EMN27
Research type
Research Study
Full title
A phase 2 study of Belantamab Mafodotin in patients with relapsed or refractory AL amyloidosis
IRAS ID
291812
Contact name
Ashutosh Wechalekar
Contact email
Sponsor organisation
European Myeloma Network – EMN
Eudract number
2020-004001-32
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 5 months, 2 days
Research summary
What is the efficacy and safety of BLMF in patients with relapsed or refractory AL amyloidosis?
Systemic light-chain (AL) amyloidosis is a rare disorder caused by the deposition of abnormal proteins called amyloid fibrils that accumulate in the body tissues and lead to multiple organs' failure. The aim of the therapy is to eliminate the abnormal, amyloid fibrils-producing cells.The tested drug, Belantamab mafodotin (BLMF), has a dual mechanism of action. First, it leads to the death of abnormal cells (a process known as apoptosis). Second, BLMF activates an immune defense mechanism (called antibody-dependent cell-mediated cytotoxicity) that eliminates abnormal cells.
The objective of the study is to evaluate the efficacy and safety of BLMF in patients with AL amyloidosis resistant to other existing treatments. This is a phase II clinical study founded by European Myeloma Network. It follows a phase I clinical study (First in Human Study) that included 80 participants with Multiple Myeloma and non-Hodgkins Lymphoma and showed initial safety and health benefit of the BLMF therapy.
During the study, BLMF will be administered to all enrolled patients intravenously every 6 weeks, for maximum 48 weeks (12 months). The medical doctor will monitor all patients and will terminate the therapy if negative health outcomes occur. An ophthalmologist will perform an assessment of vision changes. Patients will receive preservative-free artificial tears for the full time of the study and cooling eye masks during BLMF infusions. Health of each patient will be assessed during regular visits, covering: heart function using electrocardiogram (ECG), vital signs, physical exam, blood tests (including serology for Hepatitis B, Hepatitis C, and HIV), and bone marrow biopsy.
Patients will be enrolled in multiple medical clinics, and the eligibility requirements include: confirmed and previously treated AL amyloidosis, symptomatic organ involvement, and age of at least 18 years old. Pregnancy, breast feeding, and active intention to conceive a baby (males and females) are excluding criteria for this study.REC name
London - City & East Research Ethics Committee
REC reference
21/LO/0420
Date of REC Opinion
7 Jul 2021
REC opinion
Further Information Favourable Opinion