Dexamethasone or Dexamethasone in Combination With Thalidomide as Salvage Therapy
Dexamethasone or Dexamethasone in Combination With Thalidomide as Salvage Therapy
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.
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.
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.