This is a new monthly feature of
Myeloma Matters
, intended to keep the community informed about MCRN and other trials across the country. This is one of the steps Myeloma Canada is taking to raise awareness around the important role clinical trials play in both advancing medicine and providing access to new and promising therapies that are not readily accessible to patients. The trials described below include two Health Canada-approved drugs (
carfilzomib (Kyprolis
®
)
and
daratumumab (Darzalex
®
)
which are not yet covered by public health plans) and
selinexor
, a promising, first-in-class SINE XPO1 antagonist, which is still in clinical development.
Choosing to participate in a study is an important personal decision. Talk with your doctor, nurse and family members about deciding to join a study.
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MCRN 003: (KCd)
High-Dose Weekly Carfilzomib plus Cyclophosphamide and Dexamethasone in the Treatment of Relapsed Multiple Myeloma
Principal Investigator:
Dr Christopher Venner, Cross Cancer Institute, Edmonton, AB
In collaboration with the Canadian Cancer Trials Group (CCTG)
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Summary:
This is a Phase II single arm study to evaluate the safety and efficacy of once-a-week carfilzomib (Kyprolis) dosing (versus the current twice-weekly dosing schedule) in combination with cyclophosphamide and dexamethasone (KCd).
Patient population
: Relapsed (after one to three prior treatments)
Status:
As of December 31, 74 patients out of a planned total of 76 have been recruited, and the trial will close soon.
A more detailed overview of the trial will be published in the February issue of
Myeloma Matters.
Participating centres:
- Cross Cancer Institute; Edmonton, AB
- Maisonneuve-Rosemont Hospital; Montreal, QC
- Ottawa Hospital Research Institute; Ottawa, ON
- QE II Health Sciences Centre; Halifax, NS
- CHUQ-Pavillon Hôtel-Dieu de Québec; Quebec City, QC
- Princess Margaret Cancer Centre; Toronto, ON
- Regional Health Authority; Saint John, NB
- London Regional Cancer Program, London, ON
- Cancer Centre of Southeastern Ontario; Kingston, ON
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MCRN 004: The LAURENTIANS Trial
A Study of Daratumumab, Low-Dose Oral Dexamethasone and Cyclophosphamide with or without Pomalidomide (DCdP)
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Principal Investigator:
Dr Michael Debag, McGill University Health Centre; Montreal, QC
Summary:
This is a randomized phase II study of daratumumab, weekly low-dose oral cyclophosphamide and dexamethasone (DCd) with or without pomalidomide (DCdP) in patients with relapsed and refractory multiple myeloma. The study consists of two arms.
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Patient population:
Relapsed (after one to three prior treatments)
Status:
The trial was activated on October 25 and as of December 31, the following centres were open for recruitment:
- Cross Cancer Institute; Edmonton, AB
- Tom Baker Cancer Centre; Calgary, AB
- QE II Health Sciences Centre; Halifax, NS
- Regional Health Authority; Saint John, NB
- Saskatoon Cancer Centre; Saskatoon, SK
Several more centres will open in the coming weeks. We will provide monthly updates.
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MCRN 005: The BOSTON Trial
Bortezomib, Selinexor, and Dexamethasone (SVd) in Patients with Multiple Myeloma
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Principal Investigator:
Dr Nizar Bahlis; Tom Baker Cancer Centre; Calgary, AB
Summary:
This is a Phase III, 2-arm, randomized, active comparator-controlled study to compare the efficacy and health-related quality of life and assess the safety of selinexor plus bortezomib (Velcade®) plus low-dose dexamethasone (SVd) versus bortezomib plus low-dose dexamethasone (Vd) in adult patients with relapsed or refractory myeloma who have received 1 to 3 prior anti-multiple myeloma regimens.
Patient population:
Relapsed (after one to three prior treatments)
Status:
The trial was activated on June 7 and as of December 31, the following centres were open for patient recruitment:
- BCCA Vancouver General Hospital; Vancouver, BC
- Tom Baker Cancer Centre; Calgary, AB
- Cross Cancer Institute; Edmonton, AB
- Maisonneuve-Rosemont Hospital; Montreal, QC
- QE II Health Sciences Centre; Halifax, NS
- CHUQ-Pavillon Hôtel-Dieu de Québec; Quebec City, QC
- Princess Margaret Cancer Centre; Toronto, ON
- Saskatoon Cancer Centre; Saskatoon, SK
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