RecruitingPHASE1, PHASE2INTERVENTIONAL

A Study to Investigate the Safety and Efficacy of Belantamab for the Treatment of Multiple Myeloma When Used as Monotherapy and in Combination Treatments

This research study is investigating a new medication called belantamab, designed to treat multiple myeloma, a cancer of the blood. The study aims to understand how safe belantamab is and how effectively it works, both when given by itself and when combined with other existing treatments. It is divided into three main parts, each exploring different ways of using belantamab in patients whose myeloma has returned or hasn't improved much after standard treatments. We're looking for adults aged 18 or over who have multiple myeloma and have already tried several other treatments. The goal is to find better ways to manage this condition and improve the lives of those affected.

At a glance

Status

Recruiting

Phase

PHASE1, PHASE2

Sponsor

GlaxoSmithKline

Enrolment target

152

Start

14 Jun 2023

Estimated completion

03 Dec 2029

Multiple Myeloma

What is this study about?

This research study is focusing on multiple myeloma, which is a type of cancer that affects the plasma cells in your bone marrow. These cells are an important part of your immune system. When you have multiple myeloma, these cells grow too much and can cause problems in your bones, kidneys, and blood. Unfortunately, for many people, the cancer can come back or stop responding to treatments over time.

That's where this study comes in. We're looking at a new treatment called belantamab. Think of belantamab as a specially designed medicine that targets the cancer cells. This study wants to understand two main things: how safe belantamab is for patients, and how well it actually helps to control or reduce the myeloma. We're testing it in different ways: sometimes on its own, and sometimes combined with other medicines that are already used for multiple myeloma, like pomalidomide and dexamethasone.

The study is split into three parts. In the first part, we're giving belantamab by itself to patients whose myeloma has already been treated with at least three other types of therapy and hasn't responded well. The second part looks at using belantamab with another form of belantamab to see if combining them makes a difference. Finally, the third part compares belantamab, either alone or combined with another belantamab, alongside the usual treatments (pomalidomide and dexamethasone) for patients who have had at least one prior treatment line. The hope is to find more effective and safer ways to treat multiple myeloma, especially for those who have tried many treatments already.

Key takeaways

Tests a new medicine, belantamab, for multiple myeloma.
Investigates safety and effectiveness, alone and in combination.
For adults with myeloma that hasn't responded to previous treatments.
Aims to find better treatment options for patients.
Participation involves regular clinic visits and health monitoring.

Who may be eligible?

To join this study, you need to be at least 18 years old and have been diagnosed with multiple myeloma. Your doctors will need to confirm that your myeloma meets specific criteria.

For the first two parts of the study, you would need to have already tried at least three different types of anti-myeloma treatments, including medicines like lenalidomide and a proteasome inhibitor. Also, your myeloma must either have gotten worse or not responded to your most recent treatment. For the third part of the study, you would need to have had at least one previous treatment for your myeloma, including lenalidomide.

Your general health will be checked carefully to make sure you're well enough to take part. This includes having good organ function and a certain level of physical ability, measured by something called an ECOG-PS score. You should also have myeloma that can be measured with blood or urine tests. If you've had a stem cell transplant, it needs to have been more than 100 days ago, and you can't have any active infections.

Quick self-check

Are you 18 years old or older?
Do you have a diagnosis of multiple myeloma?
Have you already tried at least one other treatment for your myeloma?
Do you have suitable current general health markers (e.g., organ function, physical ability)?
Is your myeloma able to be measured by tests (e.g., blood or urine)?
If you've had a stem cell transplant, was it more than 100 days ago?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

Taking part in this study would involve regular visits to the clinic for assessments and to receive the study medication. You'll have various tests, such as blood and urine tests, and possibly scans, to monitor your health and how the treatment is working. The specific medication you receive will depend on which part of the study you are in. It could be belantamab on its own, belantamab combined with another form of belantamab, or belantamab alongside other standard myeloma drugs like pomalidomide and dexamethasone. You will be closely watched for any side effects. The total duration of your participation, including follow-up, will be explained by the study doctor, but these types of studies typically involve a period of active treatment followed by monitoring.

Potential risks and benefits

Participating in a clinical trial may offer potential benefits, such as access to a new treatment before it's widely available, and your health will be closely monitored by a dedicated medical team. However, there are also potential risks, including side effects from the study medication, which may be unknown or different from existing treatments. You will receive a detailed explanation of all known potential risks before deciding to join. It is very important to remember that joining this study is completely voluntary, and you have the right to withdraw at any time, for any reason, without it affecting your future medical care.

Locations (30)

GSK Investigational Site
Grand Rapids, United States· Recruiting
GSK Investigational Site
Chapel Hill, United States· Recruiting
GSK Investigational Site
Chattanooga, United States· Recruiting
GSK Investigational Site
Nashville, United States· Recruiting
GSK Investigational Site
Ciudadela, Argentina· Completed
GSK Investigational Site
San Juan Bautista, Argentina· Recruiting
GSK Investigational Site
Viedma, Argentina· Recruiting
GSK Investigational Site
Fitzroy, Australia· Recruiting
GSK Investigational Site
Nedlands, Australia· Completed
GSK Investigational Site
Joinville, Brazil· Recruiting
GSK Investigational Site
Salvador, Brazil· Recruiting
GSK Investigational Site
São Paulo, Brazil· Recruiting

+18 more sites — see the official record for the full list.

Common questions

What is multiple myeloma?

Multiple myeloma is a type of cancer that affects certain white blood cells (plasma cells) in your bone marrow.

What is 'belantamab'?

Belantamab is a new medicine being studied to treat multiple myeloma. It's designed to target the cancer cells.

Why is this study important?

This study hopes to find new and more effective ways to treat multiple myeloma, especially for people whose cancer hasn't responded to other treatments.

Will I get the new treatment or a standard one?

You might get belantamab on its own, or in combination with other treatments, depending on which part of the study you are eligible for.

Can I leave the study if I change my mind?

Yes, you are free to leave the study at any time, for any reason, without affecting your future medical care.

How to find out more

US GSK Clinical Trials Call Center

GSKClinicalSupportHD@gsk.com 877-379-3718 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.