ALANIS
Research type
Research Study
Full title
A Phase 2, open-label, randomized, dose optimization study evaluating the efficacy and safety of belantamab mafodotin administered in combination with cyclophosphamide, bortezomib, and dexamethasone in adult participants with newly diagnosed amyloid light chain amyloidosis (ALANIS)
IRAS ID
1013153
Contact name
Kelly Wang
Contact email
Sponsor organisation
GlaxoSmithKline Research & Development Limited
Eudract number
2025-522803-60
Clinicaltrials.gov Identifier
Research summary
Amyloid light chain (AL) amyloidosis is a rare condition where an abnormal protein called amyloid builds up in organs like the heart, kidneys, and liver, causing damage and affecting their function. These proteins are made up of light chains, which are normally part of healthy antibodies, produced by cells called plasma cells, found in the bone marrow; however, in AL amyloidosis, too many, abnormal, light chains are produced. Current treatments aim to stop the production of these excess light chains, following which the body may slowly break down the amyloid build-up within organs; however, outcomes can vary from person to person, and some organ damage may persist.
This study will involve participants with newly diagnosed AL amyloidosis to test how well a new treatment combination named belantamab mafodotin with cyclophosphamide, bortezomib, and dexamethasone (CyBorD) works. The main goal of the study is to evaluate the safety and how the new combination helps in improving the condition. This study could provide important insights into how participants respond to this treatment combination and could help enhance treatment strategies for future care.
This is an open-label study, meaning both the researchers and participants will know which treatment is being given. In the first part of the study (dose optimisation phase), participants will be randomly assigned to one of two different doses of belantamab mafodotin along with CyBorD. After a few months, treatment will continue with belantamab mafodotin alone. About 6 months into the treatment, researchers will review the results to decide which dose works best and is safest.
In the next part of the study (dose expansion phase), additional participants will receive the dose that is chosen as the best from the first part of the study.
Participants will be closely monitored throughout the study to ensure safety.REC name
East of England - Cambridge East Research Ethics Committee
REC reference
26/EE/0073
Date of REC Opinion
17 Apr 2026
REC opinion
Further Information Favourable Opinion