NCT04177823

A Study of Belantamab Mafodotin to Investigate Safety, Tolerability, Pharmacokinetics, Immunogenicity and Clinical Activity in Participants With Relapsed/Refractory Multiple Myeloma (RRMM)

A Phase I Open-label, Dose Escalation Study to Investigate the Safety, Tolerability, Pharmacokinetics, Immunogenicity and Clinical Activity of the Antibody Drug Conjugate GSK2857916 in Chinese Participants With Relapsed/Refractory Multiple Myeloma Who Have Failed At Least Two Lines of Previous Treatment, Containing an Alkylator, a Proteasome Inhibitor and an Immunomodulatory Agent

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Multiple myeloma (MM) is a neoplastic plasma cell disorder that is characterized by osteolytic bone lesions, anemia, hypercalcemia and renal failure. belantamab mafodotin was well tolerated in previous studies with at least one dose of belantamab mafodotin in heavily pre-treated participants with relapsed/refractory multiple myeloma (RRMM). This aim of the study is to explore safety, pharmacokinetics (PK), tolerability, immunogenicity and clinical activity of belantamab mafodotin monotherapy in Chinese participants with RRMM who have received at least 2 prior line of anti-myeloma therapy including an alkylator, a proteasome inhibitor (PI) and an immunomodulatory agent (IMiD). This study will include two dose cohorts 2.5 milligram per kilogram (mg/kg) and 3.4 mg/kg. A maximum of 12 participants will be enrolled, 6 each for 2.5 mg/kg cohort and 3.4 mg/kg cohort based on 3+3 design. Participants will be treated until disease progression, intolerable toxicity, end of study or informed consent withdrawal.

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
DRUG	Belantamab mafodotin	Belantamab mafodotin will be available as lyophilized powder 100 mg/vial in single-use vial for reconstitution. It will be administered at a calculated dose of 2.5 mg/kg or 3.4 mg/kg as an IV infusion on Day 1 of each cycle over 30 minutes.

Timeline

• Start date: 2019-12-09
• Primary completion: 2021-12-30
• Completion: 2021-12-30
• First posted: 2019-11-26
• Last updated: 2025-03-20
• Results posted: 2024-04-19

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study