Spectrum Reports Completion Of Enrollment For Melphalan Pivotal Trial

(RTTNews) - Spectrum Pharmaceuticals (SPPI), a biotechnology company, announced the completion of enrollment for the pivotal trial of Captisol-enabled, propylene glycol-free high-dose melphalan as a conditioning treatment prior to autologous transplant for patients with multiple myeloma. The phase 2 pivotal trial is a multi-center trial evaluating safety and efficacy in 60 patients.

The primary objective of the study is to determine the overall safety and toxicity profile in multiple myeloma patients receiving 200 mg/m2 of Melphalan HCl for Injection as myeloablative therapy prior to autologous stem cell transplantation. The secondary objective is to evaluate the efficacy of Melphalan HCl in this patient population as measured by multiple myeloma response rate, myeloablation, and engraftment.