TriangleNCT01754402 · OUTCOME
Maximum Tolerated Dose of Pomalidomide and Bendamustine
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- milligrams
- Interval / dispersion
- Not reported
- Time frame
- 2 cycles (approximately 2 months)
What was measured
In the phase I dose escalation portion, patients will be sequentially enrolled in 4 cohorts at dose levels in a standard 3+3 design until the maximum tolerated dose (MTD) is reached. Cohort 1 (bendamustine 120mg/m2 + pomalidomide 3mg); Cohort 2 (bendamustine 120mg/m2 + pomalidomide 4mg); Cohort 3 (bendamustine 150mg/m2 + pomalidomide 4mg); Cohort 4 (bendamustine 180mg/m2 + pomalidomide 4mg) If dose limiting toxicity (DLT) is observed in 2 or more of the six patients at the same dosing level while DLT is observed in only 1 or none of the 6 patients at the dosing level immediately below it, then the lower dosing level will be defined as the maximum tolerated dose (MTD).
Analysis population: All patients enrolled in cohort 1 and 2 evaluable for DLT. Cohorts 3 and 4 were not evaluated due to both patients in Cohort 2 experiencing DLT.
Groups in this outcome
Cohorts 1 and 2
* Pomalidomide: once daily oral (PO) dosing on days 1-21, every 28 days * Bendamustine: once intravenous (IV) dosing on day 1, every 28 days * Dexamethasone: weekly PO or IV dosing on days 1, 8, 15, and 22 every 28 days Study treatment will be administered starting at Cohort 1 for up to four sequential cohorts, with 3-6 patients in each cohort. (Dose escalation) Bendamustine: Bendamustine 120mg/m2 (cohort 1, 2) or 150 mg/m2 (cohort 3), or 180mg/m2 (cohort 4) will be administered intravenously on day 1, every 28 days for 12 cycles. Pomalidomide: Pomalidomide 3mg (cohort 1) or 4mg (cohort 2, 3, 4) will be administered once daily orally (PO) on days 1-21, every 28 days until disease progression or death. Dexamethasone: Dexamethasone will be administered weekly orally or intravenously on days 1, 8,
| Group | Source count |
|---|---|
| Cohorts 1 and 2 | 8 |
Reported measurements
Pomalidomide
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohorts 1 and 2 | 3 | Not reported | Not reported | Not reported | Not reported |
Bendamustine
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohorts 1 and 2 | 120 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 3
- title
- Pomalidomide
- categories
- measurements
- group Id
- OG000
- value
- 120
- title
- Bendamustine
- denoms
- counts
- group Id
- OG000
- value
- 8
- units
- Participants
- description
- In the phase I dose escalation portion, patients will be sequentially enrolled in 4 cohorts at dose levels in a standard 3+3 design until the maximum tolerated dose (MTD) is reached. Cohort 1 (bendamustine 120mg/m2 + pomalidomide 3mg); Cohort 2 (bendamustine 120mg/m2 + pomalidomide 4mg); Cohort 3 (bendamustine 150mg/m2 + pomalidomide 4mg); Cohort 4 (bendamustine 180mg/m2 + pomalidomide 4mg) If dose limiting toxicity (DLT) is observed in 2 or more of the six patients at the same dosing level while DLT is observed in only 1 or none of the 6 patients at the dosing level immediately below it, then the lower dosing level will be defined as the maximum tolerated dose (MTD).
- groups
- description
- * Pomalidomide: once daily oral (PO) dosing on days 1-21, every 28 days * Bendamustine: once intravenous (IV) dosing on day 1, every 28 days * Dexamethasone: weekly PO or IV dosing on days 1, 8, 15, and 22 every 28 days Study treatment will be administered starting at Cohort 1 for up to four sequential cohorts, with 3-6 patients in each cohort. (Dose escalation) Bendamustine: Bendamustine 120mg/m2 (cohort 1, 2) or 150 mg/m2 (cohort 3), or 180mg/m2 (cohort 4) will be administered intravenously on day 1, every 28 days for 12 cycles. Pomalidomide: Pomalidomide 3mg (cohort 1) or 4mg (cohort 2, 3, 4) will be administered once daily orally (PO) on days 1-21, every 28 days until disease progression or death. Dexamethasone: Dexamethasone will be administered weekly orally or intravenously on days 1, 8,
- id
- OG000
- title
- Cohorts 1 and 2
- param Type
- NUMBER
- population Description
- All patients enrolled in cohort 1 and 2 evaluable for DLT. Cohorts 3 and 4 were not evaluated due to both patients in Cohort 2 experiencing DLT.
- reporting Status
- POSTED
- time Frame
- 2 cycles (approximately 2 months)
- title
- Maximum Tolerated Dose of Pomalidomide and Bendamustine
- type
- PRIMARY
- unit Of Measure
- milligrams
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice