TriangleNCT01531998 · OUTCOME
Number of Participants With Response
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
- Evaluated after eight cycles of 21 days.
What was measured
Overall response defined as number of participants with International Myeloma Working Group Uniform Response Criteria: Complete Response (CR): Negative immunofixation serum \& urine, Disappearance soft tissue plasmacytomas \& =/\<5% plasma cells in bone marrow; Stringent Complete Remission: CR + Normal Normal free light chain (FLC) ratio \& Absence clonal cells in bone marrow by Immunohistochemistry/ immunofluorescence; Very Good Partial Response (VGPR): Serum \& urine M-protein detectable by immunofixation but not on electrophoresis or 90%\> reduction in serum M-protein +urine M-protein level \<100mg per 24 hour; Partial Remission (PR): =/\>50% reduction serum M-protein \& reduction in 24-hour urinaryMprotein by \>90% or to \< 200mg per 24 hour, =/\>50% reduction of serum M-protein \& reduction in 24-hour urinary Mprotein by \>90%/or \<200mg, and if present at baseline, a \>50% reduction in size of soft tissue plasmacytomas; Stable Disease: Not CR, VGPR, PR Or Progressive disease
Groups in this outcome
Siltuximab + Bortezomib + Lenalidomide
Induction of Lenalidomide 25 mg orally Days 1-14; Bortezomib 1.3 mg/m\^2 intravenous Days 1, 4, 8 and 11; Dexamethasone 20 mg orally Days 1, 2, 4, 5, 8, 9, 11, 12. Siltuximab 11 mg/kg intravenous Day 1. If delayed transplant, induction therapy continued up to 2 cycles beyond achieving a CR/nCR then transition to maintenance therapy (Lenalidomide at last tolerated dose Day 1-21 every 28 days for up to 12 months and then may be reduced to 10 mg). Siltuximab 11 mg/kg intravenous every 21 days, or maximum tolerated dose from induction therapy. Bortezomib at last tolerated dose Day 1 and Day 8 Dexamethasone at last tolerated dose or 20 mg weekly.
| Group | Source count |
|---|---|
| Siltuximab + Bortezomib + Lenalidomide | 11 |
Reported measurements
Complete Remission (CR)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Siltuximab + Bortezomib + Lenalidomide | 2 | Not reported | Not reported | Not reported | Not reported |
Stringent Complete Remission
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Siltuximab + Bortezomib + Lenalidomide | 0 | Not reported | Not reported | Not reported | Not reported |
Very good partial remission (VGPR)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Siltuximab + Bortezomib + Lenalidomide | 2 | Not reported | Not reported | Not reported | Not reported |
Partial Remission (PR)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Siltuximab + Bortezomib + Lenalidomide | 6 | Not reported | Not reported | Not reported | Not reported |
Stable Disease
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Siltuximab + Bortezomib + Lenalidomide | 0 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 2
- title
- Complete Remission (CR)
- categories
- measurements
- group Id
- OG000
- value
- 0
- title
- Stringent Complete Remission
- categories
- measurements
- group Id
- OG000
- value
- 2
- title
- Very good partial remission (VGPR)
- categories
- measurements
- group Id
- OG000
- value
- 6
- title
- Partial Remission (PR)
- categories
- measurements
- group Id
- OG000
- value
- 0
- title
- Stable Disease
- denoms
- counts
- group Id
- OG000
- value
- 11
- units
- Participants
- description
- Overall response defined as number of participants with International Myeloma Working Group Uniform Response Criteria: Complete Response (CR): Negative immunofixation serum \& urine, Disappearance soft tissue plasmacytomas \& =/\<5% plasma cells in bone marrow; Stringent Complete Remission: CR + Normal Normal free light chain (FLC) ratio \& Absence clonal cells in bone marrow by Immunohistochemistry/ immunofluorescence; Very Good Partial Response (VGPR): Serum \& urine M-protein detectable by immunofixation but not on electrophoresis or 90%\> reduction in serum M-protein +urine M-protein level \<100mg per 24 hour; Partial Remission (PR): =/\>50% reduction serum M-protein \& reduction in 24-hour urinaryMprotein by \>90% or to \< 200mg per 24 hour, =/\>50% reduction of serum M-protein \& reduction in 24-hour urinary Mprotein by \>90%/or \<200mg, and if present at baseline, a \>50% reduction in size of soft tissue plasmacytomas; Stable Disease: Not CR, VGPR, PR Or Progressive disease
- groups
- description
- Induction of Lenalidomide 25 mg orally Days 1-14; Bortezomib 1.3 mg/m\^2 intravenous Days 1, 4, 8 and 11; Dexamethasone 20 mg orally Days 1, 2, 4, 5, 8, 9, 11, 12. Siltuximab 11 mg/kg intravenous Day 1. If delayed transplant, induction therapy continued up to 2 cycles beyond achieving a CR/nCR then transition to maintenance therapy (Lenalidomide at last tolerated dose Day 1-21 every 28 days for up to 12 months and then may be reduced to 10 mg). Siltuximab 11 mg/kg intravenous every 21 days, or maximum tolerated dose from induction therapy. Bortezomib at last tolerated dose Day 1 and Day 8 Dexamethasone at last tolerated dose or 20 mg weekly.
- id
- OG000
- title
- Siltuximab + Bortezomib + Lenalidomide
- param Type
- NUMBER
- reporting Status
- POSTED
- time Frame
- Evaluated after eight cycles of 21 days.
- title
- Number of Participants With Response
- type
- SECONDARY
- unit Of Measure
- participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice