A Study of Belantamab Mafodotin in Combination With Nirogacestat and Pomalidomide in People With Multiple Myeloma That Has Not Responded to Treatment or Has Come Back After Treatment

PHASE1Active, not recruitingINTERVENTIONAL
Enrollment

9

Participants

Timeline

Start Date

October 4, 2022

Primary Completion Date

October 31, 2026

Study Completion Date

October 31, 2026

Conditions
Multiple Myeloma
Interventions
DRUG

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

DRUG

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.

DRUG

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+.

Trial Locations (7)

10065

Memorial Sloan Kettering Cancer Center (All Protocol Activities), New York

10604

Memorial Sloan Kettering Westchester (Limited Protocol Activities), Harrison

11553

Memorial Sloan Kettering Nassau (Limited Protocol Activities), Uniondale

11725

Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (Limited protocol activities), Commack

07920

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities), Basking Ridge

07748

Memorial Sloan Kettering Monmouth (Limited Protocol Activities), Middletown

07645

Memorial Sloan Kettering Bergen (Limited Protocol Activities), Montvale

All Listed Sponsors
lead

Memorial Sloan Kettering Cancer Center

OTHER