TriangleNCT02963493 · OUTCOME
Time to Response
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- months
- Interval / dispersion
- Full Range
- Time frame
- From start of treatment to first confirmed response. Longest time to response in study recorded as 15.3 months.
What was measured
Duration from start of treatment to the first occurrence of a confirmed response of PR or better as assessed by the investigator. See definitions of response in Primary Outcome (ORR).
Analysis population: This outcome measure was pre-specified to be analyzed/reported for the Mel + Dex: FAS Arm/Group and "Mel + Dex: Patients With TCR Disease. This outcome measure was analyzed/reported for patients with a best response of PR or better in the full analysis set as well as in the sub-group of patients with triple class refractory disease. This outcome measure was not analyzed/reported separately for the sub-group of patients with Extramedullary Disease. No data available to report for EMD patients.
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 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 | 53 |
| Melphalan Flufenamide (Melflufen) + Dexamethasone: Patients With Triple Class Refractory Disease | 35 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Melphalan Flufenamide (Melflufen) + Dexamethasone: Full Analysis Set | 2.1 | Not reported | 1.0 | 15.3 | Not reported |
| Melphalan Flufenamide (Melflufen) + Dexamethasone: Patients With Triple Class Refractory Disease | 2.1 | Not reported | 1.0 | 15.3 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 1.0
- upper Limit
- 15.3
- value
- 2.1
- group Id
- OG001
- lower Limit
- 1.0
- upper Limit
- 15.3
- value
- 2.1
- denoms
- counts
- group Id
- OG000
- value
- 53
- group Id
- OG001
- value
- 35
- units
- Participants
- description
- Duration from start of treatment to the first occurrence of a confirmed response of PR or better as assessed by the investigator. See definitions of response in Primary Outcome (ORR).
- dispersion Type
- Full Range
- 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
- 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
- OG001
- title
- Melphalan Flufenamide (Melflufen) + Dexamethasone: Patients With Triple Class Refractory Disease
- param Type
- MEDIAN
- population Description
- This outcome measure was pre-specified to be analyzed/reported for the Mel + Dex: FAS Arm/Group and "Mel + Dex: Patients With TCR Disease. This outcome measure was analyzed/reported for patients with a best response of PR or better in the full analysis set as well as in the sub-group of patients with triple class refractory disease. This outcome measure was not analyzed/reported separately for the sub-group of patients with Extramedullary Disease. No data available to report for EMD patients.
- reporting Status
- POSTED
- time Frame
- From start of treatment to first confirmed response. Longest time to response in study recorded as 15.3 months.
- title
- Time to Response
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice