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| Sponsor: | University of Michigan Cancer Center |
|---|---|
| Collaborator: |
GlaxoSmithKline |
| Information provided by: | University of Michigan Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00135200 |
Purpose
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 |
|---|---|---|
|
Multiple Myeloma |
Drug: Iodine I 131 Tositumomab |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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) |
Show Detailed Description
Eligibility| 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:
Contacts and Locations| 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 |
More Information
| Responsible Party: | Andrzej J. Jakubowiak, MD, PhD, University of Michigan Comprehensive Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00135200 History of Changes |
| Other Study ID Numbers: | UMCC 2005.035, IRB # 2005-0403 and HUM 43767 |
| Study First Received: | August 24, 2005 |
| Last Updated: | November 11, 2010 |
| Health Authority: | United States: Institutional Review Board |
|
Multiple Myeloma Neoplasms, Plasma Cell Neoplasms by Histologic Type Neoplasms Hemostatic Disorders Vascular Diseases Cardiovascular Diseases Paraproteinemias Blood Protein Disorders Hematologic Diseases Hemorrhagic Disorders Lymphoproliferative Disorders Immunoproliferative Disorders Immune System Diseases |
Iodine Cadexomer iodine Iodine-131 anti-B1 antibody Antibodies, Monoclonal Anti-Infective Agents, Local Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Trace Elements Micronutrients Growth Substances Physiological Effects of Drugs Antineoplastic Agents Immunologic Factors |