TriangleNCT02112045 · OUTCOME
Number of Participants With Overall Response
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- Up to 2 years
What was measured
Overall response rate=CR+sCR+VGPR+PR Complete response (CR), disappearance of monoclonal protein from the blood \& urine and \<5% plasma cells in bone marrow \&disappearance of soft tissue plasmacytomas Stringent complete response (sCR), CR \& normal free light chain ratio \& absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence Very good partial response (VGPR), serum and urine monoclonal protein detectable by immunofixation but not on electrophoresis OR \> 90% reduction in serum monoclonal protein with urine monoclonal protein \< 100 mg per 24 hours and if present, \> 50% reduction in the size of soft tissue plasmacytomas Partial response (PR), \> 50% reduction in the level of the serum monoclonal protein \& reduction in urine monoclonal protein \& \> 50% reduction in the size of soft tissue plasmacytomas \& if serum and urine monoclonal protein are unmeasurable and serum free light chain is unmeasurable, a \> 50% reduction in plasma cells is required
Groups in this outcome
Experimental: Granix and High Dose Melphalan (HDM)
Granix on Day -7 through Day -2. HDM intravenously (IV) on Day -2. Autologous stem cell transplantation on Day 0
Control: High Dose Melphalan (HDM)
HDM intravenously (IV) on Day -2.
| Group | Source count |
|---|---|
| Experimental: Granix and High Dose Melphalan (HDM) | 44 |
| Control: High Dose Melphalan (HDM) | 45 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Experimental: Granix and High Dose Melphalan (HDM) | 41 | Not reported | Not reported | Not reported | Not reported |
| Control: High Dose Melphalan (HDM) | 42 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 41
- group Id
- OG001
- value
- 42
- denoms
- counts
- group Id
- OG000
- value
- 44
- group Id
- OG001
- value
- 45
- units
- Participants
- description
- Overall response rate=CR+sCR+VGPR+PR Complete response (CR), disappearance of monoclonal protein from the blood \& urine and \<5% plasma cells in bone marrow \&disappearance of soft tissue plasmacytomas Stringent complete response (sCR), CR \& normal free light chain ratio \& absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence Very good partial response (VGPR), serum and urine monoclonal protein detectable by immunofixation but not on electrophoresis OR \> 90% reduction in serum monoclonal protein with urine monoclonal protein \< 100 mg per 24 hours and if present, \> 50% reduction in the size of soft tissue plasmacytomas Partial response (PR), \> 50% reduction in the level of the serum monoclonal protein \& reduction in urine monoclonal protein \& \> 50% reduction in the size of soft tissue plasmacytomas \& if serum and urine monoclonal protein are unmeasurable and serum free light chain is unmeasurable, a \> 50% reduction in plasma cells is required
- groups
- description
- Granix on Day -7 through Day -2. HDM intravenously (IV) on Day -2. Autologous stem cell transplantation on Day 0
- id
- OG000
- title
- Experimental: Granix and High Dose Melphalan (HDM)
- description
- HDM intravenously (IV) on Day -2.
- id
- OG001
- title
- Control: High Dose Melphalan (HDM)
- param Type
- COUNT_OF_PARTICIPANTS
- reporting Status
- POSTED
- time Frame
- Up to 2 years
- title
- Number of Participants With Overall Response
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice