MMI Professor Peter O’Gorman – Clinical trials in multiple myeloma

Irish multiple myeloma patients are availing of new treatment options at an earlier stage thanks to clinical trials, Professor Peter O’Gorman tells Danielle Barron

Over the last decade, clinical trial activity in multiple myeloma has surged. Novel treatments and combinations are being explored as part of this dynamic landscape.

Professor Peter O’Gorman, consultant haematologist at the Mater Hospital in Dublin, has been at the forefront of this research. He has worked closely with global leaders in multiple myeloma research to attract groundbreaking clinical trials to Irish hospitals, ensuring Irish patients can avail of new treatments and combinations at the earliest stage.

“It’s always reassuring for patients with a particular type of cancer when there is lots of clinical trial activity, it means there are new drugs in development,” he says.

The latest study he is involved in is Isa-RVD – a phase II study that will evaluate the efficacy and safety of the combination regimen isatuximab, lenalidomide, bortezomib, and dexamethasone in patients with newly diagnosed multiple myeloma. A study that reaches phase II is seeking to determine whether the drug is effective in patients with that disease.

“This is an investigator-initiated trial which is running concurrently between Ireland and the Dana Farber Institute in the US,” explains Prof O’Gorman. An investigator-initiated trial is one where the trial is conceived by a clinician. The professor’s team have previously collaborated with the Institute and its eminent haematologist Professor Paul Richardson on the RVD SQ phase II trial.

“The current trial is using the same backbone of RVD and adding in the new immunotherapy, isatuximab. It’s giving Irish patients access to a new combination, a quadruplet of four different drugs which otherwise would not be available,” he says. Immunotherapy is a type of treatment that manipulates the patient’s own immune system to attack cancer cells.

The trial is available at five Irish sites distributed across the country – Beaumont Hospital, St James’s Hospital, University Hospital Limerick, University Hospital Waterford, and the Mater Misericordiae University Hospital/Mater Private Hospital.

“No one in Ireland is more than around 90 minutes from a site,” the professor points out. “That was important for us, that it was fairly distributed and that it wasn’t just open to some patients.” The Isa-RVD trial is also attractive as a single-arm trial, meaning it is not randomised – each participant will receive the active drug and not a placebo.

The goal is to accrue approximately 100 patients between the US and Europe, roughly 50 on each side. Recruiting to clinical trials is typically challenging for a whole host of reasons, but in this instance it has been rapid, admits Prof O’Gorman. Some 42 patients have already agreed to participate in the trial, meaning they are close to full accrual.

It is for reasons like this that globally renowned cancer institutes are keen to collaborate with Irish centres on clinical trials, Prof O’Gorman notes.

“From their point of view. Ireland is very enthusiastic when it comes to clinical trials, very efficient at recruiting patients, and there are very high regulatory standards in Ireland – these things are very important. They need partners who will recruit actively and efficiently and also will have very high standards.”

According to the professor, multiple myeloma patients in Ireland are keen to educate themselves and are especially open to hearing about new treatments they can avail of as part of a clinical trial.

“We are very open with the patients and we explain the disease to them in detail,” he says. “Most multiple myeloma patients have never heard of it before, it’s kind of an exotic cancer in the sense that you understand if you have prostate cancer or bowel cancer, people can visualise these cancers and readily understand what it involves, whereas a cancer of the immune system is quite hard for them to understand. But I find that multiple myeloma patients are very interested and very engaged and they want to understand the biology of their disease. We explain how the drugs work and how the different drugs work together in synergy making them better in combination, and we tell them what’s available outside of the trial and what is available as part of the trial.”

Professor O’Gorman also believes that Irish participants in clinical trials are also keen to partake in research for the greater good.

“I feel that Irish patients want to give something back and contribute to knowledge and research that will benefit other patients and we have a very engaged group of myeloma doctors in Ireland that want to work together for the benefit of Irish patients.”