TriangleNCT00507442 · OUTCOME
Progression-free Survival
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- days
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Up to 48 weeks or until disease progression/death
What was measured
Progression-free survival is defined as time from the date of randomization to the date of the first documented progressive disease or death. Disease progression requires any one or more of the following: serum m-protein increase \>= 25% from nadir(absolute increase \>= 0.5 g/dL); Urine m-protein increase \>= 25% from nadir(absolute increase \>= 200 mg/24 hr), bone marrow plasma cell percentage increase \>= 25% from nadir(absolute increase \>= 10%), new bone lesion or soft tissue plasmacytomas.
Analysis population: The modified intent-to-treat population is defined as phase 2 patients received at least one dose of any drug.
Groups in this outcome
V-DR
Bortezomib: 1.3 mg/m\^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles. Dexamethasone: 40 mg orally \[PO\] on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop. Lenalidomide: 25 mg PO on Days 1 through 14 of a 3-week cycle for 8 cycles, then stop.
VDCR
Bortezomib: 1.3 mg/m\^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles. Dexamethasone: 40 mg PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop. Cyclophosphamide: 500 mg/m\^2 dose PO on Days 1 and 8 of a 3-week cycle for 8 cycles, then stop. Lenalidomide: 15 mg PO on Days 1 through 14 of a 3-week cycle for 8 cycles, then stop.
V-DC
Bortezomib: 1.3 mg/m\^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles. Dexamethasone: 40 mg orally PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop. Cyclophosphamide: 500 mg/m\^2 dose PO on Days 1 and 8 of a 3-week cycle for 8 cycles, then stop.
VDC-mod
Bortezomib: 1.3 mg/m\^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles. Dexamethasone: 40 mg PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop. Cyclophosphamide: 500 mg/m\^2 dose PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.
| Group | Source count |
|---|---|
| V-DR | 42 |
| VDCR | 48 |
| V-DC | 33 |
| VDC-mod | 17 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| V-DR | NA | Not reported | 356 | NA | Not estimable based on the Kaplan-Meier method because of insufficient follow up time |
| VDCR | 631 | Not reported | 555 | NA | Not estimable based on the Kaplan-Meier method because of insufficient follow up time |
| V-DC | NA | Not reported | 778 | NA | Not estimable based on the Kaplan-Meier method because of insufficient follow up time |
| VDC-mod | NA | Not reported | NA | NA | Not estimable based on the Kaplan-Meier method because of insufficient follow up time |
Complete source fields
- classes
- categories
- measurements
- comment
- Not estimable based on the Kaplan-Meier method because of insufficient follow up time
- group Id
- OG000
- lower Limit
- 356
- upper Limit
- NA
- value
- NA
- comment
- Not estimable based on the Kaplan-Meier method because of insufficient follow up time
- group Id
- OG001
- lower Limit
- 555
- upper Limit
- NA
- value
- 631
- comment
- Not estimable based on the Kaplan-Meier method because of insufficient follow up time
- group Id
- OG002
- lower Limit
- 778
- upper Limit
- NA
- value
- NA
- comment
- Not estimable based on the Kaplan-Meier method because of insufficient follow up time
- group Id
- OG003
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 42
- group Id
- OG001
- value
- 48
- group Id
- OG002
- value
- 33
- group Id
- OG003
- value
- 17
- units
- Participants
- description
- Progression-free survival is defined as time from the date of randomization to the date of the first documented progressive disease or death. Disease progression requires any one or more of the following: serum m-protein increase \>= 25% from nadir(absolute increase \>= 0.5 g/dL); Urine m-protein increase \>= 25% from nadir(absolute increase \>= 200 mg/24 hr), bone marrow plasma cell percentage increase \>= 25% from nadir(absolute increase \>= 10%), new bone lesion or soft tissue plasmacytomas.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Bortezomib: 1.3 mg/m\^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles. Dexamethasone: 40 mg orally \[PO\] on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop. Lenalidomide: 25 mg PO on Days 1 through 14 of a 3-week cycle for 8 cycles, then stop.
- id
- OG000
- title
- V-DR
- description
- Bortezomib: 1.3 mg/m\^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles. Dexamethasone: 40 mg PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop. Cyclophosphamide: 500 mg/m\^2 dose PO on Days 1 and 8 of a 3-week cycle for 8 cycles, then stop. Lenalidomide: 15 mg PO on Days 1 through 14 of a 3-week cycle for 8 cycles, then stop.
- id
- OG001
- title
- VDCR
- description
- Bortezomib: 1.3 mg/m\^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles. Dexamethasone: 40 mg orally PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop. Cyclophosphamide: 500 mg/m\^2 dose PO on Days 1 and 8 of a 3-week cycle for 8 cycles, then stop.
- id
- OG002
- title
- V-DC
- description
- Bortezomib: 1.3 mg/m\^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles. Dexamethasone: 40 mg PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop. Cyclophosphamide: 500 mg/m\^2 dose PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.
- id
- OG003
- title
- VDC-mod
- param Type
- MEDIAN
- population Description
- The modified intent-to-treat population is defined as phase 2 patients received at least one dose of any drug.
- reporting Status
- POSTED
- time Frame
- Up to 48 weeks or until disease progression/death
- title
- Progression-free Survival
- type
- SECONDARY
- unit Of Measure
- days
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice