TriangleNCT00530816 · OUTCOME
Best Overall Response Rate (ORR) in the Response Evaluable Subset Population
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percentage of participants
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Disease response was assessed on Day 15 of Cycle 1, Day 1 of Cycles 2 through 12, and at End of Study, 30 days after last dose. Median duration of treatment was 100 days for Part 1 and 170 days for Part 2 participants.
What was measured
ORR is defined as the percentage of patients who achieved a best response of stringent complete response (sCR), complete response (CR), very good partial response (VGPR) or partial response (PR) determined by Independent Review Committee (IRC). Responses were assessed according to International Uniform Response Criteria for Multiple Myeloma, documented by 2 consecutive assessments made at any time before the start of new therapy. sCR: CR as defined below plus normal FLC ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence. CR: absence of M-protein in serum and urine by immunofixation, disappearance of any soft tissue plasmacytomas, and ≤5% plasma cells in bone marrow. VGPR: serum and urine M-proteins detectable by immunofixation but not by electrophoresis or a ≥ 90% reduction in serum M-protein with urine M-protein level \< 100 mg/24 hours. PR: ≥ 50% reduction of serum M-protein and in urine of ≥ 90% or to \< 200 mg per 24 hours.
Analysis population: The Response Evaluable Subset population consists of all treated patients with measurable disease at Baseline as assessed by M-protein or by quantitative serum Ig for certain patients with IgA myeloma, and with a baseline and at least 1 post-baseline disease assessment. Patients whose disease was only measurable by SFLC were excluded.
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 | 31 |
| Part 2: Carfilzomib 20 mg/m² | 53 |
| Part 2: Carfilzomib 20/27 mg/m² | 66 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1: Carfilzomib 20 mg/m² | 16.1 | Not reported | 5.45 | 33.73 | Not reported |
| Part 2: Carfilzomib 20 mg/m² | 39.6 | Not reported | 26.5 | 54.0 | Not reported |
| Part 2: Carfilzomib 20/27 mg/m² | 53.0 | Not reported | 40.3 | 65.4 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 5.45
- upper Limit
- 33.73
- value
- 16.1
- group Id
- OG001
- lower Limit
- 26.5
- upper Limit
- 54.0
- value
- 39.6
- group Id
- OG002
- lower Limit
- 40.3
- upper Limit
- 65.4
- value
- 53.0
- denoms
- counts
- group Id
- OG000
- value
- 31
- group Id
- OG001
- value
- 53
- group Id
- OG002
- value
- 66
- units
- Participants
- description
- ORR is defined as the percentage of patients who achieved a best response of stringent complete response (sCR), complete response (CR), very good partial response (VGPR) or partial response (PR) determined by Independent Review Committee (IRC). Responses were assessed according to International Uniform Response Criteria for Multiple Myeloma, documented by 2 consecutive assessments made at any time before the start of new therapy. sCR: CR as defined below plus normal FLC ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence. CR: absence of M-protein in serum and urine by immunofixation, disappearance of any soft tissue plasmacytomas, and ≤5% plasma cells in bone marrow. VGPR: serum and urine M-proteins detectable by immunofixation but not by electrophoresis or a ≥ 90% reduction in serum M-protein with urine M-protein level \< 100 mg/24 hours. PR: ≥ 50% reduction of serum M-protein and in urine of ≥ 90% or to \< 200 mg per 24 hours.
- 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
- NUMBER
- population Description
- The Response Evaluable Subset population consists of all treated patients with measurable disease at Baseline as assessed by M-protein or by quantitative serum Ig for certain patients with IgA myeloma, and with a baseline and at least 1 post-baseline disease assessment. Patients whose disease was only measurable by SFLC were excluded.
- reporting Status
- POSTED
- time Frame
- Disease response was assessed on Day 15 of Cycle 1, Day 1 of Cycles 2 through 12, and at End of Study, 30 days after last dose. Median duration of treatment was 100 days for Part 1 and 170 days for Part 2 participants.
- title
- Best Overall Response Rate (ORR) in the Response Evaluable Subset Population
- type
- PRIMARY
- unit Of Measure
- percentage of participants
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Preserved source evidence · Not medical advice