Dexamethasone Ear Solution |
Decadron Ear Solution |
Clinical Trial: Dexamethasone or Dexamethasone in Combination with Thalidomide as Salvage Therapy
This study is no longer recruiting patients.
|
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
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:
- No other concurrent therapy for myeloma is permitted while on protocol.
- There must be no evidence of active infection requiring IV antibiotics.
Location Information
Arkansas
University of Arkansas for Medical Sciences/MIRT, Little Rock, Arkansas, 72205, United States
Maurizio Zangari, M.D., Principal Investigator, UAMS
More Information
Myeloma Institute for Research & Therapy website
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
Resources
- Decadron Ear Solution (Drug Digest)
- Dexamethasone Ear Solution (Drug Digest)

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