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Dexamethasone or Dexamethasone in Combination With Thalidomide as Salvage Therapy
This study has been completed.
Study NCT00083902   Information provided by University of Arkansas
First Received: June 3, 2004   Last Updated: June 27, 2005   History of Changes

June 3, 2004
June 27, 2005
June 1998
 
To evaluate the effectiveness of dexamethasone (dex) alone as compared to dex in combination with thalidomide in low risk patients relapsing after autologous transplantation.
Same as current
Complete list of historical versions of study NCT00083902 on ClinicalTrials.gov Archive Site
To evaluate the quantitative and qualitative toxicities associated with the regimens.
Same as current
 
Dexamethasone or Dexamethasone in Combination With Thalidomide as Salvage Therapy
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

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.

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.

Phase II
Interventional
Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Multiple Myeloma
  • Drug: Thalidomide
  • Drug: Dexamethasone
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
190
May 2005
 

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00083902
 
UARK 98-025
University of Arkansas
 
Principal Investigator: Maurizio Zangari, M.D. UAMS
University of Arkansas
June 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP