TriangleNCT01602224 · OUTCOME
Duration of Response (DoR)
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
- Time from Response to Objective Disease Progression (assessed up to 38 months)
What was measured
DOR is measured by the International Myeloma Working Group Uniform Response Criteria: from the date of first evidence of a confirmed response to the date of objective progression or the date of death due to any cause, whichever is earlier. If a responder is not known to have died or have objective progression as of the data inclusion cutoff date, the DOR time will be censored at the last complete objective progression-free disease assessment date. Progressive disease is an increase of 25% from baseline in Serum M, Urine M, bone marrow plasma cell increase of 10 %, development of new bone lesions, development of new soft tissue plasmacytomas or bone lesions, hypercalcemia \>11.5 milligrams per deciliter, decrease in hemoglobin of 2 grams per deciliter, rise in serum creatinine by 2 mg/deciliter.
Analysis population: All randomized participants who received at least 1 dose of study drug and had a response.
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 | 43 |
| 300 mg Tabalumab+Dexamethasone+Bortezomib | 44 |
| Placebo Comparator: Placebo + Dexamethasone + Bortezomib | 44 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| 100 mg Tabalumab+Dexamethasone+Bortezomib | 7.9 | Not reported | 6.0 | 11.6 | Not reported |
| 300 mg Tabalumab+Dexamethasone+Bortezomib | 8.6 | Not reported | 6.5 | 10.7 | Not reported |
| Placebo Comparator: Placebo + Dexamethasone + Bortezomib | 7.7 | Not reported | 5.8 | 13.1 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 6.0
- upper Limit
- 11.6
- value
- 7.9
- group Id
- OG001
- lower Limit
- 6.5
- upper Limit
- 10.7
- value
- 8.6
- group Id
- OG002
- lower Limit
- 5.8
- upper Limit
- 13.1
- value
- 7.7
- denoms
- counts
- group Id
- OG000
- value
- 43
- group Id
- OG001
- value
- 44
- group Id
- OG002
- value
- 44
- units
- Participants
- description
- DOR is measured by the International Myeloma Working Group Uniform Response Criteria: from the date of first evidence of a confirmed response to the date of objective progression or the date of death due to any cause, whichever is earlier. If a responder is not known to have died or have objective progression as of the data inclusion cutoff date, the DOR time will be censored at the last complete objective progression-free disease assessment date. Progressive disease is an increase of 25% from baseline in Serum M, Urine M, bone marrow plasma cell increase of 10 %, development of new bone lesions, development of new soft tissue plasmacytomas or bone lesions, hypercalcemia \>11.5 milligrams per deciliter, decrease in hemoglobin of 2 grams per deciliter, rise in serum creatinine by 2 mg/deciliter.
- 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 who received at least 1 dose of study drug and had a response.
- reporting Status
- POSTED
- time Frame
- Time from Response to Objective Disease Progression (assessed up to 38 months)
- title
- Duration of Response (DoR)
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice