TriangleNCT01675141 · OUTCOME
Duration of Response
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
- participants were followed for the duration of their treatment, an average of 2 years
What was measured
Duration of response is defined as time from response to disease progression or death. Progression is assessed by the International Myeloma Workshop Consensus Panel Criteria. Progressive disease requires any one or more of the following: increase of ≥25% from baseline or lowest response value in Serum M component, Urine M component, free light chain or bone marrow plasma cell percentage. Lowest response value does not need to be a confirmed value. Serum M-component absolute increase must be ≥0.5 g/dl. The serum M-component increases of ≥1 gm/dl are sufficient to define relapse if starting M-component is ≥5 g/dl. Urine M-component absolute increase must be ≥200mg/24h. Only in patients without measureable serum and urine M-protein levels: the absolute increase in difference between involved and uninvolved free light chain levels must be \>10mg/dl.
Groups in this outcome
Lenalidomide Maintenance Therapy for Multiple Myeloma
10 mg oral daily, on days 1-21 of repeated 28 day cycles, to continue until disease progression or unacceptable toxicity. Lenalidomide: 10 mg oral daily, on days 1-21 of repeated 28 day cycles, to continue until disease progression or unacceptable toxicity.
| Group | Source count |
|---|---|
| Lenalidomide Maintenance Therapy for Multiple Myeloma | 10 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Lenalidomide Maintenance Therapy for Multiple Myeloma | NA | Not reported | 0.9 | NA | The median and upper limit of 95% CI is NR (not reached). The median and upper limit were not reached because there was not enough follow up time to reach a median or upper limit. |
Complete source fields
- classes
- categories
- measurements
- comment
- The median and upper limit of 95% CI is NR (not reached). The median and upper limit were not reached because there was not enough follow up time to reach a median or upper limit.
- group Id
- OG000
- lower Limit
- 0.9
- upper Limit
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 10
- units
- Participants
- description
- Duration of response is defined as time from response to disease progression or death. Progression is assessed by the International Myeloma Workshop Consensus Panel Criteria. Progressive disease requires any one or more of the following: increase of ≥25% from baseline or lowest response value in Serum M component, Urine M component, free light chain or bone marrow plasma cell percentage. Lowest response value does not need to be a confirmed value. Serum M-component absolute increase must be ≥0.5 g/dl. The serum M-component increases of ≥1 gm/dl are sufficient to define relapse if starting M-component is ≥5 g/dl. Urine M-component absolute increase must be ≥200mg/24h. Only in patients without measureable serum and urine M-protein levels: the absolute increase in difference between involved and uninvolved free light chain levels must be \>10mg/dl.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- 10 mg oral daily, on days 1-21 of repeated 28 day cycles, to continue until disease progression or unacceptable toxicity. Lenalidomide: 10 mg oral daily, on days 1-21 of repeated 28 day cycles, to continue until disease progression or unacceptable toxicity.
- id
- OG000
- title
- Lenalidomide Maintenance Therapy for Multiple Myeloma
- param Type
- MEDIAN
- reporting Status
- POSTED
- time Frame
- participants were followed for the duration of their treatment, an average of 2 years
- title
- Duration of Response
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice