TriangleNCT00790842 · OUTCOME
Overall Survival Time
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- months
- Interval / dispersion
- 90% Confidence Interval
- Time frame
- 56 months
What was measured
Overall survival is the time from registration to death from any cause. Patients alive at the time of analysis were censored at the date last known alive.
Analysis population: Eligible, treated patients
Groups in this outcome
Group A=30-60 CrCl (mL/Min)
Lenalidomide days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days. Phase I will determine the dose of lenalidomide to be used in Phase II. Group A=30-60 CrCl (mL/min): Each Cycle=28 days. Lenalidomide by mouth days 1-21 and Dexamethasone 40 mg by mouth days 1, 8, 15 and 22. There is a 7 day rest (days 22-28) from lenalidomide. Continue until disease progression or unacceptable toxicity. Phase I will determine the dose of lenalidomide to be used in Phase II.
Group B=CrCL<30 mL/Min Not on Dialysis
Lenalidomide days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days. Phase I will determine the dose of lenalidomide to be used in Phase II. Group B=CrCL\<30 mL/min not on dialysis: Each Cycle=28 days. Lenalidomide by mouth days 1-21 and Dexamethasone 40 mg by mouth days 1, 8, 15 and 22. There is a 7 day rest (days 22-28) from lenalidomide. Continue until disease progression or unacceptable toxicity. Phase I will determine the dose of lenalidomide to be used in Phase II.
Group C=CrCL<30 mL/Min and on Dialysis
Lenalidomide days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days. Phase I will determine the dose of lenalidomide to be used in Phase II. Group C=CrCL\<30 mL/min and on dialysis: Each Cycle=28 days. Lenalidomide by mouth days 1-21 and Dexamethasone 40 mg by mouth days 1, 8, 15 and 22. There is a 7 day rest (days 22-28) from lenalidomide. Continue until disease progression or unacceptable toxicity. Phase I will determine the dose of lenalidomide to be used in Phase II. Dialysis includes hemodialysis or peritoneal dialysis. When lenalidomide and/or dexamethasone treatment occurs on a dialysis day, lenalidomide and/or dexamethasone must be taken after dialysis.
| Group | Source count |
|---|---|
| Group A=30-60 CrCl (mL/Min) | 29 |
| Group B=CrCL<30 mL/Min Not on Dialysis | 19 |
| Group C=CrCL<30 mL/Min and on Dialysis | 14 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Group A=30-60 CrCl (mL/Min) | 20.8 | Not reported | 11.0 | 42.1 | Not reported |
| Group B=CrCL<30 mL/Min Not on Dialysis | 20.0 | Not reported | 10.4 | 34.2 | Not reported |
| Group C=CrCL<30 mL/Min and on Dialysis | NA | Not reported | 10.4 | NA | Insufficient observations to estimate median or upper confidence limit |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 11.0
- upper Limit
- 42.1
- value
- 20.8
- group Id
- OG001
- lower Limit
- 10.4
- upper Limit
- 34.2
- value
- 20.0
- comment
- Insufficient observations to estimate median or upper confidence limit
- group Id
- OG002
- lower Limit
- 10.4
- upper Limit
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 29
- group Id
- OG001
- value
- 19
- group Id
- OG002
- value
- 14
- units
- Participants
- description
- Overall survival is the time from registration to death from any cause. Patients alive at the time of analysis were censored at the date last known alive.
- dispersion Type
- 90% Confidence Interval
- groups
- description
- Lenalidomide days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days. Phase I will determine the dose of lenalidomide to be used in Phase II. Group A=30-60 CrCl (mL/min): Each Cycle=28 days. Lenalidomide by mouth days 1-21 and Dexamethasone 40 mg by mouth days 1, 8, 15 and 22. There is a 7 day rest (days 22-28) from lenalidomide. Continue until disease progression or unacceptable toxicity. Phase I will determine the dose of lenalidomide to be used in Phase II.
- id
- OG000
- title
- Group A=30-60 CrCl (mL/Min)
- description
- Lenalidomide days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days. Phase I will determine the dose of lenalidomide to be used in Phase II. Group B=CrCL\<30 mL/min not on dialysis: Each Cycle=28 days. Lenalidomide by mouth days 1-21 and Dexamethasone 40 mg by mouth days 1, 8, 15 and 22. There is a 7 day rest (days 22-28) from lenalidomide. Continue until disease progression or unacceptable toxicity. Phase I will determine the dose of lenalidomide to be used in Phase II.
- id
- OG001
- title
- Group B=CrCL<30 mL/Min Not on Dialysis
- description
- Lenalidomide days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days. Phase I will determine the dose of lenalidomide to be used in Phase II. Group C=CrCL\<30 mL/min and on dialysis: Each Cycle=28 days. Lenalidomide by mouth days 1-21 and Dexamethasone 40 mg by mouth days 1, 8, 15 and 22. There is a 7 day rest (days 22-28) from lenalidomide. Continue until disease progression or unacceptable toxicity. Phase I will determine the dose of lenalidomide to be used in Phase II. Dialysis includes hemodialysis or peritoneal dialysis. When lenalidomide and/or dexamethasone treatment occurs on a dialysis day, lenalidomide and/or dexamethasone must be taken after dialysis.
- id
- OG002
- title
- Group C=CrCL<30 mL/Min and on Dialysis
- param Type
- MEDIAN
- population Description
- Eligible, treated patients
- reporting Status
- POSTED
- time Frame
- 56 months
- title
- Overall Survival Time
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice