TriangleNCT01125293 · OUTCOME
Phase II Overall Response Rate
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
- Up to 6 cycles (Day 168)
What was measured
Overall response rate is percentage of participants with complete (CR), very good partial (VGPR), partial (PR), or minimal response (MR) as best response during treatment. CR: * No serum monoclonal IgM protein by immunofixation * Normal IgM level * Complete resolution of extramedullary disease, i.e., lymphadenopathy and splenomegaly if present at baseline * Morphologically normal bone marrow aspirate and trephine biopsy VGPR: * Monoclonal IgM protein is detectable ≥90% reduction in IgM level from baseline * Complete resolution of extramedullary disease, i.e., lymphadenopathy/splenomegaly if present at baseline * No new signs/symptoms of active disease PR: * Monoclonal IgM protein is detectable ≥50% but \<90% reduction in IgM level from baseline * Reduction in extramedullary disease * No new signs/symptoms of active disease MR: * Monoclonal IgM protein is detectable ≥25% but \<50% reduction in IgM level from baseline * No new signs/symptoms of active disease
Groups in this outcome
Phase II
Combination of everolimus \& rituximab with bortezomib for 6 cycles Everolimus 10 mg: Taken orally on a daily basis x 28 days (1 cycle) Rituximab 375 mg/Kg: Given intravenously on days 1, 8, 15 and 22 of Cycle 1 and Cycle 4 only (1 cycle = 28 days) Bortezomib 1.6 mg/m\^2: Given intravenously on days 1, 8 and 15 of every cycle (1 cycle = 28 days)
| Group | Source count |
|---|---|
| Phase II | 23 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase II | 87 | Not reported | 70 | 96 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 70
- upper Limit
- 96
- value
- 87
- denoms
- counts
- group Id
- OG000
- value
- 23
- units
- Participants
- description
- Overall response rate is percentage of participants with complete (CR), very good partial (VGPR), partial (PR), or minimal response (MR) as best response during treatment. CR: * No serum monoclonal IgM protein by immunofixation * Normal IgM level * Complete resolution of extramedullary disease, i.e., lymphadenopathy and splenomegaly if present at baseline * Morphologically normal bone marrow aspirate and trephine biopsy VGPR: * Monoclonal IgM protein is detectable ≥90% reduction in IgM level from baseline * Complete resolution of extramedullary disease, i.e., lymphadenopathy/splenomegaly if present at baseline * No new signs/symptoms of active disease PR: * Monoclonal IgM protein is detectable ≥50% but \<90% reduction in IgM level from baseline * Reduction in extramedullary disease * No new signs/symptoms of active disease MR: * Monoclonal IgM protein is detectable ≥25% but \<50% reduction in IgM level from baseline * No new signs/symptoms of active disease
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Combination of everolimus \& rituximab with bortezomib for 6 cycles Everolimus 10 mg: Taken orally on a daily basis x 28 days (1 cycle) Rituximab 375 mg/Kg: Given intravenously on days 1, 8, 15 and 22 of Cycle 1 and Cycle 4 only (1 cycle = 28 days) Bortezomib 1.6 mg/m\^2: Given intravenously on days 1, 8 and 15 of every cycle (1 cycle = 28 days)
- id
- OG000
- title
- Phase II
- param Type
- NUMBER
- reporting Status
- POSTED
- time Frame
- Up to 6 cycles (Day 168)
- title
- Phase II Overall Response Rate
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice