TriangleNCT01849848 · OUTCOME
Response Rate [Stringent CR (sCR)+Complete Response (CR)+Very Good PR (VGPR)+Partial Response (PR)]Based on International Myeloma Working Group (IMWG) Criteria
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percentage of paticipants
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- up to around 44 weeks
What was measured
The criteria for sCR, CR, VGPR, and PR based on IMWG are shown below. sCR: Fulfills CR criteria as well as all of the following conditions * Normal free light chain (FLC) ratio(κ/λ) * Disappearance of clonal cells in bone marrow by immunohistochemistry or immunofluorescence CR: Fulfills all of the following criteria * Negative immunofixation of serum and urine M-protein * \<5% plasma cells in bone marrow * Disappearance of any soft tissue plasmacytoma VGPR: Fulfills at least one of the following criteria * Serum and urine M-protein detectable by immunofixation but not electrophoresis * ≥90% reduction in serum M-protein and 24-hour M-protein excretion amount in urine \<0.1 g/24 hour PR: Fulfills the following criteria * ≥50% reduction in serum M-protein, and ≥90% reduction in urine M-protein, urine M-protein excretion amount is reduced to \< 0.2 g/24hours
Groups in this outcome
SyB L-0501
SyB L-0501: The administration of SyB L-0501 at 90 mg/m\^2/day by 60-minute intravenous infusion for 2 consecutive days followed by 26 days of monitoring. This is considered to be one cycle and may be repeated up to 6 times. Dose reduction or discontinuation is permitted from the second cycle as necessary according to adverse events and the results of monitoring during the previous cycle.
| Group | Source count |
|---|---|
| SyB L-0501 | 17 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| SyB L-0501 | 0 | Not reported | 0.0 | 19.5 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.0
- upper Limit
- 19.5
- value
- 0
- denoms
- counts
- group Id
- OG000
- value
- 17
- units
- Participants
- description
- The criteria for sCR, CR, VGPR, and PR based on IMWG are shown below. sCR: Fulfills CR criteria as well as all of the following conditions * Normal free light chain (FLC) ratio(κ/λ) * Disappearance of clonal cells in bone marrow by immunohistochemistry or immunofluorescence CR: Fulfills all of the following criteria * Negative immunofixation of serum and urine M-protein * \<5% plasma cells in bone marrow * Disappearance of any soft tissue plasmacytoma VGPR: Fulfills at least one of the following criteria * Serum and urine M-protein detectable by immunofixation but not electrophoresis * ≥90% reduction in serum M-protein and 24-hour M-protein excretion amount in urine \<0.1 g/24 hour PR: Fulfills the following criteria * ≥50% reduction in serum M-protein, and ≥90% reduction in urine M-protein, urine M-protein excretion amount is reduced to \< 0.2 g/24hours
- dispersion Type
- 95% Confidence Interval
- groups
- description
- SyB L-0501: The administration of SyB L-0501 at 90 mg/m\^2/day by 60-minute intravenous infusion for 2 consecutive days followed by 26 days of monitoring. This is considered to be one cycle and may be repeated up to 6 times. Dose reduction or discontinuation is permitted from the second cycle as necessary according to adverse events and the results of monitoring during the previous cycle.
- id
- OG000
- title
- SyB L-0501
- param Type
- NUMBER
- reporting Status
- POSTED
- time Frame
- up to around 44 weeks
- title
- Response Rate [Stringent CR (sCR)+Complete Response (CR)+Very Good PR (VGPR)+Partial Response (PR)]Based on International Myeloma Working Group (IMWG) Criteria
- type
- PRIMARY
- unit Of Measure
- percentage of paticipants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice