DCEP in Combination With Thalidomide as Salvage Therapy for Post Transplantation Relapse
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|ClinicalTrials.gov Identifier: NCT00083681|
Recruitment Status : Completed
First Posted : May 28, 2004
Last Update Posted : July 2, 2010
|Condition or disease||Intervention/treatment||Phase|
|Multiple Myeloma||Drug: Thalidomide Drug: Dexamethasone Drug: Cytoxan Drug: Etoposide Drug: Cisplatin Drug: G-CSF||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||180 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||June 1998|
|Study Completion Date :||May 2005|
- 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.
- To evaluate the quantitative and qualitative toxicities associated with the regimens.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00083681
|United States, Arkansas|
|University of Arkansas for Medical Sciences/MIRT|
|Little Rock, Arkansas, United States, 72205|
|Principal Investigator:||Athanasios Fassas, M.D.||UAMS|