TriangleNCT00742560 · OUTCOME
Objective Response Rate (ORR) According to the International Myeloma Working Group Uniform Response Criteria (Phase 2)
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
- From date of randomization until 60 days following the last infusion (or before initiation of new therapy), up to 101 months
What was measured
ORR: Percentage of participants with confirmed complete response (CR; negative immunofixation on the serum and urine, disappearance of any soft tissue plasmacytomas, and ≤5% plasma cells in bone marrow), partial response (PR; ≥50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥90% or to ≤200 mg per 24 hour; if serum and urine M-protein are unmeasurable, a ≥50% decrease in the difference between involved and uninvolved free light chain (FLC\] levels is required in place of the M-protein criteria; if serum and urine M-protein are unmeasurable, and serum FLC is also unmeasurable, a ≥50% reduction in plasma cells is required in place of M-protein, provided baseline bone marrow plasma cell percentage was ≥30%; and, if present at baseline, a ≥50% reduction in the size of soft tissue plasmacytomas), very good PR (VGPR; normal FLC ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence), or stringent CR (sCR; CR plus VGPR).
Analysis population: Safety population: All randomized participants who received at least 1 dose of study drug
Groups in this outcome
Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone (Phase 2)
Elotuzumab 10 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally
Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone (Phase 2)
Elotuzumab 20 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.
Total (Phase 2)
Elotuzumab (10 or 20 mg/kg) administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.
| Group | Source count |
|---|---|
| Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone (Phase 2) | 36 |
| Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone (Phase 2) | 37 |
| Total (Phase 2) | 73 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone (Phase 2) | 91.7 | Not reported | 77.5 | 98.2 | Not reported |
| Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone (Phase 2) | 75.7 | Not reported | 58.8 | 88.2 | Not reported |
| Total (Phase 2) | 83.6 | Not reported | 73.0 | 91.2 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 77.5
- upper Limit
- 98.2
- value
- 91.7
- group Id
- OG001
- lower Limit
- 58.8
- upper Limit
- 88.2
- value
- 75.7
- group Id
- OG002
- lower Limit
- 73.0
- upper Limit
- 91.2
- value
- 83.6
- denoms
- counts
- group Id
- OG000
- value
- 36
- group Id
- OG001
- value
- 37
- group Id
- OG002
- value
- 73
- units
- Participants
- description
- ORR: Percentage of participants with confirmed complete response (CR; negative immunofixation on the serum and urine, disappearance of any soft tissue plasmacytomas, and ≤5% plasma cells in bone marrow), partial response (PR; ≥50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥90% or to ≤200 mg per 24 hour; if serum and urine M-protein are unmeasurable, a ≥50% decrease in the difference between involved and uninvolved free light chain (FLC\] levels is required in place of the M-protein criteria; if serum and urine M-protein are unmeasurable, and serum FLC is also unmeasurable, a ≥50% reduction in plasma cells is required in place of M-protein, provided baseline bone marrow plasma cell percentage was ≥30%; and, if present at baseline, a ≥50% reduction in the size of soft tissue plasmacytomas), very good PR (VGPR; normal FLC ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence), or stringent CR (sCR; CR plus VGPR).
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Elotuzumab 10 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally
- id
- OG000
- title
- Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone (Phase 2)
- description
- Elotuzumab 20 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.
- id
- OG001
- title
- Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone (Phase 2)
- description
- Elotuzumab (10 or 20 mg/kg) administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.
- id
- OG002
- title
- Total (Phase 2)
- param Type
- NUMBER
- population Description
- Safety population: All randomized participants who received at least 1 dose of study drug
- reporting Status
- POSTED
- time Frame
- From date of randomization until 60 days following the last infusion (or before initiation of new therapy), up to 101 months
- title
- Objective Response Rate (ORR) According to the International Myeloma Working Group Uniform Response Criteria (Phase 2)
- type
- PRIMARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice