TriangleNCT02477215 · OUTCOME
Number of Participants Experiencing Dose-Limiting Toxicity (DLT)
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
- Six months
What was measured
A 3+3 design was employed. At each dose, three patients were initially evaluated. If no dose limiting toxicities were observed, the bendamustine dose was increased; if one dose limiting toxicity is observed, three additional patients were treated at that dose. A dose at which 2 DLTs were observed in 3 or 6 patients were judged to be too toxic and the lower dose was defined as the maximally tolerated dose (MTD).
Groups in this outcome
Bendamustine (70 mg/m^2), MLN9708, Dexamethasone
MLN9708 : 4 mg, days 1, 8, 15. Dexamethasone: 40 mg oral weekly. Bendamustine: 70 mg/m\^2 days 1 and 2
Bendamustine (80 mg/m^2), MLN9708, Dexamethasone
MLN9708 : 4 mg, days 1, 8, 15. Dexamethasone: 40 mg oral weekly. Bendamustine: 80 mg/m\^2 days 1 and 2
Bendamustine (90 mg/m^2), MLN9708, Dexamethasone
MLN9708 : 4 mg, days 1, 8, 15. Dexamethasone: 40 mg oral weekly. Bendamustine: 90 mg/m\^2 days 1 and 2
| Group | Source count |
|---|---|
| Bendamustine (70 mg/m^2), MLN9708, Dexamethasone | 3 |
| Bendamustine (80 mg/m^2), MLN9708, Dexamethasone | 6 |
| Bendamustine (90 mg/m^2), MLN9708, Dexamethasone | 6 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Bendamustine (70 mg/m^2), MLN9708, Dexamethasone | 0 | Not reported | Not reported | Not reported | Not reported |
| Bendamustine (80 mg/m^2), MLN9708, Dexamethasone | 1 | Not reported | Not reported | Not reported | Not reported |
| Bendamustine (90 mg/m^2), MLN9708, Dexamethasone | 2 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 2
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 6
- group Id
- OG002
- value
- 6
- units
- Participants
- description
- A 3+3 design was employed. At each dose, three patients were initially evaluated. If no dose limiting toxicities were observed, the bendamustine dose was increased; if one dose limiting toxicity is observed, three additional patients were treated at that dose. A dose at which 2 DLTs were observed in 3 or 6 patients were judged to be too toxic and the lower dose was defined as the maximally tolerated dose (MTD).
- groups
- description
- MLN9708 : 4 mg, days 1, 8, 15. Dexamethasone: 40 mg oral weekly. Bendamustine: 70 mg/m\^2 days 1 and 2
- id
- OG000
- title
- Bendamustine (70 mg/m^2), MLN9708, Dexamethasone
- description
- MLN9708 : 4 mg, days 1, 8, 15. Dexamethasone: 40 mg oral weekly. Bendamustine: 80 mg/m\^2 days 1 and 2
- id
- OG001
- title
- Bendamustine (80 mg/m^2), MLN9708, Dexamethasone
- description
- MLN9708 : 4 mg, days 1, 8, 15. Dexamethasone: 40 mg oral weekly. Bendamustine: 90 mg/m\^2 days 1 and 2
- id
- OG002
- title
- Bendamustine (90 mg/m^2), MLN9708, Dexamethasone
- param Type
- COUNT_OF_PARTICIPANTS
- reporting Status
- POSTED
- time Frame
- Six months
- title
- Number of Participants Experiencing Dose-Limiting Toxicity (DLT)
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice