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Sponsored by: |
University of Arkansas |
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Information provided by: | University of Arkansas |
ClinicalTrials.gov Identifier: | NCT00083902 |
The purpose of this investigational trial is to find out how well patients respond and how long their response lasts when treated with a standard regimen of dexamethasone with or without thalidomide and also find out what kind of side effects patients will experience.
Condition | Intervention | Phase |
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Multiple Myeloma |
Drug: Thalidomide Drug: Dexamethasone |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | UARK 98-025, A Randomized Phase II Trial of Dexamethasone or Dexamethasone in Combination With Thalidomide as Salvage Therapy for Low-Risk Post Transplantation Relapse in Patients With Multiple Myeloma |
Estimated Enrollment: | 190 |
Study Start Date: | June 1998 |
Estimated Study Completion Date: | May 2005 |
Maintenance
Dexamethasone
Patients will receive 40 mg dexamethasone days 1-4 only, every 3-4 weeks. Response will be assessed at least every 3 months while on maintenance therapy. Appropriate H2 blocker and antibiotics will also be given.
Thalidomide
Thalidomide will continue at a dose of 400 mg daily, or at the dose that was reduced and judged to be well tolerated in induction therapy. Thalidomide will be given as an oral, once daily dose at bedtime. Those patients unable to tolerate dexamethasone may continue on thalidomide alone until criteria for removal from treatment is met.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Arkansas | |
University of Arkansas for Medical Sciences/MIRT | |
Little Rock, Arkansas, United States, 72205 |
Principal Investigator: | Maurizio Zangari, M.D. | UAMS |
Study ID Numbers: | UARK 98-025 |
Study First Received: | June 3, 2004 |
Last Updated: | June 27, 2005 |
ClinicalTrials.gov Identifier: | NCT00083902 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Myeloma Thalidomide Dexamethasone |
Dexamethasone Anti-Inflammatory Agents Anti-Infective Agents Thalidomide Immunologic Factors Blood Protein Disorders Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics Paraproteinemias Hemostatic Disorders Hormones Anti-Bacterial Agents Hemorrhagic Disorders |
Dexamethasone acetate Immunoproliferative Disorders Antineoplastic Agents, Hormonal Hematologic Diseases Blood Coagulation Disorders Vascular Diseases Angiogenesis Inhibitors Glucocorticoids Immunosuppressive Agents Multiple Myeloma Peripheral Nervous System Agents Lymphoproliferative Disorders Neoplasms, Plasma Cell |
Anti-Inflammatory Agents Dexamethasone Anti-Infective Agents Immunologic Factors Thalidomide Antineoplastic Agents Blood Protein Disorders Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics Paraproteinemias Hemostatic Disorders Hormones Anti-Bacterial Agents Hemorrhagic Disorders |
Therapeutic Uses Cardiovascular Diseases Growth Inhibitors Angiogenesis Modulating Agents Dexamethasone acetate Immunoproliferative Disorders Neoplasms by Histologic Type Antineoplastic Agents, Hormonal Immune System Diseases Hematologic Diseases Growth Substances Vascular Diseases Gastrointestinal Agents Angiogenesis Inhibitors Immunosuppressive Agents |