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Trials & Filings

Spectrum Completes Enrollment for Melphalan

Tests PG-free formulation in multiple myeloma

By: Gil Roth

President, Pharma & Biopharma Outsourcing Association

Spectrum Pharmaceuticals has completed enrollment for a Phase II trial of Captisol-enabled, propylene glycol-free (PG-free) high-dose melphalan as a conditioning treatment prior to autologous transplant for patients with multiple myeloma.

The trial will evaluate 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 (Propylene Glycol-Free) as myeloablative therapy prior to autologous stem cell transplantation (ASCT). The secondary objective is to evaluate the efficacy of Melphalan HCl (Propylene Glycol-Free) in this patient population as measured by multiple myeloma response rate (according to International Myeloma Working Group [IMWG] criteria), myeloablation, and engraftment. Several endpoints require 90-100 day follow-up of patients on the trial.

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