NCT05556798

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

Belantamab Mafodotin in Combination With Nirogacestat and Pomalidomide in Patients With Relapsed or Refractory Multiple Myeloma

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Memorial Sloan Kettering Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to find out whether combination treatment with the study drugs belantamab mafodotin, nirogacestat, and pomalidomide is a safe treatment for people who have relapsed or refractory multiple myeloma. The researchers will test different doses of belantamab mafodotin to find the safest dose to give with nirogacestat and pomalidomide. The researchers also want to find out whether belantamab mafodotin plus nirogacestat and pomalidomide is an effective treatment for this type of bone marrow cancer, and the researchers will do tests that show whether the study treatment slows or stops the growth of cancer.

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
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+.

Timeline

• Start date: 2022-10-04
• Primary completion: 2026-10-01
• Completion: 2026-10-01
• First posted: 2022-09-27
• Last updated: 2026-02-24

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated drug study