NCT02020941 · FLOW
Participant flow
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- groups
- description
- TREATMENT PHASE (COURSES 1-8): Patients receive carfilzomib IV over 30 minutes on days 1, 2, 8, 9, 15, and 16. Treatment repeats every 28 days for 8 courses in the absence of disease progression or unacceptable toxicity. Patients achieving less than PR also receive dexamethasone PO or IV weekly in courses 4-8. MAINTENANCE PHASE (COURSES 9-14): Patients receive carfilzomib IV over 30 minutes on days 1, 2, 15, and 16. Patients who received dexamethasone in the Treatment Phase continue to receive dexamethasone PO or IV weekly. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. carfilzomib: Given IV dexamethasone: Given IV or PO laboratory biomarker analysis: Correlative studies
- id
- FG000
- title
- Treatment (Carfilzomib, Dexamethasone)
- periods
- drop Withdraws
- reasons
- group Id
- FG000
- num Subjects
- 1
- type
- Adverse Event
- reasons
- group Id
- FG000
- num Subjects
- 2
- type
- Physician Decision
- reasons
- group Id
- FG000
- num Subjects
- 1
- type
- Withdrawal by Subject
- reasons
- group Id
- FG000
- num Subjects
- 4
- type
- Disease Progression
- milestones
- achievements
- group Id
- FG000
- num Subjects
- 10
- type
- STARTED
- achievements
- group Id
- FG000
- num Subjects
- 2
- type
- COMPLETED
- achievements
- group Id
- FG000
- num Subjects
- 8
- type
- NOT COMPLETED
- title
- Overall Study
- recruitment Details
- This protocol was based on enrolling 23 patients. Due to slow accrual, the study was closed with 10 patients enrolled.
Complete source fields
- groups
- description
- TREATMENT PHASE (COURSES 1-8): Patients receive carfilzomib IV over 30 minutes on days 1, 2, 8, 9, 15, and 16. Treatment repeats every 28 days for 8 courses in the absence of disease progression or unacceptable toxicity. Patients achieving less than PR also receive dexamethasone PO or IV weekly in courses 4-8. MAINTENANCE PHASE (COURSES 9-14): Patients receive carfilzomib IV over 30 minutes on days 1, 2, 15, and 16. Patients who received dexamethasone in the Treatment Phase continue to receive dexamethasone PO or IV weekly. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. carfilzomib: Given IV dexamethasone: Given IV or PO laboratory biomarker analysis: Correlative studies
- id
- FG000
- title
- Treatment (Carfilzomib, Dexamethasone)
- periods
- drop Withdraws
- reasons
- group Id
- FG000
- num Subjects
- 1
- type
- Adverse Event
- reasons
- group Id
- FG000
- num Subjects
- 2
- type
- Physician Decision
- reasons
- group Id
- FG000
- num Subjects
- 1
- type
- Withdrawal by Subject
- reasons
- group Id
- FG000
- num Subjects
- 4
- type
- Disease Progression
- milestones
- achievements
- group Id
- FG000
- num Subjects
- 10
- type
- STARTED
- achievements
- group Id
- FG000
- num Subjects
- 2
- type
- COMPLETED
- achievements
- group Id
- FG000
- num Subjects
- 8
- type
- NOT COMPLETED
- title
- Overall Study
- recruitment Details
- This protocol was based on enrolling 23 patients. Due to slow accrual, the study was closed with 10 patients enrolled.
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