Maintenance Therapy With Lenalidomide, Dexamethasone and Clarithromycin (Biaxin) Following Autologous/Syngeneic Transplant for Multiple Myeloma
I. Evaluate the toxicity of the use of Lenalidomide/Biaxin/Dexamethasone as maintenance
therapy after autologous/syngeneic transplant.
II. Evaluate the median time to disease progression. III. Evaluate survival.
Patients receive clarithromycin orally (PO) twice daily (BID) and dexamethasone PO once a
week. Treatment with clarithromycin and dexamethasone continues for up to 1 year* in the
absence of disease progression or unacceptable toxicity. Patients also receive lenalidomide
PO once daily (QD) on days 1-14. Courses with lenalidomide repeat every 21 days in the
absence of disease progression or unacceptable toxicity.
NOTE: *After one year of treatment, dexamethasone is tapered for an additional 4 weeks.
After completion of study treatment, patients are followed up periodically.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Incidence of grade IV non-hematological toxicities (except deep venous thrombosis [DVT] and pulmonary emboli) graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
United States: Food and Drug Administration
|Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium||Seattle, Washington 98109|