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
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.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
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.
Athanasios Fassas, M.D.
United States: Food and Drug Administration
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