NCT00083681

DCEP in Combination With Thalidomide as Salvage Therapy for Post Transplantation Relapse

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 180 (planned)
• Sponsor: University of Arkansas · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
DRUG	Thalidomide
DRUG	Dexamethasone
DRUG	Cytoxan
DRUG	Etoposide
DRUG	Cisplatin
DRUG	G-CSF

Timeline

• Start date: 1998-06-01
• Completion: 2005-05-01
• First posted: 2004-05-28
• Last updated: 2010-07-02

Locations

1 site across 1 country: United States