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Sponsors and Collaborators: |
University of Michigan Cancer Center GlaxoSmithKline |
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Information provided by: | University of Michigan Cancer Center |
ClinicalTrials.gov Identifier: | NCT00135200 |
This study is for patients with newly diagnosed or relapsed multiple myeloma. The main purpose of this study is to see how their disease responds to consolidation treatment (treatment aimed at further decreasing cancer cells) with a radioactive antibody (protein) called iodine I 131 tositumomab (known by the tradename Bexxar®) and also to look at the side effects which occur with this type of treatment. The investigators will also be looking at how long disease responds to treatment, if it responds at all, and how long patients who have had this treatment survive.
Bexxar is a monoclonal antibody (protein) to which radioactive iodine 131 is attached. The monoclonal antibody in Bexxar (tositumomab), targets a protein called CD20 found on the surface of a variety of B-cells, including lymphoma cells, and some myeloma cells. The antibody is given as an infusion and finds its way to these cells. The radioactive iodine attached to the antibody delivers radiation directly to these cells which works to harm or kill the cancer cells. Approximately 20-25% of patients with multiple myeloma have this protein on the surface of their tumor cells. In addition, this protein was found on the surface of myeloma stem cells. While myeloma stem cells represent a minority of all myeloma cells (less than 5%), these cells are resistant to chemotherapy and are believed to be responsible for a recurrence of the disease after chemotherapy. In this study, Bexxar will be used after patients complete a course of chemotherapy and have residual myeloma cells left in their body. The Investigators are hoping that the treatment with Bexxar will decrease and possibly eliminate residual myeloma cells resistant to chemotherapy.
Condition | Intervention | Phase |
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Multiple Myeloma |
Drug: Iodine I 131 Tositumomab |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment |
Official Title: | A Phase II Clinical Trial of Consolidation Treatment With Iodine I 131 Tositumomab for Multiple Myeloma |
Estimated Enrollment: | 30 |
Study Start Date: | August 2005 |
Estimated Study Completion Date: | January 2015 |
Estimated Primary Completion Date: | January 2012 (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:
Acceptable hematologic status within two weeks prior to patient registration, including:
Exclusion Criteria:
Patients with impaired bone marrow reserve, as indicated by one or more of the following:
Contact: Andrzej J Jakubowiak, MD, PhD | 734-615-1482 | |
Contact: Cancer AnswerLine | 1-800-865-1125 |
United States, Michigan | |
University of Michigan | Recruiting |
Ann Arbor, Michigan, United States, 48109 | |
Contact: Cancer AnswerLine, RN 800-865-1125 | |
Contact: Andrzej Jakubowiak, MD, PhD 734-615-1482 |
Principal Investigator: | Andrzej J Jakubowiak, MD, PhD | University of Michigan |
Responsible Party: | University of Michigan Comprehensive Cancer Center ( Andrzej J. Jakubowiak, MD, PhD ) |
Study ID Numbers: | UMCC 2005.035 |
Study First Received: | August 24, 2005 |
Last Updated: | July 24, 2008 |
ClinicalTrials.gov Identifier: | NCT00135200 |
Health Authority: | United States: Institutional Review Board |
Immunoproliferative Disorders Blood Protein Disorders Hematologic Diseases Blood Coagulation Disorders Iodine-131 anti-B1 antibody Vascular Diseases Paraproteinemias Hemostatic Disorders Multiple Myeloma |
Antibodies, Monoclonal Antibodies Hemorrhagic Disorders Multiple myeloma Iodine Lymphoproliferative Disorders Immunoglobulins Neoplasms, Plasma Cell |
Anti-Infective Agents Neoplasms by Histologic Type Immunologic Factors Immune System Diseases Antineoplastic Agents Growth Substances Physiological Effects of Drugs |
Trace Elements Pharmacologic Actions Anti-Infective Agents, Local Neoplasms Therapeutic Uses Cardiovascular Diseases Micronutrients |