 4
- type
- NOT COMPLETED
- title
- Overall Study
- recruitment Details
- This study was conducted at 10 centers in the United States.
Complete source fields
- groups
- description
- Participants received carfilzomib administered as an intravenous (IV) infusion twice-weekly for up to six 28-day cycles followed by once-weekly for another six 28-day cycles. The carfilzomib dose was 20 mg/m² on days 1 and 2 of cycle 1, 56 mg/m² for the remaining days of cycle 1 (days 8, 9, 15, and 16) and then on days 1, 2, 8, 9, 15, and 16 of each cycle for cycles 2 to 6, and 70 mg/m² on days 1, 8, and 15 of each cycle for cycles 7 to 12. Participants also received dexamethasone either orally or by IV infusion at a dose of 20 mg once daily on days 1, 2, 8, 9, 15, 16, 22, and 23 of cycles 1 to 6 and at a dose 40 mg once daily on days 1, 8, 15 of cycles 7 to 12.
- id
- FG000
- title
- Carfilzomib Plus Dexamethasone
- periods
- drop Withdraws
- reasons
- group Id
- FG000
- num Subjects
- 3
- type
- Sponsor Decision
- reasons
- group Id
- FG000
- num Subjects
- 1
- type
- Death
- milestones
- achievements
- group Id
- FG000
- num Subjects
- 7
- type
- STARTED
- achievements
- group Id
- FG000
- num Subjects
- 6
- type
- Received Treatment
- achievements
- group Id
- FG000
- num Subjects
- 3
- comment
- Study completion is defined as participants who received 12 cycles of treatment and completed the safety follow-up visit.
- type
- COMPLETED
- achievements
- group Id
- FG000
- num Subjects
- 4
- type
- NOT COMPLETED
- title
- Overall Study
- recruitment Details
- This study was conducted at 10 centers in the United States.
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Preserved source evidence · Not medical advice
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