TriangleNCT02057640 · OUTCOME
Progression-free Survival
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
- 1 year from start of treatment
What was measured
Progression-free survival will be the number of days from study entry to progression or death of any cause, whichever comes first. Progression-free survival is survival with absence of progressive disease, defined by * An increase of 25% from lowest response value in any one or more of the following: * Serum M-component (absolute increase must be \>0.5 g/100 ml) \* * Urine M-component (absolute increase must be \>200mg per 24 h) * Only in patients without measurable serum and urine M-protein levels: the difference between involved and uninvolved FLC levels (absolute increase must be \>100 mg/l) * Bone marrow plasma cell percentage (absolute % must be \>10%) * And / 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 * Development of hypercalcemia (corrected serum calcium \>11.5 mg/100 ml) that can be attributed solely to the plasma cell proliferative disorder
Groups in this outcome
DL1 - 3mg Lxazomib
Panobinostat: 20mg, on day 1, 3, 5, 15, 17, 19, 28 Dexamethasone: 20mg, on day 1, 2, 8, 9, 15, 16, 28 MLN9708: 3mg on day 1, 8, 15, 28
DL2 - 4mg Lxazomib
Panobinostat: 20mg, on day 1, 3, 5, 15, 17, 19, 28 Dexamethasone: 20mg, on day 1, 2, 8, 9, 15, 16, 28 MLN9708: 3mg on day 1, 8, 15, 28
| Group | Source count |
|---|---|
| DL1 - 3mg Lxazomib | 4 |
| DL2 - 4mg Lxazomib | 12 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| DL1 - 3mg Lxazomib | 1.2 | Not reported | 0.7 | 6.0 | Not reported |
| DL2 - 4mg Lxazomib | 3.5 | Not reported | 0.9 | 7.4 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.7
- upper Limit
- 6.0
- value
- 1.2
- group Id
- OG001
- lower Limit
- 0.9
- upper Limit
- 7.4
- value
- 3.5
- denoms
- counts
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 12
- units
- Participants
- description
- Progression-free survival will be the number of days from study entry to progression or death of any cause, whichever comes first. Progression-free survival is survival with absence of progressive disease, defined by * An increase of 25% from lowest response value in any one or more of the following: * Serum M-component (absolute increase must be \>0.5 g/100 ml) \* * Urine M-component (absolute increase must be \>200mg per 24 h) * Only in patients without measurable serum and urine M-protein levels: the difference between involved and uninvolved FLC levels (absolute increase must be \>100 mg/l) * Bone marrow plasma cell percentage (absolute % must be \>10%) * And / 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 * Development of hypercalcemia (corrected serum calcium \>11.5 mg/100 ml) that can be attributed solely to the plasma cell proliferative disorder
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Panobinostat: 20mg, on day 1, 3, 5, 15, 17, 19, 28 Dexamethasone: 20mg, on day 1, 2, 8, 9, 15, 16, 28 MLN9708: 3mg on day 1, 8, 15, 28
- id
- OG000
- title
- DL1 - 3mg Lxazomib
- description
- Panobinostat: 20mg, on day 1, 3, 5, 15, 17, 19, 28 Dexamethasone: 20mg, on day 1, 2, 8, 9, 15, 16, 28 MLN9708: 3mg on day 1, 8, 15, 28
- id
- OG001
- title
- DL2 - 4mg Lxazomib
- param Type
- MEDIAN
- reporting Status
- POSTED
- time Frame
- 1 year from start of treatment
- title
- Progression-free Survival
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice