TriangleNCT01169337 · OUTCOME
2-year Progression-free Survival (PFS) Rate (Phase III Primary 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
PFS is defined as time from randomization to progression or death, whichever occurs first. Patients are considered to have progression if both of the following criteria are met. Kaplan-Meier method was used to estimate 2-year PFS 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 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
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) | 0.93 | Not reported | 0.88 | 0.99 | Not reported |
| Arm B (Observation; Phase III) | 0.76 | Not reported | 0.66 | 0.87 | Not reported |
Source statistical analyses
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.0005
- statistical Comment
- stratified 1-sided log-rank test
- statistical Method
- Log Rank
Complete source fields
- analyses
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.0005
- statistical Comment
- stratified 1-sided log-rank test
- statistical Method
- Log Rank
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.88
- upper Limit
- 0.99
- value
- 0.93
- group Id
- OG001
- lower Limit
- 0.66
- upper Limit
- 0.87
- value
- 0.76
- denoms
- counts
- group Id
- OG000
- value
- 90
- group Id
- OG001
- value
- 92
- units
- Participants
- description
- PFS is defined as time from randomization to progression or death, whichever occurs first. Patients are considered to have progression if both of the following criteria are met. Kaplan-Meier method was used to estimate 2-year PFS 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 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
- reporting Status
- POSTED
- time Frame
- Assessed every 3 months for 2 years
- title
- 2-year Progression-free Survival (PFS) Rate (Phase III Primary Endpoint)
- type
- PRIMARY
- unit Of Measure
- proportion of participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice