TriangleNCT02963493 · OUTCOME
Progression Free Survival (PFS)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- months
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Patients were followed until documented progression, unacceptable toxicity, patient/physician decision to withdraw or date of death, whichever came first. Longest follow-up time for PFS recorded as 37.2 months at study end.
What was measured
Time from start of treatment to either progression or death, whichever comes first as assessed by the investigator using IMWG criteria. Progression of disease is defined by an increase of 25% from the lowest response for either of Serum M-component (absolute increase of ≥ 0.5 g/dL) or Urine M-component (absolute increase of ≥200 mg/ 24h); In patients without measurable M-protein a 25% increase in the difference between involved and uninvolved FLC (free light chain) levels (absolute increase must be \>10 mg/dL); If unmeasurable FLC levels, a 25% increase in bone marrow plasma cell percentage (absolute percentage must be \>10%); New bone or soft tissue plasmacytomas or definite increase in existing ones; Development of hypercalcemia (corrected serum calcium \>11.5 mg/dL) that can be attributed solely to the plasma cell proliferative disorder
Analysis population: Full analysis set
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 | 4.27 | Not reported | 3.42 | 4.90 | Not reported |
| Melphalan Flufenamide (Melflufen) + Dexamethasone: Patients With Extramedullary Disease | 2.89 | Not reported | 1.97 | 3.94 | Not reported |
| Melphalan Flufenamide (Melflufen) + Dexamethasone: Patients With Triple Class Refractory Disease | 3.94 | Not reported | 3.09 | 4.67 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 3.42
- upper Limit
- 4.90
- value
- 4.27
- group Id
- OG001
- lower Limit
- 1.97
- upper Limit
- 3.94
- value
- 2.89
- group Id
- OG002
- lower Limit
- 3.09
- upper Limit
- 4.67
- value
- 3.94
- denoms
- counts
- group Id
- OG000
- value
- 157
- group Id
- OG001
- value
- 55
- group Id
- OG002
- value
- 119
- units
- Participants
- description
- Time from start of treatment to either progression or death, whichever comes first as assessed by the investigator using IMWG criteria. Progression of disease is defined by an increase of 25% from the lowest response for either of Serum M-component (absolute increase of ≥ 0.5 g/dL) or Urine M-component (absolute increase of ≥200 mg/ 24h); In patients without measurable M-protein a 25% increase in the difference between involved and uninvolved FLC (free light chain) levels (absolute increase must be \>10 mg/dL); If unmeasurable FLC levels, a 25% increase in bone marrow plasma cell percentage (absolute percentage must be \>10%); New bone or soft tissue plasmacytomas or definite increase in existing ones; Development of hypercalcemia (corrected serum calcium \>11.5 mg/dL) that can be attributed solely to the plasma cell proliferative disorder
- dispersion Type
- 95% Confidence Interval
- 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
- MEDIAN
- population Description
- Full analysis set
- 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 follow-up time for PFS recorded as 37.2 months at study end.
- title
- Progression Free Survival (PFS)
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice