TriangleNCT00911859 · OUTCOME
Percentage of Participants Who Achieved Stringent Complete Response (sCR) - International Myeloma Working Group (IMWG) Criteria
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
- Up to disease progression, approximately 3 years
What was measured
sCR was assesses by IMWG Criteria: Negative immunofixation on the serum and urine, disappearance of any soft tissue plasmacytomas, \<=5% plasma cells in bone marrow, normal free light chain ratio, absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence. sCR is a CR that has been confirmed by immunofixation + free light chain assay + either bone marrow immunohistochemistry or immunofluorescence
Analysis population: Response-evaluable population: Participants who had a confirmed diagnosis of multiple myeloma and measurable disease according to the EBMT criteria were evaluated for disease response. Also, participants must have received at least 1 administration of study medication and have at least 1 post-baseline disease assessment.
Groups in this outcome
Part 2: VMP (Velcade+Melphalan+Prednisone)
Velcade 1.3 mg/m2 was administered as an intravenous bolus injection according to the current approved package inserts. Melphalan 9 mg/m2 and prednisone 60 mg/m2 were taken orally.
Part 2: VMP (Velcade+Melphalan+Prednisone) + Siltuximab
Siltuximab 11 mg/kg as a 1-hour intravenous infusion every 3 weeks along with VMP. VMP: Velcade 1.3 mg/m2 was administered as an intravenous bolus injection according to the current approved package inserts. Melphalan 9 mg/m2 and prednisone 60 mg/m2 were taken orally.
| Group | Source count |
|---|---|
| Part 2: VMP (Velcade+Melphalan+Prednisone) | 49 |
| Part 2: VMP (Velcade+Melphalan+Prednisone) + Siltuximab | 49 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 2: VMP (Velcade+Melphalan+Prednisone) | 6.1 | Not reported | Not reported | Not reported | Not reported |
| Part 2: VMP (Velcade+Melphalan+Prednisone) + Siltuximab | 4.1 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 6.1
- group Id
- OG001
- value
- 4.1
- denoms
- counts
- group Id
- OG000
- value
- 49
- group Id
- OG001
- value
- 49
- units
- Participants
- description
- sCR was assesses by IMWG Criteria: Negative immunofixation on the serum and urine, disappearance of any soft tissue plasmacytomas, \<=5% plasma cells in bone marrow, normal free light chain ratio, absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence. sCR is a CR that has been confirmed by immunofixation + free light chain assay + either bone marrow immunohistochemistry or immunofluorescence
- groups
- description
- Velcade 1.3 mg/m2 was administered as an intravenous bolus injection according to the current approved package inserts. Melphalan 9 mg/m2 and prednisone 60 mg/m2 were taken orally.
- id
- OG000
- title
- Part 2: VMP (Velcade+Melphalan+Prednisone)
- description
- Siltuximab 11 mg/kg as a 1-hour intravenous infusion every 3 weeks along with VMP. VMP: Velcade 1.3 mg/m2 was administered as an intravenous bolus injection according to the current approved package inserts. Melphalan 9 mg/m2 and prednisone 60 mg/m2 were taken orally.
- id
- OG001
- title
- Part 2: VMP (Velcade+Melphalan+Prednisone) + Siltuximab
- param Type
- NUMBER
- population Description
- Response-evaluable population: Participants who had a confirmed diagnosis of multiple myeloma and measurable disease according to the EBMT criteria were evaluated for disease response. Also, participants must have received at least 1 administration of study medication and have at least 1 post-baseline disease assessment.
- reporting Status
- POSTED
- time Frame
- Up to disease progression, approximately 3 years
- title
- Percentage of Participants Who Achieved Stringent Complete Response (sCR) - International Myeloma Working Group (IMWG) Criteria
- type
- SECONDARY
- unit Of Measure
- Percentage of participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice