Thalidomide, Dexamethasone, and Clarithromycin in Treating Patients With Multiple Myeloma Previously Treated With Transplant
|Refractory Multiple Myeloma Stage I Multiple Myeloma Stage II Multiple Myeloma Stage III Multiple Myeloma||Drug: clarithromycin Drug: thalidomide Drug: dexamethasone||Phase 2|
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Maintenance Therapy With Thalidomide, Dexamethasone and Clarithromycin (Biaxin) Following Autologous/Syngeneic Transplant for Multiple Myeloma|
- Toxicity of proposed treatment with clarithromycin, dexamethasone, and thalidomide [ Time Frame: First 3 months of therapy ]
- Time to disease progression [ Time Frame: Up to 15 years ]
|Study Start Date:||June 2003|
|Primary Completion Date:||April 2007 (Final data collection date for primary outcome measure)|
Experimental: Treatment (immunomodulator, antiangiogenesis, steroid therapy)
Patients receive thalidomide PO QD dexamethasone PO once weekly, and clarithromycin PO BID. Treatment continues for 1 year in the absence of disease progression or unacceptable toxicity. Treatment with thalidomide continues in the absence of disease progression or unacceptable toxicity.
Other Names:Drug: thalidomide
Other Names:Drug: dexamethasone
I. Evaluate the toxicity of the use of Thalidomide/Biaxin (Clarithromycin)/Dexamethasone as maintenance therapy after autologous/syngeneic transplant.
II. Evaluate the median time to disease progression. III. Evaluate survival.
Patients receive thalidomide orally (PO) once daily (QD), dexamethasone PO once weekly, and clarithromycin PO twice daily (BID). Treatment continues for 1 year in the absence of disease progression or unacceptable toxicity. Treatment with thalidomide continues in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up periodically.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00182663
|United States, Washington|
|Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium|
|Seattle, Washington, United States, 98109|
|Principal Investigator:||Leona Holmberg||Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium|