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The value of clinical trials in multiple myeloma

Dr Kathleen Scott, PhD, of Cancer Trials Ireland speaks to Danielle Barron about the growth in clinical trials and their value as a care option for people with blood cancers, including multiple myeloma

SPEAKER

Q: There seems to be a large number of trials now available for people with haematological malignancies. This wasn’t always the case – what has changed?

A: This is due to a combination of factors. We have some very highly motivated haematologists who have specialised in myeloma clinical research in the last five to six years. The big driver however has been the new treatments – there has been approximately 12 new drugs approved for myeloma in recent years. That is significantly higher than even other types of cancer.

So the new treatments have driven clinical trials, as for many years myeloma treatment remained the same – it was very stagnant. The big change came with the introduction Velcade (bortezomib) in 2003 and since then there has continued to be big advances, such as the immunomodulatory drugs. The current focus is on immune therapy such as daratumumab and pembrolizumab, and these are getting fast-tracked approval as they are so effective. We are currently involved in trials for a treatment for smoldering myeloma – previously for those patients, the only treatment would have been monitoring, a “wait-and-see” approach.

The Blood Cancer Network Ireland is a new national clinical research network, which was set up in 2015. It is funded by Science Foundation Ireland and Irish Cancer Society, and led by Professor Michael O’Dwyer at NUI Galway; it includes centres in Galway, Cork and Dublin (St James’s, Mater and Beaumont). The aim of this new network is to offer early stage clinical trials to blood cancer patients including myeloma, and will also establish a biobank of samples for research and a blood cancer registry. We at Cancer Trials Ireland are working very closely with them.

Q: Is it difficult to ensure there is Irish participation in major clinical trials? What is involved before patients even enrol?

A: We want Ireland on the map as much as we can with clinical trials. We find out about a new trial, usually through our close relationships with pharmaceutical companies involved in making haematology drugs. They will usually give between six and nine months’ notice of an upcoming trial, and in that time we will carry out a feasibility study, to see that we have suitable trial sites (hospitals) for that particular trial. Feasibility depends on track record – the site has to have experience in taking part in a clinical trial and built up a reputation in that area. We have to know they can perform and reach a certain standard.

Q: Is awareness of clinical trials growing among patients? How has Cancer Trials Ireland worked to achieve this?

A: Definitely. We are focusing on our communications, and are engaging with the media a lot more. We changed our name [Cancer Trials Ireland used to be ICORG – the All-Ireland Clinical Oncology Research Group] and we are always working to let people know who we are.

On our website there is a constant stream of newsworthy items, as well as a continuous updating of the ongoing or opening cancer trials. Our Twitter has also really taken off – we know that that’s how people find out about trials nowadays, through social media.

The “Just Ask” awareness campaign was a concerted effort by us to encourage people to ask their doctor or health professional about the possibility of clinical trials for their condition. If they don’t ask they won’t know.

However, this has to be countered with the fact there will be some disappointments, as not all patients are suitable for the trials that may be going on. This is the difficulty. We would rather patients come to us than not. Clinicians are definitely more involved now too in this process, and eager to share information with patients.

Q: Research shows that patients who participate in clinical trials tend to have better outcomes. Are patients aware that a clinical trial is often an effective care option?

A: There is good data that, even if the treatment is not more effective, that patients do better when they are on a trial. They are being closely monitored, they feel better and they feel empowered about their condition and their health. We are trying to get it into the vocabulary within the health service so that patients do see it as another treatment option. It is also potentially a means of early access to ground-breaking therapies. I have worked in cancer clinical trials for close to 20 years and I think the conversation around them is changing – people don’t say guinea pig anymore to the same extent and there isn’t the same anxiety about that.

Trials currently ongoing:
• ECOG 3A06 Study: Open for patients with smoldering myeloma
Lenalidomide or Observation in Treating Patients With Asymptomatic High-Risk Smoldering Multiple Myeloma. Trial Sponsor: ECOG-ACRIN (US), Cancer Trials Ireland. Two sites: Galway (Prof. Michael O’Dwyer), Mater (Prof. Peter O’Gorman)
• CyBorD DARA Study: Open for newly diagnosed/transplant eligible patients
Phase Ib study to assess Safety and Effectiveness of weekly Cyclophosphamide-Bortezomib-Dexamethasone (CyBorD) with Daratumumab (DARA). Trial Sponsor: NUI Galway/BCNI, Co-ordinated by Cancer Trials Ireland. Open in UHG (Prof. Michael O’Dwyer) and CUH (Prof. Mary Cahill). To open in Mater (Prof. Peter O’Gorman), Beaumont (Dr John Quinn), St James’s (Prof. Paul Browne/Dr Patrick Hayden).
• KEYNOTE-185 Study: Open for newly diagnosed multiple myeloma patients
Phase III Study of Lenalidomide and Dexamethasone With or Without Pembrolizumab
Trial Sponsor: Merck Sharp & Dohme. Open at Beaumont Hospital, Dublin (Dr John Quinn).
• GMI1271-230: Open for patients with refractory/relapsing multiple myeloma
GMI1271 (E-selectin antagonist) as adjunct to Bortezomib-based standard of care chemotherapy. Trial Sponsor: GlycoMimetics, Inc. Two sites actively enrolling: Galway (Prof. Michael O’Dwyer), Beaumont (Dr. John Quinn). To open soon: CUH (Prof. Mary Cahill), Mater (Prof. Peter O’Gorman)

Please see www.cancertrials.ie and www.bloodcancers.ie
Eligibility Questions relating to any clinical trials should be discussed with the treating haematologist

Additional information
Kathleen Scott PhD, is a Clinical Program Leader at Cancer Trials Ireland (formerly ICORG) and is responsible for the oversight of a number of cancer and haematology trials programs.

She has gained more than 20 years cancer clinical research experience in academic, clinical, and pharmaceutical settings throughout the UK, Australia, and Ireland. Since arriving in Ireland 5 years ago, she was awarded a Cochrane Fellowship based at Trinity College Dublin by the Health Research Board.

In her role at Cancer Trial Ireland, she co-leads a team of approximately 30 clinical research staff working across a diverse range of clinical trials and has program responsibility for haematology trials including multiple myeloma. She has worked proactively with lead haematologists in Ireland, international collaborators and pharmaceutical partners to design and develop new trials and bring new myeloma treatments to patients in Ireland. Kathleen published a Cochrane Review in 2016 titled ‘Bortezomib for the treatment of multiple myeloma’.

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