TriangleNCT00742560 · OUTCOME
Duration of Response
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
- From first dose of elotuzumab (phase 1) or randomization (phase 2) until 60 days following the last infusion (or before initiation of new therapy), up to 101 months
What was measured
Duration of response is defined as the time from the initial objective response to disease progression or death, whichever occurs first. The distribution of duration of response was estimated for each treatment group using Kaplan-Meier methodology. Point estimates and 95% CIs for the median for the duration of response distribution are provided.
Analysis population: Safety population: All randomized participants who received at least 1 dose of study drug
Groups in this outcome
Elotuzumab 5 mg/kg + Lenalidomide and Dexamethasone (Phase 1)
Elotuzumab 5 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.
Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone (Phase 1)
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 1)
Elotuzumab 20 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.
Total (Phase 1)
Elotuzumab (5, 10, or 20 mg/kg) administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.
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 5 mg/kg + Lenalidomide and Dexamethasone (Phase 1) | 3 |
| Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone (Phase 1) | 3 |
| Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone (Phase 1) | 22 |
| Total (Phase 1) | 28 |
| 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 5 mg/kg + Lenalidomide and Dexamethasone (Phase 1) | 4.47 | Not reported | 1.45 | 4.47 | Not reported |
| Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone (Phase 1) | 9.92 | Not reported | NA | NA | NA=Not calculable due to insufficient response events |
| Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone (Phase 1) | NA | Not reported | NA | NA | NA=Median was not reached (max value was 58.22) |
| Total (Phase 1) | NA | Not reported | NA | NA | NA=Median was not reached (max value was 58.22) |
| Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone (Phase 2) | 34.83 | Not reported | 14.6 | NA | NA=Not calculable due to insufficient response events |
| Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone (Phase 2) | 29.01 | Not reported | 15.0 | NA | NA=Not calculable due to insufficient response events |
| Total (Phase 2) | 29.24 | Not reported | 18.2 | NA | NA=Not calculable due to insufficient response events |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 1.45
- upper Limit
- 4.47
- value
- 4.47
- comment
- NA=Not calculable due to insufficient response events
- group Id
- OG001
- lower Limit
- NA
- upper Limit
- NA
- value
- 9.92
- comment
- NA=Median was not reached (max value was 58.22)
- group Id
- OG002
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- comment
- NA=Median was not reached (max value was 58.22)
- group Id
- OG003
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- comment
- NA=Not calculable due to insufficient response events
- group Id
- OG004
- lower Limit
- 14.6
- upper Limit
- NA
- value
- 34.83
- comment
- NA=Not calculable due to insufficient response events
- group Id
- OG005
- lower Limit
- 15.0
- upper Limit
- NA
- value
- 29.01
- comment
- NA=Not calculable due to insufficient response events
- group Id
- OG006
- lower Limit
- 18.2
- upper Limit
- NA
- value
- 29.24
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 22
- group Id
- OG003
- value
- 28
- group Id
- OG004
- value
- 36
- group Id
- OG005
- value
- 37
- group Id
- OG006
- value
- 73
- units
- Participants
- description
- Duration of response is defined as the time from the initial objective response to disease progression or death, whichever occurs first. The distribution of duration of response was estimated for each treatment group using Kaplan-Meier methodology. Point estimates and 95% CIs for the median for the duration of response distribution are provided.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Elotuzumab 5 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.
- id
- OG000
- title
- Elotuzumab 5 mg/kg + Lenalidomide and Dexamethasone (Phase 1)
- description
- Elotuzumab 10 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.
- id
- OG001
- title
- Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone (Phase 1)
- description
- Elotuzumab 20 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.
- id
- OG002
- title
- Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone (Phase 1)
- description
- Elotuzumab (5, 10, or 20 mg/kg) administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.
- id
- OG003
- title
- Total (Phase 1)
- description
- Elotuzumab 10 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.
- id
- OG004
- 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
- OG005
- 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
- OG006
- title
- Total (Phase 2)
- param Type
- MEDIAN
- population Description
- Safety population: All randomized participants who received at least 1 dose of study drug
- reporting Status
- POSTED
- time Frame
- From first dose of elotuzumab (phase 1) or randomization (phase 2) until 60 days following the last infusion (or before initiation of new therapy), up to 101 months
- title
- Duration of Response
- type
- SECONDARY
- unit Of Measure
- months
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Preserved source evidence · Not medical advice