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.

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:

Profile Page: Columbia University Medical Center, New York, NY

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Trial listings updated: June 1, 2008 at 5:45:41 AM


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