TriangleNCT03481556 · OUTCOME
Best Response (BR)
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
- Until disease progression, death or initiation of subsequent therapy (a maximum of 194.3 weeks)
What was measured
BR defined by International Myeloma Working Group Uniform Response Criteria. BR= Complete Response (CR)/Stringent CR (sCR) defined as below negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and \< 5% plasma cells in bone marrow/plus normal free light chain (FLC) ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence, Very Good Partial Response (VGPR)= serum and urine M-protein detectable by immunofixation but not on electrophoresis or \> 90% reduction in serum M-protein plus urine M-protein level \< 100 mg/24 hours, Partial Response (PR)= a \> 50% reduction of serum M-protein and reduction in 24 hours urinary M-protein by \> 90% or to \< 200 mg/24 hours, Minimal Response (MR), Stable Disease (SD)= not meeting the criteria for other response options, Progressive Disease (PD)= increase of \> 25% from lowest response value in serum/urine M-component or bone marrow plasma cell percentage, or non-evaluable.
Analysis population: All participants included in the Safety Analysis Set were included in this analysis.
Groups in this outcome
Regimen A - Melflufen 30mg + Bortezomib + Dexamethasone
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.
Regimen A - Melflufen 40mg + Bortezomib + Dexamethasone
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.
Regimen B - Melflufen 30mg + Daratumumab + Dexamethasone
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).
Regimen B - Melflufen 40mg + Daratumumab + Dexamethasone
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 |
|---|---|
| Regimen A - Melflufen 30mg + Bortezomib + Dexamethasone | 15 |
| Regimen A - Melflufen 40mg + Bortezomib + Dexamethasone | 8 |
| Regimen B - Melflufen 30mg + Daratumumab + Dexamethasone | 6 |
| Regimen B - Melflufen 40mg + Daratumumab + Dexamethasone | 27 |
Reported measurements
CR
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Regimen A - Melflufen 30mg + Bortezomib + Dexamethasone | 1 | Not reported | Not reported | Not reported | Not reported |
| Regimen A - Melflufen 40mg + Bortezomib + Dexamethasone | 0 | Not reported | Not reported | Not reported | Not reported |
| Regimen B - Melflufen 30mg + Daratumumab + Dexamethasone | 1 | Not reported | Not reported | Not reported | Not reported |
| Regimen B - Melflufen 40mg + Daratumumab + Dexamethasone | 1 | Not reported | Not reported | Not reported | Not reported |
sCR
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Regimen A - Melflufen 30mg + Bortezomib + Dexamethasone | 0 | Not reported | Not reported | Not reported | Not reported |
| Regimen A - Melflufen 40mg + Bortezomib + Dexamethasone | 1 | Not reported | Not reported | Not reported | Not reported |
| Regimen B - Melflufen 30mg + Daratumumab + Dexamethasone | 0 | Not reported | Not reported | Not reported | Not reported |
| Regimen B - Melflufen 40mg + Daratumumab + Dexamethasone | 1 | Not reported | Not reported | Not reported | Not reported |
VGPR
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Regimen A - Melflufen 30mg + Bortezomib + Dexamethasone | 2 | Not reported | Not reported | Not reported | Not reported |
| Regimen A - Melflufen 40mg + Bortezomib + Dexamethasone | 3 | Not reported | Not reported | Not reported | Not reported |
| Regimen B - Melflufen 30mg + Daratumumab + Dexamethasone | 2 | Not reported | Not reported | Not reported | Not reported |
| Regimen B - Melflufen 40mg + Daratumumab + Dexamethasone | 6 | Not reported | Not reported | Not reported | Not reported |
PR
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Regimen A - Melflufen 30mg + Bortezomib + Dexamethasone | 9 | Not reported | Not reported | Not reported | Not reported |
| Regimen A - Melflufen 40mg + Bortezomib + Dexamethasone | 2 | Not reported | Not reported | Not reported | Not reported |
| Regimen B - Melflufen 30mg + Daratumumab + Dexamethasone | 2 | Not reported | Not reported | Not reported | Not reported |
| Regimen B - Melflufen 40mg + Daratumumab + Dexamethasone | 11 | Not reported | Not reported | Not reported | Not reported |
MR
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Regimen A - Melflufen 30mg + Bortezomib + Dexamethasone | 1 | Not reported | Not reported | Not reported | Not reported |
| Regimen A - Melflufen 40mg + Bortezomib + Dexamethasone | 0 | Not reported | Not reported | Not reported | Not reported |
| Regimen B - Melflufen 30mg + Daratumumab + Dexamethasone | 0 | Not reported | Not reported | Not reported | Not reported |
| Regimen B - Melflufen 40mg + Daratumumab + Dexamethasone | 1 | Not reported | Not reported | Not reported | Not reported |
SD
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Regimen A - Melflufen 30mg + Bortezomib + Dexamethasone | 1 | Not reported | Not reported | Not reported | Not reported |
| Regimen A - Melflufen 40mg + Bortezomib + Dexamethasone | 1 | Not reported | Not reported | Not reported | Not reported |
| Regimen B - Melflufen 30mg + Daratumumab + Dexamethasone | 0 | Not reported | Not reported | Not reported | Not reported |
| Regimen B - Melflufen 40mg + Daratumumab + Dexamethasone | 2 | Not reported | Not reported | Not reported | Not reported |
PD
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Regimen A - Melflufen 30mg + Bortezomib + Dexamethasone | 0 | Not reported | Not reported | Not reported | Not reported |
| Regimen A - Melflufen 40mg + Bortezomib + Dexamethasone | 0 | Not reported | Not reported | Not reported | Not reported |
| Regimen B - Melflufen 30mg + Daratumumab + Dexamethasone | 0 | Not reported | Not reported | Not reported | Not reported |
| Regimen B - Melflufen 40mg + Daratumumab + Dexamethasone | 1 | Not reported | Not reported | Not reported | Not reported |
Non-evaluable
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Regimen A - Melflufen 30mg + Bortezomib + Dexamethasone | 0 | Not reported | Not reported | Not reported | Not reported |
| Regimen A - Melflufen 40mg + Bortezomib + Dexamethasone | 0 | Not reported | Not reported | Not reported | Not reported |
| Regimen B - Melflufen 30mg + Daratumumab + Dexamethasone | 0 | Not reported | Not reported | Not reported | Not reported |
| Regimen B - Melflufen 40mg + Daratumumab + Dexamethasone | 0 | Not reported | Not reported | Not reported | Not reported |
Missing
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Regimen A - Melflufen 30mg + Bortezomib + Dexamethasone | 1 | Not reported | Not reported | Not reported | Not reported |
| Regimen A - Melflufen 40mg + Bortezomib + Dexamethasone | 1 | Not reported | Not reported | Not reported | Not reported |
| Regimen B - Melflufen 30mg + Daratumumab + Dexamethasone | 1 | Not reported | Not reported | Not reported | Not reported |
| Regimen B - Melflufen 40mg + Daratumumab + Dexamethasone | 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
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 1
- title
- CR
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 1
- title
- sCR
- categories
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 2
- group Id
- OG003
- value
- 6
- title
- VGPR
- categories
- measurements
- group Id
- OG000
- value
- 9
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 2
- group Id
- OG003
- value
- 11
- title
- PR
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 1
- title
- MR
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 2
- title
- SD
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 1
- title
- PD
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- title
- Non-evaluable
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 4
- title
- Missing
- 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
- BR defined by International Myeloma Working Group Uniform Response Criteria. BR= Complete Response (CR)/Stringent CR (sCR) defined as below negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and \< 5% plasma cells in bone marrow/plus normal free light chain (FLC) ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence, Very Good Partial Response (VGPR)= serum and urine M-protein detectable by immunofixation but not on electrophoresis or \> 90% reduction in serum M-protein plus urine M-protein level \< 100 mg/24 hours, Partial Response (PR)= a \> 50% reduction of serum M-protein and reduction in 24 hours urinary M-protein by \> 90% or to \< 200 mg/24 hours, Minimal Response (MR), Stable Disease (SD)= not meeting the criteria for other response options, Progressive Disease (PD)= increase of \> 25% from lowest response value in serum/urine M-component or bone marrow plasma cell percentage, or non-evaluable.
- 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
- Regimen A - Melflufen 30mg + Bortezomib + Dexamethasone
- 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
- Regimen A - Melflufen 40mg + Bortezomib + Dexamethasone
- 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
- Regimen B - Melflufen 30mg + Daratumumab + Dexamethasone
- 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
- Regimen B - Melflufen 40mg + Daratumumab + Dexamethasone
- param Type
- COUNT_OF_PARTICIPANTS
- 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
- Best Response (BR)
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice