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Sponsored by: |
University of Arkansas |
Information provided by: | University of Arkansas |
ClinicalTrials.gov Identifier: | NCT00083902 |
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.
Condition | Intervention | Phase |
Multiple Myeloma |
Drug: Thalidomide Drug: Dexamethasone |
Phase II |
Genetics Home Reference related topics: | aceruloplasminemia hemophilia |
MedlinePlus related topics: | Multiple Myeloma |
ChemIDplus related topics: | Dexamethasone Dexamethasone acetate Dexamethasone Sodium Phosphate Doxiproct plus Thalidomide |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | UARK 98-025, A Randomized Phase II Trial of Dexamethasone or Dexamethasone in Combination With Thalidomide as Salvage Therapy for Low-Risk Post Transplantation Relapse in Patients With Multiple Myeloma |
Estimated Enrollment: | 190 |
Study Start Date: | June 1998 |
Estimated Study Completion Date: | May 2005 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Arkansas | |||||
University of Arkansas for Medical Sciences/MIRT | |||||
Little Rock, Arkansas, United States, 72205 |
University of Arkansas |
Principal Investigator: | Maurizio Zangari, M.D. | UAMS |
Myeloma Institute for Research & Therapy website 
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Study ID Numbers: | UARK 98-025 |
First Received: | June 3, 2004 |
Last Updated: | June 27, 2005 |
ClinicalTrials.gov Identifier: | NCT00083902 |
Health Authority: | United States: Food and Drug Administration |
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