Groundbreaking myeloma trial opens to recruitment

An innovative new myeloma clinical trial aiming to improve the treatment of myeloma has opened in the UK.

The ProMMise trial is the first clinical trial developed through the Concept and Access Research Programme (CARP), an initiative funded by Myeloma UK which aims to support the development of innovative myeloma clinical trials in the UK.

It is one of the first of its kind to be launched in the UK. Its unique platform design allows researchers to test multiple treatments at the same time in one trial. The trial will open with two arms testing two different treatments, with an additional arm starting later in the trial.

The trial will test the safety and effectiveness of belantamab mafodotin alone and in different combinations in relapsed myeloma patients who have had one to three previous rounds of treatment.

Belantamab mafodotin is a new type of anti-myeloma drug called an antibody-drug conjugate. It is a chemotherapy drug connected to a synthetic antibody. The antibody allows the drug to find and attach to a protein on the surface of myeloma cells called BCMA (B cell maturation antigen). After it connects to BCMA the chemotherapy drug separates from the antibody and kills the myeloma cell.

Shelagh McKinlay, Acting Director of Research and Patient Advocacy at Myeloma UK said:

“It is fantastic to see the ProMMise trial open to recruitment. It is a truly groundbreaking trial designed to support the development of new treatments and meet the needs of patients. Today, myeloma patients can get four or more different anti-myeloma drugs at diagnosis or by first relapse, so we are starting to see patients whose myeloma is resistant to multiple treatments earlier in the treatment pathway. This means there is a real need for drugs, like belantamab, that kill myeloma cells in different ways to be made available at earlier relapses. This trial will allow patients to access belantamab from the first relapse and provide evidence to support its use through the NHS.”

Dr Rakesh Popat, Principal Investigator for ProMMise and Consultant Haematologist at University College London Hospitals, said:

“The Concept Access Research Programme is a very important vehicle for the development of academically and clinically led clinical trials. The infrastructure funding, we received through CARP brought together the experts from Leeds Clinical Trials Unit and clinicians to develop the ProMMise trial. Partnering with Myeloma UK also helped us involve patients at an early stage. We wouldn’t have been able to launch such an innovative, patient-focused trial without CARP.”

Sarah Brown, Professor of Cancer Clinical Trials Methodology and Director of Early Phase Trials in the Cancer Division in the University of Leeds’ Clinical Trials Research Unit, said:

“Myeloma is an incurable blood cancer. Drugs often stop working, and this can be very difficult for patients and their families. We are really excited to open the ProMMise trial, which will give patients more opportunities to access different drug combinations in this trial. We hope the findings from our early-stage trial will enable us to further explore the benefits of these treatments.”

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