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Sponsored by: |
Masonic Cancer Center, University of Minnesota |
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Information provided by: | Masonic Cancer Center, University of Minnesota |
ClinicalTrials.gov Identifier: | NCT00177047 |
This is a study of a regimen of melphalan and autologous stem cells for patients with multiple myeloma. We hypothesize that this particular regimen will improve the survival of these patients.
Condition | Intervention | Phase |
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Multiple Myeloma |
Procedure: Stem Cell Transplant Drug: cyclophosphamide, melphalan |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study |
Official Title: | Autologous Transplantation for Multiple Myeloma |
Estimated Enrollment: | 80 |
Study Start Date: | January 2004 |
Estimated Study Completion Date: | December 2015 |
Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
Before starting treatment in this study, the BMT doctor will check the subject's general health. Subjects will have the following tests and evaluations to find out if they can participate:--Medical history and physical examination, including height and weight.--Blood tests (approximately 4 - 5 tablespoons) --Urine tests--Chest x-ray--Electrocardiogram (ECG or EKG)--Heart Scan (MUGA)--Pulmonary Function Test (PFT)--Bone marrow biopsies and aspirates. --If Female subjects of child-bearing age will have a serum pregnancy test performed. After eligible patients have been completely staged and exercised consent, they will undergo one cycle of chemotherapy (cyclophosphamide and Mesna) and growth factor (G-CSF) to effect cytoreduction and mobilization of PBSC for collection.All patients will receive high-dose melphalan followed by an autologous SCT. Patients will then receive two additional medications (dexamethasone and thalidomide) given by mouth. Blood tests will be performed frequently to evaluate the subject's response to treatment and possible side effects of treatment. If necessary, platelet and red cell transfusions will be given to maintain adequate levels and antibiotics will be given to treat or prevent infection. Subjects may also require intravenous nutritional support and pain medications during or after transplantation. The study coordinators will collect health information over three years. They will collect information every week for 100 days, then at 6 months, 1 year, 2 years, and 3 years.
Ages Eligible for Study: | up to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Mukta Arora, M.D. | 612-624-5620 | arora005@umn.edu |
United States, Minnesota | |
Masonic Cancer Center, University of Minnesota | Recruiting |
Minneapolis, Minnesota, United States, 55455 | |
Contact: Mukta Arora, M.D. 612-624-5620 arora005@umn.edu |
Principal Investigator: | Mukta Arora, MD | Masonic Cancer Center, University of Minnesota |
Responsible Party: | Masonic Cancer Center, University of Minnesota ( Mukta Arora, MD ) |
Study ID Numbers: | 0312M54569, MT2003-13, 2004LS001 |
Study First Received: | September 13, 2005 |
Last Updated: | April 21, 2009 |
ClinicalTrials.gov Identifier: | NCT00177047 History of Changes |
Health Authority: | United States: Institutional Review Board |
stem cell transplantation chemotherapy multiple myeloma autologous |
Morphine Melphalan Immunoproliferative Disorders Immunologic Factors Blood Protein Disorders Hematologic Diseases Blood Coagulation Disorders Vascular Diseases Paraproteinemias Cyclophosphamide |
Hemostatic Disorders Immunosuppressive Agents Multiple Myeloma Hemorrhagic Disorders Antineoplastic Agents, Alkylating Antirheumatic Agents Lymphoproliferative Disorders Alkylating Agents Neoplasms, Plasma Cell |
Melphalan Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Blood Protein Disorders Physiological Effects of Drugs Paraproteinemias Cyclophosphamide Hemostatic Disorders Hemorrhagic Disorders Therapeutic Uses Cardiovascular Diseases Alkylating Agents Immunoproliferative Disorders |
Neoplasms by Histologic Type Immune System Diseases Hematologic Diseases Vascular Diseases Immunosuppressive Agents Pharmacologic Actions Multiple Myeloma Neoplasms Myeloablative Agonists Antineoplastic Agents, Alkylating Lymphoproliferative Disorders Antirheumatic Agents Neoplasms, Plasma Cell |