TriangleNCT07217119 · OUTCOME
DE Phase: Overall Response Rate (ORR)
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
- Up to approximately 281 weeks.
What was measured
Overall Response Rate (ORR) was defined as the percentage of participants with a confirmed Partial Response (PR) or better as the best overall response (i.e., PR, Very Good Partial Response \[VGPR\], Complete Response \[CR\], and stringent Complete Response \[sCR\]), as assessed by the investigator per international myeloma working group (IMWG) (2016). PR is defined as ≥50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥90% or to \<200 mg/24 h. VGPR is defined as serum and urine M-component detectable by immunofixation but not on electrophoresis OR ≥ 90% reduction in serum M-component plus urine M-component \<100 mg/24 h. CR is defined as negative immunofixation of serum and urine AND disappearance of any soft tissue plasmacytomas AND \<5% plasmacytomas in the bone marrow. sCR is defined as CR as above PLUS normal serum free light-chain (FLC) assay ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence.
Analysis population: Safety population
Groups in this outcome
1.9 mg/kg Belantamab Mafodotin + 8 mg Feladilimab
Participants with Relapsed/Refractory Multiple Myeloma (RRMM) received 1.9 milligram (mg)/kilogram (kg) of belantamab mafodotin intravenous (IV) infusion in combination with 8 mg feladilimab IV infusion, given 1 hour after belantamab mafodotin end of infusion (EOI), once every 3 weeks (Q3W).
2.5 mg/kg Belantamab Mafodotin + 8 mg Feladilimab
Participants with RRMM received 2.5 mg/kg belantamab mafodotin IV infusion in combination with 8 mg feladilimab IV infusion, given 1 hour after belantamab mafodotin EOI Q3W.
2.5 mg/kg Belantamab Mafodotin + 24 mg Feladilimab
Participants with RRMM received 2.5 mg/kg belantamab mafodotin IV infusion in combination with 24 mg feladilimab IV infusion, given 1 hour after belantamab mafodotin EOI Q3W.
| Group | Source count |
|---|---|
| 1.9 mg/kg Belantamab Mafodotin + 8 mg Feladilimab | 9 |
| 2.5 mg/kg Belantamab Mafodotin + 8 mg Feladilimab | 10 |
| 2.5 mg/kg Belantamab Mafodotin + 24 mg Feladilimab | 6 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| 1.9 mg/kg Belantamab Mafodotin + 8 mg Feladilimab | 44 | Not reported | 13.7 | 78.8 | Not reported |
| 2.5 mg/kg Belantamab Mafodotin + 8 mg Feladilimab | 50 | Not reported | 18.7 | 81.3 | Not reported |
| 2.5 mg/kg Belantamab Mafodotin + 24 mg Feladilimab | 67 | Not reported | 22.3 | 95.7 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 13.7
- upper Limit
- 78.8
- value
- 44
- group Id
- OG001
- lower Limit
- 18.7
- upper Limit
- 81.3
- value
- 50
- group Id
- OG002
- lower Limit
- 22.3
- upper Limit
- 95.7
- value
- 67
- denoms
- counts
- group Id
- OG000
- value
- 9
- group Id
- OG001
- value
- 10
- group Id
- OG002
- value
- 6
- units
- Participants
- description
- Overall Response Rate (ORR) was defined as the percentage of participants with a confirmed Partial Response (PR) or better as the best overall response (i.e., PR, Very Good Partial Response \[VGPR\], Complete Response \[CR\], and stringent Complete Response \[sCR\]), as assessed by the investigator per international myeloma working group (IMWG) (2016). PR is defined as ≥50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥90% or to \<200 mg/24 h. VGPR is defined as serum and urine M-component detectable by immunofixation but not on electrophoresis OR ≥ 90% reduction in serum M-component plus urine M-component \<100 mg/24 h. CR is defined as negative immunofixation of serum and urine AND disappearance of any soft tissue plasmacytomas AND \<5% plasmacytomas in the bone marrow. sCR is defined as CR as above PLUS normal serum free light-chain (FLC) assay ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants with Relapsed/Refractory Multiple Myeloma (RRMM) received 1.9 milligram (mg)/kilogram (kg) of belantamab mafodotin intravenous (IV) infusion in combination with 8 mg feladilimab IV infusion, given 1 hour after belantamab mafodotin end of infusion (EOI), once every 3 weeks (Q3W).
- id
- OG000
- title
- 1.9 mg/kg Belantamab Mafodotin + 8 mg Feladilimab
- description
- Participants with RRMM received 2.5 mg/kg belantamab mafodotin IV infusion in combination with 8 mg feladilimab IV infusion, given 1 hour after belantamab mafodotin EOI Q3W.
- id
- OG001
- title
- 2.5 mg/kg Belantamab Mafodotin + 8 mg Feladilimab
- description
- Participants with RRMM received 2.5 mg/kg belantamab mafodotin IV infusion in combination with 24 mg feladilimab IV infusion, given 1 hour after belantamab mafodotin EOI Q3W.
- id
- OG002
- title
- 2.5 mg/kg Belantamab Mafodotin + 24 mg Feladilimab
- param Type
- NUMBER
- population Description
- Safety population
- reporting Status
- POSTED
- time Frame
- Up to approximately 281 weeks.
- title
- DE Phase: Overall Response Rate (ORR)
- type
- SECONDARY
- unit Of Measure
- Percentage of Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice