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Sponsored by: |
Oncotherapeutics |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00742404 |
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 |
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Multiple Myeloma and Plasma Cell Neoplasm |
Drug: bortezomib Drug: dexamethasone Drug: pegylated liposomal doxorubicin hydrochloride Procedure: immunologic technique Procedure: protein analysis |
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.
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
United States, California | |
Comprehensive Blood and Cancer Center | Recruiting |
Bakersfield, California, United States, 93309-0633 | |
Contact: Julie Leach, RN, OCN 661-862-7178 | |
James R. Berenson MD, Incorporated | Recruiting |
West Hollywood, California, United States, 90069 | |
Contact: Regina Swift, RN 310-623-1200 jberenson@imbcr.org | |
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 at Suburban Hospital | Recruiting |
Bethesda, Maryland, United States, 20817 | |
Contact: Natalie Bongiorno 301-571-2016 nbongiorno@ccbdmd.com |
Principal Investigator: | James R. Berenson, MD | Oncotherapeutics |
Responsible Party: | Oncotherapeutics ( Clinical Research & Development Manager ) |
Study ID Numbers: | CDR0000612434, ONCOTHER-X05272-DOXILMMY2010, DVD study |
Study First Received: | August 26, 2008 |
Last Updated: | December 11, 2008 |
ClinicalTrials.gov Identifier: | NCT00742404 |
Health Authority: | Unspecified |
stage I multiple myeloma stage II multiple myeloma stage III multiple myeloma |
Dexamethasone Immunoproliferative Disorders Blood Protein Disorders Hematologic Diseases Blood Coagulation Disorders Bortezomib Vascular Diseases Paraproteinemias |
Hemostatic Disorders Doxorubicin Multiple Myeloma Hemorrhagic Disorders Multiple myeloma Lymphoproliferative Disorders Dexamethasone acetate Neoplasms, Plasma Cell |
Anti-Inflammatory Agents Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Hormonal Immune System Diseases Antineoplastic Agents Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Gastrointestinal Agents Antiemetics Enzyme Inhibitors |
Antibiotics, Antineoplastic Hormones Glucocorticoids Pharmacologic Actions Protease Inhibitors Neoplasms Autonomic Agents Therapeutic Uses Cardiovascular Diseases Peripheral Nervous System Agents Central Nervous System Agents |