NCT07150104 · OUTCOME
DE Phase: Number of Participants With Post-baseline Positive Anti-drug Antibodies (ADAs) Against Belantamab Mafodotin
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
- Up to 137 weeks
What was measured
Serum samples 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
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 | 14 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| 0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Pomalidomide + Dexamethasone | 1 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 1
- denoms
- counts
- group Id
- OG000
- value
- 14
- units
- Participants
- description
- Serum samples 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.
- 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
- COUNT_OF_PARTICIPANTS
- population Description
- Safety population
- reporting Status
- POSTED
- time Frame
- Up to 137 weeks
- title
- DE Phase: Number of Participants With Post-baseline Positive Anti-drug Antibodies (ADAs) Against Belantamab Mafodotin
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
Triangle