TriangleNCT01668719 · OUTCOME
Overall Survival
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 6 years post registration
What was measured
From date of registration to date of death due to any cause
Analysis population: Eligible and evaluable participants
Groups in this outcome
Arm I (Bortezomib, Lenalidomide, Dexamethasone)
INDUCTION: Participants receive bortezomib SC or IV on days 1, 4, 8, and 11; lenalidomide PO QD on days 1-14; and dexamethasone PO or IV on days 1, 2, 4, 5, 8, 9, 11, and 12. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity (participants who received a course of chemotherapy prior to registration will begin protocol treatment with course 2 and receive a total of 7 courses of protocol therapy). MAINTENANCE: Participants receive bortezomib SC or IV on days 1, 8, and 15; lenalidomide PO QD on days 1-21; and dexamethasone PO on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Bortezomib: Given SC or IV Dexamethasone: Given PO or IV Laboratory Biomarker Analysis: Correlative studies Lenalidomide: Given PO
Arm II (Bortezomib, Lenalidomide, Dexamethasone, Elotuzumab)
INDUCTION: Participants receive bortezomib, lenalidomide, and dexamethasone as in Arm I. Participants also receive elotuzumab IV on days 1, 8, and 15 of courses 1 and 2 and on days 1 and 11 of courses 3-8. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity. MAINTENANCE:Participants receive bortezomib, lenalidomide, and dexamethasone as in Arm I. Participants also receive elotuzumab IV on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Bortezomib: Given SC or IV Dexamethasone: Given PO or IV Elotuzumab: Given IV Laboratory Biomarker Analysis: Correlative studies Lenalidomide: Given PO
| Group | Source count |
|---|---|
| Arm I (Bortezomib, Lenalidomide, Dexamethasone) | 52 |
| Arm II (Bortezomib, Lenalidomide, Dexamethasone, Elotuzumab) | 48 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm I (Bortezomib, Lenalidomide, Dexamethasone) | NA | Not reported | NA | NA | median overall survival was not reached |
| Arm II (Bortezomib, Lenalidomide, Dexamethasone, Elotuzumab) | 68 | Not reported | 61 | 68 | Not reported |
Complete source fields
- classes
- categories
- measurements
- comment
- median overall survival was not reached
- group Id
- OG000
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- group Id
- OG001
- lower Limit
- 61
- upper Limit
- 68
- value
- 68
- denoms
- counts
- group Id
- OG000
- value
- 52
- group Id
- OG001
- value
- 48
- units
- Participants
- description
- From date of registration to date of death due to any cause
- dispersion Type
- 95% Confidence Interval
- groups
- description
- INDUCTION: Participants receive bortezomib SC or IV on days 1, 4, 8, and 11; lenalidomide PO QD on days 1-14; and dexamethasone PO or IV on days 1, 2, 4, 5, 8, 9, 11, and 12. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity (participants who received a course of chemotherapy prior to registration will begin protocol treatment with course 2 and receive a total of 7 courses of protocol therapy). MAINTENANCE: Participants receive bortezomib SC or IV on days 1, 8, and 15; lenalidomide PO QD on days 1-21; and dexamethasone PO on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Bortezomib: Given SC or IV Dexamethasone: Given PO or IV Laboratory Biomarker Analysis: Correlative studies Lenalidomide: Given PO
- id
- OG000
- title
- Arm I (Bortezomib, Lenalidomide, Dexamethasone)
- description
- INDUCTION: Participants receive bortezomib, lenalidomide, and dexamethasone as in Arm I. Participants also receive elotuzumab IV on days 1, 8, and 15 of courses 1 and 2 and on days 1 and 11 of courses 3-8. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity. MAINTENANCE:Participants receive bortezomib, lenalidomide, and dexamethasone as in Arm I. Participants also receive elotuzumab IV on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Bortezomib: Given SC or IV Dexamethasone: Given PO or IV Elotuzumab: Given IV Laboratory Biomarker Analysis: Correlative studies Lenalidomide: Given PO
- id
- OG001
- title
- Arm II (Bortezomib, Lenalidomide, Dexamethasone, Elotuzumab)
- param Type
- MEDIAN
- population Description
- Eligible and evaluable participants
- reporting Status
- POSTED
- time Frame
- Up to 6 years post registration
- title
- Overall Survival
- type
- SECONDARY
- unit Of Measure
- months
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Preserved source evidence · Not medical advice