Status:
COMPLETED
Dexamethasone or Dexamethasone in Combination With Thalidomide as Salvage Therapy
Lead Sponsor:
University of Arkansas
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 a...
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 blo...
Eligibility Criteria
Inclusion
- 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
- No other concurrent therapy for myeloma is permitted while on protocol.
- There must be no evidence of active infection requiring IV antibiotics.
Key Trial Info
Start Date :
June 1 1998
Trial Type :
INTERVENTIONAL
End Date :
May 1 2005
Estimated Enrollment :
190 Patients enrolled
Trial Details
Trial ID
NCT00083902
Start Date
June 1 1998
End Date
May 1 2005
Last Update
July 2 2010
Active Locations (1)
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1
University of Arkansas for Medical Sciences/MIRT
Little Rock, Arkansas, United States, 72205