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
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.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
To evaluate the effectiveness of dexamethasone (dex) alone as compared to dex in combination with thalidomide in low risk patients relapsing after autologous transplantation.
Maurizio Zangari, M.D.
United States: Food and Drug Administration
|University of Arkansas for Medical Sciences/MIRT||Little Rock, Arkansas 72205|