MCRN 005 – The BOSTON Study Has Officially Begun Recruiting Patients in Canada for the Pivotal Phase III Clinical Trial
Dr Nizar Bahlis, Tom Baker Cancer Centre, Calgary
Informed by the Phase II STOMP (MCRN002) trial led by Dr Nizar Bahlis of Calgary, Karyopharm Therapeutics of Newton, Massachusetts has turned to Canada to lead the Phase III global registration trial for selinexor. Phase III trials compare the "standard of care" to the new treatment and are usually the largest, involving hundreds of patients at cancer centres around the world. The trial, which will be led by Dr Nizar Bahlis of Calgary, will evaluate the combination of selinexor, bortezomib, and dexamethasone (SVd) compared to bortezomib and dexamethasone (Vd). 

"Based on clinical and preclinical data to date, we believe that the combination of selinexor, Velcade and dexamethasone (SVd) could have multiple benefits for patients," said Michael G Kauffman, MD, PhD, Chief Executive Officer of Karyopharm. "The SVd regimen with once-weekly Velcade dosing utilizes 40% less Velcade and 25% less dexamethasone than the standard Vd dosing regimen. In the studies to date, the dosing schedule and regimen required fewer clinic visits for patients and had a manageable side effect profile, including rates of peripheral neuropathy, which have been significantly lower in SVd clinical data to date, compared to the historical rates of peripheral neuropathy in the standard Vd dosing regimen. We also believe that the SVd combination may resensitize myeloma cells to Velcade and other proteasome inhibitors. Clinical data to date have demonstrated a significantly higher response rate in patients who have been exposed to a proteasome inhibitor and then receive a combination of a proteasome inhibitor, selinexor and dexamethasone, compared to historical response rates with the retreatment of a proteasome inhibitor and dexamethasone alone."[1]

The first Canadian patient was dosed with this regimen June 6, 2017 and a total of 362 patients will be recruited over the course of the trial across North Amercia, Australia and Europe, including the following sites in Canada:  

  • Halifax - Queen Elizabeth II Health Sciences Centre
  • Toronto - Princess Margaret Cancer Centre
  • Saskatoon - Saskatoon Cancer Centre
  • Quebec City- Pavillon Hôtel-Dieu de Québec
  • Edmonton - Cross Cancer Institute
  • Vancouver- Vancouver General Hospital
  • Calgary- Tom Baker Cancer Centre
  • Montreal - Royal Victoria Hospital/McGill University
  • Montreal - Maisonneuve-Rosemont Hospital

For more information on this trial or how to participate, click here.
1 See press release issued by Karyopharm Therapeutics Inc. on June 7, 2017.