NCT04808037

Blmf, Lenalidomide and Dexamethasone in Transplant-ineligible Patients With Newly Diagnosed Multiple Myeloma

A Phase 1/2 Study of Belantamab Mafodotin in Combination With Lenalidomide and Dexamethasone in Transplant-ineligible Patients With Newly Diagnosed Multiple Myeloma

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 66 (actual)
• 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 lenalidomide and dexamethasone.

Detailed description

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 lenalidomide and dexamethasone. The study is comprised of two distinct parts: Part 1 will evaluate different doses of belantamab mafodotin in combination with lenalidomide and dexamethasone in up to 3 cohorts and will determine the recommended Phase 2 dose (RP2D) to be further evaluated for safety and clinical activity in the dose expansion cohort (Part 2). The RP2D dose will be used for future studies in the transplant-ineligible newly diagnosed MM setting. Part 2 of the study will also evaluate an alternative dose modification guideline for corneal adverse events. Participants will undergo visits and assessments in accordance with the Schedule of Assessments (SoA). Overall, approximately 66 participants will be enrolled in the study. Participant follow up will continue until 5 years after the last participant is randomized. The estimated accrual period will be 12 months corresponding to an approximate total study duration of 6 years.

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
DRUG	Belantamab mafodotin	Belantamab mafodotin in combination with Lenalidomide and Dexamethasone in patients with newly diagnosed Multiple Myeloma transplant-ineligible

Timeline

• Start date: 2021-02-22
• Primary completion: 2028-09-08
• Completion: 2028-11-08
• First posted: 2021-03-19
• Last updated: 2023-10-24

Locations

1 site across 1 country: Greece