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MCRN Clinical trials

Bringing Game-Changing Therapies to Canadian Patients: Updates on the Myeloma Canada Research Network's Active Clinical Trials

The Myeloma Canada Research Network (MCRN) brings innovative Canadian-designed clinical trials to hundreds of patients in 24 centres in 9 provinces across Canada. All MCRN trials are designed to improve Canadian myeloma treatment protocols, influence government decision-making policies for drug reimbursement and provide access to game-changing therapies which would otherwise not be available, leading to overall improved outcomes for Canadian patients.

MCRN 001- The BuMel Trial

When this trial protocol was being developed in 2012, most Canadian patients did not have access to lenalidomide (Revlimid) maintenance treatment. Through this trial, the MCRN was not only able to offer lenalidomide maintenance to newly-diagnosed patients following their high-dose chemotherapy (autologous stem cell transplant) but it also introduced a promising new tool for the management of myeloma - MRD or minimal residual disease. The trial was also designed to evaluate the efficacy of a modified conditioning regimen by adding busulfan to a lowered dose of melphalan.
 
This phase II trial was conducted in 10 Canadian centers. After bortezomib-based induction, usually CyBorD (cyclophosphomide, bortezomib and dexamethazone), and in the absence of disease progression, patients received busulfan in combination with melphalan conditioning, followed by an autologous stem cell transplant (ASCT). On day 100 post-ASCT, lenalidomide (Revlimid) 10 mg/day was commenced, and escalated to 15 mg/day after 3 cycles if appropriate, and continued until disease
progression.
Dr Donna Reece

The Principal Investigator (PI) for this study is Dr Donna Reece of the Princess Margaret Cancer Centre.

A total of 77 patients have been enrolled in the following sites across Canada:

  • Saint John - Saint John Regional Hospital
  • Halifax - Queen Elizabeth II Health Sciences Centre
  • Vancouver - Vancouver General Hospital
  • Montreal - Maisonneuve-Rosemont Hospital
  • Edmonton - Cross Cancer Institute
  • London - London Health Science Centre
  • Saskatoon - Saskatoon Cancer Centre
  • Ottawa - The Ottawa General Hospital
  • Toronto - Princess Margaret Hospital
  • Montreal - McGill University Health Centre

The study has been featured in poster presentations at several scientific meetings, including the American Society of Hematology (ASH) and the International Myeloma Workshop (IMW).  

MCRN 002 - The STOMP Trial

Dr Christine Chen

Led by Dr Nizar Bahlis in Calgary and Dr Christine Chen in Toronto, MCRN 002 is playing a principal role in the clinical development of a promising new molecule, selinexor or KPT-330, a first-in-class Selective Inhibitor of Nuclear Export (SINE™) compound developed by Karyopharm Therapeutics in the Boston area. This has given eligible patients across Canada early access to an innovative therapy.

Dr Nizar Bahlis

The Phase II trial combines selinexor, with dexamethasone and a"backbone" therapy: either bortezomib, lenalidomide or pomalidomide in patients with relapsed or refractory myeloma. All therapies are given orally, with the exception of bortezomib, which is given by subcutaneous injection.  

More than 75 patients in the following centres have thus far participated in the trial:

  • Tom Baker Cancer Centre, Calgary
  • Cross Cancer Institute, Edmonton
  • Vancouver General Hospital, Vancouver
  • CancerCare Manitoba, Winnipeg
  • Memorial Hospital of Newfoundland, St John's
  • Queen Elizabeth II Health Sciences Centre, Halifax
  • Princess Margaret Cancer Centre, Toronto
  • Maisonneuve-Rosemont Hospital, Montreal
  • Royal Victoria Hospital/McGill University, Montreal
  • Saskatchewan Cancer Agency - Allan Blair Cancer Centre, Regina

MCRN 003 - the KCd Trial

Dr Chris Venner

Carfilzomib (Kyrpolis), a new proteasome inhibitor, was approved by Health Canada in January 2016, but is not yet funded by any provincial drug plan. The MCRN 003 trial provides access to this new drug to eligible patients with the triplet combination of carfilzomib, cyclophosphamide and dexamethasone. Cyclophosphamide is believed to have immunomodulatory properties and provides a more cost-effective alternative to other carfilzomib triplet combinations that have been studied.

The currently approved dosing schedule for carfilzomib is twice weekly. The trial is evaluating a once-weekly dosing regimen which will not only be more convenient for the patient, but also be more cost-effective. The overall lower cost of this combination may help influence provincial drug funding decisions in the future.

Dr Andrew Belch

The trial is being led by Dr Andrew Belch and Dr Christopher Venner from the CrossCancer Institute in Edmonton.  

Participating sites: 

  • Toronto - Princess Margaret Cancer Centre
  • London - London Health Sciences Centre
  • Ottawa - The Ottawa General Hospital
  • Edmonton - Cross Cancer Institute
  • Montreal - Maisonneuve-Rosemont Hospital
  • Kingston- Kingston General Hospital
  • Halifax - Queen Elizabeth II Health Sciences Centre
  • Saint John - Saint John Regional Hospital
  • Quebec City- Pavillon Hôtel-Dieu de Québec

COMING SOON IN SUMMER 2017!

MCRN 004

Daratumumab (Darzalex) is the first monoclonal antibody for the treatment of myeloma to be approved by Health Canada. Presently, it is not reimbursed by any public drug plan, denying access to those to patients in need for the time being. Led by Dr Michael Sebag at the McGill University Health Centre in Montreal, the MCRN 004 trial will not only provide access to daratumumab for eligible patients across the country, but it will also answer the question of how to optimize the use of expensive drugs using a rational and cost-effective approach. Stay tuned for more details.

Dr Nizar Bahlis

MCRN 005 - The BOSTON Trial

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.