TriangleNCT01980589 · OUTCOME
Time To Response (TTR)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- months
- Interval / dispersion
- Full Range
- Time frame
- Disease response was assessed at the end of each cycle and 30 days after the last treatment; maximum treatment duration was 32 weeks.
What was measured
Time to response is defined as months from treatment start to first documentation of response of partial response or better. Summary of time to response includes confirmed responders of PR or better only.
Analysis population: Participants with an overall response
Groups in this outcome
Carfilzomib 36 mg/m²
Participants received 36 mg/m² carfilzomib IV infusion on days 1, 2, 8, 9,15, and 16 of each 28 day cycle (on days 1 and 2 of cycle 1, all participants received carfilzomib at 20 mg/m²), cyclophosphamide administered orally at 300 mg/m² on days 1, 8, and 15, and 40 mg dexamethasone on days 1, 8, 15, and 22, for up to eight 28 day cycles, or until progressive disease (PD), unacceptable toxicity, withdrawal of consent, or death.
Carfilzomib 45 mg/m²
Participants received 45 mg/m² carfilzomib IV infusion on days 1, 2, 8, 9,15, and 16 of each 28 day cycle (on days 1 and 2 of cycle 1, all participants received carfilzomib at 20 mg/m²), cyclophosphamide administered orally at 300 mg/m² on days 1, 8, and 15, and 40 mg dexamethasone on days 1, 8, 15, and 22, for up to eight 28 day cycles, or until progressive disease (PD), unacceptable toxicity, withdrawal of consent, or death.
Carfilzomib 56 mg/m²
Participants received 56 mg/m² carfilzomib IV infusion on days 1, 2, 8, 9,15, and 16 of each 28 day cycle (on days 1 and 2 of cycle 1, all participants received carfilzomib at 20 mg/m²), cyclophosphamide administered orally at 300 mg/m² on days 1, 8, and 15, and 40 mg dexamethasone on days 1, 8, 15, and 22, for up to eight 28 day cycles, or until progressive disease (PD), unacceptable toxicity, withdrawal of consent, or death.
| Group | Source count |
|---|---|
| Carfilzomib 36 mg/m² | 2 |
| Carfilzomib 45 mg/m² | 3 |
| Carfilzomib 56 mg/m² | 14 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Carfilzomib 36 mg/m² | 1.3 | Not reported | 1.0 | 1.6 | Not reported |
| Carfilzomib 45 mg/m² | 0.8 | Not reported | 0.7 | 1.9 | Not reported |
| Carfilzomib 56 mg/m² | 1.0 | Not reported | 0.9 | 2.8 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 1.0
- upper Limit
- 1.6
- value
- 1.3
- group Id
- OG001
- lower Limit
- 0.7
- upper Limit
- 1.9
- value
- 0.8
- group Id
- OG002
- lower Limit
- 0.9
- upper Limit
- 2.8
- value
- 1.0
- denoms
- counts
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 14
- units
- Participants
- description
- Time to response is defined as months from treatment start to first documentation of response of partial response or better. Summary of time to response includes confirmed responders of PR or better only.
- dispersion Type
- Full Range
- groups
- description
- Participants received 36 mg/m² carfilzomib IV infusion on days 1, 2, 8, 9,15, and 16 of each 28 day cycle (on days 1 and 2 of cycle 1, all participants received carfilzomib at 20 mg/m²), cyclophosphamide administered orally at 300 mg/m² on days 1, 8, and 15, and 40 mg dexamethasone on days 1, 8, 15, and 22, for up to eight 28 day cycles, or until progressive disease (PD), unacceptable toxicity, withdrawal of consent, or death.
- id
- OG000
- title
- Carfilzomib 36 mg/m²
- description
- Participants received 45 mg/m² carfilzomib IV infusion on days 1, 2, 8, 9,15, and 16 of each 28 day cycle (on days 1 and 2 of cycle 1, all participants received carfilzomib at 20 mg/m²), cyclophosphamide administered orally at 300 mg/m² on days 1, 8, and 15, and 40 mg dexamethasone on days 1, 8, 15, and 22, for up to eight 28 day cycles, or until progressive disease (PD), unacceptable toxicity, withdrawal of consent, or death.
- id
- OG001
- title
- Carfilzomib 45 mg/m²
- description
- Participants received 56 mg/m² carfilzomib IV infusion on days 1, 2, 8, 9,15, and 16 of each 28 day cycle (on days 1 and 2 of cycle 1, all participants received carfilzomib at 20 mg/m²), cyclophosphamide administered orally at 300 mg/m² on days 1, 8, and 15, and 40 mg dexamethasone on days 1, 8, 15, and 22, for up to eight 28 day cycles, or until progressive disease (PD), unacceptable toxicity, withdrawal of consent, or death.
- id
- OG002
- title
- Carfilzomib 56 mg/m²
- param Type
- MEDIAN
- population Description
- Participants with an overall response
- reporting Status
- POSTED
- time Frame
- Disease response was assessed at the end of each cycle and 30 days after the last treatment; maximum treatment duration was 32 weeks.
- title
- Time To Response (TTR)
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice