Combination Bortezomib-containing Regimens in Newly Diagnosed Patients With t (4; 14) Positive Multiple Myeloma

PHASE2CompletedINTERVENTIONAL
Enrollment

36

Participants

Timeline

Start Date

August 25, 2008

Primary Completion Date

September 15, 2015

Study Completion Date

September 15, 2015

Conditions
Multiple Myeloma
Interventions
DRUG

Bortezomib

21 day-cycle Induction therapy:bortezomib 1.3 mg/m2 (I.V. Days 1, 4, 8, and 11), then 10-day rest period. DOXIL 30 mg/m2 given after bortezomib (I.V. infusion Day 4 of each cycle). Dexamethasone 40 mg PO on days 1-4,8-11 and 15-18 during the first cycle. Subsequent 3 cycles, dexamethasone 40 mg PO given on days 1-4 and 11-14. Patients who don't progress may undergo elective stem cell mobilization, stem cell collection and cryopreservation. Patients will then receive post-induction therapy 1.5 mg/m2 bortezomib days 1, 8, and 15 I.V. + cyclophosphamide 300 mg/m2 PO weekly + prednisone 100 mg PO on alternate days for 8 monthly 28 day cycles.Maintenance therapy with weekly 40 mg dexamethasone (days 1, 8, 15 and 22) every month until disease progression occurs.

Trial Locations (7)

T6G-1Z2

Cross Cancer Institute 11560 University Ave, Edmonton

R3E 0V9

CancerCare Manitoba 675 McDermot Ave., Winnipeg

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 Hospital, Toronto

S7N 4H4

Saskatoon Cancer Centre 20 Campus Drive, Saskatoon

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Princess Margaret Hospital, Canada

OTHER

collaborator

Ortho Biotech, Inc.

INDUSTRY

lead

University Health Network, Toronto

OTHER