TriangleNCT01734928 · OUTCOME
Duration of Response by Independent Response Adjudication Committee (IRAC)
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 randomization to progressive disease or death during the IRAC assessment period, up to approximately 42 months
What was measured
Duration of myeloma response is defined as the duration from the time when the IMWG response criteria are first met for sCR or CR or VGPR or PR until the first date the response criteria are met for PD or until the subject died from any cause, whichever occurs first. Complete Response: Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and ≤ 5% plasma cells in bone marrow SCR: CR+ Normal FLC ratio and Absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine Mprotein level \< 100 mg per 24 hours PR: ≥ 50% reduction of serum M-Protein and reduction in 24-hour urinary M-protein by ≥ 90% or to \< 200 mg per 24 hours Progressive Disease: Please refer to Primary outcome measure for definition SD: Not meeting criteria for CR, VGPR, PR, or progressive disease
Analysis population: All randomized participants with a response (sCR or CR or VGPR or PR)
Groups in this outcome
Treatment 1: POM+BTZ+LD-DEX
POM (Pomalidomide) * 4 mg/day on Days 1 to 14 of each 21-day treatment cycle BTZ (Bortezomib) * For Cycles 1 - 8: 1.3 mg/m2/dose on Days 1, 4, 8, and 11 of a 21-day cycle * For Cycles 9 onwards: 1.3 mg/m2/dose on Days 1 and 8 of a 21-day cycle DEX (Dexamethasone) * For Cycles 1 to 8, 20 mg/day (≤ 75 years old) or 10 mg/day (\> 75 years old) on Days 1, 2, 4, 5, 8, 9, 11 and 12 of a 21-day cycle. * For Cycles 9 and onward, 20 mg/day (≤ 75 years old) or 10 mg/day (\> 75 years old) on Days 1, 2, 8, and 9 of a 21-day cycle.
Treatment 2: BTZ+LD-DEX
BTZ ((Bortezomib) * For Cycles 1 - 8: 1.3 mg/m2/dose on Days 1, 4, 8, and 11 of a 21-day cycle * For Cycles 9 onwards: 1.3 mg/m2/dose on Days 1 and 8 of a 21-day cycle DEX (Dexamethasone) * For Cycles 1 to 8, 20 mg/day (≤ 75 years old) or 10 mg/day (\> 75 years old) on Days 1, 2, 4, 5, 8, 9, 11 and 12 of a 21-day cycle. * For Cycles 9 and onward, 20 mg/day (≤ 75 years old) or 10 mg/day (\> 75 years old) on Days 1, 2, 8, and 9 of a 21-day cycle.
| Group | Source count |
|---|---|
| Treatment 1: POM+BTZ+LD-DEX | 231 |
| Treatment 2: BTZ+LD-DEX | 139 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Treatment 1: POM+BTZ+LD-DEX | 13.70 | Not reported | 10.94 | 18.10 | Not reported |
| Treatment 2: BTZ+LD-DEX | 10.94 | Not reported | 8.11 | 14.78 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.56
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.02
- estimate Comment
- Based on Cox proportional hazards model comparing the hazard functions associated with treatment groups
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.064
- param Type
- Hazard Ratio (HR)
- param Value
- 0.76
- statistical Comment
- The p-value is based on an unstratified log-rank test.
- statistical Method
- Unstratified log-rank test
Complete source fields
- analyses
- ci Lower Limit
- 0.56
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.02
- estimate Comment
- Based on Cox proportional hazards model comparing the hazard functions associated with treatment groups
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.064
- param Type
- Hazard Ratio (HR)
- param Value
- 0.76
- statistical Comment
- The p-value is based on an unstratified log-rank test.
- statistical Method
- Unstratified log-rank test
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 10.94
- upper Limit
- 18.10
- value
- 13.70
- group Id
- OG001
- lower Limit
- 8.11
- upper Limit
- 14.78
- value
- 10.94
- denoms
- counts
- group Id
- OG000
- value
- 231
- group Id
- OG001
- value
- 139
- units
- Participants
- description
- Duration of myeloma response is defined as the duration from the time when the IMWG response criteria are first met for sCR or CR or VGPR or PR until the first date the response criteria are met for PD or until the subject died from any cause, whichever occurs first. Complete Response: Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and ≤ 5% plasma cells in bone marrow SCR: CR+ Normal FLC ratio and Absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine Mprotein level \< 100 mg per 24 hours PR: ≥ 50% reduction of serum M-Protein and reduction in 24-hour urinary M-protein by ≥ 90% or to \< 200 mg per 24 hours Progressive Disease: Please refer to Primary outcome measure for definition SD: Not meeting criteria for CR, VGPR, PR, or progressive disease
- dispersion Type
- 95% Confidence Interval
- groups
- description
- POM (Pomalidomide) * 4 mg/day on Days 1 to 14 of each 21-day treatment cycle BTZ (Bortezomib) * For Cycles 1 - 8: 1.3 mg/m2/dose on Days 1, 4, 8, and 11 of a 21-day cycle * For Cycles 9 onwards: 1.3 mg/m2/dose on Days 1 and 8 of a 21-day cycle DEX (Dexamethasone) * For Cycles 1 to 8, 20 mg/day (≤ 75 years old) or 10 mg/day (\> 75 years old) on Days 1, 2, 4, 5, 8, 9, 11 and 12 of a 21-day cycle. * For Cycles 9 and onward, 20 mg/day (≤ 75 years old) or 10 mg/day (\> 75 years old) on Days 1, 2, 8, and 9 of a 21-day cycle.
- id
- OG000
- title
- Treatment 1: POM+BTZ+LD-DEX
- description
- BTZ ((Bortezomib) * For Cycles 1 - 8: 1.3 mg/m2/dose on Days 1, 4, 8, and 11 of a 21-day cycle * For Cycles 9 onwards: 1.3 mg/m2/dose on Days 1 and 8 of a 21-day cycle DEX (Dexamethasone) * For Cycles 1 to 8, 20 mg/day (≤ 75 years old) or 10 mg/day (\> 75 years old) on Days 1, 2, 4, 5, 8, 9, 11 and 12 of a 21-day cycle. * For Cycles 9 and onward, 20 mg/day (≤ 75 years old) or 10 mg/day (\> 75 years old) on Days 1, 2, 8, and 9 of a 21-day cycle.
- id
- OG001
- title
- Treatment 2: BTZ+LD-DEX
- param Type
- MEDIAN
- population Description
- All randomized participants with a response (sCR or CR or VGPR or PR)
- reporting Status
- POSTED
- time Frame
- From randomization to progressive disease or death during the IRAC assessment period, up to approximately 42 months
- title
- Duration of Response by Independent Response Adjudication Committee (IRAC)
- type
- SECONDARY
- unit Of Measure
- Months
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Preserved source evidence · Not medical advice