TriangleNCT01539083 · OUTCOME
Disease-free Survival (DFS)
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
- Up to 5 years
What was measured
DFS, defined as the duration from the start of CR to the time of relapse from CR. DFS applied only to participants in CR. CR as per IMWG criteria is negative immunofixation on serum and urine and disappearance of soft tissue plasmacytomas and \<5 percent plasma cells in bone marrow. Relapse from CR: reappearance of serum or urine M-protein by immunofixation or electrophoresis; development of \>= 5 percent plasma cells in the bone marrow; appearance of any other sign of progression (ie, new plasmacytoma, lytic bone lesion, or hypercalcaemia).
Analysis population: Response-evaluable-randomized analysis set defined as all participants in the response-evaluable-induction set (who received at least 1 dose of study medication;had measurable disease at baseline) who were randomized to receive consolidation treatment. Here, 'N' (number of participants analyzed) signifies the participants who had complete response.
Groups in this outcome
Thalidomide + Prednisolone [TP Consolidation]
Participants who completed induction phase entered in the consolidated treatment phase and received thalidomide 100 mg orally, once daily until disease progression (up to maximum of 12 months) and prednisolone 50 mg orally, on every alternate day until disease progression.
Bortezomib + Thalidomide + Prednisolone [VTP Consolidation]
Participants who completed induction phase entered in the consolidated treatment phase and received bortezomib 1.3 mg/m\^2 SC every 2 weeks for 32 weeks in addition to thalidomide 100 mg orally, once daily for a maximum of 12 months or until disease progression and prednisolone 50 mg orally, on every alternate day until disease progression.
| Group | Source count |
|---|---|
| Thalidomide + Prednisolone [TP Consolidation] | 56 |
| Bortezomib + Thalidomide + Prednisolone [VTP Consolidation] | 62 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Thalidomide + Prednisolone [TP Consolidation] | 18.53 | Not reported | 11.24 | 23.36 | Not reported |
| Bortezomib + Thalidomide + Prednisolone [VTP Consolidation] | 13.37 | Not reported | 10.18 | 20.96 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 11.24
- upper Limit
- 23.36
- value
- 18.53
- group Id
- OG001
- lower Limit
- 10.18
- upper Limit
- 20.96
- value
- 13.37
- denoms
- counts
- group Id
- OG000
- value
- 56
- group Id
- OG001
- value
- 62
- units
- Participants
- description
- DFS, defined as the duration from the start of CR to the time of relapse from CR. DFS applied only to participants in CR. CR as per IMWG criteria is negative immunofixation on serum and urine and disappearance of soft tissue plasmacytomas and \<5 percent plasma cells in bone marrow. Relapse from CR: reappearance of serum or urine M-protein by immunofixation or electrophoresis; development of \>= 5 percent plasma cells in the bone marrow; appearance of any other sign of progression (ie, new plasmacytoma, lytic bone lesion, or hypercalcaemia).
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants who completed induction phase entered in the consolidated treatment phase and received thalidomide 100 mg orally, once daily until disease progression (up to maximum of 12 months) and prednisolone 50 mg orally, on every alternate day until disease progression.
- id
- OG000
- title
- Thalidomide + Prednisolone [TP Consolidation]
- description
- Participants who completed induction phase entered in the consolidated treatment phase and received bortezomib 1.3 mg/m\^2 SC every 2 weeks for 32 weeks in addition to thalidomide 100 mg orally, once daily for a maximum of 12 months or until disease progression and prednisolone 50 mg orally, on every alternate day until disease progression.
- id
- OG001
- title
- Bortezomib + Thalidomide + Prednisolone [VTP Consolidation]
- param Type
- MEDIAN
- population Description
- Response-evaluable-randomized analysis set defined as all participants in the response-evaluable-induction set (who received at least 1 dose of study medication;had measurable disease at baseline) who were randomized to receive consolidation treatment. Here, 'N' (number of participants analyzed) signifies the participants who had complete response.
- reporting Status
- POSTED
- time Frame
- Up to 5 years
- title
- Disease-free Survival (DFS)
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice