Dexamethasone or Dexamethasone in Combination With Thalidomide as Salvage Therapy

• Status: Completed
• Trial end date: 2005-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Arkansas
• Treatments: BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Thalidomide

Criteria

Inclusion Criteria:

• All patients must have a confirmed diagnosis of previously treated, active multiple myeloma, with hypoproliferative/low risk relapse following at least one autologous transplant.

• Patients must be 18 years of age or older. Women of childbearing age and fertile men must use a medically acceptable means of birth control while on study and for 6 months thereafter.

• Patients must sign an informed consent to participate in this study, and be fully aware of the known teratogenic potential of this drug combination.

• 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.

• Patients must be off chemotherapy (including steroids) and local radiotherapy for > or equal 3 weeks prior to entering the study.

Exclusion Criteria:

• No other concurrent therapy for myeloma is permitted while on protocol.

• There must be no evidence of active infection requiring IV antibiotics.