drugset / Trial / NCT00097981
A Study of Thalidomide Plus Dexamethasone (Thal-Dex) Versus DOXIL plusThalidomide Plus Dexamethasone (DOXIL -Thal-Dex) in Patients With Newly Diagnosed Multiple Myeloma
Phase 3
Completed
225 enrolled
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Tibotec Therapeutics, a Division of Ortho Biotech Products, L.P., USA · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this study is to determine if Thalidomide + Dexamethasone or DOXIL (doxorubicin HCl liposome injection) + Thalidomide + Dexamethasone is more effective in treating newly diagnosed patients with multiple myeloma. The number of patients whose multiple myeloma disappears for a period of time (complete Response) will be studied to make the determination of which treatment is more effective.
Timeline
- Start
- 2005-01
- Primary completion
- 2007-10
- Completion
- 2009-10
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Doxorubicin | Other / unclassified | 40 mg/m2 | Intravenous |
| Background | Dexamethasone | Small molecule | 40 mg | Oral |
| Background | Thalidomide | Other / unclassified | 200 mg | Oral |