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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 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Myeloma Thalidomide Pamidronate Aredia |
Bisphosphonate Anti-Angiogenesis Smoldering/Indolent Myeloma Zometa |
Anti-Infective Agents Thalidomide Immunologic Factors Blood Protein Disorders Magnesium Hydroxide Paraproteinemias Bone Density Conservation Agents Hemostatic Disorders Bisacodyl Anti-Bacterial Agents Hemorrhagic Disorders Pamidronate Lactulose |
Zoledronic acid Immunoproliferative Disorders Magnesium Oxide Hematologic Diseases Blood Coagulation Disorders Vascular Diseases Angiogenesis Inhibitors Immunosuppressive Agents Bismuth subsalicylate Multiple Myeloma Diphosphonates Lymphoproliferative Disorders Neoplasms, Plasma Cell |
Anti-Infective Agents Thalidomide Immunologic Factors Antineoplastic Agents Blood Protein Disorders Physiological Effects of Drugs Paraproteinemias Bone Density Conservation Agents Hemostatic Disorders Anti-Bacterial Agents Hemorrhagic Disorders Therapeutic Uses Pamidronate Cardiovascular Diseases Growth Inhibitors |
Angiogenesis Modulating Agents Immunoproliferative Disorders Neoplasms by Histologic Type Zoledronic acid Immune System Diseases Hematologic Diseases Growth Substances Vascular Diseases Angiogenesis Inhibitors Immunosuppressive Agents Pharmacologic Actions Multiple Myeloma Neoplasms Diphosphonates Lymphoproliferative Disorders |