Active not recruitingPHASE3INTERVENTIONAL

Study of Single Agent Belantamab Mafodotin Versus Pomalidomide Plus Low-dose Dexamethasone (Pom/Dex) in Participants With Relapsed/Refractory Multiple Myeloma (RRMM)

This important study is looking into a new medicine called Belantamab Mafodotin for people with Multiple Myeloma. This is a type of cancer that affects plasma cells in your bone marrow. The study is comparing Belantamab Mafodotin against a standard treatment, which is a combination of two drugs: Pomalidomide and a low dose of Dexamethasone. The main goal is to find out if the new medicine is more effective and safe for patients whose myeloma has come back after previous treatments or hasn't responded as well as hoped. Participants will be randomly assigned to receive one of the treatments and will continue until their condition progresses, side effects become too much, or other reasons.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

GlaxoSmithKline

Enrolment target

325

Start

02 Apr 2020

Estimated completion

11 Mar 2027

Multiple Myeloma

What is this study about?

This study is designed to help doctors understand the best ways to treat a type of blood cancer called Multiple Myeloma. This is a condition where certain white blood cells, called plasma cells, become abnormal and multiply too much in the bone marrow. For many people, treatments can help, but sometimes the cancer comes back or doesn't respond well to standard medicines. When this happens, it's called 'relapsed' or 'refractory' myeloma.

The study is comparing two different treatment approaches: one involves a new medicine called Belantamab Mafodotin on its own, and the other uses a combination of two established medicines, Pomalidomide and a low dose of Dexamethasone. Pomalidomide is a drug that helps slow down cancer growth, and Dexamethasone is a steroid that can also help. By comparing these, researchers hope to find out if Belantamab Mafodotin offers a better option for people whose myeloma has been difficult to treat.

Taking part in a study like this helps improve our understanding of cancer and can lead to new and better treatments for everyone in the future. The information gathered will help doctors decide which treatments are most effective and have the fewest side effects for people living with Multiple Myeloma.

Key takeaways

This study compares a new drug (Belantamab Mafodotin) with a standard combination treatment for Multiple Myeloma.
It's for people whose myeloma has returned or not responded well to previous treatments.
You'll be randomly assigned to one of the two treatment groups.
Treatments continue until your condition progresses or side effects become unmanageable.
The study aims to find more effective and safer treatment options.
Your health will be closely monitored throughout the study.

Who may be eligible?

To be considered for this study, you need to be at least 18 years old (19 if you're in South Korea) and be able to understand and sign a consent form. It's important that your overall health is good enough to take part, and doctors will check this using a standard scale called ECOG, aiming for a score between 0 and 2.

You must have Multiple Myeloma that has been officially diagnosed and your cancer must have come back or not responded well, even after trying at least two different types of anti-myeloma treatments. These past treatments must have included medicines like lenalidomide and a proteasome inhibitor. Also, your myeloma must still be producing signs that doctors can measure, such as certain proteins in your blood or urine. 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.

Finally, your body's main organs, like your liver and kidneys, need to be working well, and your blood counts (white blood cells, red blood cells, and platelets) must be within certain healthy ranges. The study team will review all these details carefully to decide if this study is right for you.

Quick self-check

Are you 18 years old or older?
Do you have Multiple Myeloma that has come back or hasn't responded well to past treatments?
Have you already tried at least two different types of anti-myeloma medicines, including lenalidomide and a proteasome inhibitor?
Are your M-protein or other disease markers still detectable?
Are your major organs (like liver and kidneys) working well?
Is your overall health generally good enough for a clinical study?

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

What does participation involve?

If you join this study, you'll be randomly assigned to one of two groups. Two out of every three participants will receive the new medicine, Belantamab Mafodotin, as a single treatment every three weeks. The other group will receive a combination of Pomalidomide daily for three weeks out of every four-week cycle, along with low-dose Dexamethasone once a week. You won't get to choose which group you're in, but this method helps ensure the study results are fair and reliable. Both treatments are given until your illness gets worse, you experience side effects that are too uncomfortable, or if you decide you no longer wish to continue. You'll have regular visits for check-ups, blood tests, and to receive your medication. The total time you'll be in the study can vary depending on how long the treatment works for you, but it will continue until one of the reasons mentioned above occurs.

Potential risks and benefits

Taking part in any medical study like this has potential benefits and risks. The potential benefit is that one of the study treatments, particularly the new medicine, might work better for your Multiple Myeloma than standard options, or it might have different side effects. However, there's no guarantee that you will benefit, and the treatments may not work for you. There are also potential risks involved, mainly from side effects of the medicines. The study team will closely monitor you for any side effects, and they will explain all known risks to you in detail before you decide to join. Remember, participation is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (102)

GSK Investigational Site
Tucson, United States
GSK Investigational Site
Pueblo, United States
GSK Investigational Site
Detroit, United States
GSK Investigational Site
Omaha, United States
GSK Investigational Site
Clifton Park, United States
GSK Investigational Site
Cincinnati, United States
GSK Investigational Site
Corvallis, United States
GSK Investigational Site
Eugene, United States
GSK Investigational Site
Tyler, United States
GSK Investigational Site
Milwaukee, United States
GSK Investigational Site
St Leonards, Australia
GSK Investigational Site
Hobart, Australia

+90 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 plasma cells, which are white blood cells found in your bone marrow.

What are 'relapsed' or 'refractory' Multiple Myeloma?

Relapsed means your myeloma has come back after treatment. Refractory means it hasn't responded well to previous treatments.

What does 'randomized study' mean?

It means you'll be put into one of the treatment groups by chance, like flipping a coin. This helps make the study results fair.

Will I know which treatment I'm getting?

Yes, this is an 'open-label' study, so both you and your study doctor will know which treatment you are receiving.

How long will I be on the treatment?

You will stay on the treatment until your condition gets worse, side effects become too much, or if you decide to stop.