TriangleNCT03201250 · OUTCOME
Response Durability Assessed by 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
- weeks
- Interval / dispersion
- Inter-Quartile Range
- Time frame
- variable, defined by individual response durability in individual patients who would stay on therapy until disease progression
What was measured
Progressive Disease (PD) is defined per International Myeloma Working Group (IMWG) Uniform Response Criteria guidelines is an increase of 25% from the lowest response value in any one or more of the following: Serum M-component and/or Urine M-component and/or in patients without a measurable serum and urine M protein level: the difference between involved and uninvolved FLC levels must be \>10mg/dL, Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing lesions or plasmacytomas, Development of hypercalcemia attributed solely to the plasma cell proliferative disorder
Analysis population: No subjects were dosed at 60 mg dose level.
Groups in this outcome
Level -1 = 20 mg
Combination of cabozantinib, carfilzomib and dexamethasone Cabozantinib: patients will receive cabozantinib orally once daily continuously during the four weeks of a 28-day cycle. Cabozantinib: Phase I: Level -1 = 20 mg Carfilzomib: 27 mg/m2 IV over 10 min on days 1, 2, 8, 9, 15, 16 Dexamethasone: 40 mg PO/IV on days 1, 8,15 and 22 (for patient age ≥ 75, acceptable to be given as 20 mg PO/IV on days 1, 2, 8, 9, 15, 16, 22, 23)
Level 0 = 40 mg
Combination of cabozantinib, carfilzomib and dexamethasone Cabozantinib: patients will receive cabozantinib orally once daily continuously during the four weeks of a 28-day cycle. Cabozantinib: Phase I: Level 0 = 40 mg Carfilzomib: 27 mg/m2 IV over 10 min on days 1, 2, 8, 9, 15, 16 Dexamethasone: 40 mg PO/IV on days 1, 8,15 and 22 (for patient age ≥ 75, acceptable to be given as 20 mg PO/IV on days 1, 2, 8, 9, 15, 16, 22, 23)
Level +1 = 60 mg
Combination of cabozantinib, carfilzomib and dexamethasone Cabozantinib: patients will receive cabozantinib orally once daily continuously during the four weeks of a 28-day cycle. Cabozantinib: Phase I: Level +1 = 60 mg Carfilzomib: 27 mg/m2 IV over 10 min on days 1, 2, 8, 9, 15, 16 Dexamethasone: 40 mg PO/IV on days 1, 8,15 and 22 (for patient age ≥ 75, acceptable to be given as 20 mg PO/IV on days 1, 2, 8, 9, 15, 16, 22, 23)
| Group | Source count |
|---|---|
| Level -1 = 20 mg | 5 |
| Level 0 = 40 mg | 3 |
| Level +1 = 60 mg | 0 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Level -1 = 20 mg | 25 | Not reported | 12 | 68 | Not reported |
| Level 0 = 40 mg | 19 | Not reported | 12 | 28 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 12
- upper Limit
- 68
- value
- 25
- group Id
- OG001
- lower Limit
- 12
- upper Limit
- 28
- value
- 19
- denoms
- counts
- group Id
- OG000
- value
- 5
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 0
- units
- Participants
- description
- Progressive Disease (PD) is defined per International Myeloma Working Group (IMWG) Uniform Response Criteria guidelines is an increase of 25% from the lowest response value in any one or more of the following: Serum M-component and/or Urine M-component and/or in patients without a measurable serum and urine M protein level: the difference between involved and uninvolved FLC levels must be \>10mg/dL, Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing lesions or plasmacytomas, Development of hypercalcemia attributed solely to the plasma cell proliferative disorder
- dispersion Type
- Inter-Quartile Range
- groups
- description
- Combination of cabozantinib, carfilzomib and dexamethasone Cabozantinib: patients will receive cabozantinib orally once daily continuously during the four weeks of a 28-day cycle. Cabozantinib: Phase I: Level -1 = 20 mg Carfilzomib: 27 mg/m2 IV over 10 min on days 1, 2, 8, 9, 15, 16 Dexamethasone: 40 mg PO/IV on days 1, 8,15 and 22 (for patient age ≥ 75, acceptable to be given as 20 mg PO/IV on days 1, 2, 8, 9, 15, 16, 22, 23)
- id
- OG000
- title
- Level -1 = 20 mg
- description
- Combination of cabozantinib, carfilzomib and dexamethasone Cabozantinib: patients will receive cabozantinib orally once daily continuously during the four weeks of a 28-day cycle. Cabozantinib: Phase I: Level 0 = 40 mg Carfilzomib: 27 mg/m2 IV over 10 min on days 1, 2, 8, 9, 15, 16 Dexamethasone: 40 mg PO/IV on days 1, 8,15 and 22 (for patient age ≥ 75, acceptable to be given as 20 mg PO/IV on days 1, 2, 8, 9, 15, 16, 22, 23)
- id
- OG001
- title
- Level 0 = 40 mg
- description
- Combination of cabozantinib, carfilzomib and dexamethasone Cabozantinib: patients will receive cabozantinib orally once daily continuously during the four weeks of a 28-day cycle. Cabozantinib: Phase I: Level +1 = 60 mg Carfilzomib: 27 mg/m2 IV over 10 min on days 1, 2, 8, 9, 15, 16 Dexamethasone: 40 mg PO/IV on days 1, 8,15 and 22 (for patient age ≥ 75, acceptable to be given as 20 mg PO/IV on days 1, 2, 8, 9, 15, 16, 22, 23)
- id
- OG002
- title
- Level +1 = 60 mg
- param Type
- MEDIAN
- population Description
- No subjects were dosed at 60 mg dose level.
- reporting Status
- POSTED
- time Frame
- variable, defined by individual response durability in individual patients who would stay on therapy until disease progression
- title
- Response Durability Assessed by Progression Free Survival (PFS)
- type
- SECONDARY
- unit Of Measure
- weeks
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice