A Phase II Study of Pegylated Liposomal Doxorubicin, Bortezomib and Dexamethasone (DVD) for Patients With Newly Diagnosed Multiple Myeloma (MM)
OBJECTIVES:
Primary
- 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
dexamethasone.
Secondary
- 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
toxicity.
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.
Interventional
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
No
James R. Berenson, MD
Principal Investigator
Oncotherapeutics
United States: Federal Government
CDR0000612434
NCT00742404
July 2008
Name | Location |
---|---|
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 |