TriangleNCT00250926 · OUTCOME
Time to Progression
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- months
- Interval / dispersion
- Full Range
- Time frame
- 42 months
What was measured
Progressive Disease (PD) will be defined as a greater than 25% increase in serum IgM monoclonal protein levels from the lowest attained response value as determined by serum electrophoresis, confirmed by at least one other investigation, or progression of clinically significant disease related symptom(s).
Analysis population: The median time to progression was not achieved as follow-up ended before half the participants had a PD event.
Groups in this outcome
Bortezomib, Dexamethasone, Rituximab
A cycle of therapy consisted of bortezomib 1.3 mg/m(2) intravenously; dexamethasone 40 mg on days 1, 4, 8, and 11; and rituximab 375 mg/m(2) on day 11. Patients received four consecutive cycles for induction therapy and then four more cycles, each given 3 months apart, for maintenance therapy. Bortezomib: Given intravenously on days 1, 4, 8, and 11 of a 21-day cycle for 8 cycles Dexamethasone: Given intravenously on days 1, 4, 8, and 11 of a 21-day cycle for 8 cycles Rituximab: Given intravenously after bortezomib and dexamethasone on day 11 of a 21-day cycle for 8 cycles
| Group | Source count |
|---|---|
| Bortezomib, Dexamethasone, Rituximab | 23 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Bortezomib, Dexamethasone, Rituximab | NA | Not reported | 6 | NA | The median time to progression was not met before the follow-up time for the protocol was complete. Most patients had not had a PD event at the 42 month cut-off. |
Complete source fields
- classes
- categories
- measurements
- comment
- The median time to progression was not met before the follow-up time for the protocol was complete. Most patients had not had a PD event at the 42 month cut-off.
- group Id
- OG000
- lower Limit
- 6
- upper Limit
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 23
- units
- Participants
- description
- Progressive Disease (PD) will be defined as a greater than 25% increase in serum IgM monoclonal protein levels from the lowest attained response value as determined by serum electrophoresis, confirmed by at least one other investigation, or progression of clinically significant disease related symptom(s).
- dispersion Type
- Full Range
- groups
- description
- A cycle of therapy consisted of bortezomib 1.3 mg/m(2) intravenously; dexamethasone 40 mg on days 1, 4, 8, and 11; and rituximab 375 mg/m(2) on day 11. Patients received four consecutive cycles for induction therapy and then four more cycles, each given 3 months apart, for maintenance therapy. Bortezomib: Given intravenously on days 1, 4, 8, and 11 of a 21-day cycle for 8 cycles Dexamethasone: Given intravenously on days 1, 4, 8, and 11 of a 21-day cycle for 8 cycles Rituximab: Given intravenously after bortezomib and dexamethasone on day 11 of a 21-day cycle for 8 cycles
- id
- OG000
- title
- Bortezomib, Dexamethasone, Rituximab
- param Type
- MEDIAN
- population Description
- The median time to progression was not achieved as follow-up ended before half the participants had a PD event.
- reporting Status
- POSTED
- time Frame
- 42 months
- title
- Time to Progression
- type
- PRIMARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice