TriangleNCT01997840 · OUTCOME
Time to Progression (TTP)
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 progression (TTP) was defined as the time from the date of first dose to the date of first documentation of progressive disease (PD). PD: * Increase of 25% or more from nadir in serum M-protein, absolute increase of \>= 0.5 g/dL. * Increase of 25% or more from nadir in 24-hour urinary M-protein, absolute increase of \>=200 mg/24 hours. * Increase of 25% or more in the percentage of bone marrow plasma cells, absolute increase of \>=10%. * New bone lesions or soft tissue plasmacytomas or increase size of existing bone lesions or soft tissue plasmacytomas. * Hypercalcemia attributed to myeloma.
Analysis population: All treated participants in the Efficacy Evaluable population who had PD.
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 | 3 |
| Phase 1b - ACY-1215 Dose Level 3 | 4 |
| 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 1b - ACY-1215 Dose Level 1 | 22.43 | Not reported | 8.1 | 48.9 | Not reported |
| Phase 1b - ACY-1215 Dose Level 3 | 6.20 | Not reported | 4.1 | 8.1 | Not reported |
| Phase 2 - ACY-1215 Dose Level 1 | 29.82 | Not reported | 3.9 | 169.1 | Not reported |
| Phase 2 - ACY-1215 Dose Level 3 | 83.22 | Not reported | 7.7 | 183.1 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 8.1
- upper Limit
- 48.9
- value
- 22.43
- group Id
- OG001
- lower Limit
- 4.1
- upper Limit
- 8.1
- value
- 6.20
- group Id
- OG002
- lower Limit
- 3.9
- upper Limit
- 169.1
- value
- 29.82
- group Id
- OG003
- lower Limit
- 7.7
- upper Limit
- 183.1
- value
- 83.22
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 4
- group Id
- OG002
- value
- 77
- group Id
- OG003
- value
- 7
- units
- Participants
- description
- Time to progression (TTP) was defined as the time from the date of first dose to the date of first documentation of progressive disease (PD). PD: * Increase of 25% or more from nadir in serum M-protein, absolute increase of \>= 0.5 g/dL. * Increase of 25% or more from nadir in 24-hour urinary M-protein, absolute increase of \>=200 mg/24 hours. * Increase of 25% or more in the percentage of bone marrow plasma cells, absolute increase of \>=10%. * New bone lesions or soft tissue plasmacytomas or increase size of existing bone lesions or soft tissue plasmacytomas. * Hypercalcemia attributed to myeloma.
- 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 who had PD.
- 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 Progression (TTP)
- type
- SECONDARY
- unit Of Measure
- Weeks
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice