{"groups":[{"description":"In DE Phase, participants with Relapsed/Refractory Multiple Myeloma (RRMM) received 0.95 milligram (mg)/kilogram (kg) belantamab mafodotin intravenous (IV) infusion as powder for solution once every 3 weeks (Q3W) infused over 30- 60 minutes on day 1 of 21-day cycles in combination with 100 mg nirogacestat administered twice a day (BID) on day 1, 4, 8 and 15 of 21-day cycles. Treatment was administered until disease progression, intolerable toxicity, informed consent withdrawal, the end of the sub-study or death.","id":"FG000","title":"DE Phase: 0.95 mg/kg Belantamab Mafodotin + Nirogacestat"},{"description":"In DE Phase, participants with RRMM received 1.9 mg/ kg belantamab mafodotin IV infusion as powder for solution once Q3W infused over 30- 60 minutes on day 1 of 21-day cycles in combination with 100 mg nirogacestat administered BID on day 1, 4, 8 and 15 of 21-day cycles. Treatment was administered until disease progression, intolerable toxicity, informed consent withdrawal, the end of the sub-study or death.","id":"FG001","title":"DE Phase: 1.9 mg/kg Belantamab Mafodotin+ Nirogacestat"},{"description":"In DE Phase, participants with RRMM received 1.0 mg/ kg belantamab mafodotin IV infusion as powder for solution once every 4 weeks (Q4W) for Cycle 1-2 and then once every 8 weeks (Q8W) from Cycle 2 onwards, infused over 30- 60 minutes on day 1 of 28-day cycles in Q4W and 56-day cycle in Q8W in combination with 100 mg nirogacestat BID on day 1, 4, 8 and 15 of 21-day cycles. Treatment was administered until disease progression, intolerable toxicity, informed consent withdrawal, the end of the sub-study or death.","id":"FG002","title":"DE Phase: 1.0 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID"},{"description":"In DE Phase, participants with RRMM received 1.4 mg/ kg belantamab mafodotin IV infusion as powder for solution Q4W for Cycle 1 and then Q8W from Cycle2 onwards, infused over 30- 60 minutes on day 1 of 21-day cycles in combination with 100 mg nirogacestat BID on day 1, 4, 8 and 15 of 21-day cycles. Treatment was administered until disease progression, intolerable toxicity, informed consent withdrawal, the end of the sub-study or death.","id":"FG003","title":"DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID"},{"description":"In DE Phase, participants with RRMM received 1.4 mg/ kg belantamab mafodotin IV infusion as powder for solution Q4W, infused over 30- 60 minutes on day 1 of 28-day cycles in combination with 100 mg nirogacestat BID on day 1, 4, 8 and 15 of 21-day cycles. Treatment was administered until disease progression, intolerable toxicity, informed consent withdrawal, the end of the sub-study or death.","id":"FG004","title":"DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W + Nirogacestat BID"},{"description":"In CE Phase, Participants with RRMM received 0.95 mg/ kg belantamab mafodotin IV infusion as powder for solution once every 3 weeks (Q3W), infused over 30- 60 minutes on day 1 of 21-day cycles in combination with 100 mg nirogacestat BID on day 1, 4, 8 and 15 of 21-day cycles. Treatment was administered until disease progression, intolerable toxicity, informed consent withdrawal, the end of the sub-study or death.","id":"FG005","title":"CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat"},{"description":"In CE Phase, Participants with RRMM received 2.5 mg/ kg belantamab mafodotin IV infusion as powder for solution Q3W, infused over 30- 60 minutes on day 1 of 21-day cycles until disease progression, intolerable toxicity, informed consent withdrawal, the end of the sub-study or death.","id":"FG006","title":"CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"0"},{"groupId":"FG005","numSubjects":"0"},{"groupId":"FG006","numSubjects":"1"}],"type":"Lost to Follow-up"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"1"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"0"},{"groupId":"FG005","numSubjects":"2"},{"groupId":"FG006","numSubjects":"1"}],"type":"Physician Decision"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"1"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"1"},{"groupId":"FG005","numSubjects":"7"},{"groupId":"FG006","numSubjects":"9"}],"type":"Withdrawal by Subject"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"2"},{"groupId":"FG003","numSubjects":"2"},{"groupId":"FG004","numSubjects":"0"},{"groupId":"FG005","numSubjects":"1"},{"groupId":"FG006","numSubjects":"2"}],"type":"Ongoing at the time of analysis"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"10"},{"groupId":"FG001","numSubjects":"4"},{"groupId":"FG002","numSubjects":"10"},{"groupId":"FG003","numSubjects":"10"},{"groupId":"FG004","numSubjects":"1"},{"groupId":"FG005","numSubjects":"34"},{"groupId":"FG006","numSubjects":"37"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"8"},{"groupId":"FG001","numSubjects":"3"},{"groupId":"FG002","numSubjects":"6"},{"groupId":"FG003","numSubjects":"7"},{"groupId":"FG004","numSubjects":"1"},{"groupId":"FG005","numSubjects":"28"},{"groupId":"FG006","numSubjects":"36"}],"comment":"DLT Evaluable Population included participants in DE phase who have received at least 80% of all components of the intended dose of treatment in cycle 1 and were followed up for a period of one cycle length or withdrawn within the first cycle due to an AE meeting the definition of a DLT.","type":"DLT Evaluable Population"},{"achievements":[{"groupId":"FG000","numSubjects":"10"},{"groupId":"FG001","numSubjects":"4"},{"groupId":"FG002","numSubjects":"10"},{"groupId":"FG003","numSubjects":"10"},{"groupId":"FG004","numSubjects":"1"},{"groupId":"FG005","numSubjects":"34"},{"groupId":"FG006","numSubjects":"37"}],"comment":"Safety population included all participants who received at least 1 dose of any component of the combination therapy.","type":"Safety Population"},{"achievements":[{"groupId":"FG000","numSubjects":"10"},{"groupId":"FG001","numSubjects":"4"},{"groupId":"FG002","numSubjects":"10"},{"groupId":"FG003","numSubjects":"10"},{"groupId":"FG004","numSubjects":"1"},{"groupId":"FG005","numSubjects":"34"},{"groupId":"FG006","numSubjects":"37"}],"comment":"Pharmacokinetic population included all participants in the safety population from whom at least one PK sample has been obtained and analysed.","type":"Pharmacokinetic Population"},{"achievements":[{"groupId":"FG000","numSubjects":"8"},{"groupId":"FG001","numSubjects":"4"},{"groupId":"FG002","numSubjects":"6"},{"groupId":"FG003","numSubjects":"8"},{"groupId":"FG004","numSubjects":"0"},{"groupId":"FG005","numSubjects":"24"},{"groupId":"FG006","numSubjects":"24"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"4"},{"groupId":"FG003","numSubjects":"2"},{"groupId":"FG004","numSubjects":"1"},{"groupId":"FG005","numSubjects":"10"},{"groupId":"FG006","numSubjects":"13"}],"type":"NOT COMPLETED"}],"title":"Overall Study"}],"preAssignmentDetails":"The results presented are based on the data cut-off date of 17 Apr 2025. Those participants still benefiting from study drug in the opinion of their treating physician continue to receive study drug in Post Analysis Continuation of Treatment (PACT) phase and their safety data will be provided within a year of study completion.","recruitmentDetails":"This is a sub-study of the master study NCT04126200. The sub-study included two phases - Dose Escalation (DE) and Cohort Expansion (CE)."}