TriangleNCT01572480 · OUTCOME
Biochemical Progression Free Survival
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percentage of participants
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- time from enrollment in the study until development of overt clinical multiple myeloma (end organ damage or myeloma-defining event) or death, and progressive disease by IMWG criteria, up to 5 years
What was measured
Biochemical progression free survival is defined as the time from enrollment in the study until development of overt clinical multiple myeloma (end organ damage or myeloma-defining event) or death, and progressive disease by International Myeloma Working Group (IMWG) criteria. Progression is any one of the following: Increase of ≥25% from lowest response value in the following on 2 consecutive measurements: Serum M-component and/or (the absolute increase must be ≥0.5g/dl). The serum M-component increases of ≥1 gm/dl are sufficient to define relapse if starting M-component is ≥0.5g/dl. Urine M-component and/or (the absolute must be ≥200mg/24h. Only in participants without measurable serum and urine M-protein levels: the difference between involved and uninvolved free light chain (FLC) levels. The absolute increase must be \>10mg/dl. Bone marrow plasma cell percentage: the absolute % must be ≥10%.
Analysis population: 54/55 participants are evaluable for this outcome measure.
Groups in this outcome
All Participants
Carfilzomib (intravenous (IV), Days 1, 2, 8, 9, 15, and 16 of the 28-day cycle); Revlimid (by mouth (PO), Days 1-21 of the 28-day cycle; exception: not given on cycle 1 day 1); and Dexamethasone (PO or IV, Days 1, 2, 8, 9, 15, 16, 22, and 23 of the 28-day cycle; exception: not given on cycle 1 day 1) Carfilzomib intravenous (IV) 20-36 mg/m\^2 per dose on days 1, 2, 8, 9, 15, and 16 of each cycle based on arm; until disease progression or unacceptable toxicity. Revlimid by mouth (PO) 25 mg/day, days 1-21 every 28 days of each cycle based on arm; until disease progression or unacceptable toxicity.
| Group | Source count |
|---|---|
| All Participants | 54 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| All Participants | 76.6 | Not reported | 59.2 | 87.3 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 59.2
- upper Limit
- 87.3
- value
- 76.6
- denoms
- counts
- group Id
- OG000
- value
- 54
- units
- Participants
- description
- Biochemical progression free survival is defined as the time from enrollment in the study until development of overt clinical multiple myeloma (end organ damage or myeloma-defining event) or death, and progressive disease by International Myeloma Working Group (IMWG) criteria. Progression is any one of the following: Increase of ≥25% from lowest response value in the following on 2 consecutive measurements: Serum M-component and/or (the absolute increase must be ≥0.5g/dl). The serum M-component increases of ≥1 gm/dl are sufficient to define relapse if starting M-component is ≥0.5g/dl. Urine M-component and/or (the absolute must be ≥200mg/24h. Only in participants without measurable serum and urine M-protein levels: the difference between involved and uninvolved free light chain (FLC) levels. The absolute increase must be \>10mg/dl. Bone marrow plasma cell percentage: the absolute % must be ≥10%.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Carfilzomib (intravenous (IV), Days 1, 2, 8, 9, 15, and 16 of the 28-day cycle); Revlimid (by mouth (PO), Days 1-21 of the 28-day cycle; exception: not given on cycle 1 day 1); and Dexamethasone (PO or IV, Days 1, 2, 8, 9, 15, 16, 22, and 23 of the 28-day cycle; exception: not given on cycle 1 day 1) Carfilzomib intravenous (IV) 20-36 mg/m\^2 per dose on days 1, 2, 8, 9, 15, and 16 of each cycle based on arm; until disease progression or unacceptable toxicity. Revlimid by mouth (PO) 25 mg/day, days 1-21 every 28 days of each cycle based on arm; until disease progression or unacceptable toxicity.
- id
- OG000
- title
- All Participants
- param Type
- NUMBER
- population Description
- 54/55 participants are evaluable for this outcome measure.
- reporting Status
- POSTED
- time Frame
- time from enrollment in the study until development of overt clinical multiple myeloma (end organ damage or myeloma-defining event) or death, and progressive disease by IMWG criteria, up to 5 years
- title
- Biochemical Progression Free Survival
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice