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Sponsored by: |
Sylvester Cancer Center |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00504101 |
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 arsenic trioxide and melphalan, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving high-dose combination chemotherapy together with bortezomib may kill more cancer cells.
PURPOSE: This phase I trial is studying the side effects and best dose of bortezomib when given together with arsenic trioxide and melphalan in treating patients undergoing an autologous stem cell transplant for multiple myeloma.
Condition | Intervention | Phase |
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Multiple Myeloma and Plasma Cell Neoplasm |
Drug: arsenic trioxide Drug: bortezomib Drug: melphalan Procedure: autologous hematopoietic stem cell transplantation |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Phase I Clinical Trial of Dose Escalated Bortezomib + ATO (Arsenic Trioxide) + Melphalan as a Conditioning Regimen for Multiple Myeloma |
Estimated Enrollment: | 36 |
Study Start Date: | June 2007 |
Estimated Primary Completion Date: | June 2014 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a dose-escalation study of bortezomib.
After completion of study therapy, patients are followed periodically for at least 5 years.
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Inclusion criteria:
Confirmed diagnosis of multiple myeloma (M-protein by serum protein electrophoresis or urine protein electrophoresis) and either bone marrow biopsy and aspirate demonstrating a plasma cell count > 10% or biopsy of a bone or soft tissue mass demonstrating a plasmacytoma
Exclusion criteria:
PATIENT CHARACTERISTICS:
Inclusion criteria:
Exclusion criteria:
PRIOR CONCURRENT THERAPY:
Inclusion criteria:
Subjects with radiographic evidence of lytic bone disease receiving concomitant bisphosphonate therapy may be enrolled
Exclusion criteria:
United States, Florida | |
University of Miami Sylvester Comprehensive Cancer Center - Miami | |
Miami, Florida, United States, 33136 |
Study Chair: | Mark S. Goodman, MD | Sylvester Cancer Center |
Study ID Numbers: | CDR0000558058, SCCC-2006071, SCCC-EPROST-20070104 |
Study First Received: | July 17, 2007 |
Last Updated: | December 13, 2008 |
ClinicalTrials.gov Identifier: | NCT00504101 |
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 Arsenic trioxide |
Paraproteinemias Hemostatic Disorders Multiple Myeloma Hemorrhagic Disorders Multiple myeloma Lymphoproliferative Disorders Neoplasms, Plasma Cell |
Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Immune System Diseases Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Enzyme Inhibitors Immunosuppressive Agents |
Pharmacologic Actions Protease Inhibitors Neoplasms Therapeutic Uses Myeloablative Agonists Cardiovascular Diseases Antineoplastic Agents, Alkylating Alkylating Agents |