Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

An open label, multicenter, phase II study of belantamab mafodotin in combination with VRd for the treatment of newly diagnosed transplant eligible multiple myeloma patients

This study is a Phase II clinical trial looking into a new combination of treatments for people recently diagnosed with multiple myeloma, a type of blood cancer. The main new medicine being tested is called belantamab mafodotin, along with standard treatments (VRd). The study wants to understand how safe this new combination is, focusing on any side effects patients might experience, especially issues with their eyes. Researchers will also be checking various blood tests to see how the treatments affect a person's body. The aim is to find out if this new combination could be a good treatment option for patients who are strong enough to have a stem cell transplant later on.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Fundacion Pethema

Enrolment target

Start

26 Sep 2024

Multiple myeloma

What is this study about?

This study is designed to learn more about a new treatment approach for people who have recently been diagnosed with multiple myeloma. Multiple myeloma is a type of cancer that affects plasma cells, a kind of white blood cell found in the bone marrow. The study is particularly for patients who are considered strong enough to potentially have a stem cell transplant in the future, as this is often a part of multiple myeloma treatment.

The main goal is to see how safe a new combination of medicines is. This combination includes belantamab mafodotin, which is a newer type of drug, alongside other established treatments such as lenalidomide, bortezomib, and dexamethasone. Researchers will be closely monitoring how participants react to these medicines, looking for any side effects and changes in blood tests. They are especially interested in any effects on the eyes.

By carefully watching these safety aspects and how the body responds, the study helps doctors understand if this new combination could be a useful and manageable treatment option for newly diagnosed multiple myeloma patients. Finding effective and tolerable treatments is very important for improving the lives of individuals with this condition.

Key takeaways

This study tests a new combination treatment for recently diagnosed multiple myeloma.
It aims to understand the safety and side effects of belantamab mafodotin with other common drugs.
Special attention will be paid to eye-related side effects and changes in blood tests.
The study is for patients potentially strong enough for a stem cell transplant later.
All participants will receive the new treatment combination; there is no placebo.

Who may be eligible?

To be considered for this study, you must be at least 18 years old. Importantly, the study is for people who have recently been diagnosed with multiple myeloma.

Doctors will also assess whether you are generally healthy enough to potentially have a stem cell transplant in the future. This is because the study is looking at a treatment combination that might lead up to a transplant.

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 at least 18 years old?
Have you recently been diagnosed with multiple myeloma?
Are you considered strong enough to potentially have a stem cell transplant in the future?
Are you able to follow the study's treatment and visit schedule?

Answer every question to see your result.

What does participation involve?

If you join this study, you will receive a combination of medicines as part of your treatment. These medicines include belantamab mafodotin along with lenalidomide, melphalan, dexamethasone, and bortezomib. These will be given as capsules, tablets, and injections.

You will have regular hospital visits for medical check-ups, blood tests, and to receive your treatment. Doctors will pay close attention to any changes in your health, especially your blood counts, liver and kidney function, and any potential eye issues. This monitoring will happen during the initial six cycles of treatment, also known as the induction therapy. The total duration of your participation will depend on your individual treatment plan and how you respond to the medicines.

Potential risks and benefits

While joining a study can offer access to new treatments, it's important to weigh the potential benefits against the risks. You might benefit from a new treatment combination that could be more effective than existing options. However, there's always a risk of experiencing side effects from the medicines, some of which could be serious, including effects on your eyes. The research team will monitor you closely for any issues. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

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

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Unverified
Spain

Common questions

What is multiple myeloma?

Multiple myeloma is a type of cancer that affects special white blood cells called plasma cells, which are found in your bone marrow.

What is a 'Phase II' study?

A Phase II study is a stage of clinical research where doctors test a new treatment on a larger group of people to see how well it works and to further check its safety.

What does 'VRd' stand for?

'VRd' is a common medical abbreviation for a combination of three drugs: Velcade (bortezomib), Revlimid (lenalidomide), and dexamethasone. This study adds belantamab mafodotin to this combination.

Will I receive the new treatment or a placebo?

This study is an 'open label' study, which means everyone participating will receive the new treatment combination. There is no placebo group.

Why are blood tests so important in this study?

Blood tests help doctors understand how the treatment is affecting your body, checking things like blood cell counts, liver function, and kidney function, which are important for safety.