TriangleNCT00531453 · OUTCOME
Percent of Participants Achieving Overall Combined Complete Response (CR) Following High-dose Chemotherapy (HDT)/Stem Cell Transplantation (SCT)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percentage of participants
- Interval / dispersion
- Not reported
- Time frame
- all data included in clinical database as of 10 April 2009
What was measured
Percent of Participants Achieving Overall Combined Complete Response (CR) (CR w/normalized serum κ:λ ratio + CR + Near Complete Response (nCR)) following stem cell transplantation. * CR criteria: negative immunofixation on the serum and urine, disappearance of any soft tissue plasmacytomas and \<5% plasma cells in bone marrow. * κ:λ ratio: normal free light chain (FLC) ratio * nCR criteria: positive immunofixation analysis of serum or urine as the only evidence of disease; disappearance of any soft tissue plasmacytomas and \<5% plasma cells in bone marrow.
Analysis population: The response-evaluable population is defined as all subjects who have measurable disease at baseline, receive at least 1 dose of any study drug and have at least 1 post-transplantation response assessment. The response-evaluable population comprises 38 subjects in the VDT treatment group and 27 subjects in the VDTC group.
Groups in this outcome
Three Drug Regimen (VDT)
bortezomib, dexamethasone, and thalidomide
Four Drug Regimen (VDTC)
bortezomib, dexamethasone, thalidomide, and cyclophosphamide
| Group | Source count |
|---|---|
| Three Drug Regimen (VDT) | 38 |
| Four Drug Regimen (VDTC) | 27 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Three Drug Regimen (VDT) | 76 | Not reported | NE | NE | Not reported |
| Four Drug Regimen (VDTC) | 78 | Not reported | NE | NE | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- NE
- upper Limit
- NE
- value
- 76
- group Id
- OG001
- lower Limit
- NE
- upper Limit
- NE
- value
- 78
- denoms
- counts
- group Id
- OG000
- value
- 38
- group Id
- OG001
- value
- 27
- units
- Participants
- description
- Percent of Participants Achieving Overall Combined Complete Response (CR) (CR w/normalized serum κ:λ ratio + CR + Near Complete Response (nCR)) following stem cell transplantation. * CR criteria: negative immunofixation on the serum and urine, disappearance of any soft tissue plasmacytomas and \<5% plasma cells in bone marrow. * κ:λ ratio: normal free light chain (FLC) ratio * nCR criteria: positive immunofixation analysis of serum or urine as the only evidence of disease; disappearance of any soft tissue plasmacytomas and \<5% plasma cells in bone marrow.
- groups
- description
- bortezomib, dexamethasone, and thalidomide
- id
- OG000
- title
- Three Drug Regimen (VDT)
- description
- bortezomib, dexamethasone, thalidomide, and cyclophosphamide
- id
- OG001
- title
- Four Drug Regimen (VDTC)
- param Type
- NUMBER
- population Description
- The response-evaluable population is defined as all subjects who have measurable disease at baseline, receive at least 1 dose of any study drug and have at least 1 post-transplantation response assessment. The response-evaluable population comprises 38 subjects in the VDT treatment group and 27 subjects in the VDTC group.
- reporting Status
- POSTED
- time Frame
- all data included in clinical database as of 10 April 2009
- title
- Percent of Participants Achieving Overall Combined Complete Response (CR) Following High-dose Chemotherapy (HDT)/Stem Cell Transplantation (SCT)
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice