A Phase II Study of Pegylated Liposomal Doxorubicin, Bortezomib and Dexamethasone (DVD) for Patients With Newly Diagnosed Multiple Myeloma (MM)
- To determine the response rate (i.e., complete response, very good partial response ,
partial response, and minimal response) in patients with newly diagnosed multiple
myeloma treated with pegylated liposomal doxorubicin hydrochloride, bortezomib, and
- To assess the safety and tolerability of this regimen in these patients.
- To determine the time to disease progression, time to response, duration of response,
progression-free survival, and overall survival of patients treated with this regimen.
OUTLINE: Patients receive pegylated liposomal doxorubicin hydrochloride IV over 30-90
minutes, dexamethasone IV, and bortezomib IV on days 1, 4, 8, and 11. Treatment repeats
every 28 days for up to 8 courses in the absence of disease progression or unacceptable
Blood and urine samples are collected at baseline and periodically during study for
M-protein analysis by electrophoresis and immunofixation.
After completion of study therapy, patients are followed periodically.
Masking: Open Label, Primary Purpose: Treatment
Response rate (complete response, very good partial response, partial response, and minimal response) as assessed by modified Bladé criteria at baseline, on day 1 of each course, and at end-of-study
James R. Berenson, MD
United States: Federal Government
|New York Medical College||Valhalla, New York 10595|
|Loma Linda University Cancer Institute at Loma Linda University Medical Center||Loma Linda, California 92354|
|Sutter Cancer Center at Roseville Medical Center||Roseville, California 95661|
|Comprehensive Blood and Cancer Center||Bakersfield, California 93309|
|Santa Barbara Hematology Oncology Medical Group at Cancer Center of Santa Barbara||Santa Barbara, California 93105|
|Arizona Clinical Research Center, Incorporated||Tucson, Arizona 85715|
|Center for Cancer and Blood Disorders||Bethesda, Maryland 20817|
|Charleston Hematology Oncology Associates, PA||Charleston, South Carolina 29403|
|San Diego Pacific Oncology and Hematology Associates, Incorporated - Escondido||Escondido, California 92025|
|Oncology Care Medical Associates - San Gabriel||Los Angeles, California 90057|
|Desert Cancer Care||Rancho Mirage, California 92270|
|James R. Berenson MD, Incorporated||West Hollywood, California 90069|