TriangleNCT00718640 · OUTCOME
Percentage of Participants With Renal Compromised Multiple Myeloma by International Myeloma Working Group (IMWG) Uniform Response Criteria
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- Not reported
- Unit
- Not reported
- Interval / dispersion
- Not reported
- Time frame
- Week 24 or Early termination visit (30-45 days after last dose)
What was measured
The IMWG uniform response criteria define; Complete response(CR) as negative immunofixation on serum and urine, disappearance of any soft tissue plasmacytomas and \<5% plasma cells in bone marrow(BM). Stringent CR as CR+normal free light chain ratio and absence of clonal cells in BM Very good partial response (PR) as serum and urine M-protein (monoclonal paraprotein) detectable by immunofixation but not on electrophoresis or 90% or \>reduction in serum and urine M-protein level \<100 milligram(mg) per 24 hour(hr).PR as \<=50% reduction of serum and \<= 90% of urine M-protein or up to \<200 mg/24 hr.
Analysis population: The study was terminated. Due to insufficient number of participants, the outcome measure data was not analyzed.
Groups in this outcome
Bortezomib and Dexamethasone
Bortezomib 1.3 milligram (mg) per meter\^2 (m\^2) bolus (a large amount) intravenous (into the vein) injection will be administered once daily on Days 1, 4, 8 and 11 of each 21-day cycle with addition of Dexamethasone 20 mg per day administered orally, once daily on Days 1 and 2, Days 4 and 5, Days 8 and 9 and Days 11 and 12 of each 21-day cycle as per Investigator's discretion for those participants who experience disease progression after treatment completion up to Cycle 2 or have no change from Baseline after completion of at least 4 cycles. The treatment will be given up to 8 cycles (24 weeks).
| Group | Source count |
|---|---|
| Bortezomib and Dexamethasone | 0 |
Reported measurements
No numerical measurement classes were posted for this outcome. Missing is not zero.
Complete source fields
- denoms
- counts
- group Id
- OG000
- value
- 0
- units
- Participants
- description
- The IMWG uniform response criteria define; Complete response(CR) as negative immunofixation on serum and urine, disappearance of any soft tissue plasmacytomas and \<5% plasma cells in bone marrow(BM). Stringent CR as CR+normal free light chain ratio and absence of clonal cells in BM Very good partial response (PR) as serum and urine M-protein (monoclonal paraprotein) detectable by immunofixation but not on electrophoresis or 90% or \>reduction in serum and urine M-protein level \<100 milligram(mg) per 24 hour(hr).PR as \<=50% reduction of serum and \<= 90% of urine M-protein or up to \<200 mg/24 hr.
- groups
- description
- Bortezomib 1.3 milligram (mg) per meter\^2 (m\^2) bolus (a large amount) intravenous (into the vein) injection will be administered once daily on Days 1, 4, 8 and 11 of each 21-day cycle with addition of Dexamethasone 20 mg per day administered orally, once daily on Days 1 and 2, Days 4 and 5, Days 8 and 9 and Days 11 and 12 of each 21-day cycle as per Investigator's discretion for those participants who experience disease progression after treatment completion up to Cycle 2 or have no change from Baseline after completion of at least 4 cycles. The treatment will be given up to 8 cycles (24 weeks).
- id
- OG000
- title
- Bortezomib and Dexamethasone
- population Description
- The study was terminated. Due to insufficient number of participants, the outcome measure data was not analyzed.
- reporting Status
- POSTED
- time Frame
- Week 24 or Early termination visit (30-45 days after last dose)
- title
- Percentage of Participants With Renal Compromised Multiple Myeloma by International Myeloma Working Group (IMWG) Uniform Response Criteria
- type
- PRIMARY
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice