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Sponsored by: |
University of Arkansas |
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Information provided by: | University of Arkansas |
ClinicalTrials.gov Identifier: | NCT00083382 |
The purpose of this research is to study how helpful the combination of thalidomide and Pamidronate or thalidomide and Zometa is in controlling the myeloma disease and to study any side effects.
Condition | Intervention | Phase |
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Multiple Myeloma |
Drug: Pamidronate Drug: Thalidomide Drug: Zometa |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | UARK 98-036, A Phase II Trial of Combination Bisphosphonate and Anti-Angiogenesis Therapy With Pamidronate and Thalidomide in Patients With Smoldering/Indolent Myeloma |
Estimated Enrollment: | 100 |
Study Start Date: | December 1998 |
Estimated Study Completion Date: | July 2008 |
All patients will receive pamidronate at a dose of 90 mg by continuous infusion over 90 minutes, every two weeks for 2 months. Disease will be reassessed after two cycles.
Those with stable disease or better will receive 90 mg every 4 weeks as maintenance therapy.
All patients will receive zometa at a dose of 4 mg by continuous infusion every two weeks for 2 months. Disease will be reassessed after two cycles.
Those with stable disease or better will receive 4 mg every 4 weeks as maintenance therapy.
Recently laboratory research found that thalidomide can inhibit the formation of new blood vessels that are necessary for the growth and spread of cancer. In order to grow and increase in size tumors require new blood vessels to supply them with the necessary blood to grow. If we can prevent these new blood vessels feeding the tumor from being formed by using thalidomide we might slow or stop the growth of the tumor. This concept is called "anti-angiogenesis" It is hoped that thalidomide will slow or stop the growth myeloma. However, it cannot be guaranteed that you will benefit if you take part in this study. The treatment you receive may even be harmful.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | University_of_Arkansas ( Naveen Kumar, CRA ) |
Study ID Numbers: | UARK 98-036 |
Study First Received: | May 21, 2004 |
Last Updated: | December 7, 2007 |
ClinicalTrials.gov Identifier: | NCT00083382 |
Health Authority: | United States: Food and Drug Administration |
Myeloma Thalidomide Pamidronate Aredia |
Bisphosphonate Anti-Angiogenesis Smoldering/Indolent Myeloma Zometa |
Immunoproliferative Disorders Zoledronic acid Magnesium Oxide Thalidomide Blood Protein Disorders Hematologic Diseases Blood Coagulation Disorders Magnesium Hydroxide Vascular Diseases Paraproteinemias Bisacodyl |
Hemostatic Disorders Bismuth subsalicylate Multiple Myeloma Diphosphonates Hemorrhagic Disorders Multiple myeloma Pamidronate Lymphoproliferative Disorders Lactulose Neoplasms, Plasma Cell |
Anti-Infective Agents Neoplasms by Histologic Type Immune System Diseases Immunologic Factors Antineoplastic Agents Growth Substances Physiological Effects of Drugs Bone Density Conservation Agents Angiogenesis Inhibitors |
Immunosuppressive Agents Pharmacologic Actions Anti-Bacterial Agents Neoplasms Therapeutic Uses Cardiovascular Diseases Growth Inhibitors Angiogenesis Modulating Agents Leprostatic Agents |