TriangleNCT02963493 · OUTCOME
Clinical Benefit Rate
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
- Patients were followed until documented progression, unacceptable toxicity, patient/physician decision to withdraw or date of death, whichever came first. Longest time on study treatment recorded as 35.0 months at study end.
What was measured
The clinical benefit rate (CBR) will be estimated as the percentage of patients who achieve sCR, CR, VGPR, PR, or MR as their best response as assessed by the investigator. See Primary Outcome (ORR) for definitions of response categories.
Groups in this outcome
Melphalan Flufenamide (Melflufen) + Dexamethasone: Full Analysis Set
Melphalan flufenamide (melflufen) 40 mg Day 1 and dexamethasone 40 mg (reduced dose for patients 75 years or older) on Days 1, 8, 15 and 22 of each 28-day cycle. Melphalan flufenamide (Melflufen) Dexamethasone: IV dexamethasone may be substituted for oral dexamethasone in the US. Oral only in Europe.
Melphalan Flufenamide (Melflufen) + Dexamethasone: Patients With Extramedullary Disease
Patients with extramedullary disease at baseline defined as myeloma disease either originating in, but extending beyond, the cortical bone or as a separate soft tissue mass
Melphalan Flufenamide (Melflufen) + Dexamethasone: Patients With Triple Class Refractory Disease
Triple class refractory population defined as refractory to or intolerant of at least one immunomodulatory drug, at least one proteasome inhibitor, and at least one anti-CD38 monoclonal antibody
| Group | Source count |
|---|---|
| Melphalan Flufenamide (Melflufen) + Dexamethasone: Full Analysis Set | 157 |
| Melphalan Flufenamide (Melflufen) + Dexamethasone: Patients With Extramedullary Disease | 55 |
| Melphalan Flufenamide (Melflufen) + Dexamethasone: Patients With Triple Class Refractory Disease | 119 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Melphalan Flufenamide (Melflufen) + Dexamethasone: Full Analysis Set | 72 | Not reported | Not reported | Not reported | Not reported |
| Melphalan Flufenamide (Melflufen) + Dexamethasone: Patients With Extramedullary Disease | 17 | Not reported | Not reported | Not reported | Not reported |
| Melphalan Flufenamide (Melflufen) + Dexamethasone: Patients With Triple Class Refractory Disease | 48 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 72
- group Id
- OG001
- value
- 17
- group Id
- OG002
- value
- 48
- denoms
- counts
- group Id
- OG000
- value
- 157
- group Id
- OG001
- value
- 55
- group Id
- OG002
- value
- 119
- units
- Participants
- description
- The clinical benefit rate (CBR) will be estimated as the percentage of patients who achieve sCR, CR, VGPR, PR, or MR as their best response as assessed by the investigator. See Primary Outcome (ORR) for definitions of response categories.
- groups
- description
- Melphalan flufenamide (melflufen) 40 mg Day 1 and dexamethasone 40 mg (reduced dose for patients 75 years or older) on Days 1, 8, 15 and 22 of each 28-day cycle. Melphalan flufenamide (Melflufen) Dexamethasone: IV dexamethasone may be substituted for oral dexamethasone in the US. Oral only in Europe.
- id
- OG000
- title
- Melphalan Flufenamide (Melflufen) + Dexamethasone: Full Analysis Set
- description
- Patients with extramedullary disease at baseline defined as myeloma disease either originating in, but extending beyond, the cortical bone or as a separate soft tissue mass
- id
- OG001
- title
- Melphalan Flufenamide (Melflufen) + Dexamethasone: Patients With Extramedullary Disease
- description
- Triple class refractory population defined as refractory to or intolerant of at least one immunomodulatory drug, at least one proteasome inhibitor, and at least one anti-CD38 monoclonal antibody
- id
- OG002
- title
- Melphalan Flufenamide (Melflufen) + Dexamethasone: Patients With Triple Class Refractory Disease
- param Type
- COUNT_OF_PARTICIPANTS
- reporting Status
- POSTED
- time Frame
- Patients were followed until documented progression, unacceptable toxicity, patient/physician decision to withdraw or date of death, whichever came first. Longest time on study treatment recorded as 35.0 months at study end.
- title
- Clinical Benefit Rate
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice