CompletedPhase IInterventional

A platform trial investigating new combinations of therapies in patients with relapsed multiple myeloma

Multiple myeloma is a rare cancer of the bone marrow. While modern treatments help people live longer, the cancer often returns, which is known as a relapse. When this happens, doctors need new treatment options. The ProMMise trial is looking at a targeted drug called belantamab mafodotin (or belamaf for short). This medicine attacks myeloma cells directly. Researchers in the UK are testing how safe belamaf is, what doses work best, and how well it works. They are studying it on its own and in combination with other common myeloma treatments. Because this is a 'platform study', new treatment combinations can be added over time. The goal is to give patients whose cancer has come back more effective, longer-lasting options to keep their disease under control.

At a glance

Status

Completed

Phase

Phase I

Sponsor

University of Leeds

Enrolment target

Start

11 May 2022

Estimated completion

30 Jun 2026

Multiple myeloma

What is this study about?

Multiple myeloma is a type of blood cancer that develops from plasma cells inside your bone marrow. Although treatments have improved greatly over the last decade, myeloma is still difficult to cure completely. Most people find their cancer eventually comes back after treatment, which doctors call a relapse. Finding new, gentle, and effective ways to treat relapsed myeloma is essential to help people live longer, healthier lives.

The ProMMise study is exploring a newer medicine called belantamab mafodotin, often shortened to 'belamaf'. Belamaf is designed to find and stick to myeloma cells, delivering a targeted treatment directly inside them. Earlier tests showed that belamaf could keep myeloma from growing for around a year on average, even in people whose cancer had resisted other therapies. Researchers now want to see if combining belamaf with other proven cancer drugs can make it work even better.

This trial is organised as a 'platform study'. This means the research team can test several different combinations of drugs under one overall study umbrella. As new and promising drug combinations emerge, doctors can add them to the trial without needing to set up an entirely new study from scratch. This flexible approach speeds up research and helps doctors find the best treatments much faster.

Key takeaways

Tests belamaf alone and in combination with other medicines for relapsed multiple myeloma.
A flexible platform study run by the University of Leeds across UK hospitals.
Aimed at adults who have had 1 to 3 previous lines of myeloma treatment.
Requires regular eye checks to monitor and manage known eyesight side effects.
Participation is voluntary, and you can withdraw at any time without affecting your NHS care.

Who may be eligible?

This trial is open to adults aged 18 and older who have a confirmed diagnosis of multiple myeloma that has come back or stopped responding to past treatments. To take part, you must have already tried between one and three previous treatment courses, and these must have included standard myeloma drugs like proteasome inhibitors (such as bortezomib) and immunomodulatory drugs (such as lenalidomide).

Your doctor will also check that your myeloma can be measured through routine tests. This usually means looking for specific myeloma proteins in your blood or urine, or checking the number of myeloma cells in your bone marrow.

Because we do not yet know how belamaf might affect an unborn baby, you cannot take part if you are pregnant or breastfeeding. Both men and women who could have children must agree to use reliable contraception before, during, and for a set period after the trial ends.

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.

I am an adult aged 18 or older.
I have a confirmed diagnosis of multiple myeloma.
My myeloma has returned or stopped responding after 1 to 3 previous treatment courses.
My past treatments included standard medicines like bortezomib or lenalidomide.
I am not currently pregnant or breastfeeding, and I am willing to use reliable contraception if needed.

Answer every question to see your result.

What does participation involve?

Taking part involves receiving belamaf either by itself or alongside other standard myeloma drugs, depending on which group (or 'arm') of the study you join. You will first enter a safety phase with a small group of patients, where doctors keep a very close watch on how your body handles the medicine. If the dose is safe, more people are invited to join an expansion phase to see how well the treatment fights the cancer.

Belamaf is given in a hospital clinic, usually through a drip into a vein. Because the drug can affect the surface of the eye, you will need regular eye check-ups with an eye specialist alongside your usual cancer appointments. You will also have routine blood tests, urine tests, and health checks to monitor your progress.

You will continue receiving treatment for as long as it helps you and the side effects remain manageable. The study team will follow your health regularly throughout your treatment and for a period afterwards to monitor your long-term recovery.

Potential risks and benefits

Taking part may help keep your cancer under control and could help researchers discover better treatments for others in the future, although direct personal benefit cannot be guaranteed. Belamaf can cause side effects. The most common issues are blurred vision, dry or irritated eyes, and a drop in platelets (blood cells that help stop bleeding). These side effects usually improve if treatment is paused or the dose is reduced. Your study team will watch you very closely, and you are free to leave the trial at any time without giving a reason and without it affecting your standard NHS care.

Locations (12)

University College London Hospitals
City only
London, England
Royal Marsden Hospital
Approximate
London, England
Southampton General Hospital
Approximate
Southampton, England
Nottingham University Hospitals
City only
Nottingham, England
St James's University Hospital
Approximate
Leeds, England
Cardiff and Vale NHS Trust
Unverified
Cardiff, Wales
Royal Cornwall Hospitals NHS Trust
Unverified
Truro, England
Portsmouth Hospitals University NHS Trust
Unverified
Portsmouth, England
Chelsea and Westminster Hospital NHS Foundation Trust
Unverified
London, England
Calderdale and Huddersfield NHS Foundation Trust
Unverified
Huddersfield, England
University Hospital Southampton
Unverified
Southampton, England
University Hospitals Birmingham NHS Foundation Trust
Unverified
Birmingham, England

Common questions

What is a platform study?

A platform study is a flexible trial design that lets doctors test several different drug combinations at the same time and add new ones as research develops.

How is belantamab mafodotin given?

Belantamab mafodotin is typically given as an infusion into a vein (an intravenous drip) during regular clinic visits.

Why do I need eye tests during this trial?

Belamaf can cause temporary changes to the front surface of the eye, leading to blurred vision. Regular eye checks ensure any changes are spotted and treated early.

Can I leave the study if I change my mind?

Yes. You can leave the study at any point. Your decision will not change the quality of your regular medical care or your relationship with your healthcare team.

Where does this study take place?

The study is managed by the University of Leeds and runs at specialised hospital centres across the UK.

How to find out more

Heena Patel

prommise@leeds.ac.uk +44 (0)113 343 0101 Official trial record

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