9
Participants
Start Date
October 4, 2022
Primary Completion Date
October 31, 2026
Study Completion Date
October 31, 2026
Belantamab Mafodotin
Belantamab mafodotin will be administered via IV infusion in an outpatient setting on Day 1 of Cycles 1-3. Treatment with belantamab mafodotin will be given at an initial dose of 1.0 mg/kg. The study will have a 3+3 dose escalation design for belantamab mafodotin. Belantamab mafodotin dose levels are 1.0 mg/kg, 1.4 mg/kg, and 1.9 mg/kg
Nirogacestat
1:1 randomization between nirogacestat 100mg BID or 100 mg QD during the 4 day run-in period. Treatment with nirogacestat will be 100mg BID continuously during each cycle for all subjects.
Pomalidomide
After the 4-day run-in period, all patients will receive nirogacestat in combination with belantamab, mafodotin and pomalidomide. Pomalidomide was added for day 1-14 for cycle 1-3 and day 1-14 and day 21-35 for C4+.
Memorial Sloan Kettering Cancer Center (All Protocol Activities), New York
Memorial Sloan Kettering Westchester (Limited Protocol Activities), Harrison
Memorial Sloan Kettering Nassau (Limited Protocol Activities), Uniondale
Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (Limited protocol activities), Commack
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities), Basking Ridge
Memorial Sloan Kettering Monmouth (Limited Protocol Activities), Middletown
Memorial Sloan Kettering Bergen (Limited Protocol Activities), Montvale
Memorial Sloan Kettering Cancer Center
OTHER