TriangleNCT00530816 · OUTCOME
Duration of Response (DOR)
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
- Patients were followed for up to 2 years after study discontinuation. The data cutoff for the analysis is 30 November 2010 for Part 1 and 22 April 2011 for Part 2.
What was measured
DOR is defined as the time from first evidence of PR or better to disease progression assessed by the IRC or death due to any cause. Patients lost to follow-up prior to disease progression or who were alive without disease progression before the analysis cutoff date were censored at the last disease assessment. Progressive disease was defined as any of the following: * An increase of M-protein in serum (absolute increase ≥ 0.5 g/dL) or urine (absolute increase ≥ 200 mg/24 hours) of \> 25% from the nadir (if not zero). * Percentage of plasma cells in bone marrow ≥ 10%. * New or increased size of bone lesions or new plasmacytomas. * Patients without measurable serum and urine M-protein: 25% increase from nadir in the difference between involved and uninvolved FLC levels and absolute increase \>10 mg/dL. * Development of hypercalcemia (corrected serum calcium \> 11.5 mg/dL) attributed solely to the proliferative disorder. Median DOR was estimated using Kaplan-Meier methods.
Analysis population: Response Evaluable Population with a response of PR or better.
Groups in this outcome
Part 1: Carfilzomib 20 mg/m²
Participants previously treated with bortezomib received carfilzomib 20 mg/m² intravenous (IV) injection on Days 1, 2, 8, 9, 15, and 16, in 28-day treatment cycles for a maximum of 12 cycles.
Part 2: Carfilzomib 20 mg/m²
Participants not previously treated with bortezomib received carfilzomib 20 mg/m² IV injection on Days 1, 2, 8, 9, 15, and 16, in 28-day treatment cycles for a maximum of 12 cycles.
Part 2: Carfilzomib 20/27 mg/m²
Participants not previously treated with bortezomib received carfilzomib 20 mg/m² IV on Days 1, 2, 8, 9, 15, and 16 of Cycle 1. If all doses were well-tolerated the dose was escalated to 27 mg/m² IV on Days 1, 2, 8, 9, 15, and 16 for subsequent cycles, for up to 12 cycles.
| Group | Source count |
|---|---|
| Part 1: Carfilzomib 20 mg/m² | 6 |
| Part 2: Carfilzomib 20 mg/m² | 25 |
| Part 2: Carfilzomib 20/27 mg/m² | 35 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1: Carfilzomib 20 mg/m² | NA | Not reported | 10.6 | NA | Could not be estimated due to the low number of events |
| Part 2: Carfilzomib 20 mg/m² | 13.1 | Not reported | 7.2 | NA | Could not be estimated due to the low number of events |
| Part 2: Carfilzomib 20/27 mg/m² | NA | Not reported | NA | NA | Could not be estimated due to the low number of events |
Complete source fields
- classes
- categories
- measurements
- comment
- Could not be estimated due to the low number of events
- group Id
- OG000
- lower Limit
- 10.6
- upper Limit
- NA
- value
- NA
- comment
- Could not be estimated due to the low number of events
- group Id
- OG001
- lower Limit
- 7.2
- upper Limit
- NA
- value
- 13.1
- comment
- Could not be estimated due to the low number of events
- group Id
- OG002
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 6
- group Id
- OG001
- value
- 25
- group Id
- OG002
- value
- 35
- units
- Participants
- description
- DOR is defined as the time from first evidence of PR or better to disease progression assessed by the IRC or death due to any cause. Patients lost to follow-up prior to disease progression or who were alive without disease progression before the analysis cutoff date were censored at the last disease assessment. Progressive disease was defined as any of the following: * An increase of M-protein in serum (absolute increase ≥ 0.5 g/dL) or urine (absolute increase ≥ 200 mg/24 hours) of \> 25% from the nadir (if not zero). * Percentage of plasma cells in bone marrow ≥ 10%. * New or increased size of bone lesions or new plasmacytomas. * Patients without measurable serum and urine M-protein: 25% increase from nadir in the difference between involved and uninvolved FLC levels and absolute increase \>10 mg/dL. * Development of hypercalcemia (corrected serum calcium \> 11.5 mg/dL) attributed solely to the proliferative disorder. Median DOR was estimated using Kaplan-Meier methods.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants previously treated with bortezomib received carfilzomib 20 mg/m² intravenous (IV) injection on Days 1, 2, 8, 9, 15, and 16, in 28-day treatment cycles for a maximum of 12 cycles.
- id
- OG000
- title
- Part 1: Carfilzomib 20 mg/m²
- description
- Participants not previously treated with bortezomib received carfilzomib 20 mg/m² IV injection on Days 1, 2, 8, 9, 15, and 16, in 28-day treatment cycles for a maximum of 12 cycles.
- id
- OG001
- title
- Part 2: Carfilzomib 20 mg/m²
- description
- Participants not previously treated with bortezomib received carfilzomib 20 mg/m² IV on Days 1, 2, 8, 9, 15, and 16 of Cycle 1. If all doses were well-tolerated the dose was escalated to 27 mg/m² IV on Days 1, 2, 8, 9, 15, and 16 for subsequent cycles, for up to 12 cycles.
- id
- OG002
- title
- Part 2: Carfilzomib 20/27 mg/m²
- param Type
- MEDIAN
- population Description
- Response Evaluable Population with a response of PR or better.
- reporting Status
- POSTED
- time Frame
- Patients were followed for up to 2 years after study discontinuation. The data cutoff for the analysis is 30 November 2010 for Part 1 and 22 April 2011 for Part 2.
- title
- Duration of Response (DOR)
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice