78
Participants
Start Date
October 1, 2013
Primary Completion Date
July 31, 2022
Study Completion Date
July 31, 2022
Busulfan
Once daily intravenous (IV) busulfan at a dose of 3.2 mg/kg or equivalent pharmacokinetics directed dose for three consecutive days (days -5 to -3), option 1 OR Once daily intravenous (IV) busulfan at a dose of 3.2mg/kg or equivalent pharmacokinetics directed dose for three consecutive days (days -6 to -4), option 2.
Melphalan
"I.V. reduced dose of melphalan (140mg/m2) on day -2, followed by an autologous stem cell transplant on day 0 (day -1 will be a rest day) - this is referred to as Option 1 dosing schema OR I.V. reduced dose of melphalan (140mg/m2) on day -3 followed by autologous stem cell transplant on day 0 (days -2 and -1 will be rest days). This is referred to as Option 2"
Lenalidomide
Oral lenalidomide 10mg per day (on all 28 days of a 28 day cycle) for the first three cycles and then escalated to 15 mg daily if clinically appropriate to do so. The lenalidomide maintenance will start on day 100 post ASCT and continue till disease progression.
Cross Cancer Institute 11560 University Ave, Edmonton
Vancouver General Hospital, Centennial Pavilion, 6th Floor, Vancouver
Saint John Regional Hospital, 5DN Research Department, 400 University Ave, Saint John
Queen Elizabeth II Health Sciences Centre., Halifax
London Regional Cancer Program 790 Commissioners Road East, London
The Ottawa Hospital, Ottawa
Princess Margaret Cancer Centre, Toronto
Hôpital Maisonneuve-Rosemont, 5415, boul. de l'Assomption, Montreal
Royal Victoria Hospital, MUHC Glen Site, Cedars Cancer Centre, Montreal
Saskatoon Cancer Centre 20 Campus Drive, Saskatoon
Collaborators (1)
Princess Margaret Hospital, Canada
OTHER
Otsuka Pharmaceutical Development & Commercialization, Inc.
INDUSTRY
Celgene Corporation
INDUSTRY
University Health Network, Toronto
OTHER