TriangleNCT01602224 · 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 up to Objective Disease Progression or Death From Any Cause (assessed up to 9 months)
What was measured
PFS is defined as the time from date of first dose to the first observation of disease progression or death due to any cause. If a participant does not have a complete baseline disease assessment, then the PFS time is censored at the enrollment date, regardless of whether or not objectively determined disease progression (Increase of \> 25% from lowest response in serum M component, urine M component, bone marrow plasma cell percentage, development of bone lesions) or death has been observed for the participant. If a participant is not known to have died or have objective progression as of the data inclusion cutoff date for the analysis, the PFS time is censored at the last complete objective progression-free disease assessment date.
Analysis population: All randomized participants.
Groups in this outcome
100 mg Tabalumab+Dexamethasone+Bortezomib
Tabalumab 100 milligram (mg) administered once intravenously (IV) over 30 minutes on Day 1 every 21 days for 8 cycles. Dexamethasone 20 mg administered once orally on Days 1, 2, 4, 5, 8, 9, 11 and 12 every 21 days for 8 cycles. Bortezomib 1.3 milligram per square meter (mg/m\^2) administered once subcutaneously (SQ) on Days 1, 4, 8 and 11 every 21 days for 8 cycles.
300 mg Tabalumab+Dexamethasone+Bortezomib
Tabalumab 300 mg administered once IV over 30 minutes on Day 1 every 21 days for 8 cycles. Dexamethasone 20 mg administered orally on Days 1, 2, 4, 5, 8, 9, 11 and 12 every 21 days for 8 cycles. Bortezomib 1.3 mg/m\^2 administered once SQ on Days 1, 4, 8 and 11 every 21 days for 8 cycles.
Placebo Comparator: Placebo + Dexamethasone + Bortezomib
Placebo administered once IV on Day 1 every 21 days for 8 cycles. Dexamethasone 20 mg administered once orally on Days 1, 2, 4, 5, 8, 9, 11 and 12 every 21 days for 8 cycles. Bortezomib 1.3 mg/m\^2 administered once SQ on Days 1, 4, 8 and 11 every 21 days for 8 cycles.
| Group | Source count |
|---|---|
| 100 mg Tabalumab+Dexamethasone+Bortezomib | 74 |
| 300 mg Tabalumab+Dexamethasone+Bortezomib | 74 |
| Placebo Comparator: Placebo + Dexamethasone + Bortezomib | 72 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| 100 mg Tabalumab+Dexamethasone+Bortezomib | 6.6 | Not reported | 5.6 | 8.5 | Not reported |
| 300 mg Tabalumab+Dexamethasone+Bortezomib | 7.5 | Not reported | 5.8 | 9.3 | Not reported |
| Placebo Comparator: Placebo + Dexamethasone + Bortezomib | 7.6 | Not reported | 6.5 | 9.3 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 5.6
- upper Limit
- 8.5
- value
- 6.6
- group Id
- OG001
- lower Limit
- 5.8
- upper Limit
- 9.3
- value
- 7.5
- group Id
- OG002
- lower Limit
- 6.5
- upper Limit
- 9.3
- value
- 7.6
- denoms
- counts
- group Id
- OG000
- value
- 74
- group Id
- OG001
- value
- 74
- group Id
- OG002
- value
- 72
- units
- Participants
- description
- PFS is defined as the time from date of first dose to the first observation of disease progression or death due to any cause. If a participant does not have a complete baseline disease assessment, then the PFS time is censored at the enrollment date, regardless of whether or not objectively determined disease progression (Increase of \> 25% from lowest response in serum M component, urine M component, bone marrow plasma cell percentage, development of bone lesions) or death has been observed for the participant. If a participant is not known to have died or have objective progression as of the data inclusion cutoff date for the analysis, the PFS time is censored at the last complete objective progression-free disease assessment date.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Tabalumab 100 milligram (mg) administered once intravenously (IV) over 30 minutes on Day 1 every 21 days for 8 cycles. Dexamethasone 20 mg administered once orally on Days 1, 2, 4, 5, 8, 9, 11 and 12 every 21 days for 8 cycles. Bortezomib 1.3 milligram per square meter (mg/m\^2) administered once subcutaneously (SQ) on Days 1, 4, 8 and 11 every 21 days for 8 cycles.
- id
- OG000
- title
- 100 mg Tabalumab+Dexamethasone+Bortezomib
- description
- Tabalumab 300 mg administered once IV over 30 minutes on Day 1 every 21 days for 8 cycles. Dexamethasone 20 mg administered orally on Days 1, 2, 4, 5, 8, 9, 11 and 12 every 21 days for 8 cycles. Bortezomib 1.3 mg/m\^2 administered once SQ on Days 1, 4, 8 and 11 every 21 days for 8 cycles.
- id
- OG001
- title
- 300 mg Tabalumab+Dexamethasone+Bortezomib
- description
- Placebo administered once IV on Day 1 every 21 days for 8 cycles. Dexamethasone 20 mg administered once orally on Days 1, 2, 4, 5, 8, 9, 11 and 12 every 21 days for 8 cycles. Bortezomib 1.3 mg/m\^2 administered once SQ on Days 1, 4, 8 and 11 every 21 days for 8 cycles.
- id
- OG002
- title
- Placebo Comparator: Placebo + Dexamethasone + Bortezomib
- param Type
- MEDIAN
- population Description
- All randomized participants.
- reporting Status
- POSTED
- time Frame
- Baseline up to Objective Disease Progression or Death From Any Cause (assessed up to 9 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