Busulfan & Melphalan Conditioning for Autologous Stem Cell Transplant (ASCT) and Lenalidomide Maintenance

PHASE2CompletedINTERVENTIONAL
Enrollment

78

Participants

Timeline

Start Date

October 1, 2013

Primary Completion Date

July 31, 2022

Study Completion Date

July 31, 2022

Conditions
Multiple Myeloma
Interventions
DRUG

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.

DRUG

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"

DRUG

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.

Trial Locations (10)

T6G-1Z2

Cross Cancer Institute 11560 University Ave, Edmonton

V5Z 1M9

Vancouver General Hospital, Centennial Pavilion, 6th Floor, Vancouver

E2L 4L2

Saint John Regional Hospital, 5DN Research Department, 400 University Ave, Saint John

B3H 2Y9

Queen Elizabeth II Health Sciences Centre., Halifax

N6A 4L6

London Regional Cancer Program 790 Commissioners Road East, London

K1H 8L6

The Ottawa Hospital, Ottawa

M5G 2M9

Princess Margaret Cancer Centre, Toronto

H1T 2M4

Hôpital Maisonneuve-Rosemont, 5415, boul. de l'Assomption, Montreal

H4A 3J1

Royal Victoria Hospital, MUHC Glen Site, Cedars Cancer Centre, Montreal

S7N 4H4

Saskatoon Cancer Centre 20 Campus Drive, Saskatoon

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Princess Margaret Hospital, Canada

OTHER

collaborator

Otsuka Pharmaceutical Development & Commercialization, Inc.

INDUSTRY

collaborator

Celgene Corporation

INDUSTRY

lead

University Health Network, Toronto

OTHER

NCT01702831 - Busulfan & Melphalan Conditioning for Autologous Stem Cell Transplant (ASCT) and Lenalidomide Maintenance | Biotech Hunter | Biotech Hunter