Clinical trial · Interventional
Dexamethasone or Dexamethasone in Combination With Thalidomide as Salvage Therapy
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
NCT00083902CI-TRIAL-00003633completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Dexamethasone | Drug | Dexamethasone | ALIAS |
| Thalidomide | Drug | Thalidomide | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- 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.
Secondary outcomes (1)
- measure
- To evaluate the quantitative and qualitative toxicities associated with the regimens.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.