Dexamethasone or Dexamethasone in Combination With Thalidomide as Salvage Therapy
Information source: University of Arkansas
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Multiple Myeloma
Intervention: Thalidomide (Drug); Dexamethasone (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: University of Arkansas Official(s) and/or principal investigator(s):
Maurizio Zangari, M.D., Principal Investigator, Affiliation: UAMS
Summary
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.
Clinical Details
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 design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: To evaluate the effectiveness of dexamethasone (dex) alone as compared to dex in combination with thalidomide in low risk patients relapsing after autologous transplantation.
Secondary outcome: To evaluate the quantitative and qualitative toxicities associated with the regimens.
Detailed description:
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): 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.
Locations and Contacts
University of Arkansas for Medical Sciences/MIRT, Little Rock, Arkansas 72205, United States
Additional Information
Myeloma Institute for Research & Therapy website
Starting date: June 1998
Ending date: May 2005
Last updated: June 27, 2005
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