TriangleNCT02903381 · OUTCOME
2 Year Progression Free Percent
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percentage of participants
- Interval / dispersion
- 90% Confidence Interval
- Time frame
- 2 Year
What was measured
The primary endpoint will be the 2-year progression-free percent and will be reported with corresponding 90% confidence interval. All patients who have received one dose of study treatment will be included for the analysis, including those who die or are lost to follow-up before 2 years. Progression is defined as ≥ 25% increase and an absolute increase of ≥ 0.5g/dL from their nadir in their serum or urine m-spike or FLC with no CRAB features attributable to MM progression.
Analysis population: All patients receiving any amount of protocol treatment. Patients who have progressed or lost to follow-up prior to two years are counted as failures; only patients followed and progression-free for at least two years are counted as successes.
Groups in this outcome
Nivolumab, Lenalidomide, Dexamethasone
* A treatment cycle is defined as 28 consecutive days. * Participants will receive 6 cycles of induction therapy followed by 6 cycles of maintenance therapy with lower doses of lenalidomide and no dexamethasone for a total of 12 months. Nivolumab: Intravenous, predetermined dosage, Days 1 and 15 during cycles 1-12 and Lenalidomide: Oral, predetermined dosage, Days 1-21 of cycle 1-12 Dexamethasone: Oral, Days 1, 8, 15 of cycle 1-6
| Group | Source count |
|---|---|
| Nivolumab, Lenalidomide, Dexamethasone | 8 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Nivolumab, Lenalidomide, Dexamethasone | 62.5 | Not reported | 28.9 | 88.9 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 28.9
- upper Limit
- 88.9
- value
- 62.5
- denoms
- counts
- group Id
- OG000
- value
- 8
- units
- Participants
- description
- The primary endpoint will be the 2-year progression-free percent and will be reported with corresponding 90% confidence interval. All patients who have received one dose of study treatment will be included for the analysis, including those who die or are lost to follow-up before 2 years. Progression is defined as ≥ 25% increase and an absolute increase of ≥ 0.5g/dL from their nadir in their serum or urine m-spike or FLC with no CRAB features attributable to MM progression.
- dispersion Type
- 90% Confidence Interval
- groups
- description
- * A treatment cycle is defined as 28 consecutive days. * Participants will receive 6 cycles of induction therapy followed by 6 cycles of maintenance therapy with lower doses of lenalidomide and no dexamethasone for a total of 12 months. Nivolumab: Intravenous, predetermined dosage, Days 1 and 15 during cycles 1-12 and Lenalidomide: Oral, predetermined dosage, Days 1-21 of cycle 1-12 Dexamethasone: Oral, Days 1, 8, 15 of cycle 1-6
- id
- OG000
- title
- Nivolumab, Lenalidomide, Dexamethasone
- param Type
- NUMBER
- population Description
- All patients receiving any amount of protocol treatment. Patients who have progressed or lost to follow-up prior to two years are counted as failures; only patients followed and progression-free for at least two years are counted as successes.
- reporting Status
- POSTED
- time Frame
- 2 Year
- title
- 2 Year Progression Free Percent
- type
- PRIMARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice