NCT01198067 · FLOW
Participant flow
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- groups
- description
- 2mg Pomolidomide per day per Cycle (Cycle = 28 days)
- id
- FG000
- title
- Cohort 2
- description
- 1mg Pomolidomide per day per Cycle (Cycle = 28 days)
- id
- FG001
- title
- Cohort 3
- periods
- milestones
- achievements
- group Id
- FG000
- num Subjects
- 3
- group Id
- FG001
- num Subjects
- 6
- type
- STARTED
- achievements
- group Id
- FG000
- num Subjects
- 3
- group Id
- FG001
- num Subjects
- 6
- type
- COMPLETED
- achievements
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 0
- type
- NOT COMPLETED
- title
- Overall Study
- pre Assignment Details
- Six patients were screen failures; did not meet inclusion criteria. Original study design included Arms with assignment to increasing dose escalation including 3 and 4mg Pomolidomide Arms/Cohorts; however, safety concerns early on regarding Dose Limiting Toxicities for 2mg Cohort compelled omitting the 3 and 4mg Arms/Cohorts.
- recruitment Details
- Patient Eligibility:Waldenstrom relapsed,\>/18 - years old,ECOG \<\~2,Labs NCS,no prior cancers,females not preganant,\~1\> line(s) prior therapy, no therapy in 4 weeks. Excluded:pregnant, breast-feeding, serious diagnosis,chemotherapy reaction,prior pomalidomide,HIV/ Hepatitis A-C +,concurrent chemotherapy,grade\~\>2 neuropathy,andANC count \<\~1000K/ul.
Complete source fields
- groups
- description
- 2mg Pomolidomide per day per Cycle (Cycle = 28 days)
- id
- FG000
- title
- Cohort 2
- description
- 1mg Pomolidomide per day per Cycle (Cycle = 28 days)
- id
- FG001
- title
- Cohort 3
- periods
- milestones
- achievements
- group Id
- FG000
- num Subjects
- 3
- group Id
- FG001
- num Subjects
- 6
- type
- STARTED
- achievements
- group Id
- FG000
- num Subjects
- 3
- group Id
- FG001
- num Subjects
- 6
- type
- COMPLETED
- achievements
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 0
- type
- NOT COMPLETED
- title
- Overall Study
- pre Assignment Details
- Six patients were screen failures; did not meet inclusion criteria. Original study design included Arms with assignment to increasing dose escalation including 3 and 4mg Pomolidomide Arms/Cohorts; however, safety concerns early on regarding Dose Limiting Toxicities for 2mg Cohort compelled omitting the 3 and 4mg Arms/Cohorts.
- recruitment Details
- Patient Eligibility:Waldenstrom relapsed,\>/18 - years old,ECOG \<\~2,Labs NCS,no prior cancers,females not preganant,\~1\> line(s) prior therapy, no therapy in 4 weeks. Excluded:pregnant, breast-feeding, serious diagnosis,chemotherapy reaction,prior pomalidomide,HIV/ Hepatitis A-C +,concurrent chemotherapy,grade\~\>2 neuropathy,andANC count \<\~1000K/ul.
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Preserved source evidence · Not medical advice
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