TriangleNCT02119468 · OUTCOME
Overall Response Rate at the Recommended Phase II Dose (RP2D)
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
- From the initial treatment to 24 months
What was measured
Over response rate is calculated as the percent of evaluable patients that have confirmed stringent complete remission (sCR), complete remission (CR), very good partial remission (VGPR) or partial remission \[PR\]) per modified IMWG criteria. sCR as defined below plus normal FLC ratio and absence of clonal cells in bone marrow. CR defined as negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and \< 5% plasma cells in bone marrow. VGPR defined as serum and urine M-protein detectable or \> 90% reduction in serum M-protein plus urine M-protein level \< 100 mg/24 h. PR defined as \> 50% reduction of serum M-protein and reduction in 24 hours urinary M-protein by \>90% or to \< 200 mg/24 h. The exact 95% confidence intervals are calculated for the estimate.
Analysis population: Patients received 4 mg MLN9708, 4mg pomalidomide, and 40 mg dexamethasone (RP2D).
Groups in this outcome
Dose Level #2 (4mg MLN9708)
Patients receive 4mg ixazomib citrate (MLN9708) orally on days 1, 8, and 15; dexamethasone orally on days 1, 8, 15, and 22; and pomalidomide orally on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
| Group | Source count |
|---|---|
| Dose Level #2 (4mg MLN9708) | 25 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose Level #2 (4mg MLN9708) | 48 | Not reported | 27.8 | 68.7 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 27.8
- upper Limit
- 68.7
- value
- 48
- denoms
- counts
- group Id
- OG000
- value
- 25
- units
- Participants
- description
- Over response rate is calculated as the percent of evaluable patients that have confirmed stringent complete remission (sCR), complete remission (CR), very good partial remission (VGPR) or partial remission \[PR\]) per modified IMWG criteria. sCR as defined below plus normal FLC ratio and absence of clonal cells in bone marrow. CR defined as negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and \< 5% plasma cells in bone marrow. VGPR defined as serum and urine M-protein detectable or \> 90% reduction in serum M-protein plus urine M-protein level \< 100 mg/24 h. PR defined as \> 50% reduction of serum M-protein and reduction in 24 hours urinary M-protein by \>90% or to \< 200 mg/24 h. The exact 95% confidence intervals are calculated for the estimate.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Patients receive 4mg ixazomib citrate (MLN9708) orally on days 1, 8, and 15; dexamethasone orally on days 1, 8, 15, and 22; and pomalidomide orally on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
- id
- OG000
- title
- Dose Level #2 (4mg MLN9708)
- param Type
- NUMBER
- population Description
- Patients received 4 mg MLN9708, 4mg pomalidomide, and 40 mg dexamethasone (RP2D).
- reporting Status
- POSTED
- time Frame
- From the initial treatment to 24 months
- title
- Overall Response Rate at the Recommended Phase II Dose (RP2D)
- type
- PRIMARY
- unit Of Measure
- Percentage of Participants (%)
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice