NCT01415882 · FLOW
Participant flow
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- groups
- description
- Patients receive ixazomib citrate PO on days 1, 8, and 15. Patients with lack of minor response by the end of the second cycle or lack of partial response by the end of the fourth cycle also receive dexamethasone PO on days 1, 2, 8, 9, 15, and 16. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
- id
- FG000
- title
- Arm A (Ixazomib Citrate and Dexamethasone)
- description
- Patients receive ixazomib citrate PO on days 1, 8, and 15 and dexamethasone PO on days 1, 8, and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
- id
- FG001
- title
- Arm B (Ixazomib Citrate and Dexamethasone)
- description
- Patients receive higher doses of ixazomib citrate PO on days 1, 8, and 15 and dexamethasone PO on days 1, 8, and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
- id
- FG002
- title
- Arm C (Higher-dose Ixazomib Citrate and Dexamethasone)
- description
- Patients receive ixazomib citrate PO on days 1, 8, and 15 and cyclophosphamide PO (cycles 1-18 only) and dexamethasone PO on days 1, 8, 15, and 22. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
- id
- FG003
- title
- Arm D (Ixazomib Citrate, Dexamethasone, and Cyclophosphamide)
- description
- Patients receive ixazomib citrate PO on days 1, 8, and 15, cyclophosphamide PO (cycles 1-12 only) on days 1, 8, 15, 22, and daratumumab IV on days 1, 8, 15, 22 (cycles 1-2), days 1 and 15 (cycles 3-6), and day 1 in all subsequent cycles. Patients also receive dexamethasone IV or PO on days 1, 8, 15, and 22. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
- id
- FG004
- title
- Arm E (Ixazomib Citrate, Cyclophosphamide, Daratumumab)
- periods
- drop Withdraws
- reasons
- group Id
- FG000
- num Subjects
- 1
- group Id
- FG001
- num Subjects
- 0
- group Id
- FG002
- num Subjects
- 0
- group Id
- FG003
- num Subjects
- 3
- group Id
- FG004
- num Subjects
- 0
- type
- Ineligible
- reasons
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 1
- group Id
- FG002
- num Subjects
- 0
- group Id
- FG003
- num Subjects
- 1
- group Id
- FG004
- num Subjects
- 0
- type
- Withdrawal by Subject
- milestones
- achievements
- group Id
- FG000
- num Subjects
- 33
- group Id
- FG001
- num Subjects
- 36
- group Id
- FG002
- num Subjects
- 35
- group Id
- FG003
- num Subjects
- 37
- group Id
- FG004
- num Subjects
- 24
- type
- STARTED
- achievements
- group Id
- FG000
- num Subjects
- 32
- group Id
- FG001
- num Subjects
- 35
- group Id
- FG002
- num Subjects
- 35
- group Id
- FG003
- num Subjects
- 33
- group Id
- FG004
- num Subjects
- 24
- type
- COMPLETED
- achievements
- group Id
- FG000
- num Subjects
- 1
- group Id
- FG001
- num Subjects
- 1
- group Id
- FG002
- num Subjects
- 0
- group Id
- FG003
- num Subjects
- 4
- group Id
- FG004
- num Subjects
- 0
- type
- NOT COMPLETED
- title
- Overall Study
Complete source fields
- groups
- description
- Patients receive ixazomib citrate PO on days 1, 8, and 15. Patients with lack of minor response by the end of the second cycle or lack of partial response by the end of the fourth cycle also receive dexamethasone PO on days 1, 2, 8, 9, 15, and 16. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
- id
- FG000
- title
- Arm A (Ixazomib Citrate and Dexamethasone)
- description
- Patients receive ixazomib citrate PO on days 1, 8, and 15 and dexamethasone PO on days 1, 8, and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
- id
- FG001
- title
- Arm B (Ixazomib Citrate and Dexamethasone)
- description
- Patients receive higher doses of ixazomib citrate PO on days 1, 8, and 15 and dexamethasone PO on days 1, 8, and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
- id
- FG002
- title
- Arm C (Higher-dose Ixazomib Citrate and Dexamethasone)
- description
- Patients receive ixazomib citrate PO on days 1, 8, and 15 and cyclophosphamide PO (cycles 1-18 only) and dexamethasone PO on days 1, 8, 15, and 22. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
- id
- FG003
- title
- Arm D (Ixazomib Citrate, Dexamethasone, and Cyclophosphamide)
- description
- Patients receive ixazomib citrate PO on days 1, 8, and 15, cyclophosphamide PO (cycles 1-12 only) on days 1, 8, 15, 22, and daratumumab IV on days 1, 8, 15, 22 (cycles 1-2), days 1 and 15 (cycles 3-6), and day 1 in all subsequent cycles. Patients also receive dexamethasone IV or PO on days 1, 8, 15, and 22. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
- id
- FG004
- title
- Arm E (Ixazomib Citrate, Cyclophosphamide, Daratumumab)
- periods
- drop Withdraws
- reasons
- group Id
- FG000
- num Subjects
- 1
- group Id
- FG001
- num Subjects
- 0
- group Id
- FG002
- num Subjects
- 0
- group Id
- FG003
- num Subjects
- 3
- group Id
- FG004
- num Subjects
- 0
- type
- Ineligible
- reasons
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 1
- group Id
- FG002
- num Subjects
- 0
- group Id
- FG003
- num Subjects
- 1
- group Id
- FG004
- num Subjects
- 0
- type
- Withdrawal by Subject
- milestones
- achievements
- group Id
- FG000
- num Subjects
- 33
- group Id
- FG001
- num Subjects
- 36
- group Id
- FG002
- num Subjects
- 35
- group Id
- FG003
- num Subjects
- 37
- group Id
- FG004
- num Subjects
- 24
- type
- STARTED
- achievements
- group Id
- FG000
- num Subjects
- 32
- group Id
- FG001
- num Subjects
- 35
- group Id
- FG002
- num Subjects
- 35
- group Id
- FG003
- num Subjects
- 33
- group Id
- FG004
- num Subjects
- 24
- type
- COMPLETED
- achievements
- group Id
- FG000
- num Subjects
- 1
- group Id
- FG001
- num Subjects
- 1
- group Id
- FG002
- num Subjects
- 0
- group Id
- FG003
- num Subjects
- 4
- group Id
- FG004
- num Subjects
- 0
- type
- NOT COMPLETED
- title
- Overall Study
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
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