TriangleNCT00928486 · OUTCOME
Kaplan-Meier Estimates of Duration of Response (DoR)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- weeks
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- From the time of the first dose of study drug to study completion; the median duration on study was 42.1 weeks
What was measured
Duration of response was defined as the time from the first observation of a response (CR, RR or PR) to the first documented disease progression or relapse. For participants who did not progress during the study, duration of response was censored at the last adequate response assessment showing evidence of no disease progression. Disease progression is defined as an increase in M-protein serum monoclonal paraprotein and/or urine paraprotein or evidence of bone marrow plasmacytosis and plasma cells, an appearance of new or existing soft tissue plasmacytomas, an appearance of new or existing lytic bone lesions and/or hypercalcemia \>11.5mg/dL
Analysis population: Efficacy Population = all participants who received at least one dose of study drug, who were evaluated for efficacy at least once after study drug dose administration and who met inclusion criteria who were responders
Groups in this outcome
Lenalidomide and Dexamethasone
Lenalidomide 25mg by mouth (PO) once daily (QD) on Days 1-21 of each 28 day cycle; When creatinine (CrCl) clearance \<60 mL/min, the initial dose was 10mg and the dose could be increased to 15mg after 2 cycles if the investigator judged therapeutic effect was insufficient and tolerability was acceptable. Dexamethasone 40 mg by PO once QD on days 1-4, 9-12 and 17-20 of each 28 day cycle for the first 4 cycles and Days 1-4 for the remaining cycles beginning at Cycle 5.
| Group | Source count |
|---|---|
| Lenalidomide and Dexamethasone | 15 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Lenalidomide and Dexamethasone | NA | Not reported | NA | NA | The median duration of response estimate was not reached at the last time data was censored at the last assessment date with no evidence of progression. |
Complete source fields
- classes
- categories
- measurements
- comment
- The median duration of response estimate was not reached at the last time data was censored at the last assessment date with no evidence of progression.
- group Id
- OG000
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 15
- units
- Participants
- description
- Duration of response was defined as the time from the first observation of a response (CR, RR or PR) to the first documented disease progression or relapse. For participants who did not progress during the study, duration of response was censored at the last adequate response assessment showing evidence of no disease progression. Disease progression is defined as an increase in M-protein serum monoclonal paraprotein and/or urine paraprotein or evidence of bone marrow plasmacytosis and plasma cells, an appearance of new or existing soft tissue plasmacytomas, an appearance of new or existing lytic bone lesions and/or hypercalcemia \>11.5mg/dL
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Lenalidomide 25mg by mouth (PO) once daily (QD) on Days 1-21 of each 28 day cycle; When creatinine (CrCl) clearance \<60 mL/min, the initial dose was 10mg and the dose could be increased to 15mg after 2 cycles if the investigator judged therapeutic effect was insufficient and tolerability was acceptable. Dexamethasone 40 mg by PO once QD on days 1-4, 9-12 and 17-20 of each 28 day cycle for the first 4 cycles and Days 1-4 for the remaining cycles beginning at Cycle 5.
- id
- OG000
- title
- Lenalidomide and Dexamethasone
- param Type
- MEDIAN
- population Description
- Efficacy Population = all participants who received at least one dose of study drug, who were evaluated for efficacy at least once after study drug dose administration and who met inclusion criteria who were responders
- reporting Status
- POSTED
- time Frame
- From the time of the first dose of study drug to study completion; the median duration on study was 42.1 weeks
- title
- Kaplan-Meier Estimates of Duration of Response (DoR)
- type
- SECONDARY
- unit Of Measure
- weeks
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice