TriangleNCT01903811 · OUTCOME
Progression-free Survival of Crossover Group
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 date of crossover to date of subsequent documentation of progression or symptomatic deterioration, or death due to any cause, assessed up to 3 years from randomization
What was measured
Assessed in the crossover arm using the method of Kaplan Meier. Progression is defined using the International Uniform Response Criteria for Multiple Myeloma as new or increase in size of existing bone lesions or soft tissue plasmacytomas; or development of hypercalcemia attributable solely to MM; or ≥ 25% increase from baseline or lowest response level of either serum M protein, urine M protein, difference in involved \& uninvolved serum free light chain level or bone marrow plasma cell percentage.
Analysis population: Patients on Arm 1 that progress after the start of course 2 and prior to completion of 12 courses receive high dose carfilzomib
Groups in this outcome
Arm III (Crossover Group)
Patients on Arm 1 that progress after the start of course 2 and prior to completion of 12 courses receive 20 mg dexamethasone IV and high-dose (56 mg/m\^2) carfilzomib IV over 30 minutes on days 1, 2, 8, 9, 15, and 16. Treatment repeats every 28 days for up to 12 additional courses in the absence of disease progression or unacceptable toxicity. Carfilzomib: Given IV Dexamethasone: Given IV Laboratory Biomarker Analysis: Correlative studies
| Group | Source count |
|---|---|
| Arm III (Crossover Group) | 16 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm III (Crossover Group) | 3 | Not reported | 2 | 6 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 2
- upper Limit
- 6
- value
- 3
- denoms
- counts
- group Id
- OG000
- value
- 16
- units
- Participants
- description
- Assessed in the crossover arm using the method of Kaplan Meier. Progression is defined using the International Uniform Response Criteria for Multiple Myeloma as new or increase in size of existing bone lesions or soft tissue plasmacytomas; or development of hypercalcemia attributable solely to MM; or ≥ 25% increase from baseline or lowest response level of either serum M protein, urine M protein, difference in involved \& uninvolved serum free light chain level or bone marrow plasma cell percentage.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Patients on Arm 1 that progress after the start of course 2 and prior to completion of 12 courses receive 20 mg dexamethasone IV and high-dose (56 mg/m\^2) carfilzomib IV over 30 minutes on days 1, 2, 8, 9, 15, and 16. Treatment repeats every 28 days for up to 12 additional courses in the absence of disease progression or unacceptable toxicity. Carfilzomib: Given IV Dexamethasone: Given IV Laboratory Biomarker Analysis: Correlative studies
- id
- OG000
- title
- Arm III (Crossover Group)
- param Type
- MEDIAN
- population Description
- Patients on Arm 1 that progress after the start of course 2 and prior to completion of 12 courses receive high dose carfilzomib
- reporting Status
- POSTED
- time Frame
- From date of crossover to date of subsequent documentation of progression or symptomatic deterioration, or death due to any cause, assessed up to 3 years from randomization
- title
- Progression-free Survival of Crossover Group
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice