TriangleNCT00507416 · 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
- From randomization until disease progression. Median follow-up time was 43 months.
What was measured
PFS is defined as the time from randomization to disease progression or death, whichever occurs first. Participants who did not progress and were still alive at the cut-off date were censored at the date of last contact. Response was assessed by the Investigator using the International Myeloma Working Group (IMWG) uniform response criteria. Progressive disease requires 1 of the following: * Increase of ≥ 25% from nadir in: * Serum M-component (absolute increase ≥ 0.5 g/dl) * Urine M-component (absolute increase ≥ 200 mg/24 hours) * In patients without measurable serum and urine M-protein levels the difference between involved and uninvolved free light chain (FLC) levels (absolute increase \> 100 mg/dl) * Bone marrow plasma cell percentage (absolute % ≥ 10%) * Development of new or increase in the size of existing bone lesions or soft tissue plasmacytomas. * Development of hypercalcemia (corrected serum calcium \> 11.5 mg/dl) attributed solely to plasma cell proliferative disease
Analysis population: Intent-to-treat (all randomized participants)
Groups in this outcome
Bortezomib and Dexamethasone
Participants received bortezomib (Velcade) 1.3 mg/m\^2 administered as a bolus intravenous (IV) injection on Days 1, 4, 8, and 11, and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 and 12 for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/\^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).
Bortezomib, Thalidomide, and Dexamethasone
Participants received bortezomib 1.3 mg/m\^2 administered as a bolus IV injection on Days 1, 4, 8, and 11, and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 and 12, and thalidomide 100 mg orally on Days 1-21 for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/\^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).
Bortezomib, Melphalan and Prednisone
Participants received bortezomib 1.3 mg/m\^2 administered as a bolus IV injection on Days 1, 4, 8, and 11, and melphalan 9 mg/m\^2 orally on Days 1-4 every other cycle and prednisone 60 mg/m\^2 orally on Days 1-4 every other cycle for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/\^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).
| Group | Source count |
|---|---|
| Bortezomib and Dexamethasone | 168 |
| Bortezomib, Thalidomide, and Dexamethasone | 167 |
| Bortezomib, Melphalan and Prednisone | 167 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Bortezomib and Dexamethasone | 14.7 | Not reported | 12.0 | 18.6 | Not reported |
| Bortezomib, Thalidomide, and Dexamethasone | 15.4 | Not reported | 12.6 | 24.2 | Not reported |
| Bortezomib, Melphalan and Prednisone | 17.3 | Not reported | 14.8 | 20.3 | Not reported |
Source statistical analyses
- group Ids
- OG000
- OG001
- OG002
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.458
- p Value Comment
- The global difference among arms was based on the Wald test.
- statistical Method
- Wald test
- tested Non Inferiority
- false
Complete source fields
- analyses
- group Ids
- OG000
- OG001
- OG002
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.458
- p Value Comment
- The global difference among arms was based on the Wald test.
- statistical Method
- Wald test
- tested Non Inferiority
- false
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 12.0
- upper Limit
- 18.6
- value
- 14.7
- group Id
- OG001
- lower Limit
- 12.6
- upper Limit
- 24.2
- value
- 15.4
- group Id
- OG002
- lower Limit
- 14.8
- upper Limit
- 20.3
- value
- 17.3
- denoms
- counts
- group Id
- OG000
- value
- 168
- group Id
- OG001
- value
- 167
- group Id
- OG002
- value
- 167
- units
- Participants
- description
- PFS is defined as the time from randomization to disease progression or death, whichever occurs first. Participants who did not progress and were still alive at the cut-off date were censored at the date of last contact. Response was assessed by the Investigator using the International Myeloma Working Group (IMWG) uniform response criteria. Progressive disease requires 1 of the following: * Increase of ≥ 25% from nadir in: * Serum M-component (absolute increase ≥ 0.5 g/dl) * Urine M-component (absolute increase ≥ 200 mg/24 hours) * In patients without measurable serum and urine M-protein levels the difference between involved and uninvolved free light chain (FLC) levels (absolute increase \> 100 mg/dl) * Bone marrow plasma cell percentage (absolute % ≥ 10%) * Development of new or increase in the size of existing bone lesions or soft tissue plasmacytomas. * Development of hypercalcemia (corrected serum calcium \> 11.5 mg/dl) attributed solely to plasma cell proliferative disease
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received bortezomib (Velcade) 1.3 mg/m\^2 administered as a bolus intravenous (IV) injection on Days 1, 4, 8, and 11, and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 and 12 for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/\^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).
- id
- OG000
- title
- Bortezomib and Dexamethasone
- description
- Participants received bortezomib 1.3 mg/m\^2 administered as a bolus IV injection on Days 1, 4, 8, and 11, and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 and 12, and thalidomide 100 mg orally on Days 1-21 for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/\^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).
- id
- OG001
- title
- Bortezomib, Thalidomide, and Dexamethasone
- description
- Participants received bortezomib 1.3 mg/m\^2 administered as a bolus IV injection on Days 1, 4, 8, and 11, and melphalan 9 mg/m\^2 orally on Days 1-4 every other cycle and prednisone 60 mg/m\^2 orally on Days 1-4 every other cycle for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/\^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).
- id
- OG002
- title
- Bortezomib, Melphalan and Prednisone
- param Type
- MEDIAN
- population Description
- Intent-to-treat (all randomized participants)
- reporting Status
- POSTED
- time Frame
- From randomization until disease progression. Median follow-up time was 43 months.
- title
- Progression Free Survival (PFS)
- type
- PRIMARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice