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 high-dose chemotherapy with autologous stem cell transplantation (ASCT), but also introduced a promising new tool for the management of myeloma - MRD or minimal residual disease. The trial also evaluated the efficacy of a modified conditioning regimen by adding busulfan to a lower dose of melphalan.
This Phase II trial was conducted in 10 Canadian centres. After bortezomib (Velcade®)-based induction, usually CyBorD (cyclophosphamide, bortezomib and dexamethasone), and in the absence of disease progression, patients received busulfan in combination with melphalan conditioning, followed by an ASCT. On day 100 post-ASCT, lenalidomide 10 mg/day was commenced, and escalated to 15 mg/day after 3 cycles (if appropriate), and continued until disease progression.
The Principal Investigator (PI) for this study is Dr Donna Reece of the Princess Margaret Cancer Centre in Toronto. A total of 77 patients have been enrolled in the following sites across Canada:
- Edmonton – Cross Cancer Institute
- Halifax – Queen Elizabeth II Health Sciences Centre
- London – London Health Science Centre
- Montreal – McGill University Health Centre
- Montreal – Maisonneuve-Rosemont Hospital
- Ottawa – The Ottawa General Hospital
- Saint John – Saint John Regional Hospital
- Saskatoon – Saskatoon Cancer Centre
- Toronto – Princess Margaret Hospital
- Vancouver – Vancouver General Hospital
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).