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Home > "D" Clinical Trials Conditions > DCEP in Combination with Thalidomide as Salvage Therapy for Post Transplantation Relapse  DCEP in Combination with Thalidomide as Salvage Therapy for Post Transplantation Relapse
DCEP in Combination with Thalidomide as Salvage Therapy for Post Transplantation Relapse
For Condition: Multiple Myeloma
Status: No longer recruiting
Sponsor(s): University of Arkansas ,
Synopsis: 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.
Details: 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.
Eligibility:
Study Type: Interventional, Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria: - All patients must have a confirmed diagnosis of previously treated, active multiple myeloma, with relapse or progression following at least one autologous transplant - Patients must be 18 years of age or older - Patients must have a SWOG performance status of 0-2 - Patients must have adequate renal function, as defined by serum creatinine < or = 3.0 mg/dl - Before starting treatment, women of childbearing potential should have a negative pregnancy test performed within 24 hours prior to beginning therapy Exclusion Criteria: - There must be no evidence of active infection requiring IV antibiotics - No other concurrent therapy for myeloma is permitted while on protocol
Total Enrollment: 180
Location and Contact Information:
Overall Study Official:
AthanasiosFassas, Principal Investigator, UAMS
University of Arkansas for Medical Sciences/MIRT
Little Rock, Arkansas, 72205
United States
Additional Information:
Study ID Numbers: UARK 98-018;
Study Start Date: June 1998
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00083681
Other Multiple Myeloma Studies:
1. Tipifarnib in Treating Patients With Advanced Hematologic Cancer
2. Study of Combination PS-341 and Thalidomide in Multiple Myeloma
3. Growth Factor to Prevent Oral Mucositis in Patients With Hematologic Cancer
4. A Study of PS-341 Given to Patients With Multiple Myeloma who Experienced Progressive Disease After Receiving Dexamethasone in M34101-039
5. Epoetin alfa in Treating Anemia in Patients Who Are Receiving Chemotherapy
Related Studies:
Other Multiple Myeloma Clinical Trials
Other Arkansas Clinical Trials
Other Little Rock Clinical Trials
DCEP in Combination with Thalidomide as Salvage Therapy for Post Transplantation Relapse
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