A Prospective Phase I/II Trial to Jointly Optimize the Administration Schedule and Dose of Melphalan for Injection (Evomela) As a Preparative Regimen for Autologous Hematopoietic Stem Cell Transplantation in Newly Diagnosed Multiple Myeloma

Introduction: The most commonly used conditioning regimen for autologous hematopoietic cell transplantation (auto-HCT) in multiple myeloma (MM) is high-dose melphalan. However, conventional melphalan formulations can put patients at risk of potential propylene glycol (PG)-associated toxicities. In addition, the traditional melphalan formulations are unstable at room temperature, which prevents studying longer infusion schedules. The higher stability and potentially lower toxicity of PG-free (PGF) melphalan (Evomela) supports the evaluation of different doses and prolonged infusion schedules, in addition to the traditional 30-60 minute bolus doses.