TriangleNCT03481556 · OUTCOME
Clinical Benefit Rate (≥ Minimal Response)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percentage of participants
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Until disease progression, death or initiation of subsequent therapy (a maximum of 194.3 weeks)
What was measured
≥ Minimal response for participants included sCR, CR, VGPR, PR and MR.
Analysis population: All participants included in the Safety Analysis Set 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 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 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 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 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 | 15 |
| A (Melflufen+Bortezomib+Dex) 40 mg | 8 |
| B (Melflufen+Daratumumab+Dex) 30 mg | 6 |
| B (Melflufen+Daratumumab+Dex) 40 mg | 27 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| A (Melflufen+Bortezomib+Dex) 30 mg | 86.7 | Not reported | 59.5 | 98.3 | Not reported |
| A (Melflufen+Bortezomib+Dex) 40 mg | 75.0 | Not reported | 34.9 | 96.8 | Not reported |
| B (Melflufen+Daratumumab+Dex) 30 mg | 83.3 | Not reported | 35.9 | 99.6 | Not reported |
| B (Melflufen+Daratumumab+Dex) 40 mg | 74.1 | Not reported | 53.7 | 88.9 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 59.5
- upper Limit
- 98.3
- value
- 86.7
- group Id
- OG001
- lower Limit
- 34.9
- upper Limit
- 96.8
- value
- 75.0
- group Id
- OG002
- lower Limit
- 35.9
- upper Limit
- 99.6
- value
- 83.3
- group Id
- OG003
- lower Limit
- 53.7
- upper Limit
- 88.9
- value
- 74.1
- denoms
- counts
- group Id
- OG000
- value
- 15
- group Id
- OG001
- value
- 8
- group Id
- OG002
- value
- 6
- group Id
- OG003
- value
- 27
- units
- Participants
- description
- ≥ Minimal response for participants included sCR, CR, VGPR, PR and MR.
- dispersion Type
- 95% Confidence Interval
- 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 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 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 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 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
- NUMBER
- population Description
- All participants included in the Safety Analysis Set 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
- Clinical Benefit Rate (≥ Minimal Response)
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice