NCT05280275

A Study to Investigate the Safety and Clinical Activity of Belantamab Mafodotin in Combination With Daratumumab, Lenalidomide and Dexamethasone in Patients With Newly Diagnosed Multiple Myeloma Transplant Ineligible

A Phase 1/2, Dose and Schedule Evaluation Study to Investigate the Safety and Clinical Activity of Belantamab Mafodotin Administered in Combination With Daratumumab, Lenalidomide and Dexamethasone in Patients With Newly Diagnosed Multiple Myeloma Transplant Ineligible (EAE 120)

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: Hellenic Society of Hematology · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a phase 1/2, open label, study designed to assess the safety and clinical activity of different belantamab mafodotin doses in combination with daratumumab, lenalidomide and dexamethasone. The study will evaluate different doses of belantamab mafodotin in combination with daratumumab, lenalidomide and dexamethasone in 2 cohorts and will determine the recommended phase 2 dose (RP2D) to be further evaluated for safety and clinical activity in the dose expansion cohort. The RP2D dose will be used for future studies in the transplant ineligible newly diagnosed multiple myeloma setting. Overall, approximately 36 participants will be enrolled in the study. Participant follow-up will continue up to 3 years after the last participant is randomized. The estimated accrual period will be 12 months corresponding to an approximate total study duration of 4 years.

Conditions

• Multiple Myeloma
• Neoplasms
• Neoplasms, Plasma Cell
• Gammopathy, Monoclonal
• Paraproteinemias
• Blood Protein Disorders
• Haematologic Disease
• Corneal Disease

Interventions

Type	Name	Description
DRUG	Belantamab Mafodotin-Blmf	Blmf will be available as 100 mg/vial in single-use vial for reconstitution, supplied as lyophilized powder. Blmf will be delivered as IV solution over at least 30 minutes.
DRUG	Daratumumab	Daratumumab will be administered with subcutaneous injections. On days where Blmf is given together with daratumumab, daratumumab should be performed first.
DRUG	Lenalidomide	Lenalidomide will be administered per os.
DRUG	Dexamethasone	Dexamethasone will be administered intravenously or per os.

Timeline

• Start date: 2022-04-13
• Primary completion: 2026-03-15
• Completion: 2026-03-15
• First posted: 2022-03-15
• Last updated: 2023-12-01

Locations

2 sites across 1 country: Greece