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
18 Years
N/A
Both
Multiple Myeloma
Trial Information
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
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.
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.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
To evaluate the effectiveness of dexamethasone (dex) alone as compared to dex in combination with thalidomide in low risk patients relapsing after autologous transplantation.
Principal Investigator
Maurizio Zangari, M.D.
Investigator Role:
Principal Investigator
Investigator Affiliation:
UAMS
Authority:
United States: Food and Drug Administration
Study ID:
UARK 98-025
NCT ID:
NCT00083902
Start Date:
June 1998
Completion Date:
May 2005
Related Keywords:
- Multiple Myeloma
- Myeloma
- Thalidomide
- Dexamethasone
- Multiple Myeloma
- Neoplasms, Plasma Cell
Name | Location |
|---|---|
| University of Arkansas for Medical Sciences/MIRT | Little Rock, Arkansas 72205 |
