TriangleNCT04649060 · OUTCOME
Clinical Benefit Rate (CBR)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percentage of patients
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- From the date of randomization until the end of study (approximately 12 months).
What was measured
The proportion of patients who achieve a best confirmed response of sCR, CR, VGPR, PR, or MR.
Analysis population: Analysis was performed using the Full Analysis Set (FAS).
Groups in this outcome
Arm A (Melflufen+Dexamethasone+Daratumumab)
Treatment was given in 28-day cycles in an outpatient treatment setting. * Melflufen 30 mg intravenous (i.v.) infusion on Day 1 of each cycle * Dexamethasone 40 mg per oral (p.o.) weekly (20 mg p.o. weekly if ≥75 years) * Daratumumab 1800 mg subcutaneously (s.c.) on Days 1, 8, 15, and 22 in Cycles 1 and 2, on Days 1 and 15 in Cycles 3 to 6, and on Day 1 from Cycle 7
Arm B (Daratumumab)
Treatment was given in 28-day cycles in an outpatient treatment setting. • Daratumumab 1800 mg s.c. on Days 1, 8, 15, and 22 in Cycles 1 and 2, on Days 1 and 15 in Cycles 3 to 6, and on Day 1 from Cycle 7
| Group | Source count |
|---|---|
| Arm A (Melflufen+Dexamethasone+Daratumumab) | 27 |
| Arm B (Daratumumab) | 27 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm A (Melflufen+Dexamethasone+Daratumumab) | 70.4 | Not reported | 49.8 | 86.2 | Not reported |
| Arm B (Daratumumab) | 48.1 | Not reported | 28.7 | 68.1 | Not reported |
Source statistical analyses
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.0997
- statistical Method
- Cochran-Mantel-Haenszel
Complete source fields
- analyses
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.0997
- statistical Method
- Cochran-Mantel-Haenszel
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 49.8
- upper Limit
- 86.2
- value
- 70.4
- group Id
- OG001
- lower Limit
- 28.7
- upper Limit
- 68.1
- value
- 48.1
- denoms
- counts
- group Id
- OG000
- value
- 27
- group Id
- OG001
- value
- 27
- units
- Participants
- description
- The proportion of patients who achieve a best confirmed response of sCR, CR, VGPR, PR, or MR.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Treatment was given in 28-day cycles in an outpatient treatment setting. * Melflufen 30 mg intravenous (i.v.) infusion on Day 1 of each cycle * Dexamethasone 40 mg per oral (p.o.) weekly (20 mg p.o. weekly if ≥75 years) * Daratumumab 1800 mg subcutaneously (s.c.) on Days 1, 8, 15, and 22 in Cycles 1 and 2, on Days 1 and 15 in Cycles 3 to 6, and on Day 1 from Cycle 7
- id
- OG000
- title
- Arm A (Melflufen+Dexamethasone+Daratumumab)
- description
- Treatment was given in 28-day cycles in an outpatient treatment setting. • Daratumumab 1800 mg s.c. on Days 1, 8, 15, and 22 in Cycles 1 and 2, on Days 1 and 15 in Cycles 3 to 6, and on Day 1 from Cycle 7
- id
- OG001
- title
- Arm B (Daratumumab)
- param Type
- NUMBER
- population Description
- Analysis was performed using the Full Analysis Set (FAS).
- reporting Status
- POSTED
- time Frame
- From the date of randomization until the end of study (approximately 12 months).
- title
- Clinical Benefit Rate (CBR)
- type
- SECONDARY
- unit Of Measure
- percentage of patients
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice