TriangleNCT01794520 · OUTCOME
Time to Response (TTR)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- months
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Response was assessed at Cycle 2, Day 1, and on Day 1 of every cycle thereafter; Estimated median time on follow-up was 8.1 months for Phase 1 and 31.7 months for Phase 2
What was measured
TTR is defined as the number of days from the date of first dose of study drug until the date of their first favorable response of Partial Response (PR) or better (PR, Very good partial response \[VGPR\], Complete response \[CR\], or Stringent complete response \[sCR\]) per 2011 International Myeloma Working Group (IMWG) criteria (Phase 1) or 2016 IMWG criteria (Phase 2). If a participant did not experience a favorable response, they were to be censored at the date of last adequate assessment. TTR was analyzed by Kaplan- Meier (K-M)\\ methodology.
Analysis population: All enrolled participants who received venetoclax, had active disease at baseline, and achieved a response (PR or better)
Groups in this outcome
Phase 1: Venetoclax 300 mg
Participants in the dose-escalation cohort received 300 mg of venetoclax daily on Days 1 -21 of each cycle after a 2-week lead-in period, during which venetoclax doses were increased weekly.
Phase 1: Venetoclax 600 mg
Participants in the dose-escalation cohort received 600 mg of venetoclax daily on Days 1 -21 of each cycle after a 2-week lead-in period, during which venetoclax doses were increased weekly.
Phase 1: Venetoclax 900 mg
Participants in the dose-escalation cohort received 900 mg of venetoclax daily on Days 1 -21 of each cycle after a 2-week lead-in period, during which venetoclax doses were increased weekly.
Phase 1: Venetoclax 1200 mg
Participants in the dose-escalation cohort received 1200 mg of venetoclax daily on Days 1 -21 of each cycle after a 2-week lead-in period, during which venetoclax doses were increased weekly.
Phase 1 Safety Expansion: Venetoclax 1200 mg
Participants in the safety expansion cohort received 1200 mg of venetoclax daily on Days 1 - 21 of each cycle after a 2-week lead-in period, during which venetoclax doses were increased weekly.
Phase 1 Combination: Venetoclax 800 mg/Dexamethasone 20 or 40 mg
Participants with t(11;14) translocation multiple myeloma received daily venetoclax at a dose of 800 mg (no lead-in period) on Days 1- 21 of each cycle concomitant with weekly dexamethasone at a dose of 40 mg (20 mg for those aged ≥ 75 years).
Phase 2 Expansion: Venetoclax 800 mg/Dexamethasone 20 or 40 mg
The Phase 2 cohort further explored the efficacy of venetoclax in combination with dexamethasone in relapsed or refractory participants with t(11;14) translocation multiple myeloma. Participants received daily venetoclax at a dose of 800 mg (no lead-in period) on Days 1- 21 of each cycle concomitant with weekly dexamethasone at a dose of 40 mg (20 mg for those aged ≥ 75 years).
| Group | Source count |
|---|---|
| Phase 1: Venetoclax 300 mg | 0 |
| Phase 1: Venetoclax 600 mg | 1 |
| Phase 1: Venetoclax 900 mg | 1 |
| Phase 1: Venetoclax 1200 mg | 0 |
| Phase 1 Safety Expansion: Venetoclax 1200 mg | 13 |
| Phase 1 Combination: Venetoclax 800 mg/Dexamethasone 20 or 40 mg | 13 |
| Phase 2 Expansion: Venetoclax 800 mg/Dexamethasone 20 or 40 mg | 15 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1: Venetoclax 600 mg | NA | Not reported | 1.9 | NA | Not estimable/calculable due to low number of participants with events |
| Phase 1: Venetoclax 900 mg | NA | Not reported | 1.2 | NA | Not estimable/calculable due to low number of participants with events |
| Phase 1 Safety Expansion: Venetoclax 1200 mg | 9.0 | Not reported | 1.9 | NA | Not estimable/calculable due to low number of participants with events |
| Phase 1 Combination: Venetoclax 800 mg/Dexamethasone 20 or 40 mg | 2.6 | Not reported | 1.4 | NA | Not estimable/calculable due to low number of participants with events |
| Phase 2 Expansion: Venetoclax 800 mg/Dexamethasone 20 or 40 mg | 0.8 | Not reported | 0.7 | NA | Not estimable/calculable due to low number of participants with events |
Complete source fields
- classes
- categories
- measurements
- comment
- Not estimable/calculable due to low number of participants with events
- group Id
- OG001
- lower Limit
- 1.9
- upper Limit
- NA
- value
- NA
- comment
- Not estimable/calculable due to low number of participants with events
- group Id
- OG002
- lower Limit
- 1.2
- upper Limit
- NA
- value
- NA
- comment
- Not estimable/calculable due to low number of participants with events
- group Id
- OG004
- lower Limit
- 1.9
- upper Limit
- NA
- value
- 9.0
- comment
- Not estimable/calculable due to low number of participants with events
- group Id
- OG005
- lower Limit
- 1.4
- upper Limit
- NA
- value
- 2.6
- comment
- Not estimable/calculable due to low number of participants with events
- group Id
- OG006
- lower Limit
- 0.7
- upper Limit
- NA
- value
- 0.8
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 13
- group Id
- OG005
- value
- 13
- group Id
- OG006
- value
- 15
- units
- Participants
- description
- TTR is defined as the number of days from the date of first dose of study drug until the date of their first favorable response of Partial Response (PR) or better (PR, Very good partial response \[VGPR\], Complete response \[CR\], or Stringent complete response \[sCR\]) per 2011 International Myeloma Working Group (IMWG) criteria (Phase 1) or 2016 IMWG criteria (Phase 2). If a participant did not experience a favorable response, they were to be censored at the date of last adequate assessment. TTR was analyzed by Kaplan- Meier (K-M)\\ methodology.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants in the dose-escalation cohort received 300 mg of venetoclax daily on Days 1 -21 of each cycle after a 2-week lead-in period, during which venetoclax doses were increased weekly.
- id
- OG000
- title
- Phase 1: Venetoclax 300 mg
- description
- Participants in the dose-escalation cohort received 600 mg of venetoclax daily on Days 1 -21 of each cycle after a 2-week lead-in period, during which venetoclax doses were increased weekly.
- id
- OG001
- title
- Phase 1: Venetoclax 600 mg
- description
- Participants in the dose-escalation cohort received 900 mg of venetoclax daily on Days 1 -21 of each cycle after a 2-week lead-in period, during which venetoclax doses were increased weekly.
- id
- OG002
- title
- Phase 1: Venetoclax 900 mg
- description
- Participants in the dose-escalation cohort received 1200 mg of venetoclax daily on Days 1 -21 of each cycle after a 2-week lead-in period, during which venetoclax doses were increased weekly.
- id
- OG003
- title
- Phase 1: Venetoclax 1200 mg
- description
- Participants in the safety expansion cohort received 1200 mg of venetoclax daily on Days 1 - 21 of each cycle after a 2-week lead-in period, during which venetoclax doses were increased weekly.
- id
- OG004
- title
- Phase 1 Safety Expansion: Venetoclax 1200 mg
- description
- Participants with t(11;14) translocation multiple myeloma received daily venetoclax at a dose of 800 mg (no lead-in period) on Days 1- 21 of each cycle concomitant with weekly dexamethasone at a dose of 40 mg (20 mg for those aged ≥ 75 years).
- id
- OG005
- title
- Phase 1 Combination: Venetoclax 800 mg/Dexamethasone 20 or 40 mg
- description
- The Phase 2 cohort further explored the efficacy of venetoclax in combination with dexamethasone in relapsed or refractory participants with t(11;14) translocation multiple myeloma. Participants received daily venetoclax at a dose of 800 mg (no lead-in period) on Days 1- 21 of each cycle concomitant with weekly dexamethasone at a dose of 40 mg (20 mg for those aged ≥ 75 years).
- id
- OG006
- title
- Phase 2 Expansion: Venetoclax 800 mg/Dexamethasone 20 or 40 mg
- param Type
- MEDIAN
- population Description
- All enrolled participants who received venetoclax, had active disease at baseline, and achieved a response (PR or better)
- reporting Status
- POSTED
- time Frame
- Response was assessed at Cycle 2, Day 1, and on Day 1 of every cycle thereafter; Estimated median time on follow-up was 8.1 months for Phase 1 and 31.7 months for Phase 2
- title
- Time to Response (TTR)
- type
- SECONDARY
- unit Of Measure
- months
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Preserved source evidence · Not medical advice