TriangleNCT02514239 · OUTCOME
Number of Participants With an Objective Response
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- On-treatment: From start of treatment till end of trial (EOT) visit, up to 61 weeks. Extended follow-up: From start of treatment till the last extended follow-up visit which was scheduled at 12 months after end of treatment, up to 113 weeks.
What was measured
Objective responses: Stringent complete response (sCR): CR + normal Free light chain (FLC) ratio and no clonal cells in bone marrow by immunohistochemistry or immunofluorescence. CR: negative immunofixation on serum and urine, disappearance of soft tissue plasmacytomas, and \<5% plasma cells in bone marrow. Very good partial response (VGPR): serum and urine M protein detectable by immunofixation but not on electrophoresis or \>90% reduction in serum M protein plus urine M protein level \<100 mg/24h. PR: \>50% reduction of serum and 24 h urinary M protein by \>90% or to \<200mg/24h. If unmeasurable, a \>50% decrease in difference between involved and uninvolved FLC levels instead of M protein criteria. if FLC assay was not measurable, a \>50% reduction in plasma cells was required instead of M protein, provided baseline bone marrow plasma cell was \>30%. In addition to the listed criteria, a \>50% reduction in the size of soft tissue plasmacytomas was also required, if present at baseline.
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
On treatment
Stringent complete response (sCR)
| 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) | 0 | Not reported | Not reported | Not reported | Not reported |
| Intravenous Infusion of BI 836909 (3.2 μg/d) | 0 | Not reported | Not reported | Not reported | Not reported |
| Intravenous Infusion of BI 836909 (6.5 μg/d) | 0 | Not reported | Not reported | Not reported | Not reported |
| Intravenous Infusion of BI 836909 (13 μg/d) | 0 | Not reported | Not reported | Not reported | Not reported |
| Intravenous Infusion of BI 836909 (25 μg/d) | 0 | Not reported | Not reported | Not reported | Not reported |
| Intravenous Infusion of BI 836909 (50 μg/d) | 0 | Not reported | Not reported | Not reported | Not reported |
| Intravenous Infusion of BI 836909 (100 μg/d) | 0 | Not reported | Not reported | Not reported | Not reported |
| Intravenous Infusion of BI 836909 (200 μg/d) | 1 | Not reported | Not reported | Not reported | Not reported |
| Intravenous Infusion of BI 836909 (400 μg/d) | 5 | Not reported | Not reported | Not reported | Not reported |
| Intravenous Infusion of BI 836909 (800 μg/d) | 0 | Not reported | Not reported | Not reported | Not reported |
Complete response (CR)
| 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) | 0 | Not reported | Not reported | Not reported | Not reported |
| Intravenous Infusion of BI 836909 (3.2 μg/d) | 0 | Not reported | Not reported | Not reported | Not reported |
| Intravenous Infusion of BI 836909 (6.5 μg/d) | 1 | Not reported | Not reported | Not reported | Not reported |
| Intravenous Infusion of BI 836909 (13 μg/d) | 0 | Not reported | Not reported | Not reported | Not reported |
| Intravenous Infusion of BI 836909 (25 μg/d) | 0 | Not reported | Not reported | Not reported | Not reported |
| Intravenous Infusion of BI 836909 (50 μg/d) | 0 | Not reported | Not reported | Not reported | Not reported |
| Intravenous Infusion of BI 836909 (100 μg/d) | 1 | Not reported | Not reported | Not reported | Not reported |
| Intravenous Infusion of BI 836909 (200 μg/d) | 0 | Not reported | Not reported | Not reported | Not reported |
| Intravenous Infusion of BI 836909 (400 μg/d) | 0 | Not reported | Not reported | Not reported | Not reported |
| Intravenous Infusion of BI 836909 (800 μg/d) | 0 | Not reported | Not reported | Not reported | Not reported |
Very good partial response (VGPR)
| 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) | 0 | Not reported | Not reported | Not reported | Not reported |
| Intravenous Infusion of BI 836909 (3.2 μg/d) | 0 | Not reported | Not reported | Not reported | Not reported |
| Intravenous Infusion of BI 836909 (6.5 μg/d) | 0 | Not reported | Not reported | Not reported | Not reported |
| Intravenous Infusion of BI 836909 (13 μg/d) | 0 | Not reported | Not reported | Not reported | Not reported |
| Intravenous Infusion of BI 836909 (25 μg/d) | 0 | Not reported | Not reported | Not reported | Not reported |
| Intravenous Infusion of BI 836909 (50 μg/d) | 0 | Not reported | Not reported | Not reported | Not reported |
| Intravenous Infusion of BI 836909 (100 μg/d) | 0 | Not reported | Not reported | Not reported | Not reported |
| Intravenous Infusion of BI 836909 (200 μg/d) | 0 | Not reported | Not reported | Not reported | Not reported |
| Intravenous Infusion of BI 836909 (400 μg/d) | 1 | Not reported | Not reported | Not reported | Not reported |
| Intravenous Infusion of BI 836909 (800 μg/d) | 1 | Not reported | Not reported | Not reported | Not reported |
Partial response (PR)
| 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) | 0 | Not reported | Not reported | Not reported | Not reported |
| Intravenous Infusion of BI 836909 (3.2 μg/d) | 0 | Not reported | Not reported | Not reported | Not reported |
| Intravenous Infusion of BI 836909 (6.5 μg/d) | 0 | Not reported | Not reported | Not reported | Not reported |
| Intravenous Infusion of BI 836909 (13 μg/d) | 0 | Not reported | Not reported | Not reported | Not reported |
| Intravenous Infusion of BI 836909 (25 μg/d) | 0 | Not reported | Not reported | Not reported | Not reported |
| Intravenous Infusion of BI 836909 (50 μg/d) | 1 | Not reported | Not reported | Not reported | Not reported |
| Intravenous Infusion of BI 836909 (100 μg/d) | 0 | Not reported | Not reported | Not reported | Not reported |
| Intravenous Infusion of BI 836909 (200 μg/d) | 0 | Not reported | Not reported | Not reported | Not reported |
| Intravenous Infusion of BI 836909 (400 μg/d) | 1 | Not reported | Not reported | Not reported | Not reported |
| Intravenous Infusion of BI 836909 (800 μg/d) | 1 | Not reported | Not reported | Not reported | Not reported |
No response (stable disease or disease progression)
| 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) | 5 | Not reported | Not reported | Not reported | Not reported |
| Intravenous Infusion of BI 836909 (3.2 μg/d) | 3 | Not reported | Not reported | Not reported | Not reported |
| Intravenous Infusion of BI 836909 (6.5 μg/d) | 2 | Not reported | Not reported | Not reported | Not reported |
| Intravenous Infusion of BI 836909 (13 μg/d) | 3 | Not reported | Not reported | Not reported | Not reported |
| Intravenous Infusion of BI 836909 (25 μg/d) | 3 | Not reported | Not reported | Not reported | Not reported |
| Intravenous Infusion of BI 836909 (50 μg/d) | 4 | Not reported | Not reported | Not reported | Not reported |
| Intravenous Infusion of BI 836909 (100 μg/d) | 3 | Not reported | Not reported | Not reported | Not reported |
| Intravenous Infusion of BI 836909 (200 μg/d) | 2 | Not reported | Not reported | Not reported | Not reported |
| Intravenous Infusion of BI 836909 (400 μg/d) | 3 | Not reported | Not reported | Not reported | Not reported |
| Intravenous Infusion of BI 836909 (800 μg/d) | 1 | Not reported | Not reported | Not reported | Not reported |
On treatment + extended follow-up visits (follow-up
Stringent complete response (sCR)
| 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) | 0 | Not reported | Not reported | Not reported | Not reported |
| Intravenous Infusion of BI 836909 (3.2 μg/d) | 0 | Not reported | Not reported | Not reported | Not reported |
| Intravenous Infusion of BI 836909 (6.5 μg/d) | 0 | Not reported | Not reported | Not reported | Not reported |
| Intravenous Infusion of BI 836909 (13 μg/d) | 0 | Not reported | Not reported | Not reported | Not reported |
| Intravenous Infusion of BI 836909 (25 μg/d) | 0 | Not reported | Not reported | Not reported | Not reported |
| Intravenous Infusion of BI 836909 (50 μg/d) | 0 | Not reported | Not reported | Not reported | Not reported |
| Intravenous Infusion of BI 836909 (100 μg/d) | 0 | Not reported | Not reported | Not reported | Not reported |
| Intravenous Infusion of BI 836909 (200 μg/d) | 1 | Not reported | Not reported | Not reported | Not reported |
| Intravenous Infusion of BI 836909 (400 μg/d) | 5 | Not reported | Not reported | Not reported | Not reported |
| Intravenous Infusion of BI 836909 (800 μg/d) | 0 | Not reported | Not reported | Not reported | Not reported |
Complete response (CR)
| 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) | 0 | Not reported | Not reported | Not reported | Not reported |
| Intravenous Infusion of BI 836909 (3.2 μg/d) | 0 | Not reported | Not reported | Not reported | Not reported |
| Intravenous Infusion of BI 836909 (6.5 μg/d) | 1 | Not reported | Not reported | Not reported | Not reported |
| Intravenous Infusion of BI 836909 (13 μg/d) | 0 | Not reported | Not reported | Not reported | Not reported |
| Intravenous Infusion of BI 836909 (25 μg/d) | 0 | Not reported | Not reported | Not reported | Not reported |
| Intravenous Infusion of BI 836909 (50 μg/d) | 0 | Not reported | Not reported | Not reported | Not reported |
| Intravenous Infusion of BI 836909 (100 μg/d) | 1 | Not reported | Not reported | Not reported | Not reported |
| Intravenous Infusion of BI 836909 (200 μg/d) | 0 | Not reported | Not reported | Not reported | Not reported |
| Intravenous Infusion of BI 836909 (400 μg/d) | 0 | Not reported | Not reported | Not reported | Not reported |
| Intravenous Infusion of BI 836909 (800 μg/d) | 1 | Not reported | Not reported | Not reported | Not reported |
Very good partial response (VGPR)
| 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) | 0 | Not reported | Not reported | Not reported | Not reported |
| Intravenous Infusion of BI 836909 (3.2 μg/d) | 0 | Not reported | Not reported | Not reported | Not reported |
| Intravenous Infusion of BI 836909 (6.5 μg/d) | 0 | Not reported | Not reported | Not reported | Not reported |
| Intravenous Infusion of BI 836909 (13 μg/d) | 0 | Not reported | Not reported | Not reported | Not reported |
| Intravenous Infusion of BI 836909 (25 μg/d) | 0 | Not reported | Not reported | Not reported | Not reported |
| Intravenous Infusion of BI 836909 (50 μg/d) | 0 | Not reported | Not reported | Not reported | Not reported |
| Intravenous Infusion of BI 836909 (100 μg/d) | 0 | Not reported | Not reported | Not reported | Not reported |
| Intravenous Infusion of BI 836909 (200 μg/d) | 0 | Not reported | Not reported | Not reported | Not reported |
| Intravenous Infusion of BI 836909 (400 μg/d) | 1 | Not reported | Not reported | Not reported | Not reported |
| Intravenous Infusion of BI 836909 (800 μg/d) | 1 | Not reported | Not reported | Not reported | Not reported |
Partial response (PR)
| 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) | 0 | Not reported | Not reported | Not reported | Not reported |
| Intravenous Infusion of BI 836909 (3.2 μg/d) | 0 | Not reported | Not reported | Not reported | Not reported |
| Intravenous Infusion of BI 836909 (6.5 μg/d) | 0 | Not reported | Not reported | Not reported | Not reported |
| Intravenous Infusion of BI 836909 (13 μg/d) | 0 | Not reported | Not reported | Not reported | Not reported |
| Intravenous Infusion of BI 836909 (25 μg/d) | 0 | Not reported | Not reported | Not reported | Not reported |
| Intravenous Infusion of BI 836909 (50 μg/d) | 1 | Not reported | Not reported | Not reported | Not reported |
| Intravenous Infusion of BI 836909 (100 μg/d) | 0 | Not reported | Not reported | Not reported | Not reported |
| Intravenous Infusion of BI 836909 (200 μg/d) | 0 | Not reported | Not reported | Not reported | Not reported |
| Intravenous Infusion of BI 836909 (400 μg/d) | 1 | Not reported | Not reported | Not reported | Not reported |
| Intravenous Infusion of BI 836909 (800 μg/d) | 0 | Not reported | Not reported | Not reported | Not reported |
No response (stable disease or disease progression)
| 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) | 5 | Not reported | Not reported | Not reported | Not reported |
| Intravenous Infusion of BI 836909 (3.2 μg/d) | 3 | Not reported | Not reported | Not reported | Not reported |
| Intravenous Infusion of BI 836909 (6.5 μg/d) | 2 | Not reported | Not reported | Not reported | Not reported |
| Intravenous Infusion of BI 836909 (13 μg/d) | 3 | Not reported | Not reported | Not reported | Not reported |
| Intravenous Infusion of BI 836909 (25 μg/d) | 3 | Not reported | Not reported | Not reported | Not reported |
| Intravenous Infusion of BI 836909 (50 μg/d) | 4 | Not reported | Not reported | Not reported | Not reported |
| Intravenous Infusion of BI 836909 (100 μg/d) | 3 | Not reported | Not reported | Not reported | Not reported |
| Intravenous Infusion of BI 836909 (200 μg/d) | 2 | Not reported | Not reported | Not reported | Not reported |
| Intravenous Infusion of BI 836909 (400 μg/d) | 3 | Not reported | Not reported | Not reported | Not reported |
| Intravenous Infusion of BI 836909 (800 μg/d) | 1 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 1
- group Id
- OG008
- value
- 5
- group Id
- OG009
- value
- 0
- title
- Stringent complete response (sCR)
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 1
- group Id
- OG007
- value
- 0
- group Id
- OG008
- value
- 0
- group Id
- OG009
- value
- 0
- title
- Complete response (CR)
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 0
- group Id
- OG008
- value
- 1
- group Id
- OG009
- value
- 1
- title
- Very good partial response (VGPR)
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 1
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 0
- group Id
- OG008
- value
- 1
- group Id
- OG009
- value
- 1
- title
- Partial response (PR)
- measurements
- group Id
- OG000
- value
- 5
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 2
- group Id
- OG003
- value
- 3
- group Id
- OG004
- value
- 3
- group Id
- OG005
- value
- 4
- group Id
- OG006
- value
- 3
- group Id
- OG007
- value
- 2
- group Id
- OG008
- value
- 3
- group Id
- OG009
- value
- 1
- title
- No response (stable disease or disease progression)
- title
- On treatment
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 1
- group Id
- OG008
- value
- 5
- group Id
- OG009
- value
- 0
- title
- Stringent complete response (sCR)
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 1
- group Id
- OG007
- value
- 0
- group Id
- OG008
- value
- 0
- group Id
- OG009
- value
- 1
- title
- Complete response (CR)
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 0
- group Id
- OG008
- value
- 1
- group Id
- OG009
- value
- 1
- title
- Very good partial response (VGPR)
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 1
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 0
- group Id
- OG008
- value
- 1
- group Id
- OG009
- value
- 0
- title
- Partial response (PR)
- measurements
- group Id
- OG000
- value
- 5
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 2
- group Id
- OG003
- value
- 3
- group Id
- OG004
- value
- 3
- group Id
- OG005
- value
- 4
- group Id
- OG006
- value
- 3
- group Id
- OG007
- value
- 2
- group Id
- OG008
- value
- 3
- group Id
- OG009
- value
- 1
- title
- No response (stable disease or disease progression)
- title
- On treatment + extended follow-up visits (follow-up
- 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
- Objective responses: Stringent complete response (sCR): CR + normal Free light chain (FLC) ratio and no clonal cells in bone marrow by immunohistochemistry or immunofluorescence. CR: negative immunofixation on serum and urine, disappearance of soft tissue plasmacytomas, and \<5% plasma cells in bone marrow. Very good partial response (VGPR): serum and urine M protein detectable by immunofixation but not on electrophoresis or \>90% reduction in serum M protein plus urine M protein level \<100 mg/24h. PR: \>50% reduction of serum and 24 h urinary M protein by \>90% or to \<200mg/24h. If unmeasurable, a \>50% decrease in difference between involved and uninvolved FLC levels instead of M protein criteria. if FLC assay was not measurable, a \>50% reduction in plasma cells was required instead of M protein, provided baseline bone marrow plasma cell was \>30%. In addition to the listed criteria, a \>50% reduction in the size of soft tissue plasmacytomas was also required, if present at baseline.
- 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
- COUNT_OF_PARTICIPANTS
- population Description
- Treated set (TS): all patients who were administered trial medication.
- reporting Status
- POSTED
- time Frame
- On-treatment: From start of treatment till end of trial (EOT) visit, up to 61 weeks. Extended follow-up: From start of treatment till the last extended follow-up visit which was scheduled at 12 months after end of treatment, up to 113 weeks.
- title
- Number of Participants With an Objective Response
- type
- SECONDARY
- unit Of Measure
- Participants
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Preserved source evidence · Not medical advice