CompletedNot ApplicableInterventional

Pomalidomide Specific Targeting in Relapsed and Refractory Myeloma (MUK Seven)

Multiple myeloma is a cancer that develops in the bone marrow. Even after successful treatment, the cancer can return (relapse) or stop responding to medicines (refractory). When this happens, doctors need safe and effective new options. Currently, a standard NHS treatment combines two medicines: pomalidomide and a steroid called dexamethasone. This trial, called MUK Seven, tests whether adding a third medicine, cyclophosphamide, helps treat myeloma more effectively. Around 250 patients across the UK will take part. Half will receive the standard two-drug combination, while the other half will receive all three medicines. Patients take their treatment in four-week cycles and visit the hospital regularly for check-ups. Doctors will also examine blood and bone marrow samples to learn how the drugs work in the body and to find clues that predict who will benefit most.

At a glance

Status

Completed

Phase

Not Applicable

Sponsor

University of Leeds (UK)

Enrolment target

250

Start

01 Sep 2015

Estimated completion

01 Sep 2017

Relapsed multiple myeloma or refractory multiple myeloma

What is this study about?

Multiple myeloma is a type of blood cancer that affects plasma cells inside the bone marrow. The bone marrow is the spongy tissue found inside our bones where blood cells are made. While modern treatments can keep myeloma under control for long periods, the disease often returns or becomes resistant to the medicines used. When this happens, it is known as relapsed or refractory myeloma.

In the NHS, patients in this situation often receive a combination of two medicines: pomalidomide (an anti-cancer medicine that supports the immune system) and dexamethasone (a steroid). This study is exploring whether adding an established chemotherapy drug called cyclophosphamide can make the treatment work better and keep the cancer away for longer.

Researchers also want to understand the biology behind why some people respond well to these drugs while others do not. By collecting and testing blood and bone marrow samples throughout the study, scientists hope to discover biological 'markers'. In the future, these markers could help doctors match individual patients with the treatment most likely to work for them, moving closer to truly personalised cancer care.

Key takeaways

Tests whether adding cyclophosphamide to a standard two-drug treatment improves outcomes for relapsed myeloma.
Designed for adults who have already received at least two prior lines of myeloma therapy.
Participants are randomly assigned to receive either two or three medicines in four-week cycles.
Requires regular hospital visits, blood tests, and bone marrow checks to monitor progress.
Taking part is voluntary, and you are free to leave the trial at any point.

Who may be eligible?

This study is open to adults aged 18 and older who have been diagnosed with active multiple myeloma that needs further treatment. To join, your cancer must have either returned or stopped responding to past treatments.

You must have already tried at least two other types of myeloma treatment in the past. These previous treatments must have included specific medicines known as proteasome inhibitors (such as bortezomib) and lenalidomide, as well as another common type of chemotherapy known as an alkylating drug.

You will also need to be reasonably active and well enough to carry out daily tasks, have an expected life span of at least three months, and meet safe blood test targets for your kidneys, blood counts, and calcium levels. Your hospital doctor will review these tests with you to make sure it is safe for you to take part.

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 diagnosed with multiple myeloma.
My myeloma has come back or stopped responding to past treatments.
I have already tried at least two previous types of myeloma therapy.
My past treatments included lenalidomide and a proteasome inhibitor.
I feel well enough to manage daily activities and attend monthly hospital appointments.

Answer every question to see your result.

What does participation involve?

If you decide to join the study, a computer will randomly place you into one of two groups. You cannot choose your group. One group takes two medicines (pomalidomide and dexamethasone), while the other group takes three (pomalidomide, dexamethasone, and cyclophosphamide).

Treatment is taken in repeating 28-day (four-week) cycles. For the first 21 days of each cycle, you will take your study medicines, followed by a 7-day rest period. You will visit the hospital at least once a month for check-ups, health reviews, and routine blood tests.

Taking part also involves having bone marrow tests and extra blood samples taken at the start of the study, during treatment, and at the end. You will stay on the study treatment for as long as it continues to help keep your cancer under control and the side effects remain manageable. The study is running at 15 NHS hospital sites across the UK.

Potential risks and benefits

A potential benefit of taking part is receiving active, closely monitored care that may help control your myeloma. The findings may also help improve care for future patients. However, there are risks. Like all cancer treatments, these medicines can cause side effects such as fatigue, an upset stomach, or a lowered immune system. Having bone marrow biopsies and extra blood tests can also cause temporary discomfort or bruising. Your medical team will monitor you closely and can adjust doses or give supportive medicines to help manage any side effects. Taking part is completely voluntary, and you can leave the study at any time without your regular NHS care being affected.

Locations (14)

The Royal Marsden NHS Foundation Trust
City only
London, England
St Bartholomew’s Hospital
Approximate
London, England
Guy's and St Thomas' Hospitals
City only
London, England
Birmingham Heartlands Hospital
Approximate
Birmingham, England
St James Hospital
Approximate
Leeds, England
Churchill Hospital
Unverified
Oxford, England
University Hospitals Birmingham NHS Foundation Trust
Unverified
Birmingham, England
Royal Hallamshire Hospital
Unverified
Sheffield, England
University College London Hospitals NHS Foundation Trust
Unverified
London, England
Beatson Oncology Centre
Unverified
Glasgow, Scotland
Belfast City Hospital
Unverified
Belfast, Northern Ireland
Leicester Royal Infirmary
Unverified
Leicester, England

Common questions

What does 'relapsed and refractory' mean?

'Relapsed' means the cancer has returned after a period of improvement. 'Refractory' means the cancer has stopped responding to the medicines you were taking.

Can I choose which treatment group I am in?

No. A computer assigns you to a group by chance. This process is called randomisation, and it ensures the study results are fair and scientifically accurate.

Do I have to pay for the trial medicines?

No. All study medicines and trial-related hospital visits are provided free of charge through the NHS and the study sponsors.

Are the bone marrow tests optional?

No. Giving blood and bone marrow samples is a required part of this study so researchers can understand how the medicines work inside the body.

What happens if the treatment stops working for me?

Your doctor will stop the trial treatment and discuss other suitable care options available to you through the NHS.

How to find out more

Gareth Morgan

Official trial record

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