TriangleNCT01177683 · OUTCOME
Phase II : Overall Response 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
- From C1D1 up to a maximum of 52 months or until death
What was measured
Overall response rate (CR+PR) of bendamustine in association with bortezomib and pegylated liposomal doxorubicin was assessed in patients with relapsed or refractory Multiple Myeloma. Per modified International Myeloma Working Group criteria: Complete Response (CR) : Negative for monoclonal protein by immunofixation on the serum and urine, and Disappearance of any soft tissue plasmacytomas, and \<5% plasma cells in bone marrow ; PR : 50% or more reduction in serum M-protein and 90% or more reduction in urine M-protein or to \<200 mg/24hours or a 50% or more reduction in free light chain level ; Overall Response (OR) = CR +PR.
Analysis population: Two subjects never received treatment. Therefore, they were not included in any assessment of objectives.
Groups in this outcome
Phase II : Bendamustine in Combination With Bortezomib and Pegylated Liposomal Doxorubicin.
Bendamustine: At phase II, Bendamustine will be administered at 90mg/m\^2 by IV over 1 hour at days 1 and 4 of the 28 day treatment cycle. Doxorubicin: Pegylated liposomal doxorubicin at phase II will be administered at 30 mg/m2 by IV over 1 hour,at day 4 of the 28 day treatment cycle. Bortezomib: Bortezomib at Phase II will be administered at 1.3 mg/m2 by IV bolus or SQ injection on days 1, 4, 8, and 11 of the 28 day cycle.
| Group | Source count |
|---|---|
| Phase II : Bendamustine in Combination With Bortezomib and Pegylated Liposomal Doxorubicin. | 24 |
Reported measurements
Source class 1
CR+PR
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase II : Bendamustine in Combination With Bortezomib and Pegylated Liposomal Doxorubicin. | 14 | Not reported | Not reported | Not reported | Not reported |
Non-CR+PR
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase II : Bendamustine in Combination With Bortezomib and Pegylated Liposomal Doxorubicin. | 9 | Not reported | Not reported | Not reported | Not reported |
Missing
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase II : Bendamustine in Combination With Bortezomib and Pegylated Liposomal Doxorubicin. | 1 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 14
- title
- CR+PR
- measurements
- group Id
- OG000
- value
- 9
- title
- Non-CR+PR
- measurements
- group Id
- OG000
- value
- 1
- title
- Missing
- denoms
- counts
- group Id
- OG000
- value
- 24
- units
- Participants
- description
- Overall response rate (CR+PR) of bendamustine in association with bortezomib and pegylated liposomal doxorubicin was assessed in patients with relapsed or refractory Multiple Myeloma. Per modified International Myeloma Working Group criteria: Complete Response (CR) : Negative for monoclonal protein by immunofixation on the serum and urine, and Disappearance of any soft tissue plasmacytomas, and \<5% plasma cells in bone marrow ; PR : 50% or more reduction in serum M-protein and 90% or more reduction in urine M-protein or to \<200 mg/24hours or a 50% or more reduction in free light chain level ; Overall Response (OR) = CR +PR.
- groups
- description
- Bendamustine: At phase II, Bendamustine will be administered at 90mg/m\^2 by IV over 1 hour at days 1 and 4 of the 28 day treatment cycle. Doxorubicin: Pegylated liposomal doxorubicin at phase II will be administered at 30 mg/m2 by IV over 1 hour,at day 4 of the 28 day treatment cycle. Bortezomib: Bortezomib at Phase II will be administered at 1.3 mg/m2 by IV bolus or SQ injection on days 1, 4, 8, and 11 of the 28 day cycle.
- id
- OG000
- title
- Phase II : Bendamustine in Combination With Bortezomib and Pegylated Liposomal Doxorubicin.
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Two subjects never received treatment. Therefore, they were not included in any assessment of objectives.
- reporting Status
- POSTED
- time Frame
- From C1D1 up to a maximum of 52 months or until death
- title
- Phase II : Overall Response Rate
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice