TriangleNCT04649060 · OUTCOME
Best Response
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- From the date of randomization until the end of study (approximately 12 months).
What was measured
Proportion of patients with sCR, CR, VGPR, PR, Minimal Response (MR), Stable Disease (SD), PD, or non-evaluable (NE).
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
Complete Response (CR)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm A (Melflufen+Dexamethasone+Daratumumab) | 1 | Not reported | Not reported | Not reported | Not reported |
| Arm B (Daratumumab) | 0 | Not reported | Not reported | Not reported | Not reported |
Very Good Partial Response (VGPR)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm A (Melflufen+Dexamethasone+Daratumumab) | 4 | Not reported | Not reported | Not reported | Not reported |
| Arm B (Daratumumab) | 3 | Not reported | Not reported | Not reported | Not reported |
Partial Response (PR)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm A (Melflufen+Dexamethasone+Daratumumab) | 11 | Not reported | Not reported | Not reported | Not reported |
| Arm B (Daratumumab) | 5 | Not reported | Not reported | Not reported | Not reported |
Minimal Response (MR)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm A (Melflufen+Dexamethasone+Daratumumab) | 3 | Not reported | Not reported | Not reported | Not reported |
| Arm B (Daratumumab) | 5 | Not reported | Not reported | Not reported | Not reported |
Stable Disease (SD)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm A (Melflufen+Dexamethasone+Daratumumab) | 3 | Not reported | Not reported | Not reported | Not reported |
| Arm B (Daratumumab) | 5 | Not reported | Not reported | Not reported | Not reported |
Progressive Disease (PD)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm A (Melflufen+Dexamethasone+Daratumumab) | 1 | Not reported | Not reported | Not reported | Not reported |
| Arm B (Daratumumab) | 5 | Not reported | Not reported | Not reported | Not reported |
Not Evaluable (NE)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm A (Melflufen+Dexamethasone+Daratumumab) | 4 | Not reported | Not reported | Not reported | Not reported |
| Arm B (Daratumumab) | 4 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 0
- title
- Complete Response (CR)
- measurements
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 3
- title
- Very Good Partial Response (VGPR)
- measurements
- group Id
- OG000
- value
- 11
- group Id
- OG001
- value
- 5
- title
- Partial Response (PR)
- measurements
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 5
- title
- Minimal Response (MR)
- measurements
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 5
- title
- Stable Disease (SD)
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 5
- title
- Progressive Disease (PD)
- measurements
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 4
- title
- Not Evaluable (NE)
- denoms
- counts
- group Id
- OG000
- value
- 27
- group Id
- OG001
- value
- 27
- units
- Participants
- description
- Proportion of patients with sCR, CR, VGPR, PR, Minimal Response (MR), Stable Disease (SD), PD, or non-evaluable (NE).
- 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
- COUNT_OF_PARTICIPANTS
- 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
- Best Response
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice