AuthorisedTherapeutic exploratory (Phase II)Interventional

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)

AL amyloidosis is a rare condition where abnormal proteins build up in organs such as the heart, kidneys, and liver. The standard treatment uses a combination of three medicines known as cyclophosphamide, bortezomib, and dexamethasone. This Phase 2 clinical trial is looking at what happens when a newer targeted medicine, belantamab mafodotin, is added to this standard mix. Belantamab mafodotin specifically targets the abnormal bone marrow cells that produce the harmful proteins. The main goal is to find the best dose and find out how effectively this combination clears the abnormal proteins from the blood. Doctors will also check whether it helps damaged organs recover and monitor any side effects closely, especially changes in eye health and vision, to ensure the treatment is as safe as possible.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

Glaxosmithkline Research & Development Limited

Enrolment target

Start

21 Jul 2026

newly diagnosed amyloid light chain amyloidosis

What is this study about?

Amyloid light chain (AL) amyloidosis is a rare condition that begins in the bone marrow. Special white blood cells start making faulty proteins called light chains. These proteins can clump together into deposits called amyloid, which build up in vital organs like the heart, kidneys, and liver. Over time, this buildup stops the organs from working properly.

Currently, the usual first treatment in the UK aims to stop these faulty cells using a mix of three medications: cyclophosphamide, bortezomib, and dexamethasone. While this treatment can work well, doctors are looking for ways to clear the harmful proteins more quickly and completely. This study tests whether adding a targeted medicine called belantamab mafodotin makes the treatment work better.

Belantamab mafodotin is designed to seek out and attach directly to the faulty cells, delivering a medicine that destroys them while trying to spare healthy cells. Because this is a dose-finding study, researchers also want to determine the safest and most effective amount of the new medicine to give, so patients get the maximum benefit with the fewest side effects.

Key takeaways

The ALANIS study tests whether adding belantamab mafodotin to standard treatment improves outcomes for newly diagnosed AL amyloidosis.
It aims to find the most effective and safest dose of the new medicine.
Researchers will monitor how well the treatment clears abnormal proteins and helps affected organs like the heart and kidneys.
Because the study drug can cause eye changes, regular vision checks with an eye doctor are a key safety measure.
Taking part is completely voluntary and you can withdraw at any time.

Who may be eligible?

This trial is open to adults aged 18 and over who have recently been diagnosed with AL amyloidosis. Because it is designed for initial treatment, it is meant for people who have not yet received chemotherapy or targeted therapy for their amyloidosis.

To take part, participants must have evidence of abnormal light chain proteins in their blood and have amyloid deposits affecting one or more organs, such as their kidneys or heart.

Patients will need to be well enough to attend regular clinic appointments and take part in health checks. Because the study drug can affect the surface of the eye, participants must also be willing to have regular eye examinations.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

I am aged 18 or older.
I have been newly diagnosed with AL amyloidosis.
I have not yet started treatment for this condition.
I have one or more organs (such as kidneys or heart) affected by amyloid deposits.
I am able and willing to attend regular hospital appointments and eye tests.

Answer every question to see your result.

What does participation involve?

If you decide to join this study, you will receive the study treatment in cycles, usually lasting a few weeks at a time. The standard medicines are given either as injections just under the skin, through a drip into a vein, or as tablets to swallow at home. The study drug, belantamab mafodotin, is given as a drip into a vein at the clinic.

You will need to visit the hospital regularly for health checks. These visits will include blood and urine tests to see how your organs are working, physical examinations, heart scans, and specialised eye tests to check your vision. Your medical team will monitor you closely during treatment and continue to follow up with you afterwards to track your long-term health. The total time you spend in the trial will depend on how well your body responds to the treatment.

Potential risks and benefits

The possible benefit of taking part is that the new drug combination may clear the harmful amyloid proteins more completely than standard treatment alone, potentially protecting your organs. However, there is no guarantee that this treatment will work for you. As with any clinical trial, there are risks of side effects. Belantamab mafodotin can cause changes to the surface of the eye, which may lead to dry eyes, blurred vision, or sight changes. Other side effects may include tiredness, low blood counts, nausea, and an increased risk of infections. Taking part is completely voluntary, and you are free to leave the trial at any time without your normal medical care being affected.

Locations (3)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Italy
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Unverified
Greece
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Unverified
Spain

Common questions

What is AL amyloidosis?

It is a rare condition where abnormal plasma cells in the bone marrow make misshapen proteins. These build up in organs such as the heart and kidneys, causing damage over time.

How does belantamab mafodotin work?

It is an antibody-drug conjugate. It acts like a guided missile, finding a specific marker on the abnormal cells and releasing a medicine inside them to destroy them.

Why do I need eye tests during the study?

Belantamab mafodotin is known to sometimes affect the cornea (the clear surface of the eye), which can cause temporary dry eyes or blurry vision. Regular eye checks ensure any issues are spotted and treated early.

Do I have to pay to take part?

No. In the UK, clinical trial medications and study-related tests are provided free of charge, and you may be able to get help with travel expenses.

Can I leave the study if I change my mind?

Yes. You can leave the trial at any point, for any reason. Your regular hospital team will continue to look after you and discuss other treatment options.