NCT07217119 · OUTCOME
DE Phase: Titer of ADAs Against Belantamab Mafodotin
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- Titer
- Interval / dispersion
- Full Range
- Time frame
- Up to approximately 281 weeks
What was measured
Serum samples were collected for the analysis of the presence of ADAs using validated immunoassays. All samples were tested in screening assay, and positive samples were further characterized for antibody titers.
Analysis population: Safety population. Only those participants with positive post-baseline antibody against belantamab mafodotin were analyzed.
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 | 0 |
| 2.5 mg/kg Belantamab Mafodotin + 8 mg Feladilimab | 1 |
| 2.5 mg/kg Belantamab Mafodotin + 24 mg Feladilimab | 0 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| 2.5 mg/kg Belantamab Mafodotin + 8 mg Feladilimab | 100 | Not reported | NA | NA | Full range is not applicable as only a single participant was analyzed. Median value presented here is the actual titer value for this single participant. |
Complete source fields
- classes
- categories
- measurements
- comment
- Full range is not applicable as only a single participant was analyzed. Median value presented here is the actual titer value for this single participant.
- group Id
- OG001
- lower Limit
- NA
- upper Limit
- NA
- value
- 100
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 0
- units
- Participants
- description
- Serum samples were collected for the analysis of the presence of ADAs using validated immunoassays. All samples were tested in screening assay, and positive samples were further characterized for antibody titers.
- dispersion Type
- Full Range
- 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
- MEDIAN
- population Description
- Safety population. Only those participants with positive post-baseline antibody against belantamab mafodotin were analyzed.
- reporting Status
- POSTED
- time Frame
- Up to approximately 281 weeks
- title
- DE Phase: Titer of ADAs Against Belantamab Mafodotin
- type
- SECONDARY
- unit Of Measure
- Titer
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
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