TriangleNCT02514239 · OUTCOME
Progression-free Survival (PFS) - on Treatment
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- Months
- Interval / dispersion
- Inter-Quartile Range
- Time frame
- From start of treatment till end of trial (EOT) visit, up to 61 weeks.
What was measured
PFS was defined as time from first treatment with BI 836909 till disease progression or death. Progression was defined according to International Myeloma Working Group (IMWG 2006) response criteria as an increase \>25% from lowest response value in any of the following parameters: -Serum M protein (absolute increase had to be \>0.5 gram/ deciliters (dL)) -Urine M protein (absolute increase had to be \>200 milligram (mg)/24 hour) -Only in patients without measurable serum and urine M protein levels The difference between involved and uninvolved FLC levels. Absolute increase had to be \>10 mg/dL -Bone marrow plasma cell percentage; absolute percentage had to be \>10% -Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas -Development of hypercalcaemia (corrected serum calcium \>11.5 mg/dL or 2.65 Millimole/Liter) that was attributed solely to the plasma cell proliferative disorder.
Analysis population: Treated set (TS): all patients who were administered trial medication.
Groups in this outcome
Intravenous Infusion of BI 836909 (Overall in the 4 Lowest Dose Cohorts 0.2, 0.4, 0.8, 1.6 μg/d)
Intravenous infusion of BI 836909 (overall in the 4 lowest dose cohorts 0.2, 0.4, 0.8, 1.6 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
Intravenous Infusion of BI 836909 (3.2 μg/d)
Intravenous infusion of BI 836909 (3.2 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
Intravenous Infusion of BI 836909 (6.5 μg/d)
Intravenous infusion of BI 836909 (6.5 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
Intravenous Infusion of BI 836909 (13 μg/d)
Intravenous infusion of BI 836909 (13 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
Intravenous Infusion of BI 836909 (25 μg/d)
Intravenous infusion of BI 836909 (25 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
Intravenous Infusion of BI 836909 (50 μg/d)
Intravenous infusion of BI 836909 (50 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
Intravenous Infusion of BI 836909 (100 μg/d)
Intravenous infusion of BI 836909 (100 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
Intravenous Infusion of BI 836909 (200 μg/d)
Intravenous infusion of BI 836909 (200 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
Intravenous Infusion of BI 836909 (400 μg/d)
Intravenous infusion of BI 836909 (400 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
Intravenous Infusion of BI 836909 (800 μg/d)
Intravenous infusion of BI 836909 (800 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
| Group | Source count |
|---|---|
| Intravenous Infusion of BI 836909 (Overall in the 4 Lowest Dose Cohorts 0.2, 0.4, 0.8, 1.6 μg/d) | 5 |
| Intravenous Infusion of BI 836909 (3.2 μg/d) | 3 |
| Intravenous Infusion of BI 836909 (6.5 μg/d) | 3 |
| Intravenous Infusion of BI 836909 (13 μg/d) | 3 |
| Intravenous Infusion of BI 836909 (25 μg/d) | 3 |
| Intravenous Infusion of BI 836909 (50 μg/d) | 5 |
| Intravenous Infusion of BI 836909 (100 μg/d) | 4 |
| Intravenous Infusion of BI 836909 (200 μg/d) | 3 |
| Intravenous Infusion of BI 836909 (400 μg/d) | 10 |
| Intravenous Infusion of BI 836909 (800 μg/d) | 3 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Intravenous Infusion of BI 836909 (Overall in the 4 Lowest Dose Cohorts 0.2, 0.4, 0.8, 1.6 μg/d) | NA | Not reported | NA | NA | Estimates for median and/or IQR are missing because the largest observation was censored and the estimation was restricted to the largest event time observed in this clinical trial. |
| Intravenous Infusion of BI 836909 (3.2 μg/d) | NA | Not reported | NA | NA | Estimates for median and/or IQR are missing because the largest observation was censored and the estimation was restricted to the largest event time observed in this clinical trial. |
| Intravenous Infusion of BI 836909 (6.5 μg/d) | NA | Not reported | NA | NA | Estimates for median and/or IQR are missing because the largest observation was censored and the estimation was restricted to the largest event time observed in this clinical trial. |
| Intravenous Infusion of BI 836909 (13 μg/d) | NA | Not reported | NA | NA | Estimates for median and/or IQR are missing because the largest observation was censored and the estimation was restricted to the largest event time observed in this clinical trial. |
| Intravenous Infusion of BI 836909 (25 μg/d) | NA | Not reported | NA | NA | Estimates for median and/or IQR are missing because the largest observation was censored and the estimation was restricted to the largest event time observed in this clinical trial. |
| Intravenous Infusion of BI 836909 (50 μg/d) | NA | Not reported | NA | NA | Estimates for median and/or IQR are missing because the largest observation was censored and the estimation was restricted to the largest event time observed in this clinical trial. |
| Intravenous Infusion of BI 836909 (100 μg/d) | NA | Not reported | NA | NA | Estimates for median and/or IQR are missing because the largest observation was censored and the estimation was restricted to the largest event time observed in this clinical trial. |
| Intravenous Infusion of BI 836909 (200 μg/d) | NA | Not reported | NA | NA | Estimates for median and/or IQR are missing because the largest observation was censored and the estimation was restricted to the largest event time observed in this clinical trial. |
| Intravenous Infusion of BI 836909 (400 μg/d) | 5.55 | Not reported | 0.95 | NA | Estimates for median and/or IQR are missing because the largest observation was censored and the estimation was restricted to the largest event time observed in this clinical trial. |
| Intravenous Infusion of BI 836909 (800 μg/d) | NA | Not reported | NA | NA | Estimates for median and/or IQR are missing because the largest observation was censored and the estimation was restricted to the largest event time observed in this clinical trial. |
Complete source fields
- classes
- categories
- measurements
- comment
- Estimates for median and/or IQR are missing because the largest observation was censored and the estimation was restricted to the largest event time observed in this clinical trial.
- group Id
- OG000
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- comment
- Estimates for median and/or IQR are missing because the largest observation was censored and the estimation was restricted to the largest event time observed in this clinical trial.
- group Id
- OG001
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- comment
- Estimates for median and/or IQR are missing because the largest observation was censored and the estimation was restricted to the largest event time observed in this clinical trial.
- group Id
- OG002
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- comment
- Estimates for median and/or IQR are missing because the largest observation was censored and the estimation was restricted to the largest event time observed in this clinical trial.
- group Id
- OG003
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- comment
- Estimates for median and/or IQR are missing because the largest observation was censored and the estimation was restricted to the largest event time observed in this clinical trial.
- group Id
- OG004
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- comment
- Estimates for median and/or IQR are missing because the largest observation was censored and the estimation was restricted to the largest event time observed in this clinical trial.
- group Id
- OG005
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- comment
- Estimates for median and/or IQR are missing because the largest observation was censored and the estimation was restricted to the largest event time observed in this clinical trial.
- group Id
- OG006
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- comment
- Estimates for median and/or IQR are missing because the largest observation was censored and the estimation was restricted to the largest event time observed in this clinical trial.
- group Id
- OG007
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- comment
- Estimates for median and/or IQR are missing because the largest observation was censored and the estimation was restricted to the largest event time observed in this clinical trial.
- group Id
- OG008
- lower Limit
- 0.95
- upper Limit
- NA
- value
- 5.55
- comment
- Estimates for median and/or IQR are missing because the largest observation was censored and the estimation was restricted to the largest event time observed in this clinical trial.
- group Id
- OG009
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 5
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 3
- group Id
- OG004
- value
- 3
- group Id
- OG005
- value
- 5
- group Id
- OG006
- value
- 4
- group Id
- OG007
- value
- 3
- group Id
- OG008
- value
- 10
- group Id
- OG009
- value
- 3
- units
- Participants
- description
- PFS was defined as time from first treatment with BI 836909 till disease progression or death. Progression was defined according to International Myeloma Working Group (IMWG 2006) response criteria as an increase \>25% from lowest response value in any of the following parameters: -Serum M protein (absolute increase had to be \>0.5 gram/ deciliters (dL)) -Urine M protein (absolute increase had to be \>200 milligram (mg)/24 hour) -Only in patients without measurable serum and urine M protein levels The difference between involved and uninvolved FLC levels. Absolute increase had to be \>10 mg/dL -Bone marrow plasma cell percentage; absolute percentage had to be \>10% -Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas -Development of hypercalcaemia (corrected serum calcium \>11.5 mg/dL or 2.65 Millimole/Liter) that was attributed solely to the plasma cell proliferative disorder.
- dispersion Type
- Inter-Quartile Range
- groups
- description
- Intravenous infusion of BI 836909 (overall in the 4 lowest dose cohorts 0.2, 0.4, 0.8, 1.6 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
- id
- OG000
- title
- Intravenous Infusion of BI 836909 (Overall in the 4 Lowest Dose Cohorts 0.2, 0.4, 0.8, 1.6 μg/d)
- description
- Intravenous infusion of BI 836909 (3.2 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
- id
- OG001
- title
- Intravenous Infusion of BI 836909 (3.2 μg/d)
- description
- Intravenous infusion of BI 836909 (6.5 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
- id
- OG002
- title
- Intravenous Infusion of BI 836909 (6.5 μg/d)
- description
- Intravenous infusion of BI 836909 (13 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
- id
- OG003
- title
- Intravenous Infusion of BI 836909 (13 μg/d)
- description
- Intravenous infusion of BI 836909 (25 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
- id
- OG004
- title
- Intravenous Infusion of BI 836909 (25 μg/d)
- description
- Intravenous infusion of BI 836909 (50 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
- id
- OG005
- title
- Intravenous Infusion of BI 836909 (50 μg/d)
- description
- Intravenous infusion of BI 836909 (100 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
- id
- OG006
- title
- Intravenous Infusion of BI 836909 (100 μg/d)
- description
- Intravenous infusion of BI 836909 (200 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
- id
- OG007
- title
- Intravenous Infusion of BI 836909 (200 μg/d)
- description
- Intravenous infusion of BI 836909 (400 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
- id
- OG008
- title
- Intravenous Infusion of BI 836909 (400 μg/d)
- description
- Intravenous infusion of BI 836909 (800 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
- id
- OG009
- title
- Intravenous Infusion of BI 836909 (800 μg/d)
- param Type
- MEDIAN
- population Description
- Treated set (TS): all patients who were administered trial medication.
- reporting Status
- POSTED
- time Frame
- From start of treatment till end of trial (EOT) visit, up to 61 weeks.
- title
- Progression-free Survival (PFS) - on Treatment
- type
- SECONDARY
- unit Of Measure
- Months
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Preserved source evidence · Not medical advice