drugset / Trial / NCT01116128

Dasatinib in Combination With Melphalan and Prednisone to Treat Relapsed and Refractory Multiple Myeloma Patients

NCT01116128 ↗

Phase 2 Terminated 8 enrolled Fondazione EMN Italy Onlus
Non-randomizedSingle-groupOpen-labelTreatment

Summary

Clinically demonstrated efficacy of Melphalan and Prednisone in MM subjects as well as the confirmed inhibitory effect of dasatinib on several tyrosine kinase receptors and pathways implicated in the pathophysiology of MM. Additionally, as a SRC inhibitor, dasatinib plays an important role on bone metabolism through inhibition of osteoclast-mediated bone resorption in vitro. Dasatinib could, thus, be beneficial on bone density of patients on study, through blockage of osteolysis and control of bone lesions.

Timeline

Start
2008-02
Primary completion
2011-05
Completion
2011-05

Outcome

Outcome not reported

Stopped (Enrollment): “difficulty in enrolling patients”

Drugs

EvaluationDrugModalityDoseRoute
Subject Melphalan Small molecule 0.18 mg/kg —
Subject Prednisone Other / unclassified 1.5 mg/kg —
Subject dasatinib anhydrous Small molecule 100 mg —

Indications