TriangleNCT01029054 · OUTCOME
The Percentage of Patients Alive Without Progression
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percentage of patients
- Interval / dispersion
- Not reported
- Time frame
- 12 Months and 24 Months Post Treatment
What was measured
The Progression Free Survival (PFS) rate will be determined at 12 and 24 months post treatment. Progressive Disease (PD) is defined as an increase of greater than or equal to 25% from lowest response level in serum M-component and/ or urine M-component and/ or the difference between involved or uninvolved SFLC levels and/ or bone marrow % plasma cells. PD may also be the development of new bone lesions or soft tissue plasmacytomas or the increase in size of existing lesions. PD may also be the development of hypercalcemia.
Groups in this outcome
Carfilzomib, Lenalidomide w/Dexamethasone
Carfilzomib will be administered as an IV infusion on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle for Cycles 1 - 8 (induction) and on Days 1, 2, 15, and 16 of a 28-day cycle for Cycles 9+ (maintenance). Lenalidomide will be administered PO daily at 25 mg on Days 1- 21 of the 28-day cycle for Cycles 1 - 8+. Dexamethasone will be administered PO or IV between 30 minutes and 4 hours preceding the carfilzomib push.
| Group | Source count |
|---|---|
| Carfilzomib, Lenalidomide w/Dexamethasone | 53 |
Reported measurements
Percentage of Patients Without Progression at 12 m
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Carfilzomib, Lenalidomide w/Dexamethasone | 97 | Not reported | Not reported | Not reported | Not reported |
Percentage of Patients Without Progression at 24 m
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Carfilzomib, Lenalidomide w/Dexamethasone | 92 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 97
- title
- Percentage of Patients Without Progression at 12 m
- categories
- measurements
- group Id
- OG000
- value
- 92
- title
- Percentage of Patients Without Progression at 24 m
- denoms
- counts
- group Id
- OG000
- value
- 53
- units
- Participants
- description
- The Progression Free Survival (PFS) rate will be determined at 12 and 24 months post treatment. Progressive Disease (PD) is defined as an increase of greater than or equal to 25% from lowest response level in serum M-component and/ or urine M-component and/ or the difference between involved or uninvolved SFLC levels and/ or bone marrow % plasma cells. PD may also be the development of new bone lesions or soft tissue plasmacytomas or the increase in size of existing lesions. PD may also be the development of hypercalcemia.
- groups
- description
- Carfilzomib will be administered as an IV infusion on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle for Cycles 1 - 8 (induction) and on Days 1, 2, 15, and 16 of a 28-day cycle for Cycles 9+ (maintenance). Lenalidomide will be administered PO daily at 25 mg on Days 1- 21 of the 28-day cycle for Cycles 1 - 8+. Dexamethasone will be administered PO or IV between 30 minutes and 4 hours preceding the carfilzomib push.
- id
- OG000
- title
- Carfilzomib, Lenalidomide w/Dexamethasone
- param Type
- NUMBER
- reporting Status
- POSTED
- time Frame
- 12 Months and 24 Months Post Treatment
- title
- The Percentage of Patients Alive Without Progression
- type
- SECONDARY
- unit Of Measure
- percentage of patients
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice