TriangleNCT02917941 · OUTCOME
Overall Response Rate (ORR)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percentage of participants
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Up to approximately 33 months
What was measured
ORR:percentage of participants with CR including stringent complete response(sCR),VGPR,partial response(PR) per independent review committee(IRC)by IMWG criteria.CR: serum,urine -ve immunofixation; disappearance of soft tissue plasmacytomas,\<5%plasma cells in bone marrow(CR in those with only measurable disease by serum FLC levels=normal FLC ratio 0.26 to 1.65+CR criteria).sCR:CR+normal FLC ratio,absence of clonal plasma cells(immunohistochemistry)or 2-to 4-color flow cytometry.VGPR:serum,urine M-protein detectable by immunofixation,not by electrophoresis or ≥90%reduction,\<100mg/24hrs(VGPR in those with only measurable disease by serum FLC levels,requires\>90%decrease in involved-uninvolved FLC level difference).PR: ≥50%reduction of serum M protein+reduction in 24-hr urinary M protein by≥90%/ to\<200mg/24-hr or ≥50%decrease in difference between involved-uninvolved FLC levels/≥50%reduction in bone marrow plasma cells,if≥30%at baseline/≥50%soft tissue plasmacytoma size reduction.
Analysis population: Response-evaluable analysis set was defined as all FAS participants with measurable disease at baseline, and at least one postbaseline response assessment.
Groups in this outcome
Ixazomib 4 mg + Lenalidomide 25 mg + Dexamethasone 40 mg
Ixazomib 4 mg, capsules, orally on Days 1, 8, and 15 plus lenalidomide 25 mg, capsule, orally, once daily on Days 1 through 21 and dexamethasone 40 mg, tablet, orally on Days 1, 8, 15, and 22 of a 28-day cycle up to 32 cycles.
| Group | Source count |
|---|---|
| Ixazomib 4 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | 32 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Ixazomib 4 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | 84.4 | Not reported | 67.2 | 94.7 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 67.2
- upper Limit
- 94.7
- value
- 84.4
- denoms
- counts
- group Id
- OG000
- value
- 32
- units
- Participants
- description
- ORR:percentage of participants with CR including stringent complete response(sCR),VGPR,partial response(PR) per independent review committee(IRC)by IMWG criteria.CR: serum,urine -ve immunofixation; disappearance of soft tissue plasmacytomas,\<5%plasma cells in bone marrow(CR in those with only measurable disease by serum FLC levels=normal FLC ratio 0.26 to 1.65+CR criteria).sCR:CR+normal FLC ratio,absence of clonal plasma cells(immunohistochemistry)or 2-to 4-color flow cytometry.VGPR:serum,urine M-protein detectable by immunofixation,not by electrophoresis or ≥90%reduction,\<100mg/24hrs(VGPR in those with only measurable disease by serum FLC levels,requires\>90%decrease in involved-uninvolved FLC level difference).PR: ≥50%reduction of serum M protein+reduction in 24-hr urinary M protein by≥90%/ to\<200mg/24-hr or ≥50%decrease in difference between involved-uninvolved FLC levels/≥50%reduction in bone marrow plasma cells,if≥30%at baseline/≥50%soft tissue plasmacytoma size reduction.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Ixazomib 4 mg, capsules, orally on Days 1, 8, and 15 plus lenalidomide 25 mg, capsule, orally, once daily on Days 1 through 21 and dexamethasone 40 mg, tablet, orally on Days 1, 8, 15, and 22 of a 28-day cycle up to 32 cycles.
- id
- OG000
- title
- Ixazomib 4 mg + Lenalidomide 25 mg + Dexamethasone 40 mg
- param Type
- NUMBER
- population Description
- Response-evaluable analysis set was defined as all FAS participants with measurable disease at baseline, and at least one postbaseline response assessment.
- reporting Status
- POSTED
- time Frame
- Up to approximately 33 months
- title
- Overall Response Rate (ORR)
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice