TriangleNCT00721734 · OUTCOME
Duration of Response
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
- Participants were followed for disease progression for up to 2 years.
What was measured
Duration of Response is defined as the time from first evidence of PR or better to confirmation of disease progression or death. Progressive disease was defined as any of the following: * An increase of more than 25% from nadir in any one of the following: * M-protein in serum (the absolute increase had to be ≥ 0.5 g/dL); * Urine (the absolute increase had to be ≥ 200 mg/24 hours); * The difference between involved and uninvolved sFLC (the absolute increase in the concentration of involved light chain had to be \> 10 mg/dL); * ≥ 10% bone marrow infiltration by plasma cells; * Increased size of pre-existing bone lesions or plasmacytomas or new bone lesions or plasmacytomas. Median duration of response was estimated using the Kaplan-Meier method.
Analysis population: Response Evaluable Population with a best overall response of sCR, CR, VGPR, or PR.
Groups in this outcome
Carfilzomib - Normal RF
Participants with normal renal function (RF; defined as 24-hour urine creatinine clearance (CrCL) \> 80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously (IV) on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles. If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles.
Carfilzomib - Mild RI
Participants with mild renal impairment (RI; CrCL between 50-80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles. If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles.
Carfilzomib - Moderate RI
Participants with moderate renal impairment (CrCL between 30-49 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles. If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles.
Carfilzomib - Severe RI
Participants with severe renal impairment (CrCL \< 30 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles. If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles.
Carfilzomib - Dialysis
Participants undergoing chronic hemodialysis received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles. If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles.
| Group | Source count |
|---|---|
| Carfilzomib - Normal RF | 2 |
| Carfilzomib - Mild RI | 3 |
| Carfilzomib - Moderate RI | 2 |
| Carfilzomib - Severe RI | 2 |
| Carfilzomib - Dialysis | 3 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Carfilzomib - Normal RF | NA | Not reported | 2.0 | NA | Could not be estimated due to the low number of events |
| Carfilzomib - Mild RI | NA | Not reported | 4.2 | NA | Could not be estimated due to the low number of events |
| Carfilzomib - Moderate RI | 14.8 | Not reported | 2.3 | 27.4 | Not reported |
| Carfilzomib - Severe RI | NA | Not reported | 7.9 | NA | Could not be estimated due to the low number of events |
| Carfilzomib - Dialysis | 7.9 | Not reported | 6.5 | 8.5 | Not reported |
Complete source fields
- classes
- categories
- measurements
- comment
- Could not be estimated due to the low number of events
- group Id
- OG000
- lower Limit
- 2.0
- upper Limit
- NA
- value
- NA
- comment
- Could not be estimated due to the low number of events
- group Id
- OG001
- lower Limit
- 4.2
- upper Limit
- NA
- value
- NA
- group Id
- OG002
- lower Limit
- 2.3
- upper Limit
- 27.4
- value
- 14.8
- comment
- Could not be estimated due to the low number of events
- group Id
- OG003
- lower Limit
- 7.9
- upper Limit
- NA
- value
- NA
- group Id
- OG004
- lower Limit
- 6.5
- upper Limit
- 8.5
- value
- 7.9
- denoms
- counts
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 2
- group Id
- OG003
- value
- 2
- group Id
- OG004
- value
- 3
- units
- Participants
- description
- Duration of Response is defined as the time from first evidence of PR or better to confirmation of disease progression or death. Progressive disease was defined as any of the following: * An increase of more than 25% from nadir in any one of the following: * M-protein in serum (the absolute increase had to be ≥ 0.5 g/dL); * Urine (the absolute increase had to be ≥ 200 mg/24 hours); * The difference between involved and uninvolved sFLC (the absolute increase in the concentration of involved light chain had to be \> 10 mg/dL); * ≥ 10% bone marrow infiltration by plasma cells; * Increased size of pre-existing bone lesions or plasmacytomas or new bone lesions or plasmacytomas. Median duration of response was estimated using the Kaplan-Meier method.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants with normal renal function (RF; defined as 24-hour urine creatinine clearance (CrCL) \> 80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously (IV) on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles. If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles.
- id
- OG000
- title
- Carfilzomib - Normal RF
- description
- Participants with mild renal impairment (RI; CrCL between 50-80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles. If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles.
- id
- OG001
- title
- Carfilzomib - Mild RI
- description
- Participants with moderate renal impairment (CrCL between 30-49 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles. If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles.
- id
- OG002
- title
- Carfilzomib - Moderate RI
- description
- Participants with severe renal impairment (CrCL \< 30 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles. If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles.
- id
- OG003
- title
- Carfilzomib - Severe RI
- description
- Participants undergoing chronic hemodialysis received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles. If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles.
- id
- OG004
- title
- Carfilzomib - Dialysis
- param Type
- MEDIAN
- population Description
- Response Evaluable Population with a best overall response of sCR, CR, VGPR, or PR.
- reporting Status
- POSTED
- time Frame
- Participants were followed for disease progression for up to 2 years.
- title
- Duration of Response
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice