TriangleNCT01335685 · OUTCOME
Time to First Response (Phase 2)
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 the date of enrollment to the date of the first documented response for up to 5.5 years
What was measured
Response is defined as CR, VGPR and PR. Per IMWG criteria, CR:1)Negative immunofixation on serum+urine, 2)Disappearance of any soft tissue plasmacytomas, 3)\< 5% plasma cells in bone marrow. VGPR: Serum+urine M-protein detectable by immunofixation but not on electrophoresis/ 90% or \>reduction in serum M-protein + urine M-protein level \< 100 mg/ 24-hour. PR:1)≥50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥90% or to \<200 mg/24-hour. If serum+urine M-protein are unmeasurable, ≥50% decrease in difference between involved and uninvolved FLC levels is required. Else, ≥50% reduction in plasma cells is required in place of M-protein, provided baseline bone marrow plasma cell percentage was ≥30%. In addition, if present at baseline, a ≥50% reduction in size of soft tissue plasmacytomas is required.
Analysis population: The safety population consisted of participants who received at least 1 dose of any study drug.
Groups in this outcome
Arm B: Ixazomib 4.0 mg (RP2D)
Ixazomib 4.0 mg, capsules, orally, on Days 1, 8, 15 plus melphalan 6 mg/m\^2, tablets, orally, on Days 1 to 4 and prednisone 60 mg/m\^2, tablets, orally, on Days 1 to 4 in 28-day cycle for up to 13 cycles in induction phase followed by ixazomib at dose last tolerated in induction, orally, on Days 1, 8, 15 in 28-day cycle up to 12 cycles or until disease progression or unacceptable toxicity if deriving benefit in maintenance phase (up to 49 maintenance cycles; overall up to 61 cycles \[58 months\]).
| Group | Source count |
|---|---|
| Arm B: Ixazomib 4.0 mg (RP2D) | 15 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm B: Ixazomib 4.0 mg (RP2D) | 1.9 | Not reported | 1 | 7 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 1
- upper Limit
- 7
- value
- 1.9
- denoms
- counts
- group Id
- OG000
- value
- 15
- units
- Participants
- description
- Response is defined as CR, VGPR and PR. Per IMWG criteria, CR:1)Negative immunofixation on serum+urine, 2)Disappearance of any soft tissue plasmacytomas, 3)\< 5% plasma cells in bone marrow. VGPR: Serum+urine M-protein detectable by immunofixation but not on electrophoresis/ 90% or \>reduction in serum M-protein + urine M-protein level \< 100 mg/ 24-hour. PR:1)≥50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥90% or to \<200 mg/24-hour. If serum+urine M-protein are unmeasurable, ≥50% decrease in difference between involved and uninvolved FLC levels is required. Else, ≥50% reduction in plasma cells is required in place of M-protein, provided baseline bone marrow plasma cell percentage was ≥30%. In addition, if present at baseline, a ≥50% reduction in size of soft tissue plasmacytomas is required.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Ixazomib 4.0 mg, capsules, orally, on Days 1, 8, 15 plus melphalan 6 mg/m\^2, tablets, orally, on Days 1 to 4 and prednisone 60 mg/m\^2, tablets, orally, on Days 1 to 4 in 28-day cycle for up to 13 cycles in induction phase followed by ixazomib at dose last tolerated in induction, orally, on Days 1, 8, 15 in 28-day cycle up to 12 cycles or until disease progression or unacceptable toxicity if deriving benefit in maintenance phase (up to 49 maintenance cycles; overall up to 61 cycles \[58 months\]).
- id
- OG000
- title
- Arm B: Ixazomib 4.0 mg (RP2D)
- param Type
- MEDIAN
- population Description
- The safety population consisted of participants who received at least 1 dose of any study drug.
- reporting Status
- POSTED
- time Frame
- From the date of enrollment to the date of the first documented response for up to 5.5 years
- title
- Time to First Response (Phase 2)
- type
- SECONDARY
- unit Of Measure
- months
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Preserved source evidence · Not medical advice