TriangleNCT00718640 · OUTCOME
Best Response to Treatment
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
- Day 1 of Cycle 1, 2, 3, 4, 5, 5, 6, 7, 8 and Final/Early termination visit (30-45 days after last dose)
What was measured
It was assessed by IMWG criteria. It defines complete response as negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and \<5% plasma cells in bone marrow. Very good partial response as serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or \> reduction in serum and urine M-protein level\<100 mg per 24 hour. Partial Response as \<=50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by \<=90% or to \<200mg per 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
- It was assessed by IMWG criteria. It defines complete response as negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and \<5% plasma cells in bone marrow. Very good partial response as serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or \> reduction in serum and urine M-protein level\<100 mg per 24 hour. Partial Response as \<=50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by \<=90% or to \<200mg per 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
- Day 1 of Cycle 1, 2, 3, 4, 5, 5, 6, 7, 8 and Final/Early termination visit (30-45 days after last dose)
- title
- Best Response to Treatment
- type
- SECONDARY
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice