TriangleNCT01179490 · OUTCOME
Response Rate (Based on the Bladé Criteria)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- Percentage of participants
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Up to 36 weeks
What was measured
The proportion of subjects evaluated as response (CR + PR) was calculated. PR (Bladé) requires 1. or all of the others: 1. Some, but not all, of the criteria for CR are fulfilled 2. ≥50% reduction in the level of the serum monoclonal paraprotein, maintained for a minimum of 6 weeks. 3. Reduction in 24 h urinary light chain excretion either by ≥90% or to \<200 mg, maintained for a minimum of 6 weeks. 4. For patients with non-secretory myeloma only, ≥50% reduction in plasma cells in a bone marrow aspirate and on trephine biopsy, if biopsy is performed, maintained for a minimum of 6 weeks. 5. ≥50% reduction in the size of soft tissue plasmacytomas (by radiography or clinical examination). 6. No increase in size or number of lytic bone lesions (development of a compression fracture does not exclude response).
Groups in this outcome
SyB L-0501 + Prednisolone
SyB L-0501 (150 mg/m2/day) will be administered by intravenous drip infusion for 60 min for 2 consecutive days and the course will be observed for the next 26 days. This is taken as one cycle and administration is repeated for 2-9 cycles (when a plateau is not reached after nine cycles, administration of up to an additional three cycles for a maximum of 12 cycles is possible. Prednisolone (60 mg/m2/day) will be administered orally for 4 consecutive days and the course will be observed for the next 24 days.
| Group | Source count |
|---|---|
| SyB L-0501 + Prednisolone | 5 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| SyB L-0501 + Prednisolone | 60.0 | Not reported | 14.7 | 94.7 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 14.7
- upper Limit
- 94.7
- value
- 60.0
- denoms
- counts
- group Id
- OG000
- value
- 5
- units
- Participants
- description
- The proportion of subjects evaluated as response (CR + PR) was calculated. PR (Bladé) requires 1. or all of the others: 1. Some, but not all, of the criteria for CR are fulfilled 2. ≥50% reduction in the level of the serum monoclonal paraprotein, maintained for a minimum of 6 weeks. 3. Reduction in 24 h urinary light chain excretion either by ≥90% or to \<200 mg, maintained for a minimum of 6 weeks. 4. For patients with non-secretory myeloma only, ≥50% reduction in plasma cells in a bone marrow aspirate and on trephine biopsy, if biopsy is performed, maintained for a minimum of 6 weeks. 5. ≥50% reduction in the size of soft tissue plasmacytomas (by radiography or clinical examination). 6. No increase in size or number of lytic bone lesions (development of a compression fracture does not exclude response).
- dispersion Type
- 95% Confidence Interval
- groups
- description
- SyB L-0501 (150 mg/m2/day) will be administered by intravenous drip infusion for 60 min for 2 consecutive days and the course will be observed for the next 26 days. This is taken as one cycle and administration is repeated for 2-9 cycles (when a plateau is not reached after nine cycles, administration of up to an additional three cycles for a maximum of 12 cycles is possible. Prednisolone (60 mg/m2/day) will be administered orally for 4 consecutive days and the course will be observed for the next 24 days.
- id
- OG000
- title
- SyB L-0501 + Prednisolone
- param Type
- NUMBER
- reporting Status
- POSTED
- time Frame
- Up to 36 weeks
- title
- Response Rate (Based on the Bladé Criteria)
- type
- SECONDARY
- unit Of Measure
- Percentage of participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice