TriangleNCT04119336 · OUTCOME
Progression Free Survival
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
- Up to 2 years
What was measured
Progression-free survival (PFS) is defined as the time from starting study treatment to disease progression or death from any cause. The International Myeloma Working Group (IMWG) criteria defines progressive disease (PD) as at least 25% increase from lowest response value of any of the following: * Serum M-component (absolute increase must be at least 0.5 g/dL) * Urine M-component (absolute increase must be at least 200 mg/24 h) * If serum and urine M-protein unmeasurable, absolute increase in free light chain (FLC) must be \>10 mg/dL. If FLC levels also unmeasurable, absolute increase in bone marrow plasma cell percentage must be at least 10%. * Definite development of new bone lesions or soft tissue plasmacytomas, or definite increase in size of existing bone lesions or soft tissue plasmacytomas * Development of hypercalcemia (corrected serum calcium \>11.5 mg/dL) that can be attributed solely to the plasma cell proliferative disorder
Groups in this outcome
Nivolumab and Ixazomib
\- Participants will receive Nivolumab, Ixazomib, Cyclophosphamide, and Dexamethasone on a 28-day cycle. * Oral: * Ixazomib given weekly on days 1, 8, 15 * Dexamethasone given weekly during cycle * Infused: * Nivolumab given once per cycle * Cyclophosphamide given on days 1, 8, 15 during cycle Nivolumab: Given intravenously once per cycle Ixazomib: Given orally on days 1, 8, 15. Dexamethasone: Given orally on days 1, 8, 15, 22 Cyclophosphamide: Given intravenously on days 1, 8, 15.
| Group | Source count |
|---|---|
| Nivolumab and Ixazomib | 2 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Nivolumab and Ixazomib | 3.96 | Not reported | 1.15 | NA | Upper limit was not reached due to insufficient number of participants with events. |
Complete source fields
- classes
- categories
- measurements
- comment
- Upper limit was not reached due to insufficient number of participants with events.
- group Id
- OG000
- lower Limit
- 1.15
- upper Limit
- NA
- value
- 3.96
- denoms
- counts
- group Id
- OG000
- value
- 2
- units
- Participants
- description
- Progression-free survival (PFS) is defined as the time from starting study treatment to disease progression or death from any cause. The International Myeloma Working Group (IMWG) criteria defines progressive disease (PD) as at least 25% increase from lowest response value of any of the following: * Serum M-component (absolute increase must be at least 0.5 g/dL) * Urine M-component (absolute increase must be at least 200 mg/24 h) * If serum and urine M-protein unmeasurable, absolute increase in free light chain (FLC) must be \>10 mg/dL. If FLC levels also unmeasurable, absolute increase in bone marrow plasma cell percentage must be at least 10%. * Definite development of new bone lesions or soft tissue plasmacytomas, or definite increase in size of existing bone lesions or soft tissue plasmacytomas * 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
- \- Participants will receive Nivolumab, Ixazomib, Cyclophosphamide, and Dexamethasone on a 28-day cycle. * Oral: * Ixazomib given weekly on days 1, 8, 15 * Dexamethasone given weekly during cycle * Infused: * Nivolumab given once per cycle * Cyclophosphamide given on days 1, 8, 15 during cycle Nivolumab: Given intravenously once per cycle Ixazomib: Given orally on days 1, 8, 15. Dexamethasone: Given orally on days 1, 8, 15, 22 Cyclophosphamide: Given intravenously on days 1, 8, 15.
- id
- OG000
- title
- Nivolumab and Ixazomib
- param Type
- MEDIAN
- reporting Status
- POSTED
- time Frame
- Up to 2 years
- title
- Progression Free Survival
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice