TriangleNCT02917941 · OUTCOME
Duration of Response (DOR)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- months
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Up to approximately 33 months
What was measured
DOR was measured as time in months from date of first documentation of response, VGPR or better, and ORR (CR+PR (including sCR and VGPR) or better, to date of first documented PD among participants who responded to treatment. Response was assessed by investigator using IMWG Criteria. CR:negative immunofixation in serum and urine and; disappearance of any soft tissue plasmacytomas and;\<5% plasma cells in bone marrow. sCR:CR plus normal FLC ratio, absence of clonal plasma cells by immunohistochemistry or 2- to 4-color flow cytometry. VGPR:serum and urine M-protein detectable by immunofixation but not on electrophoresis/≥90% reduction in serum M-protein plus urine M-protein level \<100 mg/24 hours. PR:≥50% reduction of serum M protein+reduction in 24-hour urinary M protein by ≥90%/ to \<200 mg/24-hour or ≥50% decrease in difference between involved and uninvolved FLC levels/≥50% reduction in bone marrow plasma cells, if ≥30% at baseline/≥50% reduction in size of soft tissue plasmacytomas.
Analysis population: FAS included all participants who received at least one dose of study drug during the treatment period. Each responder for VGPR or better, and PR or better in FAS were evaluated in this outcome measure. Responders without documentation of PD were censored at the date of last response assessment that is SD or better.
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 | 27 |
Reported measurements
VGPR or better
| Group | Source count |
|---|---|
| Ixazomib 4 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | 16 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Ixazomib 4 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | NA | Not reported | 16.03 | NA | Median and upper limit of CI was not estimable due to low number of participants. |
ORR
| Group | Source count |
|---|---|
| Ixazomib 4 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | 27 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Ixazomib 4 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | 21.65 | Not reported | 16.03 | NA | Upper limit of CI was not estimable due to low number of participants. |
Complete source fields
- classes
- categories
- measurements
- comment
- Median and upper limit of CI was not estimable due to low number of participants.
- group Id
- OG000
- lower Limit
- 16.03
- upper Limit
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 16
- units
- Participants
- title
- VGPR or better
- categories
- measurements
- comment
- Upper limit of CI was not estimable due to low number of participants.
- group Id
- OG000
- lower Limit
- 16.03
- upper Limit
- NA
- value
- 21.65
- denoms
- counts
- group Id
- OG000
- value
- 27
- units
- Participants
- title
- ORR
- denoms
- counts
- group Id
- OG000
- value
- 27
- units
- Participants
- description
- DOR was measured as time in months from date of first documentation of response, VGPR or better, and ORR (CR+PR (including sCR and VGPR) or better, to date of first documented PD among participants who responded to treatment. Response was assessed by investigator using IMWG Criteria. CR:negative immunofixation in serum and urine and; disappearance of any soft tissue plasmacytomas and;\<5% plasma cells in bone marrow. sCR:CR plus normal FLC ratio, absence of clonal plasma cells by immunohistochemistry or 2- to 4-color flow cytometry. VGPR:serum and urine M-protein detectable by immunofixation but not on electrophoresis/≥90% reduction in serum M-protein plus urine M-protein level \<100 mg/24 hours. PR:≥50% reduction of serum M protein+reduction in 24-hour urinary M protein by ≥90%/ to \<200 mg/24-hour or ≥50% decrease in difference between involved and uninvolved FLC levels/≥50% reduction in bone marrow plasma cells, if ≥30% at baseline/≥50% reduction in size of soft tissue plasmacytomas.
- 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
- MEDIAN
- population Description
- FAS included all participants who received at least one dose of study drug during the treatment period. Each responder for VGPR or better, and PR or better in FAS were evaluated in this outcome measure. Responders without documentation of PD were censored at the date of last response assessment that is SD or better.
- reporting Status
- POSTED
- time Frame
- Up to approximately 33 months
- title
- Duration of Response (DOR)
- type
- SECONDARY
- unit Of Measure
- months
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Preserved source evidence · Not medical advice