TriangleNCT01169337 · OUTCOME
2-year Progression-free Rate (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 for 2 years
What was measured
TTP is defined as the time from randomization to progression. Patients are considered to have progression if both of the following criteria are met. Kaplan-Meier method was used to estimate 2-year progression-free rate. 1. Any of the following: * Increase in serum M-protein to ≥ 25% above the lowest response level with an absolute increase of at least 0.5g/dl to qualify as "progression" * Increase in urine M-protein to ≥ 25% above the lowest response level for 24-hour excretion with an absolute increase of at least 200mg/24 hours of urine M-protein to qualify as "progression" * Increase in bone marrow plasma cell percentage to ≥ 25% from lowest response value (the absolute % increase must be ≥ 10%) 2. Any one or more of the following felt related to the underlying clonal plasma cell proliferative disorder: * Hypercalcemia (\> 11 mg/dL) * Decrease in hemoglobin of ≥ 2 gms/dL * Serum creatinine level ≥ 2mg/dL * Development of myeloma bone lesions or soft tissue plasmacytoma
Analysis population: All randomized patients in the phase III part of the study
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) | 90 |
| Arm B (Observation; Phase III) | 92 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm A (Lenalidomide; Phase III) | 94.3 | Not reported | 85.4 | 97.9 | Not reported |
| Arm B (Observation; Phase III) | 75.8 | Not reported | 63.6 | 84.4 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 85.4
- upper Limit
- 97.9
- value
- 94.3
- group Id
- OG001
- lower Limit
- 63.6
- upper Limit
- 84.4
- value
- 75.8
- denoms
- counts
- group Id
- OG000
- value
- 90
- group Id
- OG001
- value
- 92
- units
- Participants
- description
- TTP is defined as the time from randomization to progression. Patients are considered to have progression if both of the following criteria are met. Kaplan-Meier method was used to estimate 2-year progression-free rate. 1. Any of the following: * Increase in serum M-protein to ≥ 25% above the lowest response level with an absolute increase of at least 0.5g/dl to qualify as "progression" * Increase in urine M-protein to ≥ 25% above the lowest response level for 24-hour excretion with an absolute increase of at least 200mg/24 hours of urine M-protein to qualify as "progression" * Increase in bone marrow plasma cell percentage to ≥ 25% from lowest response value (the absolute % increase must be ≥ 10%) 2. Any one or more of the following felt related to the underlying clonal plasma cell proliferative disorder: * Hypercalcemia (\> 11 mg/dL) * Decrease in hemoglobin of ≥ 2 gms/dL * Serum creatinine level ≥ 2mg/dL * Development of myeloma bone lesions or soft tissue plasmacytoma
- 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
- All randomized patients in the phase III part of the study
- reporting Status
- POSTED
- time Frame
- Assessed every 3 months for 2 years
- title
- 2-year Progression-free Rate (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