TriangleNCT00790842 · OUTCOME
Progression-free 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
- 90% Confidence Interval
- Time frame
- 56 months
What was measured
Progression-free survival is the time from registration to disease progression or death. Patients alive without disease progression were censored at the time of the last disease assessment.
Analysis population: Patients treated at the recommended phase II dose
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) | 20 |
| Group B=CrCL<30 mL/Min Not on Dialysis | 10 |
| Group C=CrCL<30 mL/Min and on Dialysis | 5 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Group A=30-60 CrCl (mL/Min) | 12.6 | Not reported | 6.5 | 25.1 | Not reported |
| Group B=CrCL<30 mL/Min Not on Dialysis | 11.4 | Not reported | 10.4 | 14.5 | Not reported |
| Group C=CrCL<30 mL/Min and on Dialysis | NA | Not reported | 2.1 | NA | Median and upper confidence limit are not estimable due to small sample size |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 6.5
- upper Limit
- 25.1
- value
- 12.6
- group Id
- OG001
- lower Limit
- 10.4
- upper Limit
- 14.5
- value
- 11.4
- comment
- Median and upper confidence limit are not estimable due to small sample size
- group Id
- OG002
- lower Limit
- 2.1
- upper Limit
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 20
- group Id
- OG001
- value
- 10
- group Id
- OG002
- value
- 5
- units
- Participants
- description
- Progression-free survival is the time from registration to disease progression or death. Patients alive without disease progression were censored at the time of the last disease assessment.
- 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
- Patients treated at the recommended phase II dose
- reporting Status
- POSTED
- time Frame
- 56 months
- title
- Progression-free Survival
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice