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.
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 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.
- All patients must have a confirmed diagnosis of previously treated, active multiple
myeloma, with hypoproliferative/low risk relapse following at least one autologous
- 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
- 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
- Patients must be off chemotherapy (including steroids) and local radiotherapy for >
or equal 3 weeks prior to entering the study.
- No other concurrent therapy for myeloma is permitted while on protocol.
- There must be no evidence of active infection requiring IV antibiotics.