Overview

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

Status:
Completed
Trial end date:
2012-11-01
Target enrollment:
Participant gender:
Summary
PRIMARY STUDY OBJECTIVES - To evaluate the efficacy of the combination of bortezomib, dexamethasone, with and without DOXIL, followed by high-dose cyclophosphamide as a therapy for two different subsets of multiple myeloma patients: 1. Patients post first line therapy 2. Patients with relapsed/refractory disease who are bortezomib-naïve - To evaluate the safety of the combination of bortezomib and dexamethasone, with and without DOXIL, followed by high-dose cyclophosphamide as therapy for patients with multiple myeloma. SECONDARY STUDY OBJECTIVES - To evaluate the role of the combination of bortezomib dexamethasone, with and without DOXIL, followed by high-dose cyclophosphamide on the ability to collect > 10 x 106 CD34+ cells/kg in < 7 collections (for both subsets of multiple myeloma patients). - To evaluate the survival of patients who receive the combination of bortezomib dexamethasone, with and without DOXIL, followed by high-dose cyclophosphamide (for both subsets of patients).
Phase:
Phase 2
Details
Lead Sponsor:
Weill Medical College of Cornell University
Collaborator:
Millennium Pharmaceuticals, Inc.
Treatments:
BB 1101
Bortezomib
Cyclophosphamide
Dexamethasone
Dexamethasone 21-phosphate
Dexamethasone acetate
Doxorubicin
Liposomal doxorubicin