Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

A phase 2 study of Belantamab Mafodotin in patients with relapsed or refractory AL amyloidosis

This research study is investigating a new medication, belantamab mafodotin, for patients who have AL amyloidosis that has either returned after treatment or isn't responding to current therapies. This is a Phase 2 study, which means the main goal is to find out how effective the treatment is and to continue checking its safety. Over a period of 6 months, doctors will be looking closely to see if the treatment helps to significantly reduce the harmful proteins causing the disease. They will also be monitoring for any side effects. Both men and women aged 18 and older can take part. The hope is to find a new, effective way to treat this challenging condition.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

European Myeloma Network B.V., Emn Trial Office S.r.l. Impresa Sociale

Enrolment target

Start

22 Aug 2024

Relapsed or refractory AL amyloidosis

What is this study about?

This study is about a new treatment called belantamab mafodotin for a condition called AL amyloidosis. AL amyloidosis is a serious illness where abnormal proteins (called amyloid) build up in organs like the heart, kidneys, and liver. This can stop these organs from working properly. Sometimes, the usual treatments don't work well, or the disease comes back; this is called 'relapsed or refractory' amyloidosis.

Researchers want to see if belantamab mafodotin can help people in this situation. This is a Phase 2 study, which means they are focusing on how well the treatment works and making sure it's safe. They will be looking to see if the treatment can cause a good response, meaning a significant reduction in the amount of harmful amyloid proteins. They'll measure this carefully over 6 months.

Ultimately, the goal of this research is to find new and better ways to treat AL amyloidosis, especially for people who haven't responded to other treatments. By understanding how belantamab mafodotin works and if it's safe, doctors hope to offer more options for patients living with this complex condition.

Key takeaways

This study is testing a new drug for AL amyloidosis.
It's for people whose AL amyloidosis has come back or isn't improving.
The main goal is to check how well the drug works and if it's safe.
It's a Phase 2 study, focusing on effectiveness and safety.
Participants must be 18 or older, men or women.

Who may be eligible?

To join this study, participants must be at least 18 years old. Both men and women are welcome to take part.

The most important health requirement is that you must have AL amyloidosis that has either returned after previous treatment or isn't responding to your current treatments. Your doctor will need to confirm this before you can join.

There might be other specific health checks or past medical history requirements that the study doctors will go through with you to make sure the study is a good fit and safe for you.

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.

Are you 18 years old or older?
Do you have a diagnosis of AL amyloidosis?
Has your AL amyloidosis come back after previous treatment?
Or, is your AL amyloidosis not getting better with your current treatment?
Are you able to attend regular clinic visits?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would receive the study treatment, belantamab mafodotin. The study will last for at least 6 months, during which time doctors will regularly check your health and how the treatment is affecting you. This will involve regular visits to the clinic for assessments.

These assessments will include blood tests to check how the disease is responding and to monitor for any side effects. You might also have other tests to see how your body is handling the medication. The research team will explain exactly how often you need to visit and what tests will be done, as the full details are in the study plan.

Throughout the study, your health will be carefully monitored. After the treatment period, there will likely be follow-up visits to continue checking your long-term health and the lasting effects of the treatment.

Potential risks and benefits

Taking part in any clinical study has potential benefits and risks. You might benefit if the new treatment, belantamab mafodotin, helps to control your AL amyloidosis better than current options. It could also lead to a deeper understanding of the disease that helps future patients. However, there's no guarantee the treatment will work for you. Potential risks include side effects from the medication. The medical team will carefully monitor you for any side effects and will explain them fully before you join. Remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (5)

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

—
Unverified
Netherlands
—
Unverified
Germany
—
Unverified
Greece
—
Unverified
France
—
Unverified
Italy

Common questions

What is AL amyloidosis?

AL amyloidosis is a rare condition where abnormal proteins build up in organs, making them struggle to work properly.

What does 'relapsed or refractory' mean?

It means the disease has either come back after treatment or isn't getting better with current medications.

What is belantamab mafodotin?

It's a new medication being tested to see if it can help treat AL amyloidosis that is difficult to manage.

How long will the study last?

The main treatment part of the study will last for at least 6 months, with ongoing monitoring.

Will I have to pay to be in the study?

No, all study-related treatments and assessments are typically provided at no cost to you.