Clinical Trials

Newly Diagnosed

UK MRA Myeloma XIV, FiTNEss

Chief Investigators: Prof Gordon Cook and Prof Graham Jackson

This is a phase III, multi-centre, randomised controlled trial to compare standard (reactive) and frailty-adjusted (adaptive) induction therapy delivery with the novel triplet ixazomib, lenalidomide and dexamethasone (IRD), and to compare maintenance lenalidomide (R) to lenalidomide plus ixazomib (R+I) in patients with newly diagnosed multiple myeloma not suitable for a stem cell transplant. All participants receive induction treatment with ixazomib, lenalidomide and dexamethasone and are randomised on a 1:1 basis at trial entry to the use of frailty score-adjusted up-front dose reductions vs. standard up-front dosing followed by toxicity dependent reactive dose-modifications during therapy. Following 12 cycles of induction treatment participants alive and progression-free undergo a second randomisation on a 1:1 basis to maintenance treatment with lenalidomide plus placebo versus lenalidomide plus ixazomib. Participants and their treating physicians will be blinded to maintenance allocation. For further details see [https://clinicaltrials.gov/ct2/show/NCT03720041]

We believe that the UKMF/BSH myeloma guidelines are improved as a result of the closecollaboration of the group with Myeloma UK to ensure that they are ‘patient-focussed.’

UK MRA Myeloma XV, Radar

Risk-Adapted therapy Directed According to Response comparing treatment escalation and de-escalation strategies in newly diagnosed patients with multiple myeloma (NDMM) suitable for stem cell transplant (TE).Chief Investigators: Prof Kwee Yong and Dr Karthik Ramasamy

Some patients have been found to have genetic abnormalities in the myeloma cells and these ‘high-risk’ patients do not respond well to standard treatment. Some patients without these genetic abnormalities are also known to not respond as well to initial therapy. This study will investigate different treatment combinations for these two groups of patients. It will also investigate whether a third group of patients, who do respond well to initial treatment, can receive treatment for a shorter period of time without coming to harm. This study gives access to new treatments (the unlicensed drug isatuximab) and treatment combinations. All participants will receive the same initial induction treatment and during this time will have genetic tests to determine whether they have ‘standard-risk’ or ‘high-risk’ disease. Following this chemotherapy treatment participants will receive ASCT (A stands for autologous, meaning that the participant’s own stem cells are used).After induction treatment participants will be allocated to a second stage treatment group based on their genetic risk, high-risk or standard-risk, and on how well the myeloma has responded to the initial treatment. Each treatment group will then receive different combinations of medication to investigate their benefit. Treatment will comprise of combinations of isatuximab, bortezomib, cyclophosphamide, lenalidomide and dexamethasone. Newly diagnosed myeloma patients, above the age of 18 who are suitable for SCT will be eligible for the study. Patients will be required to have bone marrow, blood and urine tests throughout the trial. Participants will also be asked to complete questionnaires about their quality of life. The study will be conducted in multiple hospitals throughout the UK.

Relapsed/ refractory multiple myeloma

UK MRA CARP: ProMMise

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

UK MRA Myeloma XV, Radar

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

Chief Investigator: DrRakesh Popat

The aims of this study is to investigate the outcomes, safety, and tolerability of belantamab mafodotin, as both a monotherapy and in combination with standard of care myeloma agents, in relapsed refractory multiple myeloma patients. This is a multi-centre, multi-arm, phase I platform study in relapsed/refractory multiple myeloma patients with 1-3 prior lines of therapy. The study comprises a dose escalation phase and a dose expansion phase. The trial will investigate the safety of belantamab both as a monotherapy (once every 28-day treatment cycle, intravenously) and in novel combinations with other agents (belantamabonce every other 28-day treatment cycle; combination treatments may vary). Participants will remain on treatment until progression, withdrawal, or unacceptable toxicities.

Areas under investigation:

The UKMRAis currently developing strategies across key priority areas for myeloma research. These areas are discussed in group meetings held throughout the year and are presented at national meetings.

Public Engagement:

The UKMRA keeps patients at the centre of its mission and ensures there is patient representation across all areas. Through the NCRI, there is patient representation on the main group. Furthermore, each clinical trial or research project will be expected to have patient representation to guide and provide feedback to the project. The UKMRA works closely with Myeloma UK to achieve this. The UKMRA is dedicated to equality and diversity across the research programme. There is currently an active programme working to promote adequate representation across ethnic groups and social classes in clinical trials.

The UKMRA is pleased to be working closely with other stakeholders to ensure its research is patient centric and of high impact. We have close links with Myeloma UK, with representation on the main group as well as other cancer charities. The UKMRA also activity engages with the pharmaceutical industry to keep abreast of their pipelines and strategy. Through these collaborations, it is able to obtain funding and access to novel therapies for clinical trials. A pharma engagement event is held annually and additional in depth meetings are arranged throughout the year. If you wish to present your drug development pipeline or interact with the UKMRA, please contact us