Overview

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.