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Sponsors and Collaborators: |
Accelerated Community Oncology Research Network Millennium Pharmaceuticals, Inc. |
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Information provided by: | Accelerated Community Oncology Research Network |
ClinicalTrials.gov Identifier: | NCT00366106 |
The purpose of this research study is to see if the combination of Velcade and dexamethasone provides better response than other alternatives, and can be used longer as maintenance therapy for the treatment of multiple myeloma. In addition, this study is being conducted to see if using different schedules of the two study drugs might reduce peripheral neuropathy (pain and tingling in the hands and feet).
Condition | Intervention | Phase |
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Multiple Myeloma |
Drug: bortezomib Drug: Dexamethasone Drug: doxorubicin HCl liposome |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase II, Open Label Study Evaluating an Alternative Schedule of Velcade/Dexamethasone Plus Doxil in the Treatment of Multiple Myeloma |
Estimated Enrollment: | 45 |
Study Start Date: | July 2006 |
Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, California | |
Wilshire Oncology Medical Group, Inc. | |
La Verne, California, United States, 91750 | |
United States, Connecticut | |
Medical Oncology & Hematology | |
Waterbury, Connecticut, United States, 06708 | |
United States, Florida | |
Advanced Medical Specialties | |
Miami, Florida, United States, 33176 | |
United States, Georgia | |
Augusta Oncology Associates, PC | |
Augusta, Georgia, United States, 30901 | |
Northwest Georgia Oncology Centers, PC | |
Marietta, Georgia, United States, 30060 | |
Northeast Georgia Cancer Care | |
Athens, Georgia, United States, 30607 | |
United States, Idaho | |
North Idaho Cancer Center | |
Coeur d'Alene, Idaho, United States, 83814 | |
United States, Maryland | |
Oncology-Hematology Associates, P.A. | |
Clinton, Maryland, United States, 20735 | |
United States, Montana | |
Hematology Oncology Centers of the Northern Rockies, PC | |
Billings, Montana, United States, 59101 | |
United States, New York | |
Arena Oncology Associates | |
Lake Success, New York, United States, 11042 | |
United States, Ohio | |
Tri-County Hematology and Oncology Associates | |
Canton, Ohio, United States, 44718 | |
Mid Ohio Oncology/Hematology, Inc. | |
Columbus, Ohio, United States, 43215 | |
United States, Pennsylvania | |
Lancaster Cancer Center, Ltd. | |
Lancaster, Pennsylvania, United States, 17605 | |
United States, Tennessee | |
The West Clinic | |
Memphis, Tennessee, United States, 38120 | |
United States, Virginia | |
Cancer Specialists of Tidewater, Ltd. | |
Chesapeake, Virginia, United States, 23320 |
Principal Investigator: | Johnetta Blakely, MD | Accelerared Community Oncology Research Network, Inc. |
Responsible Party: | Accelerated Community Oncology Research Network ( Cindy Lee, RN, MSN, CCRP ) |
Study ID Numbers: | ACORN ALJBMM0502 |
Study First Received: | August 16, 2006 |
Last Updated: | January 5, 2009 |
ClinicalTrials.gov Identifier: | NCT00366106 |
Health Authority: | United States: Institutional Review Board |
Relapsed Multiple Myeloma Refractory 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 |