TriangleNCT02541383 · OUTCOME
Post-Consolidation Stringent Complete Response (sCR) Rate
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
- At day 100 post Autologous Stem Cell Transplant (ASCT), up to 114 days post ASCT
What was measured
Post-consolidation sCR rate is defined as the percentage of ITT subjects who achieved or maintained sCR status within 30 days of Day 100 post Autologous Stem Cell Transplant (ASCT). The sCR status is assessed using the computerized algorithm according to IMWG response criteria, and must be achieved on or prior to start of subsequent therapies. Subjects must not die or progress by Day 100 post ASCT. According to the IMWG consensus recommendations for multiple myeloma treatment response criteria from 2006, the stringent complete response (sCR) was defined by a negative immunofixation on the serum and urine, and a disappearance of any soft tissue plasmacytomas, and \< 5% plasma cells in bone marrow, plus normal free-light chain ratio and the absence of clonal bone marrow plasma cells by immunohistochemistry, immunofluorescence or 2- to 4-color flow cytometry.
Analysis population: All participants randomized in the first randomization.
Groups in this outcome
Arm A Part 1
Bortezomib (VELCADE), Thalidomide, and Dexamethasone (VTD) Bortezomib (VELCADE), Thalidomide, and Dexamethasone (VTD): Part 1: 4 Cycles of Bortezomib,Thalidomide and Dexamethasone induction therapy, followed by Autologous Stem Cell Transplantation, followed by 2 cycles of Bortezomib, Thalidomide and Dexamethasone consolidation
Arm B Part 1
Bortezomib (VELCADE), Thalidomide, and Dexamethasone (VTD) plus daratumumab Bortezomib, Thalidomide, Dexamethasone (VTD) + daratumumab: Part 1: 4 Cycles of Bortezomib, Thalidomide and Dexamethasone plus daratumumab 16mg/kg induction therapy, followed by Autologous Stem Cell Transplantation, followed by 2 cycles of Bortezomib, Thalidomide and Dexamethasone plus daratumumab 16 mg/kg consolidation
| Group | Source count |
|---|---|
| Arm A Part 1 | 542 |
| Arm B Part 1 | 543 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm A Part 1 | 110 | Not reported | Not reported | Not reported | Not reported |
| Arm B Part 1 | 157 | Not reported | Not reported | Not reported | Not reported |
Source statistical analyses
- ci Lower Limit
- 1.21
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 2.12
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.0010
- param Type
- Odds Ratio (OR)
- param Value
- 1.6
- statistical Method
- Cochran-Mantel-Haenszel
Complete source fields
- analyses
- ci Lower Limit
- 1.21
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 2.12
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.0010
- param Type
- Odds Ratio (OR)
- param Value
- 1.6
- statistical Method
- Cochran-Mantel-Haenszel
- classes
- categories
- measurements
- group Id
- OG000
- value
- 110
- group Id
- OG001
- value
- 157
- denoms
- counts
- group Id
- OG000
- value
- 542
- group Id
- OG001
- value
- 543
- units
- Participants
- description
- Post-consolidation sCR rate is defined as the percentage of ITT subjects who achieved or maintained sCR status within 30 days of Day 100 post Autologous Stem Cell Transplant (ASCT). The sCR status is assessed using the computerized algorithm according to IMWG response criteria, and must be achieved on or prior to start of subsequent therapies. Subjects must not die or progress by Day 100 post ASCT. According to the IMWG consensus recommendations for multiple myeloma treatment response criteria from 2006, the stringent complete response (sCR) was defined by a negative immunofixation on the serum and urine, and a disappearance of any soft tissue plasmacytomas, and \< 5% plasma cells in bone marrow, plus normal free-light chain ratio and the absence of clonal bone marrow plasma cells by immunohistochemistry, immunofluorescence or 2- to 4-color flow cytometry.
- groups
- description
- Bortezomib (VELCADE), Thalidomide, and Dexamethasone (VTD) Bortezomib (VELCADE), Thalidomide, and Dexamethasone (VTD): Part 1: 4 Cycles of Bortezomib,Thalidomide and Dexamethasone induction therapy, followed by Autologous Stem Cell Transplantation, followed by 2 cycles of Bortezomib, Thalidomide and Dexamethasone consolidation
- id
- OG000
- title
- Arm A Part 1
- description
- Bortezomib (VELCADE), Thalidomide, and Dexamethasone (VTD) plus daratumumab Bortezomib, Thalidomide, Dexamethasone (VTD) + daratumumab: Part 1: 4 Cycles of Bortezomib, Thalidomide and Dexamethasone plus daratumumab 16mg/kg induction therapy, followed by Autologous Stem Cell Transplantation, followed by 2 cycles of Bortezomib, Thalidomide and Dexamethasone plus daratumumab 16 mg/kg consolidation
- id
- OG001
- title
- Arm B Part 1
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- All participants randomized in the first randomization.
- reporting Status
- POSTED
- time Frame
- At day 100 post Autologous Stem Cell Transplant (ASCT), up to 114 days post ASCT
- title
- Post-Consolidation Stringent Complete Response (sCR) Rate
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice