TriangleNCT01903811 · OUTCOME
Progression-free Survival
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 registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause, assessed up to 2 years
What was measured
Assessed in each arm using the method of Kaplan Meier and compared between arms using the stratified long-rank test. 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: Group of participants that were eligible and analyzable per protocol.
Groups in this outcome
Arm I (Dexamethasone, Low-dose Carfilzomib)
Patients receive 20 mg dexamethasone IV and low-dose (27 mg/m\^2) carfilzomib IV over 2-10 minutes on days 1, 2, 8, 9, 15, and 16. (Note that course 1 is given at a reduced dose of 20 mg/m\^2.) Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. Patients with progression cross-over to Arm II. Carfilzomib: Given IV Dexamethasone: Given IV Laboratory Biomarker Analysis: Correlative studies
Arm II (Dexamethasone, High-dose Carfilzomib)
Patients 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. (Note that course 1 is given at a reduced dose of 20 mg/m\^2 over 2-10 minutes.) Treatment repeats every 28 days for up to 12 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 I (Dexamethasone, Low-dose Carfilzomib) | 64 |
| Arm II (Dexamethasone, High-dose Carfilzomib) | 57 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm I (Dexamethasone, Low-dose Carfilzomib) | 5 | Not reported | 4 | 11 | Not reported |
| Arm II (Dexamethasone, High-dose Carfilzomib) | 8 | Not reported | 6 | 12 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.821
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 80
- ci Upper Limit
- 1.370
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.384
- p Value Comment
- Stratified by pre-specified randomization stratification factors: 1 - 3 prior therapies vs. 4-6 prior therapies and refractory to bortezomib vs. not refractory to bortezomib.
- param Type
- Hazard Ratio (HR)
- param Value
- 1.061
- statistical Comment
- One-sided stratified log rank test
- statistical Method
- Log Rank
Complete source fields
- analyses
- ci Lower Limit
- 0.821
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 80
- ci Upper Limit
- 1.370
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.384
- p Value Comment
- Stratified by pre-specified randomization stratification factors: 1 - 3 prior therapies vs. 4-6 prior therapies and refractory to bortezomib vs. not refractory to bortezomib.
- param Type
- Hazard Ratio (HR)
- param Value
- 1.061
- statistical Comment
- One-sided stratified log rank test
- statistical Method
- Log Rank
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 4
- upper Limit
- 11
- value
- 5
- group Id
- OG001
- lower Limit
- 6
- upper Limit
- 12
- value
- 8
- denoms
- counts
- group Id
- OG000
- value
- 64
- group Id
- OG001
- value
- 57
- units
- Participants
- description
- Assessed in each arm using the method of Kaplan Meier and compared between arms using the stratified long-rank test. 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 receive 20 mg dexamethasone IV and low-dose (27 mg/m\^2) carfilzomib IV over 2-10 minutes on days 1, 2, 8, 9, 15, and 16. (Note that course 1 is given at a reduced dose of 20 mg/m\^2.) Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. Patients with progression cross-over to Arm II. Carfilzomib: Given IV Dexamethasone: Given IV Laboratory Biomarker Analysis: Correlative studies
- id
- OG000
- title
- Arm I (Dexamethasone, Low-dose Carfilzomib)
- description
- Patients 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. (Note that course 1 is given at a reduced dose of 20 mg/m\^2 over 2-10 minutes.) Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. Carfilzomib: Given IV Dexamethasone: Given IV Laboratory Biomarker Analysis: Correlative studies
- id
- OG001
- title
- Arm II (Dexamethasone, High-dose Carfilzomib)
- param Type
- MEDIAN
- population Description
- Group of participants that were eligible and analyzable per protocol.
- reporting Status
- POSTED
- time Frame
- From date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause, assessed up to 2 years
- title
- Progression-free Survival
- type
- PRIMARY
- unit Of Measure
- months
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Preserved source evidence · Not medical advice