TriangleNCT01997840 · OUTCOME
Overall Response Rate (ORR) Per Investigator - Phase 2
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- Percent of Participants
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- From first dose until disease progression, study drug toxicity, end of study, or death due to any cause (up to approximately 120 months).
What was measured
Overall response rate (ORR) is defined as the percentage of participants with a best response of stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR). sCR: * No detectable myeloma cells in the bone marrow. * Normal free light chain ratio. * Absence of clonal cells in the bone marrow. CR: * Negative immunofixation on the serum and urine. * Disappearance of any soft tissue plasmacytomas. * Less than 5% plasma cells in the bone marrow. VGPR: * Serum and urine M-protein detectable by immunofixation but not on electrophoresis, or * At least a 90% reduction in serum M-protein plus urine M-protein level less than 100 mg per 24 hours. PR: * At least a 50% reduction in serum M-protein. * Reduction in 24-hour urinary M-protein by at least 90% or to less than 200 mg per 24 hours. * For patients with non-secretory myeloma, a reduction of at least 50% in the size of soft tissue plasmacytomas is required.
Analysis population: All treated participants in Phase 2 Efficacy evaluable population. Prespecified to be reported for Phase 2 only.
Groups in this outcome
Phase 2 - ACY-1215 Dose Level 1
Participants received 160 mg ACY-1215 and 4 mg pomalidomide daily on Days 1-21 of each 28-day cycle. Participants also received 40 mg (\<=75 years) or 20 mg (\>75 years) dexamethasone on Days 1, 8, 15, and 22 of each 28-day treatment cycle.
Phase 2 - ACY-1215 Dose Level 3
Participants received 160 mg ACY-1215 twice daily in combination with 4 mg pomalidomide once daily on Days 1-21 of each 28-day cycle. Participants also received 40 mg (\<=75 years) or 20 mg (\>75 years) dexamethasone on Days 1, 8, 15, and 22 of each 28-day treatment cycle.
| Group | Source count |
|---|---|
| Phase 2 - ACY-1215 Dose Level 1 | 77 |
| Phase 2 - ACY-1215 Dose Level 3 | 7 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 2 - ACY-1215 Dose Level 1 | 39.0 | Not reported | 28.0 | 50.8 | Not reported |
| Phase 2 - ACY-1215 Dose Level 3 | 71.4 | Not reported | 29.0 | 96.3 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 28.0
- upper Limit
- 50.8
- value
- 39.0
- group Id
- OG001
- lower Limit
- 29.0
- upper Limit
- 96.3
- value
- 71.4
- denoms
- counts
- group Id
- OG000
- value
- 77
- group Id
- OG001
- value
- 7
- units
- Participants
- description
- Overall response rate (ORR) is defined as the percentage of participants with a best response of stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR). sCR: * No detectable myeloma cells in the bone marrow. * Normal free light chain ratio. * Absence of clonal cells in the bone marrow. CR: * Negative immunofixation on the serum and urine. * Disappearance of any soft tissue plasmacytomas. * Less than 5% plasma cells in the bone marrow. VGPR: * Serum and urine M-protein detectable by immunofixation but not on electrophoresis, or * At least a 90% reduction in serum M-protein plus urine M-protein level less than 100 mg per 24 hours. PR: * At least a 50% reduction in serum M-protein. * Reduction in 24-hour urinary M-protein by at least 90% or to less than 200 mg per 24 hours. * For patients with non-secretory myeloma, a reduction of at least 50% in the size of soft tissue plasmacytomas is required.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received 160 mg ACY-1215 and 4 mg pomalidomide daily on Days 1-21 of each 28-day cycle. Participants also received 40 mg (\<=75 years) or 20 mg (\>75 years) dexamethasone on Days 1, 8, 15, and 22 of each 28-day treatment cycle.
- id
- OG000
- title
- Phase 2 - ACY-1215 Dose Level 1
- description
- Participants received 160 mg ACY-1215 twice daily in combination with 4 mg pomalidomide once daily on Days 1-21 of each 28-day cycle. Participants also received 40 mg (\<=75 years) or 20 mg (\>75 years) dexamethasone on Days 1, 8, 15, and 22 of each 28-day treatment cycle.
- id
- OG001
- title
- Phase 2 - ACY-1215 Dose Level 3
- param Type
- NUMBER
- population Description
- All treated participants in Phase 2 Efficacy evaluable population. Prespecified to be reported for Phase 2 only.
- reporting Status
- POSTED
- time Frame
- From first dose until disease progression, study drug toxicity, end of study, or death due to any cause (up to approximately 120 months).
- title
- Overall Response Rate (ORR) Per Investigator - Phase 2
- type
- PRIMARY
- unit Of Measure
- Percent of Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice