TriangleNCT01602224 · OUTCOME
Participants With Best Overall Response (BOR) in Each Category
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- Baseline to Objective Disease Progression or Initiation of New Cancer Treatment (28 Months)
What was measured
Stringent Complete Response-Complete Response and normal free light chain ration and no clonal cells in bone marrow Complete Response- no monoclonal protein (mp) in blood, no serum or urine mp, less than 5% plasma cells in bone marrow Very Good Partial Response-more than 90% decrease in mp and urine protein Partial Response- over 50% decrease in serum mp Stable Disease- less than 25 percent decrease of monoclonal protein Progressive Disease- 25% increase compared to lowest value of serum mp, urine mp, no measurable mp
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
Stringent Complete Response
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| 100 mg Tabalumab+Dexamethasone+Bortezomib | 1 | Not reported | Not reported | Not reported | Not reported |
| 300 mg Tabalumab+Dexamethasone+Bortezomib | 0 | Not reported | Not reported | Not reported | Not reported |
| Placebo Comparator: Placebo + Dexamethasone + Bortezomib | 2 | Not reported | Not reported | Not reported | Not reported |
Complete Response
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| 100 mg Tabalumab+Dexamethasone+Bortezomib | 10 | Not reported | Not reported | Not reported | Not reported |
| 300 mg Tabalumab+Dexamethasone+Bortezomib | 4 | Not reported | Not reported | Not reported | Not reported |
| Placebo Comparator: Placebo + Dexamethasone + Bortezomib | 4 | Not reported | Not reported | Not reported | Not reported |
Very Good Partial Response
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| 100 mg Tabalumab+Dexamethasone+Bortezomib | 10 | Not reported | Not reported | Not reported | Not reported |
| 300 mg Tabalumab+Dexamethasone+Bortezomib | 16 | Not reported | Not reported | Not reported | Not reported |
| Placebo Comparator: Placebo + Dexamethasone + Bortezomib | 9 | Not reported | Not reported | Not reported | Not reported |
Partial Response
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| 100 mg Tabalumab+Dexamethasone+Bortezomib | 23 | Not reported | Not reported | Not reported | Not reported |
| 300 mg Tabalumab+Dexamethasone+Bortezomib | 23 | Not reported | Not reported | Not reported | Not reported |
| Placebo Comparator: Placebo + Dexamethasone + Bortezomib | 29 | Not reported | Not reported | Not reported | Not reported |
Minimal Response
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| 100 mg Tabalumab+Dexamethasone+Bortezomib | 6 | Not reported | Not reported | Not reported | Not reported |
| 300 mg Tabalumab+Dexamethasone+Bortezomib | 8 | Not reported | Not reported | Not reported | Not reported |
| Placebo Comparator: Placebo + Dexamethasone + Bortezomib | 6 | Not reported | Not reported | Not reported | Not reported |
Stable Disease
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| 100 mg Tabalumab+Dexamethasone+Bortezomib | 14 | Not reported | Not reported | Not reported | Not reported |
| 300 mg Tabalumab+Dexamethasone+Bortezomib | 10 | Not reported | Not reported | Not reported | Not reported |
| Placebo Comparator: Placebo + Dexamethasone + Bortezomib | 12 | Not reported | Not reported | Not reported | Not reported |
Progressive Disease
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| 100 mg Tabalumab+Dexamethasone+Bortezomib | 6 | Not reported | Not reported | Not reported | Not reported |
| 300 mg Tabalumab+Dexamethasone+Bortezomib | 7 | Not reported | Not reported | Not reported | Not reported |
| Placebo Comparator: Placebo + Dexamethasone + Bortezomib | 6 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- calculate Pct
- false
- classes
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 2
- title
- Stringent Complete Response
- categories
- measurements
- group Id
- OG000
- value
- 10
- group Id
- OG001
- value
- 4
- group Id
- OG002
- value
- 4
- title
- Complete Response
- categories
- measurements
- group Id
- OG000
- value
- 10
- group Id
- OG001
- value
- 16
- group Id
- OG002
- value
- 9
- title
- Very Good Partial Response
- categories
- measurements
- group Id
- OG000
- value
- 23
- group Id
- OG001
- value
- 23
- group Id
- OG002
- value
- 29
- title
- Partial Response
- categories
- measurements
- group Id
- OG000
- value
- 6
- group Id
- OG001
- value
- 8
- group Id
- OG002
- value
- 6
- title
- Minimal Response
- categories
- measurements
- group Id
- OG000
- value
- 14
- group Id
- OG001
- value
- 10
- group Id
- OG002
- value
- 12
- title
- Stable Disease
- categories
- measurements
- group Id
- OG000
- value
- 6
- group Id
- OG001
- value
- 7
- group Id
- OG002
- value
- 6
- title
- Progressive Disease
- denoms
- counts
- group Id
- OG000
- value
- 74
- group Id
- OG001
- value
- 74
- group Id
- OG002
- value
- 72
- units
- Participants
- description
- Stringent Complete Response-Complete Response and normal free light chain ration and no clonal cells in bone marrow Complete Response- no monoclonal protein (mp) in blood, no serum or urine mp, less than 5% plasma cells in bone marrow Very Good Partial Response-more than 90% decrease in mp and urine protein Partial Response- over 50% decrease in serum mp Stable Disease- less than 25 percent decrease of monoclonal protein Progressive Disease- 25% increase compared to lowest value of serum mp, urine mp, no measurable mp
- 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
- COUNT_OF_PARTICIPANTS
- population Description
- All randomized participants.
- reporting Status
- POSTED
- time Frame
- Baseline to Objective Disease Progression or Initiation of New Cancer Treatment (28 Months)
- title
- Participants With Best Overall Response (BOR) in Each Category
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice