NCT03836053 · FLOW
Participant flow
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- groups
- description
- 28 day continuous intravenous infusion of AMG 420 200 µg/day followed by a 2 week treatment-free interval, until progressive disease (PD) or relapse as defined by International Myeloma Working Group (IMWG) response criteria, unacceptable safety events, next anti-multiple myeloma treatment, or other reason for permanent treatment discontinuation
- id
- FG000
- title
- AMG 420 200 µg/Day
- description
- 28 day continuous intravenous infusion of AMG 420 400 µg/day followed by a 2 week treatment-free interval, until PD or relapse as defined by IMWG response criteria, unacceptable safety events, next anti-multiple myeloma treatment, or other reason for permanent treatment discontinuation
- id
- FG001
- title
- AMG 420 400 µg/Day
- description
- 28 day continuous intravenous infusion of AMG 420 600 µg/day followed by a 2 week treatment-free interval, until PD or relapse as defined by IMWG response criteria, unacceptable safety events, next anti-multiple myeloma treatment, or other reason for permanent treatment discontinuation
- id
- FG002
- title
- AMG 420 600 µg/Day
- periods
- drop Withdraws
- reasons
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 2
- group Id
- FG002
- num Subjects
- 1
- type
- Protocol-specified criteria
- reasons
- group Id
- FG000
- num Subjects
- 1
- group Id
- FG001
- num Subjects
- 6
- group Id
- FG002
- num Subjects
- 4
- type
- Death
- reasons
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 0
- group Id
- FG002
- num Subjects
- 1
- type
- Withdrawal of consent from study
- reasons
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 2
- group Id
- FG002
- num Subjects
- 4
- type
- Decision by sponsor
- milestones
- achievements
- group Id
- FG000
- num Subjects
- 1
- group Id
- FG001
- num Subjects
- 12
- group Id
- FG002
- num Subjects
- 10
- type
- STARTED
- achievements
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 2
- group Id
- FG002
- num Subjects
- 0
- type
- COMPLETED
- achievements
- group Id
- FG000
- num Subjects
- 1
- group Id
- FG001
- num Subjects
- 10
- group Id
- FG002
- num Subjects
- 10
- type
- NOT COMPLETED
- title
- Overall Study
- pre Assignment Details
- 23 participants were enrolled and all 23 of those participants received study drug.
- recruitment Details
- This study was conducted at 10 centers in Australia, Belgium, Japan, Switzerland, and the United States from 04 March 2019 to 21 April 2022.
Complete source fields
- groups
- description
- 28 day continuous intravenous infusion of AMG 420 200 µg/day followed by a 2 week treatment-free interval, until progressive disease (PD) or relapse as defined by International Myeloma Working Group (IMWG) response criteria, unacceptable safety events, next anti-multiple myeloma treatment, or other reason for permanent treatment discontinuation
- id
- FG000
- title
- AMG 420 200 µg/Day
- description
- 28 day continuous intravenous infusion of AMG 420 400 µg/day followed by a 2 week treatment-free interval, until PD or relapse as defined by IMWG response criteria, unacceptable safety events, next anti-multiple myeloma treatment, or other reason for permanent treatment discontinuation
- id
- FG001
- title
- AMG 420 400 µg/Day
- description
- 28 day continuous intravenous infusion of AMG 420 600 µg/day followed by a 2 week treatment-free interval, until PD or relapse as defined by IMWG response criteria, unacceptable safety events, next anti-multiple myeloma treatment, or other reason for permanent treatment discontinuation
- id
- FG002
- title
- AMG 420 600 µg/Day
- periods
- drop Withdraws
- reasons
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 2
- group Id
- FG002
- num Subjects
- 1
- type
- Protocol-specified criteria
- reasons
- group Id
- FG000
- num Subjects
- 1
- group Id
- FG001
- num Subjects
- 6
- group Id
- FG002
- num Subjects
- 4
- type
- Death
- reasons
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 0
- group Id
- FG002
- num Subjects
- 1
- type
- Withdrawal of consent from study
- reasons
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 2
- group Id
- FG002
- num Subjects
- 4
- type
- Decision by sponsor
- milestones
- achievements
- group Id
- FG000
- num Subjects
- 1
- group Id
- FG001
- num Subjects
- 12
- group Id
- FG002
- num Subjects
- 10
- type
- STARTED
- achievements
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 2
- group Id
- FG002
- num Subjects
- 0
- type
- COMPLETED
- achievements
- group Id
- FG000
- num Subjects
- 1
- group Id
- FG001
- num Subjects
- 10
- group Id
- FG002
- num Subjects
- 10
- type
- NOT COMPLETED
- title
- Overall Study
- pre Assignment Details
- 23 participants were enrolled and all 23 of those participants received study drug.
- recruitment Details
- This study was conducted at 10 centers in Australia, Belgium, Japan, Switzerland, and the United States from 04 March 2019 to 21 April 2022.
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Preserved source evidence · Not medical advice
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