Doxorubicin Hydrochloride Liposome, Bortezomib, and Dexamethasone in Treating Patients With Newly Diagnosed Multiple Myeloma
- Conditions
- Multiple Myeloma and Plasma Cell Neoplasm
- Registration Number
- NCT00742404
- Lead Sponsor
- Oncotherapeutics
- Brief Summary
RATIONALE: Drugs used in chemotherapy, such as doxorubicin hydrochloride liposome and dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Giving bortezomib together with combination chemotherapy may kill more cancer cells.
PURPOSE: This phase II trial is studying how well giving doxorubicin hydrochloride liposome together with bortezomib and dexamethasone works in treating patients with newly diagnosed multiple myeloma.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 35
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method Time to progression Safety and tolerability as assessed by NCI CTCAE v3.0 Overall survival Changes in serum M-protein Changes in 24-hour urine M-protein Time to response Progression-free survival Duration of response
Trial Locations
- Locations (12)
James R. Berenson MD, Incorporated
🇺🇸West Hollywood, California, United States
San Diego Pacific Oncology and Hematology Associates, Incorporated - Escondido
🇺🇸Escondido, California, United States
Comprehensive Blood and Cancer Center
🇺🇸Bakersfield, California, United States
Oncology Care Medical Associates - San Gabriel
🇺🇸Los Angeles, California, United States
Loma Linda University Cancer Institute at Loma Linda University Medical Center
🇺🇸Loma Linda, California, United States
New York Medical College
🇺🇸Valhalla, New York, United States
Desert Cancer Care
🇺🇸Rancho Mirage, California, United States
Santa Barbara Hematology Oncology Medical Group at Cancer Center of Santa Barbara
🇺🇸Santa Barbara, California, United States
Sutter Cancer Center at Roseville Medical Center
🇺🇸Roseville, California, United States
Arizona Clinical Research Center, Incorporated
🇺🇸Tucson, Arizona, United States
Center for Cancer and Blood Disorders
🇺🇸Bethesda, Maryland, United States
Charleston Hematology Oncology Associates, PA
🇺🇸Charleston, South Carolina, United States