TriangleNCT01179490 · OUTCOME
CR 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 CR was calculated. CR (Bladé) requires all of the followings: 1. Absence of the original monoclonal paraprotein in serum and urine by immunofixation, maintained for a minimum of 6 weeks. The presence of oligoclonal bands consistent with oligoclonal immune reconstitution does not exclude CR. 2. \<5% plasma cells in a bone marrow aspirate and also on trephine bone biopsy, if biopsy is performed. If absence of monoclonal protein is sustained for 6 weeks it is not necessary to repeat the bone marrow, except in patients with non-secretory myeloma where the marrow examination must be repeated after an interval of at least 6 weeks to confirm CR. 3. No increase in size or number of lytic bone lesions (development of a compression fracture does not exclude response) 4. Disappearance of soft tissue plasmacytomas
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 | 0.0 | Not reported | 0.0 | 52.2 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.0
- upper Limit
- 52.2
- value
- 0.0
- denoms
- counts
- group Id
- OG000
- value
- 5
- units
- Participants
- description
- The proportion of subjects evaluated as CR was calculated. CR (Bladé) requires all of the followings: 1. Absence of the original monoclonal paraprotein in serum and urine by immunofixation, maintained for a minimum of 6 weeks. The presence of oligoclonal bands consistent with oligoclonal immune reconstitution does not exclude CR. 2. \<5% plasma cells in a bone marrow aspirate and also on trephine bone biopsy, if biopsy is performed. If absence of monoclonal protein is sustained for 6 weeks it is not necessary to repeat the bone marrow, except in patients with non-secretory myeloma where the marrow examination must be repeated after an interval of at least 6 weeks to confirm CR. 3. No increase in size or number of lytic bone lesions (development of a compression fracture does not exclude response) 4. Disappearance of soft tissue plasmacytomas
- 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
- CR 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