Dexamethasone or Dexamethasone in Combination With Thalidomide as Salvage Therapy
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|ClinicalTrials.gov Identifier: NCT00083902|
Recruitment Status : Completed
First Posted : June 4, 2004
Last Update Posted : July 2, 2010
|Condition or disease||Intervention/treatment||Phase|
|Multiple Myeloma||Drug: Thalidomide Drug: Dexamethasone||Phase 2|
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 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||190 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||June 1998|
|Estimated Study Completion Date :||May 2005|
- To evaluate the effectiveness of dexamethasone (dex) alone as compared to dex in combination with thalidomide in low risk patients relapsing after autologous transplantation.
- To evaluate the quantitative and qualitative toxicities associated with the regimens.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00083902
|United States, Arkansas|
|University of Arkansas for Medical Sciences/MIRT|
|Little Rock, Arkansas, United States, 72205|
|Principal Investigator:||Maurizio Zangari, M.D.||UAMS|