TriangleNCT03411031 · OUTCOME
Percentage of Participants With Progression Free Survival (PFS)
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
- An average of 8 months
What was measured
Progression free survival (PFS) is defined as the time of randomization to date of death from any cause, date of relapse/progression, or the last follow-up date, whichever comes first. The Kaplan-Meier method will be used to estimate PFS for each Study Arm. The method of Brookmeyer and Crowley will be used to construct 95% confidence interval.
Groups in this outcome
A: Elotuzumab + Lenalidomide at 25 mg
Elotuzumab 10 mg/kg intravenously (IV) weekly (days 1, 8, 15 and 22) for 2 cycles, then 20 mg/kg every 4 weeks. Dexamethasone will be administered as premedication for elotuzumab. Lenalidomide 25 mg by mouth (PO) daily days 1-21 out of a 28-day schedule. Elotuzumab: Elotuzumab according to dosing schedule outlined in treatment arms. Lenalidomide: Lenalidomide according to dosing schedule outlined in treatment arms. Dexamethasone: Dexamethasone is a commercially available drug. The description, how supplied, and storage instructions for dexamethasone product are found in the prescribing information. During the study, dexamethasone will be administered as premedication for elotuzumab as indicated in the package insert.
B: Elotuzumab + Lenalidomide at 10 mg
Elotuzumab 10 mg/kg IV weekly (days 1, 8, 15 and 22) for 2 cycles, then 20 mg/kg every 4 weeks. Dexamethasone will be administered as premedication for elotuzumab. Lenalidomide 10 mg PO daily days 1-21 out of a 28-day schedule. Elotuzumab: Elotuzumab according to dosing schedule outlined in treatment arms. Lenalidomide: Lenalidomide according to dosing schedule outlined in treatment arms. Dexamethasone: Dexamethasone is a commercially available drug. The description, how supplied, and storage instructions for dexamethasone product are found in the prescribing information. During the study, dexamethasone will be administered as premedication for elotuzumab as indicated in the package insert.
| Group | Source count |
|---|---|
| A: Elotuzumab + Lenalidomide at 25 mg | 9 |
| B: Elotuzumab + Lenalidomide at 10 mg | 9 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| A: Elotuzumab + Lenalidomide at 25 mg | 11.1 | Not reported | 0.1 | 38.8 | Not reported |
| B: Elotuzumab + Lenalidomide at 10 mg | 22.2 | Not reported | 3.4 | 51.3 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.1
- upper Limit
- 38.8
- value
- 11.1
- group Id
- OG001
- lower Limit
- 3.4
- upper Limit
- 51.3
- value
- 22.2
- denoms
- counts
- group Id
- OG000
- value
- 9
- group Id
- OG001
- value
- 9
- units
- Participants
- description
- Progression free survival (PFS) is defined as the time of randomization to date of death from any cause, date of relapse/progression, or the last follow-up date, whichever comes first. The Kaplan-Meier method will be used to estimate PFS for each Study Arm. The method of Brookmeyer and Crowley will be used to construct 95% confidence interval.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Elotuzumab 10 mg/kg intravenously (IV) weekly (days 1, 8, 15 and 22) for 2 cycles, then 20 mg/kg every 4 weeks. Dexamethasone will be administered as premedication for elotuzumab. Lenalidomide 25 mg by mouth (PO) daily days 1-21 out of a 28-day schedule. Elotuzumab: Elotuzumab according to dosing schedule outlined in treatment arms. Lenalidomide: Lenalidomide according to dosing schedule outlined in treatment arms. Dexamethasone: Dexamethasone is a commercially available drug. The description, how supplied, and storage instructions for dexamethasone product are found in the prescribing information. During the study, dexamethasone will be administered as premedication for elotuzumab as indicated in the package insert.
- id
- OG000
- title
- A: Elotuzumab + Lenalidomide at 25 mg
- description
- Elotuzumab 10 mg/kg IV weekly (days 1, 8, 15 and 22) for 2 cycles, then 20 mg/kg every 4 weeks. Dexamethasone will be administered as premedication for elotuzumab. Lenalidomide 10 mg PO daily days 1-21 out of a 28-day schedule. Elotuzumab: Elotuzumab according to dosing schedule outlined in treatment arms. Lenalidomide: Lenalidomide according to dosing schedule outlined in treatment arms. Dexamethasone: Dexamethasone is a commercially available drug. The description, how supplied, and storage instructions for dexamethasone product are found in the prescribing information. During the study, dexamethasone will be administered as premedication for elotuzumab as indicated in the package insert.
- id
- OG001
- title
- B: Elotuzumab + Lenalidomide at 10 mg
- param Type
- NUMBER
- reporting Status
- POSTED
- time Frame
- An average of 8 months
- title
- Percentage of Participants With Progression Free Survival (PFS)
- type
- PRIMARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice