TriangleNCT02011113 · OUTCOME
Time to Response (Later Cut-off Date)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- weeks
- Interval / dispersion
- Full Range
- Time frame
- From the first dose until the final data cut-off date of 25 September 2015; maximum duration on treatment was 80.9 weeks
What was measured
Time to response was calculated as the time from the first dose to the initial documented response (partial response or better) based on IMWG criteria. SCR: CR and normal free light chain (FLC) ratio and no clonal cells in bone marrow; CR: Negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤ 5% plasma cells in bone marrow; VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥ 90% reduction in serum M-protein and urine M-protein level \< 100 mg/24 hours; PR: ≥ 50% reduction of serum M-Protein and reduction in urinary M-protein by ≥ 90% or to \< 200 mg/24 hours. If present at baseline a ≥ 50% reduction in size of soft tissue plasmacytomas is also required.
Analysis population: Included participants with at least a PR or better based on Assessment using IMWG criteria; EPP includes all participants who meet eligibility criteria, take at least one dose of study medication, and have a baseline and a post-baseline efficacy assessment.
Groups in this outcome
Pomalidomide Plus Dexamethasone
Participants received 4 mg pomalidomide administered by mouth on Days 1-21 of each 28-day treatment cycle and 40 mg dexamethasone (participants \> 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1, 8, 15, and 22 of a 28-day cycle until disease progression.
| Group | Source count |
|---|---|
| Pomalidomide Plus Dexamethasone | 15 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Pomalidomide Plus Dexamethasone | 8.10 | Not reported | 4.1 | 24.1 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 4.1
- upper Limit
- 24.1
- value
- 8.10
- denoms
- counts
- group Id
- OG000
- value
- 15
- units
- Participants
- description
- Time to response was calculated as the time from the first dose to the initial documented response (partial response or better) based on IMWG criteria. SCR: CR and normal free light chain (FLC) ratio and no clonal cells in bone marrow; CR: Negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤ 5% plasma cells in bone marrow; VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥ 90% reduction in serum M-protein and urine M-protein level \< 100 mg/24 hours; PR: ≥ 50% reduction of serum M-Protein and reduction in urinary M-protein by ≥ 90% or to \< 200 mg/24 hours. If present at baseline a ≥ 50% reduction in size of soft tissue plasmacytomas is also required.
- dispersion Type
- Full Range
- groups
- description
- Participants received 4 mg pomalidomide administered by mouth on Days 1-21 of each 28-day treatment cycle and 40 mg dexamethasone (participants \> 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1, 8, 15, and 22 of a 28-day cycle until disease progression.
- id
- OG000
- title
- Pomalidomide Plus Dexamethasone
- param Type
- MEDIAN
- population Description
- Included participants with at least a PR or better based on Assessment using IMWG criteria; EPP includes all participants who meet eligibility criteria, take at least one dose of study medication, and have a baseline and a post-baseline efficacy assessment.
- reporting Status
- POSTED
- time Frame
- From the first dose until the final data cut-off date of 25 September 2015; maximum duration on treatment was 80.9 weeks
- title
- Time to Response (Later Cut-off Date)
- type
- SECONDARY
- unit Of Measure
- weeks
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice