NCT00083902

Dexamethasone or Dexamethasone in Combination With Thalidomide as Salvage Therapy

UARK 98-025, A Randomized Phase II Trial of Dexamethasone or Dexamethasone in Combination With Thalidomide as Salvage Therapy for Low-Risk Post Transplantation Relapse in Patients With Multiple Myeloma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 190 (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 standard regimen of dexamethasone with or without thalidomide and also find out what kind of side effects patients will experience.

Detailed description

Maintenance Dexamethasone Patients will receive 40 mg dexamethasone days 1-4 only, every 3-4 weeks. Response will be assessed at least every 3 months while on maintenance therapy. Appropriate H2 blocker and antibiotics will also be given. Thalidomide Thalidomide will continue at a dose of 400 mg daily, or at the dose that was reduced and judged to be well tolerated in induction therapy. Thalidomide will be given as an oral, once daily dose at bedtime. Those patients unable to tolerate dexamethasone may continue on thalidomide alone until criteria for removal from treatment is met.

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
DRUG	Thalidomide
DRUG	Dexamethasone

Timeline

• Start date: 1998-06-01
• Completion: 2005-05-01
• First posted: 2004-06-04
• Last updated: 2010-07-02

Locations

1 site across 1 country: United States