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| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | May 27, 2004 | ||||
| Last Updated Date | June 27, 2005 | ||||
| Start Date ICMJE | June 1998 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE |
To evaluate the effectiveness of the DCEP chemoregimen with G-CSF support as compared to the DCEP regimen with G-CSF support in combination with thalidomide in high risk patients relapsing after autologous transplantation. | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00083681 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
To evaluate the quantitative and qualitative toxicities associated with the regimens. | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | DCEP in Combination With Thalidomide as Salvage Therapy for Post Transplantation Relapse | ||||
| Official Title ICMJE | 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 | ||||
| Brief Summary | 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. |
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| Detailed Description | 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. |
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| Study Phase | Phase II | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Safety/Efficacy Study | ||||
| Condition ICMJE | Multiple Myeloma | ||||
| Intervention ICMJE |
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| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 180 | ||||
| Completion Date | May 2005 | ||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00083681 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | UARK 98-018 | ||||
| Study Sponsor ICMJE | University of Arkansas | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | University of Arkansas | ||||
| Verification Date | June 2005 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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