Administration of an Oral PDE5 Inhibitor, Tadalafil in Conjunction With Lenalidomide and Dexamethasone in Patients With Multiple Myeloma
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Anti-tumor efficacy of tadalafil, Lenalidomide/dexamethasone in multiple myeloma
Hypothesis testing will be used to test the null that 5% patients will have a response versus the alternative hypothesis of 25% (a 20% improvement). If 3 or more out of 19 patients had response, the null hypothesis is rejected at a type I error rate of 0.05 (one-sided) given 20% type II error rate. If initial review after 12 patients shows at least 1 response, 7 more patients will be enrolled. The therapy will be continued until progression or intolerable adverse effects. Clinical response will be evaluated by calculating the increase or decrease in the M-protein levels in blood and marrow.
Nilanjan Ghosh, M.D., Ph.D.
Johns Hopkins University
United States: Institutional Review Board
|Sidney Kimmel Comprehensive Cancer Center||Lutherville, Maryland|