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| Sponsor: | Oncotherapeutics |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00742404 |
Purpose
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 | Intervention | Phase |
|---|---|---|
|
Multiple Myeloma and Plasma Cell Neoplasm |
Drug: bortezomib Drug: dexamethasone Drug: pegylated liposomal doxorubicin hydrochloride Genetic: protein analysis Other: immunologic technique |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label |
| Official Title: | A Phase II Study of Pegylated Liposomal Doxorubicin, Bortezomib and Dexamethasone (DVD) for Patients With Newly Diagnosed Multiple Myeloma (MM) |
| Estimated Enrollment: | 35 |
| Study Start Date: | July 2008 |
| Estimated Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of multiple myeloma based on the following criteria:
Major criteria
Minor criteria
Meets 1 of the following sets of diagnostic criteria:
Measurable disease, defined as a monoclonal immunoglobulin spike on serum electrophoresis ≥ 1 g/dL and/or urine monoclonal immunoglobulin spike ≥ 200 mg/24 hours, or evidence of lytic bone disease
PATIENT CHARACTERISTICS:
No impaired cardiac function or clinically significant cardiac disease, including any one of the following:
ECG evidence of acute ischemia or active conduction system abnormalities
No known HIV positivity or hepatitis B or C positivity
PRIOR CONCURRENT THERAPY:
No prior or concurrent anti-myeloma therapy except steroids
More than 4 weeks since prior major surgery and recovered
Contacts and Locations| United States, Arizona | |
| Arizona Clinical Research Center, Incorporated | Recruiting |
| Tucson, Arizona, United States, 85712 | |
| Contact: Patricia M. Plezia, PharmD 520-290-2510 | |
| United States, California | |
| Comprehensive Blood and Cancer Center | Recruiting |
| Bakersfield, California, United States, 93309-0633 | |
| Contact: Julie Leach, RN, OCN 661-862-7178 | |
| Desert Cancer Care | Recruiting |
| Rancho Mirage, California, United States, 92270 | |
| Contact: Barbara Phlaum 760-346-7655 | |
| Oncology Care Medical Associates - San Gabriel | Recruiting |
| Los Angeles, California, United States, 90057 | |
| Contact: Saoul Malcolm 213-989-1888 | |
| Loma Linda University Cancer Institute at Loma Linda University Medical Center | Recruiting |
| Loma Linda, California, United States, 92354 | |
| Contact: Clinical Trials Office - Loma Linda University Cancer Institut 909-558-3375 | |
| James R. Berenson MD, Incorporated | Recruiting |
| West Hollywood, California, United States, 90069 | |
| Contact: Regina Swift, RN 310-623-1200 jberenson@imbcr.org | |
| San Diego Pacific Oncology and Hematology Associates, Incorporated - Escondido | Recruiting |
| Escondido, California, United States, 92025 | |
| Contact: Karen Brady, RN 760-452-3340 | |
| Santa Barbara Hematology Oncology Medical Group at Cancer Center of Santa Barbara | Recruiting |
| Santa Barbara, California, United States, 93105 | |
| Contact: Clinical Trials Office - Santa Barbara Hematology Oncology Med 805-898-2119 | |
| Sutter Cancer Center at Roseville Medical Center | Recruiting |
| Roseville, California, United States, 95661 | |
| Contact: Clinical Trials Office - Sutter Cancer Center 916-454-6595 | |
| United States, Maryland | |
| Center for Cancer and Blood Disorders | Recruiting |
| Bethesda, Maryland, United States, 20817 | |
| Contact: Natalie Bongiorno, RN 301-571-2016 nbongiorno@ccbdmd.com | |
| United States, New York | |
| New York Medical College | Recruiting |
| Valhalla, New York, United States, 10595 | |
| Contact: Delong Liu, MD 888-850-9152 | |
| United States, South Carolina | |
| Charleston Hematology Oncology Associates, PA | Recruiting |
| Charleston, South Carolina, United States, 29403 | |
| Contact: Deborah McNeal 843-577-2276 | |
| Principal Investigator: | James R. Berenson, MD | Oncotherapeutics |
More Information
| Responsible Party: | Oncotherapeutics ( Regulatory Affairs Associate ) |
| Study ID Numbers: | CDR0000612434, ONCOTHER-X05272-DOXILMMY2010, DVD study |
| Study First Received: | August 26, 2008 |
| Last Updated: | October 7, 2009 |
| ClinicalTrials.gov Identifier: | NCT00742404 History of Changes |
| Health Authority: | Unspecified |
|
stage I multiple myeloma stage II multiple myeloma stage III multiple myeloma |
|
Anti-Inflammatory Agents Dexamethasone Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Blood Protein Disorders Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics Paraproteinemias Antibiotics, Antineoplastic Hemostatic Disorders Hormones Hemorrhagic Disorders Therapeutic Uses Cardiovascular Diseases |
Dexamethasone acetate Immunoproliferative Disorders Neoplasms by Histologic Type Antineoplastic Agents, Hormonal Immune System Diseases Hematologic Diseases Bortezomib Gastrointestinal Agents Vascular Diseases Enzyme Inhibitors Glucocorticoids Doxorubicin Pharmacologic Actions Protease Inhibitors Multiple Myeloma |