NCT01946477 · FLOW
Participant flow
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- groups
- description
- (Pomalidomide + low dose Dexamethasone) in participants with 2 prior lines of therapy with the most recent line of therapy containing lenalidomide. The starting dose level of POM was 4 mg. The starting dose level of Dex was 40 mg/day (≤75 years old) or 20 mg/day (\> 75 years old).
- id
- FG000
- title
- Cohort A
- description
- (Pomalidomide + Daratumumab + low dose Dexamethasone) in participants with 1 or 2 prior lines of therapy with the most recent line of therapy containing lenalidomide. The starting dose level of POM was 4 mg. The starting dose level of Dex was 40 mg/day (≤75 years old) or 20 mg/day (\> 75 years old). DARA was administered intravenously (IV) at a starting dose of 16 mg/kg.
- id
- FG001
- title
- Cohort B
- description
- (Pomalidomide + Daratumumab + low dose Dexamethasone) in Japanese participants with 1 or 2 prior lines of therapy with the most recent line of therapy containing lenalidomide. The starting dose level of POM was 4 mg. The starting dose level of Dex was 40 mg/day (≤75 years old) or 20 mg/day (\> 75 years old). DARA was administered intravenously (IV) at a starting dose of 16 mg/kg.
- id
- FG002
- title
- Cohort C
- periods
- drop Withdraws
- reasons
- group Id
- FG000
- num Subjects
- 32
- group Id
- FG001
- num Subjects
- 53
- group Id
- FG002
- num Subjects
- 7
- type
- Progressive Disease
- reasons
- group Id
- FG000
- num Subjects
- 4
- group Id
- FG001
- num Subjects
- 7
- group Id
- FG002
- num Subjects
- 6
- type
- Other reasons
- reasons
- group Id
- FG000
- num Subjects
- 8
- group Id
- FG001
- num Subjects
- 23
- group Id
- FG002
- num Subjects
- 0
- type
- Withdrawal by Subject
- reasons
- group Id
- FG000
- num Subjects
- 2
- group Id
- FG001
- num Subjects
- 0
- group Id
- FG002
- num Subjects
- 0
- type
- Lack of Efficacy
- reasons
- group Id
- FG000
- num Subjects
- 8
- group Id
- FG001
- num Subjects
- 10
- group Id
- FG002
- num Subjects
- 3
- type
- Adverse Event
- reasons
- group Id
- FG000
- num Subjects
- 2
- group Id
- FG001
- num Subjects
- 4
- group Id
- FG002
- num Subjects
- 0
- type
- Death
- reasons
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 4
- group Id
- FG002
- num Subjects
- 1
- type
- Transition to commercially available treatment
- reasons
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 10
- group Id
- FG002
- num Subjects
- 0
- type
- Study terminated by sponsor
- reasons
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 1
- group Id
- FG002
- num Subjects
- 0
- type
- Lost to Follow-up
- reasons
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 0
- group Id
- FG002
- num Subjects
- 1
- type
- Protocol Violation
- milestones
- achievements
- group Id
- FG000
- num Subjects
- 56
- group Id
- FG001
- num Subjects
- 112
- group Id
- FG002
- num Subjects
- 18
- type
- STARTED
- achievements
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 0
- group Id
- FG002
- num Subjects
- 0
- type
- COMPLETED
- achievements
- group Id
- FG000
- num Subjects
- 56
- group Id
- FG001
- num Subjects
- 112
- group Id
- FG002
- num Subjects
- 18
- type
- NOT COMPLETED
- title
- Overall Study
Complete source fields
- groups
- description
- (Pomalidomide + low dose Dexamethasone) in participants with 2 prior lines of therapy with the most recent line of therapy containing lenalidomide. The starting dose level of POM was 4 mg. The starting dose level of Dex was 40 mg/day (≤75 years old) or 20 mg/day (\> 75 years old).
- id
- FG000
- title
- Cohort A
- description
- (Pomalidomide + Daratumumab + low dose Dexamethasone) in participants with 1 or 2 prior lines of therapy with the most recent line of therapy containing lenalidomide. The starting dose level of POM was 4 mg. The starting dose level of Dex was 40 mg/day (≤75 years old) or 20 mg/day (\> 75 years old). DARA was administered intravenously (IV) at a starting dose of 16 mg/kg.
- id
- FG001
- title
- Cohort B
- description
- (Pomalidomide + Daratumumab + low dose Dexamethasone) in Japanese participants with 1 or 2 prior lines of therapy with the most recent line of therapy containing lenalidomide. The starting dose level of POM was 4 mg. The starting dose level of Dex was 40 mg/day (≤75 years old) or 20 mg/day (\> 75 years old). DARA was administered intravenously (IV) at a starting dose of 16 mg/kg.
- id
- FG002
- title
- Cohort C
- periods
- drop Withdraws
- reasons
- group Id
- FG000
- num Subjects
- 32
- group Id
- FG001
- num Subjects
- 53
- group Id
- FG002
- num Subjects
- 7
- type
- Progressive Disease
- reasons
- group Id
- FG000
- num Subjects
- 4
- group Id
- FG001
- num Subjects
- 7
- group Id
- FG002
- num Subjects
- 6
- type
- Other reasons
- reasons
- group Id
- FG000
- num Subjects
- 8
- group Id
- FG001
- num Subjects
- 23
- group Id
- FG002
- num Subjects
- 0
- type
- Withdrawal by Subject
- reasons
- group Id
- FG000
- num Subjects
- 2
- group Id
- FG001
- num Subjects
- 0
- group Id
- FG002
- num Subjects
- 0
- type
- Lack of Efficacy
- reasons
- group Id
- FG000
- num Subjects
- 8
- group Id
- FG001
- num Subjects
- 10
- group Id
- FG002
- num Subjects
- 3
- type
- Adverse Event
- reasons
- group Id
- FG000
- num Subjects
- 2
- group Id
- FG001
- num Subjects
- 4
- group Id
- FG002
- num Subjects
- 0
- type
- Death
- reasons
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 4
- group Id
- FG002
- num Subjects
- 1
- type
- Transition to commercially available treatment
- reasons
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 10
- group Id
- FG002
- num Subjects
- 0
- type
- Study terminated by sponsor
- reasons
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 1
- group Id
- FG002
- num Subjects
- 0
- type
- Lost to Follow-up
- reasons
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 0
- group Id
- FG002
- num Subjects
- 1
- type
- Protocol Violation
- milestones
- achievements
- group Id
- FG000
- num Subjects
- 56
- group Id
- FG001
- num Subjects
- 112
- group Id
- FG002
- num Subjects
- 18
- type
- STARTED
- achievements
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 0
- group Id
- FG002
- num Subjects
- 0
- type
- COMPLETED
- achievements
- group Id
- FG000
- num Subjects
- 56
- group Id
- FG001
- num Subjects
- 112
- group Id
- FG002
- num Subjects
- 18
- type
- NOT COMPLETED
- title
- Overall Study
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
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