TriangleNCT02046070 · OUTCOME
Percentage of Participants With CR + VGPR + PR (ORR), CR, VGPR, PR and Stable Disease (SD), Progressive Disease (PD) During the Induction Phase
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
- Day 1 of Cycles 1-13, 28-day cycles (Up to 1 year)
What was measured
Percentage of participants with CR + VGPR + PR (ORR), CR, VGPR, PR, SD, PD according to IMWG criteria. CR=negative immunofixation of serum and urine; disappearance of soft tissue plasmacytomas;\<5% PC in bone marrow. VGPR=serum and urine M-component detectable by immunofixation but not on electrophoresis or 90% reduction in serum M-component plus urine M-component \<100 mg/24 hour. PR=50% reduction of serum M-protein and reduction in 24 hour urine M-protein by 90% or \<200 mg/24 hour or decrease 50% difference between involved FLC levels or 50% reduction in bone marrow plasma cells if baseline percentage was 30%; and if present at Baseline, 50% reduction in the size of soft tissue plasmacytomas. SD=not meeting criteria for VGPR, PR or PD. PD=25% increase in lowest value any of the following: serum M-component, urine M-component, difference between involved and uninvolved FLC levels, bone marrow PC percentage; new or increase in size of existing bone lesions or soft tissue plasmacytomas.
Analysis population: Response Evaluable Population was defined as participants who received at least 2 of the 3 ixazomib doses during Cycle 1, had measurable disease at Baseline, and at least 1 postbaseline response assessment.
Groups in this outcome
Ixazomib 4.0 mg + CYC 300 mg/m^2 + DEX 40 mg (NDMM)
Ixazomib 4.0 mg, capsules, orally, on Days 1, 8, 15 of a 28-day cycle until progressive disease (PD)/death or unacceptable toxicity \[13 cycles in the Induction Phase continuing in the Maintenance Phase for up to 36 Months\] and cyclophosphamide (CYC) 300 mg/m\^2, tablets, orally, on Days 1, 8 and 15 of a 28-day cycle for 13 cycles or until PD/death or unacceptable toxicity and dexamethasone (DEX) 40 mg, tablets, orally, on Days 1, 8, 15 and 22 (dose reduced to 20 mg for patients \>75 years) of a 28-day cycle for 13 cycles or until PD/death or unacceptable toxicity in participants with NDMM.
Ixazomib 4.0 mg + CYC 400 mg/m^2 + DEX 40 mg (NDMM)
Ixazomib 4.0 mg, capsules, orally, on Days 1, 8, 15 of a 28-day cycle until PD/death or unacceptable toxicity \[13 cycles in the Induction Phase continuing in the Maintenance Phase for up to 36 Months\] and cyclophosphamide (CYC) 400 mg/m\^2, tablets, orally, on Days 1, 8 and 15 of a 28-day cycle for 13 cycles or until PD/death or unacceptable toxicity and dexamethasone (DEX) 40 mg, tablets, orally, on Days 1, 8, 15 and 22 (dose reduced to 20 mg for patients \>75 years) of a 28-day cycle for 13 cycles or until PD/death or unacceptable toxicity in participants with NDMM.
| Group | Source count |
|---|---|
| Ixazomib 4.0 mg + CYC 300 mg/m^2 + DEX 40 mg (NDMM) | 33 |
| Ixazomib 4.0 mg + CYC 400 mg/m^2 + DEX 40 mg (NDMM) | 34 |
Reported measurements
CR + VGPR + PR
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Ixazomib 4.0 mg + CYC 300 mg/m^2 + DEX 40 mg (NDMM) | 79 | Not reported | 61 | 91 | Not reported |
| Ixazomib 4.0 mg + CYC 400 mg/m^2 + DEX 40 mg (NDMM) | 71 | Not reported | 53 | 85 | Not reported |
CR
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Ixazomib 4.0 mg + CYC 300 mg/m^2 + DEX 40 mg (NDMM) | 12 | Not reported | 3 | 28 | Not reported |
| Ixazomib 4.0 mg + CYC 400 mg/m^2 + DEX 40 mg (NDMM) | 9 | Not reported | 2 | 24 | Not reported |
VGPR
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Ixazomib 4.0 mg + CYC 300 mg/m^2 + DEX 40 mg (NDMM) | 15 | Not reported | 5 | 32 | Not reported |
| Ixazomib 4.0 mg + CYC 400 mg/m^2 + DEX 40 mg (NDMM) | 15 | Not reported | 5 | 31 | Not reported |
PR
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Ixazomib 4.0 mg + CYC 300 mg/m^2 + DEX 40 mg (NDMM) | 67 | Not reported | 48 | 82 | Not reported |
| Ixazomib 4.0 mg + CYC 400 mg/m^2 + DEX 40 mg (NDMM) | 62 | Not reported | 44 | 78 | Not reported |
SD
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Ixazomib 4.0 mg + CYC 300 mg/m^2 + DEX 40 mg (NDMM) | 12 | Not reported | 3 | 28 | Not reported |
| Ixazomib 4.0 mg + CYC 400 mg/m^2 + DEX 40 mg (NDMM) | 18 | Not reported | 7 | 35 | Not reported |
PD
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Ixazomib 4.0 mg + CYC 300 mg/m^2 + DEX 40 mg (NDMM) | 0 | Not reported | 0 | 0 | Not reported |
| Ixazomib 4.0 mg + CYC 400 mg/m^2 + DEX 40 mg (NDMM) | 3 | Not reported | 1 | 15 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 61
- upper Limit
- 91
- value
- 79
- group Id
- OG001
- lower Limit
- 53
- upper Limit
- 85
- value
- 71
- title
- CR + VGPR + PR
- categories
- measurements
- group Id
- OG000
- lower Limit
- 3
- upper Limit
- 28
- value
- 12
- group Id
- OG001
- lower Limit
- 2
- upper Limit
- 24
- value
- 9
- title
- CR
- categories
- measurements
- group Id
- OG000
- lower Limit
- 5
- upper Limit
- 32
- value
- 15
- group Id
- OG001
- lower Limit
- 5
- upper Limit
- 31
- value
- 15
- title
- VGPR
- categories
- measurements
- group Id
- OG000
- lower Limit
- 48
- upper Limit
- 82
- value
- 67
- group Id
- OG001
- lower Limit
- 44
- upper Limit
- 78
- value
- 62
- title
- PR
- categories
- measurements
- group Id
- OG000
- lower Limit
- 3
- upper Limit
- 28
- value
- 12
- group Id
- OG001
- lower Limit
- 7
- upper Limit
- 35
- value
- 18
- title
- SD
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0
- upper Limit
- 0
- value
- 0
- group Id
- OG001
- lower Limit
- 1
- upper Limit
- 15
- value
- 3
- title
- PD
- denoms
- counts
- group Id
- OG000
- value
- 33
- group Id
- OG001
- value
- 34
- units
- Participants
- description
- Percentage of participants with CR + VGPR + PR (ORR), CR, VGPR, PR, SD, PD according to IMWG criteria. CR=negative immunofixation of serum and urine; disappearance of soft tissue plasmacytomas;\<5% PC in bone marrow. VGPR=serum and urine M-component detectable by immunofixation but not on electrophoresis or 90% reduction in serum M-component plus urine M-component \<100 mg/24 hour. PR=50% reduction of serum M-protein and reduction in 24 hour urine M-protein by 90% or \<200 mg/24 hour or decrease 50% difference between involved FLC levels or 50% reduction in bone marrow plasma cells if baseline percentage was 30%; and if present at Baseline, 50% reduction in the size of soft tissue plasmacytomas. SD=not meeting criteria for VGPR, PR or PD. PD=25% increase in lowest value any of the following: serum M-component, urine M-component, difference between involved and uninvolved FLC levels, bone marrow PC percentage; new or increase in size of existing bone lesions or soft tissue plasmacytomas.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Ixazomib 4.0 mg, capsules, orally, on Days 1, 8, 15 of a 28-day cycle until progressive disease (PD)/death or unacceptable toxicity \[13 cycles in the Induction Phase continuing in the Maintenance Phase for up to 36 Months\] and cyclophosphamide (CYC) 300 mg/m\^2, tablets, orally, on Days 1, 8 and 15 of a 28-day cycle for 13 cycles or until PD/death or unacceptable toxicity and dexamethasone (DEX) 40 mg, tablets, orally, on Days 1, 8, 15 and 22 (dose reduced to 20 mg for patients \>75 years) of a 28-day cycle for 13 cycles or until PD/death or unacceptable toxicity in participants with NDMM.
- id
- OG000
- title
- Ixazomib 4.0 mg + CYC 300 mg/m^2 + DEX 40 mg (NDMM)
- description
- Ixazomib 4.0 mg, capsules, orally, on Days 1, 8, 15 of a 28-day cycle until PD/death or unacceptable toxicity \[13 cycles in the Induction Phase continuing in the Maintenance Phase for up to 36 Months\] and cyclophosphamide (CYC) 400 mg/m\^2, tablets, orally, on Days 1, 8 and 15 of a 28-day cycle for 13 cycles or until PD/death or unacceptable toxicity and dexamethasone (DEX) 40 mg, tablets, orally, on Days 1, 8, 15 and 22 (dose reduced to 20 mg for patients \>75 years) of a 28-day cycle for 13 cycles or until PD/death or unacceptable toxicity in participants with NDMM.
- id
- OG001
- title
- Ixazomib 4.0 mg + CYC 400 mg/m^2 + DEX 40 mg (NDMM)
- param Type
- NUMBER
- population Description
- Response Evaluable Population was defined as participants who received at least 2 of the 3 ixazomib doses during Cycle 1, had measurable disease at Baseline, and at least 1 postbaseline response assessment.
- reporting Status
- POSTED
- time Frame
- Day 1 of Cycles 1-13, 28-day cycles (Up to 1 year)
- title
- Percentage of Participants With CR + VGPR + PR (ORR), CR, VGPR, PR and Stable Disease (SD), Progressive Disease (PD) During the Induction Phase
- type
- SECONDARY
- unit Of Measure
- percentage of participants
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Preserved source evidence · Not medical advice