Participation in Clinical Trials:
The Key to Improving Patient Outcomes
by Aldo Del Col, Co-founder Chairman, Myeloma Canada
When I was diagnosed in 2002, the first question I asked my doctor was: ”Are there any clinical trials I would be eligible for?” Fifteen years ago, there weren’t many trials available. There was much excitement around thalidomide and bortezomib (which was called PS-134 at the time) as effective new treatments but neither was yet approved by Health Canada and hence only available through a clinical trial.
One of the important clinical questions at the time was the role of maintenance following high-dose therapy (more commonly referred to as autologous stem cell transplant or ASCT).

There was a Canadian trial that sought to help answer this important question by comparing outcomes in patients who were given thalidomide as maintenance versus those in the “standard of care” or control arm. I enrolled in the study and was randomized into the control arm, feeling honoured to do my part to advance science and help answer an important disease management question. Today, lenalidomide maintenance therapy following an ASCT has become the standard of care, thanks to the hundreds of patients who volunteered to participate in the many maintenance trials around the world. This is how progress is made.

Since my diagnosis, overall survival has more than doubled thanks to new treatments. Last year alone, Health Canada approved four new myeloma drugs. And many more promising therapies are in the pipeline, many of which address the unmet needs of patients with relapsed and refractory myeloma. Trials evaluating these novel agents and new combinations offer eligible patients access to treatment options that would not be otherwise available.  

One of Myeloma Canada’s goals is to have more clinical trials available to more patents in more centres across Canada. Researchers working with the Myeloma Canada Research Network (MCRN) are developing trials that not only answer important scientific questions but also provide access to treatments that may not otherwise be available. The latest trial to be activated is MCRN 005, referred to as the BOSTON study, a large Phase III randomized clinical trial evaluating selinexor, a new first-in-class SINE™ XPO1 antagonist, in combination with bortezomib and dexamethasone (SVd). And this fall, MCRN 004, a randomized Phase II trial evaluating the combination of daratumumab, pomalidomide, cyclophosphamide and dexamethasone, will be activated in 12 centres across Canada.  

Patients often enquire about the risk of participating in a clinical trial. Occasionally, a clinical trial is halted because of safety concerns (see the separate article on the pembrolizumab studies) or other factors. Generally speaking, the benefits of participating in a clinical trial outweigh the risk. And there are numerous checks and balances to minimize potential risks to the patient.  

There are presently 25 myeloma trials active across Canada, a huge increase from the few that were available to Canadian patients only 15 years ago. But Canada lags in patient participation when compared to countries in Europe. In the coming months, Myeloma Canada will work on developing an awareness program to encourage patients to consider the possibility of enrolling in a clinical trial and help accelerate access to new game-changing therapies.
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