TriangleNCT01997840 · OUTCOME
Time to Response (TTR)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- Weeks
- Interval / dispersion
- Full Range
- 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
Time to response (TTR) was defined as the time from first dose of study treatment to the first documentation of response (either partial response (PR) or complete response (CR)). CR: * Negative immunofixation on the serum and urine. * Disappearance of any soft tissue plasmacytomas. * Less than 5% plasma cells in the bone marrow. 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 the Efficacy Evaluable population with a best response of PR or CR.
Groups in this outcome
Phase 1b - 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 1b - 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.
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 1b - ACY-1215 Dose Level 1 | 2 |
| Phase 1b - ACY-1215 Dose Level 3 | 0 |
| Phase 2 - ACY-1215 Dose Level 1 | 30 |
| Phase 2 - ACY-1215 Dose Level 3 | 5 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1b - ACY-1215 Dose Level 1 | 8.50 | Not reported | 4.1 | 12.9 | Not reported |
| Phase 2 - ACY-1215 Dose Level 1 | 10.83 | Not reported | 4.1 | 40.1 | Not reported |
| Phase 2 - ACY-1215 Dose Level 3 | 12.96 | Not reported | 7.9 | 31.9 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 4.1
- upper Limit
- 12.9
- value
- 8.50
- group Id
- OG002
- lower Limit
- 4.1
- upper Limit
- 40.1
- value
- 10.83
- group Id
- OG003
- lower Limit
- 7.9
- upper Limit
- 31.9
- value
- 12.96
- denoms
- counts
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 30
- group Id
- OG003
- value
- 5
- units
- Participants
- description
- Time to response (TTR) was defined as the time from first dose of study treatment to the first documentation of response (either partial response (PR) or complete response (CR)). CR: * Negative immunofixation on the serum and urine. * Disappearance of any soft tissue plasmacytomas. * Less than 5% plasma cells in the bone marrow. 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
- Full Range
- 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 1b - 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 1b - ACY-1215 Dose Level 3
- 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
- OG002
- 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
- OG003
- title
- Phase 2 - ACY-1215 Dose Level 3
- param Type
- MEAN
- population Description
- All treated participants in the Efficacy Evaluable population with a best response of PR or CR.
- 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
- Time to Response (TTR)
- type
- SECONDARY
- unit Of Measure
- Weeks
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice