AuthorisedTherapeutic exploratory (Phase II)Interventional

A Phase 2, multicenter, open label, non-randomized study to evaluate the efficacy and safety of extended dosing of belantamab mafodotin in different combinations with standard of care regimens in participants with relapsed-refractory multiple myeloma (DREAMM-15)

This research, called DREAMM-15, is a Phase 2 study for people with multiple myeloma that has either returned after treatment or hasn't responded to previous medications. It's an 'open label' study, meaning both patients and doctors know which treatment is being given. The main goal is to find out how effective different combinations of belantamab mafodotin with other standard myeloma drugs are at shrinking the cancer. Researchers will also be carefully checking for any side effects to understand how safe these new treatment combinations are for patients. This study helps to explore better treatment options for this type of blood cancer.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

Glaxosmithkline Research & Development Limited

Enrolment target

Start

13 Apr 2026

Relapsed or Refractory Multiple Myeloma

What is this study about?

Imagine you have multiple myeloma, a type of cancer that affects certain blood cells, and your current treatments aren't working as well as hoped, or the cancer has come back. This study, known as DREAMM-15, is designed to look at new ways to treat this specific situation. It focuses on a medication called belantamab mafodotin and uses it alongside other standard treatments. The main purpose is to see if these combinations can help more people, and if they are a safe option.

The research is in 'Phase 2', which means it's one of the earlier stages of drug development. At this point, scientists are trying to get a clearer picture of how well a new treatment works and to identify common side effects in a larger group of people. Think of it as carefully testing a new recipe – you try different ingredients and combinations to see what tastes best and is easiest to prepare.

The study will measure how many people see their cancer improve or shrink after treatment. They will also keep a very close eye on any side effects, including specific eye-related issues, to make sure the treatments are as safe as possible. The information gathered from this study will help doctors understand if these new combinations could become part of standard care for multiple myeloma in the future.

Key takeaways

Investigation into new ways to use belantamab mafodotin with other standard treatments.
Aims to find effective and safe options for multiple myeloma that has returned or not responded to previous treatments.
Closely monitors for cancer response and all potential side effects, including eye health.
This is a Phase 2 study, an earlier stage of testing for new drug combinations.
Participants must have relapsed or refractory multiple myeloma and be over 18.

Who may be eligible?

To join this study, you would need to be an adult, aged 18 or over. The study is open to both men and women.

Critically, you must have been diagnosed with multiple myeloma that has either returned after previous treatment or has not responded well to treatments you've had in the past. This means your cancer is considered 'relapsed or refractory', which is a key requirement for taking part.

There might be other specific medical details that determine if you can join, which your doctor would discuss with you. These could include your general health, how your kidneys or liver are working, and if you have certain other medical conditions. It’s important to talk to your doctor to understand all the specific requirements.

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 multiple myeloma?
Has your multiple myeloma come back after treatment or not responded to past treatments?
Are you able to attend regular hospital or clinic visits for treatment and check-ups?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive combinations of drugs like belantamab mafodotin, pomalidomide, dexamethasone, carfilzomib, and bortezomib. These treatments will be given under close medical supervision. The exact schedule of visits and treatments would be explained in detail, but you can expect regular appointments for medication administration, blood tests, and check-ups to monitor your health and how you're responding to the treatment.

Researchers will regularly assess how your cancer is responding, for example, by checking if it has shrunk or stabilised. They will also meticulously record any side effects you experience, including specific eye examinations to check your vision and eye health. You might be asked to fill out questionnaires about your well-being. The total duration of your participation would depend on your response to treatment and will be fully explained by the study team.

Potential risks and benefits

Participating in this study might offer potential benefits, such as access to new possible treatment combinations for your multiple myeloma that are not yet widely available. There's a chance your cancer could respond well to these therapies. However, like all medications, the treatments in this study come with potential risks, including side effects that can range from mild to serious, and some specifically affect the eyes. It's crucial to remember that participation is completely voluntary; you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (5)

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

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Unverified
France
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Unverified
Germany
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Unverified
Greece
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Unverified
Netherlands
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Unverified
Spain

Common questions

What is multiple myeloma?

Multiple myeloma is a cancer of plasma cells, a type of white blood cell found in the bone marrow. These cells normally help fight infections. In multiple myeloma, they grow too much and can cause problems in the bones, kidneys, and immune system.

What does 'relapsed or refractory' mean?

This means your cancer has either come back after you've had treatment (relapsed) or it hasn't responded to the treatments you've received in the past (refractory).

What is a 'Phase 2' study?

In a Phase 2 study, researchers are looking to see if a new treatment, or a new way of using an existing treatment, works well and is safe in a larger group of people than in earlier studies. It helps them decide if the treatment should move on to bigger trials.

Will I know which treatment I'm getting?

Yes, this is an 'open label' study, which means both you and your doctor will know exactly which combination of treatments you are receiving.

What are 'side effects'?

Side effects are unwanted or unexpected effects caused by taking a medicine. In this study, particular attention will be paid to eye-related side effects.