TriangleNCT07150104 · 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 137 weeks
What was measured
Serum samples were collected for the analysis of the presence of ADAs using validated immunoassays. All samples were further 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
0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Pomalidomide + Dexamethasone
Participants with Relapsed/Refractory Multiple Myeloma (RRMM) received 0.5 mg/kg belantamab mafodotin intravenous (IV) infusion as powder for solution once every 4 weeks (Q4W) infused over 30- 60 minutes on day 1 of each 28-day cycle in combination with 100 mg Nirogacestat administered orally twice a day (BID) up to Day 28. Along with 4 mg Pomalidomide orally per day (QD) on Days 1-21 of each 28-day cycle and Dexamethasone 40mg (20 mg for participants \>75 years old or BMI \<18.5 kg/m\^2) administered orally on days 1, 8, 15 and 22 of each 28-day cycle.
| Group | Source count |
|---|---|
| 0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Pomalidomide + Dexamethasone | 1 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| 0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Pomalidomide + Dexamethasone | 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
- OG000
- lower Limit
- NA
- upper Limit
- NA
- value
- 100
- denoms
- counts
- group Id
- OG000
- value
- 1
- units
- Participants
- description
- Serum samples were collected for the analysis of the presence of ADAs using validated immunoassays. All samples were further 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 0.5 mg/kg belantamab mafodotin intravenous (IV) infusion as powder for solution once every 4 weeks (Q4W) infused over 30- 60 minutes on day 1 of each 28-day cycle in combination with 100 mg Nirogacestat administered orally twice a day (BID) up to Day 28. Along with 4 mg Pomalidomide orally per day (QD) on Days 1-21 of each 28-day cycle and Dexamethasone 40mg (20 mg for participants \>75 years old or BMI \<18.5 kg/m\^2) administered orally on days 1, 8, 15 and 22 of each 28-day cycle.
- id
- OG000
- title
- 0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Pomalidomide + Dexamethasone
- 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 137 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