TriangleNCT00469209 · OUTCOME
Number of Patients Reaching Complete Response (CR)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- participants
- Interval / dispersion
- Not reported
- Time frame
- Baseline through Day 180, with assessments at Day 90 and Day 180
What was measured
Number of participants with CR at Day 180 who had maintained CR for at minimum of 4 weeks, and who had: No monoclonal protein in urine/serum when analyzed by immunofixation electrophoresis; bone marrow normal by morphological examination with \<5% plasma cells, \<1% aneuploid light chain restricted population by flow cytometry for DNA/cIg; and, while healing of bony lesion is not required, no new lytic lesion should appear. Further compression fracture of spine not considered progressive disease.
Analysis population: Analysis was per protocol.
Groups in this outcome
No Bortezomib
Melphalan 100 mg/m\^2 intravenous (IV) days -4,-3 + Arsenic Trioxide 0.25 mg/kg IV for 7 days + Vitamin C IV daily
Bortezomib 1.0 mg/m^2
Bortezomib (Level 1) 1.0 mg/m\^2 IV push on Days -9, -6, and -3, Melphalan 100 mg/m\^2 IV days -4,-3 + Arsenic Trioxide 0.25 mg/kg IV for 7 days + Vitamin C IV daily
Bortezomib 1.5 mg/m^2
Bortezomib (Level 2) 1.5 mg/m\^2 IV push on Days -9, -6, and -3, Melphalan + Arsenic Trioxide 0.25 mg/kg IV for 7 days + Vitamin C IV daily
| Group | Source count |
|---|---|
| No Bortezomib | 20 |
| Bortezomib 1.0 mg/m^2 | 20 |
| Bortezomib 1.5 mg/m^2 | 20 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| No Bortezomib | 4 | Not reported | Not reported | Not reported | Not reported |
| Bortezomib 1.0 mg/m^2 | 1 | Not reported | Not reported | Not reported | Not reported |
| Bortezomib 1.5 mg/m^2 | 4 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 4
- denoms
- counts
- group Id
- OG000
- value
- 20
- group Id
- OG001
- value
- 20
- group Id
- OG002
- value
- 20
- units
- Participants
- description
- Number of participants with CR at Day 180 who had maintained CR for at minimum of 4 weeks, and who had: No monoclonal protein in urine/serum when analyzed by immunofixation electrophoresis; bone marrow normal by morphological examination with \<5% plasma cells, \<1% aneuploid light chain restricted population by flow cytometry for DNA/cIg; and, while healing of bony lesion is not required, no new lytic lesion should appear. Further compression fracture of spine not considered progressive disease.
- groups
- description
- Melphalan 100 mg/m\^2 intravenous (IV) days -4,-3 + Arsenic Trioxide 0.25 mg/kg IV for 7 days + Vitamin C IV daily
- id
- OG000
- title
- No Bortezomib
- description
- Bortezomib (Level 1) 1.0 mg/m\^2 IV push on Days -9, -6, and -3, Melphalan 100 mg/m\^2 IV days -4,-3 + Arsenic Trioxide 0.25 mg/kg IV for 7 days + Vitamin C IV daily
- id
- OG001
- title
- Bortezomib 1.0 mg/m^2
- description
- Bortezomib (Level 2) 1.5 mg/m\^2 IV push on Days -9, -6, and -3, Melphalan + Arsenic Trioxide 0.25 mg/kg IV for 7 days + Vitamin C IV daily
- id
- OG002
- title
- Bortezomib 1.5 mg/m^2
- param Type
- NUMBER
- population Description
- Analysis was per protocol.
- reporting Status
- POSTED
- time Frame
- Baseline through Day 180, with assessments at Day 90 and Day 180
- title
- Number of Patients Reaching Complete Response (CR)
- type
- PRIMARY
- unit Of Measure
- participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice