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Sponsored by: |
University of Arkansas |
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Information provided by: | University of Arkansas |
ClinicalTrials.gov Identifier: | NCT00083681 |
The purpose of this investigational trial is to find out how well patients respond and how long their response lasts when treated with a four day chemotherapy regimen involving dexamethasone, cytoxan, etoposide, and cisplatinum, or DCEP with or without thalidomide. Another purpose is to find out what kind of side effects patients will experience.
Condition | Intervention | Phase |
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Multiple Myeloma |
Drug: Thalidomide Drug: Dexamethasone Drug: Cytoxan Drug: Etoposide Drug: Cisplatin Drug: G-CSF |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Safety/Efficacy Study |
Official Title: | UARK 98-018, A Randomized Phase II Trial of DCEP or DCEP in Combination With Thalidomide as Salvage Therapy for Post Transplantation Relapse in Patients With Multiple Myeloma |
Estimated Enrollment: | 180 |
Study Start Date: | June 1998 |
Estimated Study Completion Date: | May 2005 |
Each patient enrolled to this study will be assigned to either receive DCEP alone, or in combination with thalidomide. Since it is not known at this time which treatment is the best, you will be placed by chance in one of the two groups.
Treatment consists of three cycles of combination chemotherapy, each over four days. Three drugs, Cytoxan, etoposide, and cisplatin will be given into the vein as a continuous four-day infusion. Decadron will be given by mouth over four days. G-CSF will also be given daily as a shot under the skin to help bone marrow recover.
After 3 cycles of combination chemotherapy, your myeloma will be reassessed. If myeloma is stable or responding, patients will receive an additional 3 cycles of chemotherapy. Then myeloma will again be reassessed and if again found to be stable or responding,3 final cycles of chemotherapy will be given.
Following the completion of chemotherapy, or sooner if your physician feels that the chemotherapy side effects are to great, patients will receive maintenance therapy with dexamethasone. Patients originally assigned to receive thalidomide, will continue to take thalidomide daily throughout protocol treatment.
The major reason for conducting this research is to gather biologic information from patients who have myeloma. Information gained from such research may contribute to a greater understanding of the reasons for treatment failure and may assist in the selection of appropriate treatment for individual patients.
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: | Athanasios Fassas, M.D. | UAMS |
Study ID Numbers: | UARK 98-018 |
Study First Received: | May 27, 2004 |
Last Updated: | June 27, 2005 |
ClinicalTrials.gov Identifier: | NCT00083681 |
Health Authority: | United States: Food and Drug Administration |
Multiple Myeloma Thalidomide G-CSF Cisplatin Etoposide |
Dexamethasone Cytoxan DCEP Relapse |
Dexamethasone Immunoproliferative Disorders Thalidomide Blood Protein Disorders Hematologic Diseases Blood Coagulation Disorders Vascular Diseases Paraproteinemias Cyclophosphamide Hemostatic Disorders |
Etoposide phosphate Recurrence Multiple Myeloma Hemorrhagic Disorders Cisplatin Multiple myeloma Lymphoproliferative Disorders Etoposide Dexamethasone acetate Neoplasms, Plasma Cell |
Anti-Inflammatory Agents Anti-Infective Agents Disease Attributes Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics Hormones Anti-Bacterial Agents Pathologic Processes Therapeutic Uses Cardiovascular Diseases Growth Inhibitors |
Angiogenesis Modulating Agents Alkylating Agents Neoplasms by Histologic Type Antineoplastic Agents, Hormonal Immune System Diseases Growth Substances Gastrointestinal Agents Angiogenesis Inhibitors Immunosuppressive Agents Glucocorticoids Pharmacologic Actions Neoplasms Radiation-Sensitizing Agents Autonomic Agents Myeloablative Agonists |