TriangleNCT01169337 · OUTCOME
Proportion of Participants With Response (Phase III Secondary Endpoint)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- proportion of participants
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Assessed every 3 months if patient is < 2 years from study entry, every 6 months if patient is 2-5 years from study entry, then annually for years 6-10
What was measured
Response is defined as complete response (CR), very good partial response (VGPR) or partial response (PR). CR: Negative immunofixation on the serum and urine, disappearance of any soft tissue plasmacytomas and \<=5% plasma cells in bone marrow VGPR: Serum and urine M-component detectable by immunofixation but not on electrophoresis or ≥ 90% reduction in serum M-component plus urine M-component \< 100 mg per 24 hours PR: * ≥ 50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥ 90% or to \< 200 mg per 24 hours * If followed by free light chain (FLC) only, a ≥ 50% decrease in the difference between involved and uninvolved FLC levels * If unmeasurable disease by serum M-protein, urine M-protein, and serum FLC at baseline, a ≥50% reduction in plasma cells provided baseline bone marrow percentage was ≥ 30% * If present at baseline, a ≥ 50% reduction in the size of soft tissue plasmacytomas
Analysis population: Among randomized patients who received treatment or observation
Groups in this outcome
Arm A (Lenalidomide; Phase III)
Patients receive lenalidomide PO QD on days 1-21. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Arm B (Observation; Phase III)
Patients undergo observation until progression to symptomatic myeloma.
| Group | Source count |
|---|---|
| Arm A (Lenalidomide; Phase III) | 88 |
| Arm B (Observation; Phase III) | 86 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm A (Lenalidomide; Phase III) | 0.50 | Not reported | 0.391 | 0.608 | Not reported |
| Arm B (Observation; Phase III) | 0 | Not reported | 0 | 0.042 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.391
- upper Limit
- 0.608
- value
- 0.50
- group Id
- OG001
- lower Limit
- 0
- upper Limit
- 0.042
- value
- 0
- denoms
- counts
- group Id
- OG000
- value
- 88
- group Id
- OG001
- value
- 86
- units
- Participants
- description
- Response is defined as complete response (CR), very good partial response (VGPR) or partial response (PR). CR: Negative immunofixation on the serum and urine, disappearance of any soft tissue plasmacytomas and \<=5% plasma cells in bone marrow VGPR: Serum and urine M-component detectable by immunofixation but not on electrophoresis or ≥ 90% reduction in serum M-component plus urine M-component \< 100 mg per 24 hours PR: * ≥ 50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥ 90% or to \< 200 mg per 24 hours * If followed by free light chain (FLC) only, a ≥ 50% decrease in the difference between involved and uninvolved FLC levels * If unmeasurable disease by serum M-protein, urine M-protein, and serum FLC at baseline, a ≥50% reduction in plasma cells provided baseline bone marrow percentage was ≥ 30% * If present at baseline, a ≥ 50% reduction in the size of soft tissue plasmacytomas
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Patients receive lenalidomide PO QD on days 1-21. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
- id
- OG000
- title
- Arm A (Lenalidomide; Phase III)
- description
- Patients undergo observation until progression to symptomatic myeloma.
- id
- OG001
- title
- Arm B (Observation; Phase III)
- param Type
- NUMBER
- population Description
- Among randomized patients who received treatment or observation
- reporting Status
- POSTED
- time Frame
- Assessed every 3 months if patient is < 2 years from study entry, every 6 months if patient is 2-5 years from study entry, then annually for years 6-10
- title
- Proportion of Participants With Response (Phase III Secondary Endpoint)
- type
- SECONDARY
- unit Of Measure
- proportion of participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice