Trial Information
Summary: Phase I/II Study of Liposomal Doxorubicin (DoxilŽ)/ Melphalan/ Bortezomib (VelcadeŽ) in Relapsed/Refractory Multiple Myeloma
The goals of this study are to examine a investigational
combination of chemotherapy drugs including liposomal doxorubicin
(DoxilŽ), melphalan, and bortezomib (VelcadeŽ) and to see if this
combination is safe and effective at controlling the multiple
myeloma.
PRIMARY OBJECTIVE
To evaluate the safety and tolerability of four dose levels of
liposomal doxorubicin, melphalan, and bortezomib in patients with
relapsed/ refractory MM and to identify a maximum tolerated dose
(MTD) of this combination.
SECONDARY OBJECTIVE
To determine the efficacy of DMV therapy using the following
endpoints: The overall response rate, including complete, near
complete, partial, and minimal response rate (CR + nCR + PR +MR) of
relapsed/refractory MM to DMV combination therapy.
Time to response, progression-free survival, and overall
survival.
Tabulate all the toxicities of DMV at the MTD by NCI
criteria.
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Contact:
Eva Diaz, Project Coordinator/Data Manager
Columbia University Medical Center
177 Fort Washington Ave
MBH 6 NK 435
New York, NY 10032
Telephone: 212-305-8857
Fax: 212-305-6798
Email:
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Trial listings updated: June 1, 2008 at 5:45:41 AM