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Sponsored by: |
Oncotherapeutics |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00317811 |
RATIONALE: Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as melphalan, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Ascorbic acid may help melphalan work better by making cancer cells more sensitive to the drug. Giving bortezomib together with ascorbic acid and melphalan may kill more cancer cells.
PURPOSE: This phase II trial is studying how well giving bortezomib together with ascorbic acid and melphalan works in treating patients with newly diagnosed multiple myeloma.
Condition | Intervention | Phase |
---|---|---|
Multiple Myeloma and Plasma Cell Neoplasm |
Drug: ascorbic acid Drug: bortezomib Drug: melphalan |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase II Trial of Bortezomib + Ascorbic Acid + Melphalan (BAM) Combination Therapy for Patients With Newly Diagnosed Multiple Myeloma |
Estimated Enrollment: | 35 |
Study Start Date: | November 2005 |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is an open-label study.
After completion of study treatment, patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 35 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Newly diagnosed symptomatic multiple myeloma based on the following criteria:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
No prior therapy for myeloma
United States, California | |
Hematology Oncology Medical Group of Orange County, Incorporated | |
Orange, California, United States, 92868 | |
Hematology-Oncology Medical Group of Fresno, Incorporated | |
Fresno, California, United States, 93720 | |
Oncotherapeutics | |
West Hollywood, California, United States, 90069 | |
United States, Florida | |
Florida Cancer Specialists - Bonita Springs | |
Bonita Springs, Florida, United States, 34135 | |
Florida Oncology Associates | |
Orange Park, Florida, United States, 32073 | |
United States, Georgia | |
Atlanta Cancer Care - Roswell | |
Roswell, Georgia, United States, 30076 | |
United States, Illinois | |
University of Chicago Cancer Research Center | |
Chicago, Illinois, United States, 60637-1470 | |
United States, New York | |
SUNY Downstate Medical Center | |
Brooklyn, New York, United States, 11203 |
Principal Investigator: | James R. Berenson, MD | Oncotherapeutics |
Study ID Numbers: | CDR0000479708, ONCOTHER-20052183, ONCOTHER-BAM2005, MILLENNIUM-ONCOTHER-20052183 |
Study First Received: | April 24, 2006 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00317811 |
Health Authority: | United States: Federal Government |
stage I multiple myeloma stage II multiple myeloma stage III multiple myeloma |
Melphalan Immunoproliferative Disorders Blood Protein Disorders Hematologic Diseases Blood Coagulation Disorders Bortezomib Vascular Diseases Paraproteinemias |
Hemostatic Disorders Multiple Myeloma Hemorrhagic Disorders Multiple myeloma Lymphoproliferative Disorders Ascorbic Acid Neoplasms, Plasma Cell |
Neoplasms by Histologic Type Antioxidants Immunologic Factors Immune System Diseases Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Growth Substances Physiological Effects of Drugs Enzyme Inhibitors Immunosuppressive Agents Protective Agents |
Pharmacologic Actions Protease Inhibitors Neoplasms Therapeutic Uses Vitamins Myeloablative Agonists Cardiovascular Diseases Antineoplastic Agents, Alkylating Micronutrients Alkylating Agents |