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Dexamethasone or Dexamethasone in Combination with Thalidomide as Salvage Therapy - Article


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Dexamethasone Liquid

Decadron Liquid; Hexadrol Liquid



Clinical Trial: Dexamethasone or Dexamethasone in Combination with Thalidomide as Salvage Therapy

This study is no longer recruiting patients.

Sponsored by: University of Arkansas
Information provided by: University of Arkansas

Purpose

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 Treatment or Intervention Phase
Multiple Myeloma
 Drug: Thalidomide
 Drug: Dexamethasone
Phase II

MedlinePlus related topics:  Multiple Myeloma

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

Further Study Details: 

Expected Total Enrollment:  190

Study start: June 1998

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

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:


Location Information


Arkansas
      University of Arkansas for Medical Sciences/MIRT, Little Rock,  Arkansas,  72205,  United States

Study chairs or principal investigators

Maurizio Zangari, M.D.,  Principal Investigator,  UAMS   

More Information

Myeloma Institute for Research & Therapy website

Study ID Numbers:  UARK 98-025
Record last reviewed:  September 2004
Last Updated:  October 13, 2004
Record first received:  June 3, 2004
ClinicalTrials.gov Identifier:  NCT00083902
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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November 18, 2008



Page Updated: June 1, 2005
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