TriangleNCT02020941 · 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
- Time from first dose to first observed disease progression or death, assessed up to 2 years
What was measured
Analysis will be performed using Kaplan-Meier estimates. Time from date on treatment to date of progression for patients who progressed or date of death for patients who died without progressing. The observations of patients remaining alive and progression free were censored at date of last disease evaluation.
Analysis population: All patients enrolled and received treatment.
Groups in this outcome
Treatment (Carfilzomib, Dexamethasone)
TREATMENT PHASE (COURSES 1-8): Patients receive carfilzomib IV over 30 minutes on days 1, 2, 8, 9, 15, and 16. Treatment repeats every 28 days for 8 courses in the absence of disease progression or unacceptable toxicity. Patients achieving less than PR also receive dexamethasone PO or IV weekly in courses 4-8. MAINTENANCE PHASE (COURSES 9-14): Patients receive carfilzomib IV over 30 minutes on days 1, 2, 15, and 16. Patients who received dexamethasone in the Treatment Phase continue to receive dexamethasone PO or IV weekly. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. carfilzomib: Given IV dexamethasone: Given IV or PO laboratory biomarker analysis: Correlative studies
| Group | Source count |
|---|---|
| Treatment (Carfilzomib, Dexamethasone) | 10 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Treatment (Carfilzomib, Dexamethasone) | 11.5 | Not reported | 2.9 | 16.4 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 2.9
- upper Limit
- 16.4
- value
- 11.5
- denoms
- counts
- group Id
- OG000
- value
- 10
- units
- Participants
- description
- Analysis will be performed using Kaplan-Meier estimates. Time from date on treatment to date of progression for patients who progressed or date of death for patients who died without progressing. The observations of patients remaining alive and progression free were censored at date of last disease evaluation.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- TREATMENT PHASE (COURSES 1-8): Patients receive carfilzomib IV over 30 minutes on days 1, 2, 8, 9, 15, and 16. Treatment repeats every 28 days for 8 courses in the absence of disease progression or unacceptable toxicity. Patients achieving less than PR also receive dexamethasone PO or IV weekly in courses 4-8. MAINTENANCE PHASE (COURSES 9-14): Patients receive carfilzomib IV over 30 minutes on days 1, 2, 15, and 16. Patients who received dexamethasone in the Treatment Phase continue to receive dexamethasone PO or IV weekly. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. carfilzomib: Given IV dexamethasone: Given IV or PO laboratory biomarker analysis: Correlative studies
- id
- OG000
- title
- Treatment (Carfilzomib, Dexamethasone)
- param Type
- MEDIAN
- population Description
- All patients enrolled and received treatment.
- reporting Status
- POSTED
- time Frame
- Time from first dose to first observed disease progression or death, assessed up to 2 years
- title
- Progression-free Survival (PFS)
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice