Phase II Study of Velcade, Decadron, and Doxil Followed by Cyclophosphamide in Multiple Myeloma

PHASE2CompletedINTERVENTIONAL
Enrollment

38

Participants

Timeline

Start Date

June 30, 2005

Primary Completion Date

February 28, 2011

Study Completion Date

November 30, 2012

Conditions
Multiple Myeloma
Interventions
DRUG

Bortezomib

During Induction Phase (6 cycles): Bortezomib 1.3 mg/m2 on days 1, 4, 8, and 11 During 21-day mobilization cycle (1 cycle): Bortezomib 1.3 mg/m2 on days 1, 4, 8, and 11

DRUG

dexamethasone

During Induction Phase (6 cycles): dexamethasone 40 mg on days 1-4, 8-11, and 15-18

DRUG

liposomal doxorubicin

If patients achieve less then a PR during the induction phase after 2 cycles, or less then a CR after 4 cycles: Liposomal doxorubicin was added at 30 mg/m2 on day 4 for the remaining cycles

DRUG

cyclophoshamide

During the 21 day mobilization phase (1 cycle): cyclophosphamide at 3 g/m2 on day 8

DRUG

filgrastim

During the 21 day mobilization phase (1 cycle): 10 μg/kg/day for 10 consecutive days starting 24 hours after cyclophosphamide administration on day 9

Trial Locations (1)

10021

Weill Medical College of Cornell University, New York

Sponsors
All Listed Sponsors
collaborator

Millennium Pharmaceuticals, Inc.

INDUSTRY

lead

Weill Medical College of Cornell University

OTHER