TriangleNCT01539083 · OUTCOME
Progression Free Survival (PFS)
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
- Baseline until progressive disease (up to 5 years)
What was measured
PFS, calculated as the time between randomization to disease progression or death (regardless of cause), whichever occurred first. Progressive disease as per IMWG criteria: increase of \>= 25 percent from lowest response level in Serum M-component and/or (the absolute increase must be \>=0.5 gram per deciliter \[g/dL\]) Urine M-component and/or (the absolute increase must be \>=200 mg/24 hour. Only in participants without measurable serum and urine M-protein levels: the difference between involved and uninvolved free light chain levels. The absolute increase must be \>10 mg/dL. Bone marrow plasma cell percentage: the absolute percent must be \>=10 percent. Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas. Development of hypercalcemia (corrected serum calcium \>11.5 mg/dL or 2.65 millimole per liter (mmol/L) that can be attributed solely to the plasma cell proliferative disorder.
Analysis population: All response-evaluable-randomized analysis set was defined as all participants in the response-evaluable-induction set (all participants who received at least 1 dose of study medication in the induction phase and had measurable disease at baseline) who were randomized to receive consolidation treatment.
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] | 96 |
| Bortezomib + Thalidomide + Prednisolone [VTP Consolidation] | 98 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Thalidomide + Prednisolone [TP Consolidation] | 22.05 | Not reported | 18.46 | 25.49 | Not reported |
| Bortezomib + Thalidomide + Prednisolone [VTP Consolidation] | 22.51 | Not reported | 18.56 | 24.15 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 18.46
- upper Limit
- 25.49
- value
- 22.05
- group Id
- OG001
- lower Limit
- 18.56
- upper Limit
- 24.15
- value
- 22.51
- denoms
- counts
- group Id
- OG000
- value
- 96
- group Id
- OG001
- value
- 98
- units
- Participants
- description
- PFS, calculated as the time between randomization to disease progression or death (regardless of cause), whichever occurred first. Progressive disease as per IMWG criteria: increase of \>= 25 percent from lowest response level in Serum M-component and/or (the absolute increase must be \>=0.5 gram per deciliter \[g/dL\]) Urine M-component and/or (the absolute increase must be \>=200 mg/24 hour. Only in participants without measurable serum and urine M-protein levels: the difference between involved and uninvolved free light chain levels. The absolute increase must be \>10 mg/dL. Bone marrow plasma cell percentage: the absolute percent must be \>=10 percent. Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas. Development of hypercalcemia (corrected serum calcium \>11.5 mg/dL or 2.65 millimole per liter (mmol/L) that can be attributed solely to the plasma cell proliferative disorder.
- 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
- All response-evaluable-randomized analysis set was defined as all participants in the response-evaluable-induction set (all participants who received at least 1 dose of study medication in the induction phase and had measurable disease at baseline) who were randomized to receive consolidation treatment.
- reporting Status
- POSTED
- time Frame
- Baseline until progressive disease (up to 5 years)
- title
- Progression Free Survival (PFS)
- type
- SECONDARY
- unit Of Measure
- months
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Preserved source evidence · Not medical advice