Doxorubicin Hydrochloride Liposome, Bortezomib, and Dexamethasone in Treating Patients With Newly Diagnosed Multiple Myeloma
|ClinicalTrials.gov Identifier: NCT00742404|
Recruitment Status : Unknown
Verified June 2010 by National Cancer Institute (NCI).
Recruitment status was: Active, not recruiting
First Posted : August 27, 2008
Last Update Posted : December 18, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Multiple Myeloma and Plasma Cell Neoplasm||Drug: bortezomib Drug: dexamethasone Drug: pegylated liposomal doxorubicin hydrochloride Genetic: protein analysis Other: immunologic technique||Phase 2|
- 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.
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||35 participants|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Pegylated Liposomal Doxorubicin, Bortezomib and Dexamethasone (DVD) for Patients With Newly Diagnosed Multiple Myeloma (MM)|
|Study Start Date :||July 2008|
|Estimated Primary Completion Date :||July 2010|
U.S. FDA Resources
- 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
- Safety and tolerability as assessed by NCI CTCAE v3.0
- Time to progression
- Time to response
- Duration of response
- Progression-free survival
- Overall survival
- Changes in serum M-protein
- Changes in 24-hour urine M-protein
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00742404
|United States, Arizona|
|Arizona Clinical Research Center, Incorporated|
|Tucson, Arizona, United States, 85712|
|United States, California|
|Comprehensive Blood and Cancer Center|
|Bakersfield, California, United States, 93309-0633|
|San Diego Pacific Oncology and Hematology Associates, Incorporated - Escondido|
|Escondido, California, United States, 92025|
|Loma Linda University Cancer Institute at Loma Linda University Medical Center|
|Loma Linda, California, United States, 92354|
|Oncology Care Medical Associates - San Gabriel|
|Los Angeles, California, United States, 90057|
|Desert Cancer Care|
|Rancho Mirage, California, United States, 92270|
|Sutter Cancer Center at Roseville Medical Center|
|Roseville, California, United States, 95661|
|Santa Barbara Hematology Oncology Medical Group at Cancer Center of Santa Barbara|
|Santa Barbara, California, United States, 93105|
|James R. Berenson MD, Incorporated|
|West Hollywood, California, United States, 90069|
|United States, Maryland|
|Center for Cancer and Blood Disorders|
|Bethesda, Maryland, United States, 20817|
|United States, New York|
|New York Medical College|
|Valhalla, New York, United States, 10595|
|United States, South Carolina|
|Charleston Hematology Oncology Associates, PA|
|Charleston, South Carolina, United States, 29403|
|Principal Investigator:||James R. Berenson, MD||Oncotherapeutics|