TriangleNCT03481556 · 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
- Full Range
- Time frame
- Until disease progression, death or initiation of subsequent therapy (a maximum of 194.3 weeks)
What was measured
Time from Cycle 1 Day 1 to a response of PR or better.
Analysis population: Only participants included in the Safety Analysis Set who achieved a response of PR or better were included in this analysis.
Groups in this outcome
A (Melflufen+Bortezomib+Dex) 30 mg
Participants were administered IV melflufen at a dose of 30 mg on Day 1 of each 28-day cycle in combination with SQ bortezomib at a dose of 1.3mg/m\^2 on Days 1, 4, 8, and 11 and dexamethasone PO at a dose of 20 mg (12 mg if the participants is ≥ 75 years of age) on Days 1, 4, 8, and 11 and 40 mg (20 mg if the participants is ≥ 75 years of age) on Day 15 and 22 of each 28-day cycle.
A (Melflufen+Bortezomib+Dex) 40 mg
Participants were administered IV melflufen at a dose of 40 mg on Day 1 of each 28-day cycle in combination with SQ bortezomib at a dose of 1.3mg/m\^2 on Days 1, 4, 8, and 11 and dexamethasone PO at a dose of 20 mg (12 mg if the participants is ≥ 75 years of age) on Days 1, 4, 8, and 11 and 40 mg (20 mg if the participants is ≥ 75 years of age) on Day 15 and 22 of each 28-day cycle.
B (Melflufen+Daratumumab+Dex) 30 mg
Participants were administered IV melflufen at a dose of 30 mg on Day 1 of each 28-day cycle in combination with IV daratumumab at a dose of 16 mg/kg weekly for 8 doses, every other week for 8 doses and then once every 4 weeks. Participants were also administered dexamethasone orally (PO) at a dose of 40 mg weekly (20 mg weekly if the participants is ≥ 75 years of age).
B (Melflufen+Daratumumab+Dex) 40 mg
Participants were administered IV melflufen at a dose of 40 mg on Day 1 of each 28-day cycle in combination with IV daratumumab at a dose of 16 mg/kg weekly for 8 doses, every other week for 8 doses and then once every 4 weeks. Participants were also administered dexamethasone orally (PO) at a dose of 40 mg weekly (20 mg weekly if the participants is ≥ 75 years of age).
| Group | Source count |
|---|---|
| A (Melflufen+Bortezomib+Dex) 30 mg | 12 |
| A (Melflufen+Bortezomib+Dex) 40 mg | 6 |
| B (Melflufen+Daratumumab+Dex) 30 mg | 5 |
| B (Melflufen+Daratumumab+Dex) 40 mg | 19 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| A (Melflufen+Bortezomib+Dex) 30 mg | 3.0 | Not reported | 1.0 | 8.6 | Not reported |
| A (Melflufen+Bortezomib+Dex) 40 mg | 2.2 | Not reported | 1.0 | 4.6 | Not reported |
| B (Melflufen+Daratumumab+Dex) 30 mg | 3.3 | Not reported | 1.0 | 4.2 | Not reported |
| B (Melflufen+Daratumumab+Dex) 40 mg | 1.1 | Not reported | 0.9 | 5.3 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 1.0
- upper Limit
- 8.6
- value
- 3.0
- group Id
- OG001
- lower Limit
- 1.0
- upper Limit
- 4.6
- value
- 2.2
- group Id
- OG002
- lower Limit
- 1.0
- upper Limit
- 4.2
- value
- 3.3
- group Id
- OG003
- lower Limit
- 0.9
- upper Limit
- 5.3
- value
- 1.1
- denoms
- counts
- group Id
- OG000
- value
- 12
- group Id
- OG001
- value
- 6
- group Id
- OG002
- value
- 5
- group Id
- OG003
- value
- 19
- units
- Participants
- description
- Time from Cycle 1 Day 1 to a response of PR or better.
- dispersion Type
- Full Range
- groups
- description
- Participants were administered IV melflufen at a dose of 30 mg on Day 1 of each 28-day cycle in combination with SQ bortezomib at a dose of 1.3mg/m\^2 on Days 1, 4, 8, and 11 and dexamethasone PO at a dose of 20 mg (12 mg if the participants is ≥ 75 years of age) on Days 1, 4, 8, and 11 and 40 mg (20 mg if the participants is ≥ 75 years of age) on Day 15 and 22 of each 28-day cycle.
- id
- OG000
- title
- A (Melflufen+Bortezomib+Dex) 30 mg
- description
- Participants were administered IV melflufen at a dose of 40 mg on Day 1 of each 28-day cycle in combination with SQ bortezomib at a dose of 1.3mg/m\^2 on Days 1, 4, 8, and 11 and dexamethasone PO at a dose of 20 mg (12 mg if the participants is ≥ 75 years of age) on Days 1, 4, 8, and 11 and 40 mg (20 mg if the participants is ≥ 75 years of age) on Day 15 and 22 of each 28-day cycle.
- id
- OG001
- title
- A (Melflufen+Bortezomib+Dex) 40 mg
- description
- Participants were administered IV melflufen at a dose of 30 mg on Day 1 of each 28-day cycle in combination with IV daratumumab at a dose of 16 mg/kg weekly for 8 doses, every other week for 8 doses and then once every 4 weeks. Participants were also administered dexamethasone orally (PO) at a dose of 40 mg weekly (20 mg weekly if the participants is ≥ 75 years of age).
- id
- OG002
- title
- B (Melflufen+Daratumumab+Dex) 30 mg
- description
- Participants were administered IV melflufen at a dose of 40 mg on Day 1 of each 28-day cycle in combination with IV daratumumab at a dose of 16 mg/kg weekly for 8 doses, every other week for 8 doses and then once every 4 weeks. Participants were also administered dexamethasone orally (PO) at a dose of 40 mg weekly (20 mg weekly if the participants is ≥ 75 years of age).
- id
- OG003
- title
- B (Melflufen+Daratumumab+Dex) 40 mg
- param Type
- MEDIAN
- population Description
- Only participants included in the Safety Analysis Set who achieved a response of PR or better were included in this analysis.
- reporting Status
- POSTED
- time Frame
- Until disease progression, death or initiation of subsequent therapy (a maximum of 194.3 weeks)
- title
- Time to Response (TTR)
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice