TriangleNCT01496118 · OUTCOME
Progression-free-survival (PFS)
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
- up to 6 years
What was measured
Measured from date of first protocol treatment until date of tumor progression or death as per International Myeloma Working Group Uniform Response Criteria. Progressive disease id defined as an increase of ≥ 25% from the nadir in at least one of the following criteria: serum M-protein (absolute increase must be ≥0.5 g/dL); urine M-protein (absolute increase must be ≥200 mg/24h) ; only in patients with non-measurable serum and urine M-protein levels: difference in involved and uninvolved FLC levels (absolute increase must be \>10 mg/dL); only in patients with non-measurable serum and urine M-protein levels and non-measurable disease by FLC levels, bone marrow plasma cell percentage (absolute % must be ≥10%) OR Definite development of new bone lesions or soft tissue plasmacytomas OR definite increase in the size of existing bone lesions or soft tissue plasmacytomas OR Development of hypercalcemia (corrected serum Ca \>11.5mg/dL) for patients without hypercalcemia at baseline
Analysis population: All patients receiving dose level 4 and dose level 6 doses (both escalation and expansion phases combined) who had a post-baseline disease assessment per protocol were included in the analysis. 3 patients in dose level 4 and 1 patient in dose level 6 did not have a post-baseline assessment and were excluded from analysis.
Groups in this outcome
Dose Level 4 - Escalation and Expansion
Carfilzomib : cycle 1 - 20 mg/m\^2 IV D1, 2 ; 45 mg/m\^2 IV D 8, 9, 15, 16 cycle 2 to progression - 45 mg/m\^2 IV D 1, 2, 8, 9, 15, 16 Panobinostat : cycle 1 and cycle 2 to progression - 30 mg D 1, 3, 5, 15, 17, 19
Dose Level 6 - Escalation and Expansion
Carfilzomib : cycle 1 - 20 mg/m\^2 IV D1, 2 ; 56 mg/m\^2 IV D 8, 9, 15, 16 cycle 2 to progression - 56 mg/m\^2 IV D 1, 2, 8, 9, 15, 16 Panobinostat : cycle 1 and cycle 2 to progression - 20 mg D 1, 3, 5, 15, 17, 19
| Group | Source count |
|---|---|
| Dose Level 4 - Escalation and Expansion | 31 |
| Dose Level 6 - Escalation and Expansion | 32 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose Level 4 - Escalation and Expansion | 12.1 | Not reported | 5.8 | 22.4 | Not reported |
| Dose Level 6 - Escalation and Expansion | 10.3 | Not reported | 6.1 | 13.9 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 5.8
- upper Limit
- 22.4
- value
- 12.1
- group Id
- OG001
- lower Limit
- 6.1
- upper Limit
- 13.9
- value
- 10.3
- denoms
- counts
- group Id
- OG000
- value
- 31
- group Id
- OG001
- value
- 32
- units
- Participants
- description
- Measured from date of first protocol treatment until date of tumor progression or death as per International Myeloma Working Group Uniform Response Criteria. Progressive disease id defined as an increase of ≥ 25% from the nadir in at least one of the following criteria: serum M-protein (absolute increase must be ≥0.5 g/dL); urine M-protein (absolute increase must be ≥200 mg/24h) ; only in patients with non-measurable serum and urine M-protein levels: difference in involved and uninvolved FLC levels (absolute increase must be \>10 mg/dL); only in patients with non-measurable serum and urine M-protein levels and non-measurable disease by FLC levels, bone marrow plasma cell percentage (absolute % must be ≥10%) OR Definite development of new bone lesions or soft tissue plasmacytomas OR definite increase in the size of existing bone lesions or soft tissue plasmacytomas OR Development of hypercalcemia (corrected serum Ca \>11.5mg/dL) for patients without hypercalcemia at baseline
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Carfilzomib : cycle 1 - 20 mg/m\^2 IV D1, 2 ; 45 mg/m\^2 IV D 8, 9, 15, 16 cycle 2 to progression - 45 mg/m\^2 IV D 1, 2, 8, 9, 15, 16 Panobinostat : cycle 1 and cycle 2 to progression - 30 mg D 1, 3, 5, 15, 17, 19
- id
- OG000
- title
- Dose Level 4 - Escalation and Expansion
- description
- Carfilzomib : cycle 1 - 20 mg/m\^2 IV D1, 2 ; 56 mg/m\^2 IV D 8, 9, 15, 16 cycle 2 to progression - 56 mg/m\^2 IV D 1, 2, 8, 9, 15, 16 Panobinostat : cycle 1 and cycle 2 to progression - 20 mg D 1, 3, 5, 15, 17, 19
- id
- OG001
- title
- Dose Level 6 - Escalation and Expansion
- param Type
- MEDIAN
- population Description
- All patients receiving dose level 4 and dose level 6 doses (both escalation and expansion phases combined) who had a post-baseline disease assessment per protocol were included in the analysis. 3 patients in dose level 4 and 1 patient in dose level 6 did not have a post-baseline assessment and were excluded from analysis.
- reporting Status
- POSTED
- time Frame
- up to 6 years
- title
- Progression-free-survival (PFS)
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice