NCT02076009 · 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 lenalidomide at a dose of 25 milligrams (mg) orally on Day 1 through Day 21 of each 28-day treatment cycle and low-dose dexamethasone at a total dose of 40 mg weekly (or 20 mg weekly for participants greater than \[\>\] 75 years old or with a body mass index less than \[\<\] 18.5 kilograms per meter square \[kg/m\^2\]).
- id
- FG000
- title
- Lenalidomide, Low-dose Dexamethasone (Rd)
- description
- Participants received daratumumab 16 milligrams per kilogram (mg/kg) as an intravenous (IV) infusion once a week during treatment cycles 1 and 2 (for 8 weeks, each 28-day cycle); every 2 weeks during treatment cycles 3 to 6 (for 16 weeks, each 28-day cycle); once only on Day 1 during treatment cycles 7 onwards (for every 4 weeks). Lenalidomide was administered at a dose of 25 mg orally on Day 1 through Day 21 of each 28-day treatment cycle and low-dose dexamethasone was administered at a total dose of 40 mg weekly (or 20 mg weekly for participants \>75 years old or with a body mass index \< 18.5 kg/m\^2).
- id
- FG001
- title
- Daratumumab, Lenalidomide, Low-dose Dexamethasone (DRd)
- periods
- drop Withdraws
- reasons
- group Id
- FG000
- num Subjects
- 172
- group Id
- FG001
- num Subjects
- 153
- type
- Death
- reasons
- group Id
- FG000
- num Subjects
- 16
- group Id
- FG001
- num Subjects
- 12
- type
- Withdrawal by Subject
- reasons
- group Id
- FG000
- num Subjects
- 4
- group Id
- FG001
- num Subjects
- 2
- type
- Lost to Follow-up
- reasons
- group Id
- FG000
- num Subjects
- 1
- group Id
- FG001
- num Subjects
- 0
- type
- Progressive Disease
- reasons
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 1
- type
- Physician Decision
- reasons
- group Id
- FG000
- num Subjects
- 90
- group Id
- FG001
- num Subjects
- 118
- type
- End of data collection
- milestones
- achievements
- group Id
- FG000
- num Subjects
- 283
- group Id
- FG001
- num Subjects
- 286
- type
- STARTED
- achievements
- group Id
- FG000
- num Subjects
- 281
- group Id
- FG001
- num Subjects
- 283
- type
- Treated (Safety Population)
- achievements
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 0
- type
- COMPLETED
- achievements
- group Id
- FG000
- num Subjects
- 283
- group Id
- FG001
- num Subjects
- 286
- type
- NOT COMPLETED
- title
- Overall Study
Complete source fields
- groups
- description
- Participants received lenalidomide at a dose of 25 milligrams (mg) orally on Day 1 through Day 21 of each 28-day treatment cycle and low-dose dexamethasone at a total dose of 40 mg weekly (or 20 mg weekly for participants greater than \[\>\] 75 years old or with a body mass index less than \[\<\] 18.5 kilograms per meter square \[kg/m\^2\]).
- id
- FG000
- title
- Lenalidomide, Low-dose Dexamethasone (Rd)
- description
- Participants received daratumumab 16 milligrams per kilogram (mg/kg) as an intravenous (IV) infusion once a week during treatment cycles 1 and 2 (for 8 weeks, each 28-day cycle); every 2 weeks during treatment cycles 3 to 6 (for 16 weeks, each 28-day cycle); once only on Day 1 during treatment cycles 7 onwards (for every 4 weeks). Lenalidomide was administered at a dose of 25 mg orally on Day 1 through Day 21 of each 28-day treatment cycle and low-dose dexamethasone was administered at a total dose of 40 mg weekly (or 20 mg weekly for participants \>75 years old or with a body mass index \< 18.5 kg/m\^2).
- id
- FG001
- title
- Daratumumab, Lenalidomide, Low-dose Dexamethasone (DRd)
- periods
- drop Withdraws
- reasons
- group Id
- FG000
- num Subjects
- 172
- group Id
- FG001
- num Subjects
- 153
- type
- Death
- reasons
- group Id
- FG000
- num Subjects
- 16
- group Id
- FG001
- num Subjects
- 12
- type
- Withdrawal by Subject
- reasons
- group Id
- FG000
- num Subjects
- 4
- group Id
- FG001
- num Subjects
- 2
- type
- Lost to Follow-up
- reasons
- group Id
- FG000
- num Subjects
- 1
- group Id
- FG001
- num Subjects
- 0
- type
- Progressive Disease
- reasons
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 1
- type
- Physician Decision
- reasons
- group Id
- FG000
- num Subjects
- 90
- group Id
- FG001
- num Subjects
- 118
- type
- End of data collection
- milestones
- achievements
- group Id
- FG000
- num Subjects
- 283
- group Id
- FG001
- num Subjects
- 286
- type
- STARTED
- achievements
- group Id
- FG000
- num Subjects
- 281
- group Id
- FG001
- num Subjects
- 283
- type
- Treated (Safety Population)
- achievements
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 0
- type
- COMPLETED
- achievements
- group Id
- FG000
- num Subjects
- 283
- group Id
- FG001
- num Subjects
- 286
- type
- NOT COMPLETED
- title
- Overall Study
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice
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