TriangleNCT02726581 · OUTCOME
Progression Free Survival (PFS)
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
- From randomization to the date of the first documented tumor progression or death due to any cause, whichever occurred first (Up to approximately 64 month)
What was measured
Randomization to first documented tumor progression or death due to any cause, whichever occurred first. Participants who die without reported prior progression are considered to have progressed on date of their death. Participants who did not progress or die will be censored at their last efficacy assessment. Participants who did not have on study efficacy assessments and alive will be censored on randomization date. Participants who started subsequent anti-cancer therapy without prior reported progression will be censored at last efficacy assessment prior to subsequent anti-cancer therapy. Progression is 1) increase of 25% from lowest confirmed response value in specific Serum M-protein and Urine M-protein criteria and increase of FLC for patients with no measurable M protein in blood or urine at baseline and/or 2) appearance of a new lesion(s), \>/= 50% increase from nadir in SPD of \> 1 lesion, or \>/= 50% increase in the longest diameter of a previous lesion \> 1 cm in short axis.
Analysis population: All randomized participants in Arm A and B. Data was pre-specified to be collected only in the N-Pd and Pd arms.
Groups in this outcome
Arm A: N-Pd
Nivolumab: * Cycles 1 through 4: 240 mg IV Days 1, 15 of each 28-day cycle. * Cycles 5 and beyond: 480 mg IV Day 1 of each 28-day cycle. Pomalidomide: \- 4 mg PO QD Days 1-21 of each 28-day cycle. Dexamethasone: * Participants \</= 75 years old: 40 mg PO Days (1, 8, 15, and 22) of each cycle * Participants \> 75 years old: 20 mg PO Days (1, 8, 15, and 22) of each cycle.
Arm B: Pd
Pomalidomide: \- 4 mg PO QD Days 1-21 of each 28-day cycle. Dexamethasone: * Participants \</= 75 years old: 40 mg PO Days (1, 8, 15, and 22) of each cycle * Participants \> 75 years old: 20 mg PO Days (1, 8, 15, and 22) of each cycle.
| Group | Source count |
|---|---|
| Arm A: N-Pd | 75 |
| Arm B: Pd | 71 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm A: N-Pd | 8.38 | Not reported | 5.78 | 12.06 | Not reported |
| Arm B: Pd | 7.33 | Not reported | 6.47 | 8.44 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.62
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.30
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- param Type
- Hazard Ratio (HR)
- param Value
- 0.90
Complete source fields
- analyses
- ci Lower Limit
- 0.62
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.30
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- param Type
- Hazard Ratio (HR)
- param Value
- 0.90
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 5.78
- upper Limit
- 12.06
- value
- 8.38
- group Id
- OG001
- lower Limit
- 6.47
- upper Limit
- 8.44
- value
- 7.33
- denoms
- counts
- group Id
- OG000
- value
- 75
- group Id
- OG001
- value
- 71
- units
- Participants
- description
- Randomization to first documented tumor progression or death due to any cause, whichever occurred first. Participants who die without reported prior progression are considered to have progressed on date of their death. Participants who did not progress or die will be censored at their last efficacy assessment. Participants who did not have on study efficacy assessments and alive will be censored on randomization date. Participants who started subsequent anti-cancer therapy without prior reported progression will be censored at last efficacy assessment prior to subsequent anti-cancer therapy. Progression is 1) increase of 25% from lowest confirmed response value in specific Serum M-protein and Urine M-protein criteria and increase of FLC for patients with no measurable M protein in blood or urine at baseline and/or 2) appearance of a new lesion(s), \>/= 50% increase from nadir in SPD of \> 1 lesion, or \>/= 50% increase in the longest diameter of a previous lesion \> 1 cm in short axis.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Nivolumab: * Cycles 1 through 4: 240 mg IV Days 1, 15 of each 28-day cycle. * Cycles 5 and beyond: 480 mg IV Day 1 of each 28-day cycle. Pomalidomide: \- 4 mg PO QD Days 1-21 of each 28-day cycle. Dexamethasone: * Participants \</= 75 years old: 40 mg PO Days (1, 8, 15, and 22) of each cycle * Participants \> 75 years old: 20 mg PO Days (1, 8, 15, and 22) of each cycle.
- id
- OG000
- title
- Arm A: N-Pd
- description
- Pomalidomide: \- 4 mg PO QD Days 1-21 of each 28-day cycle. Dexamethasone: * Participants \</= 75 years old: 40 mg PO Days (1, 8, 15, and 22) of each cycle * Participants \> 75 years old: 20 mg PO Days (1, 8, 15, and 22) of each cycle.
- id
- OG001
- title
- Arm B: Pd
- param Type
- MEDIAN
- population Description
- All randomized participants in Arm A and B. Data was pre-specified to be collected only in the N-Pd and Pd arms.
- reporting Status
- POSTED
- time Frame
- From randomization to the date of the first documented tumor progression or death due to any cause, whichever occurred first (Up to approximately 64 month)
- title
- Progression Free Survival (PFS)
- type
- PRIMARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice