A Phase IIb, Multicenter, Open-Label, Safety and Efficacy Study of High Dose Melphalan HCL for Injection (Propylene Glycol-Free)for Myeloablative Conditioning in Multiple Myeloma Patients Undergoing Autologous Transplantation

Trial Profile

A Phase IIb, Multicenter, Open-Label, Safety and Efficacy Study of High Dose Melphalan HCL for Injection (Propylene Glycol-Free)for Myeloablative Conditioning in Multiple Myeloma Patients Undergoing Autologous Transplantation

Completed
Phase of Trial: Phase II

Latest Information Update: 01 Dec 2015

At a glance

  • Drugs Melphalan (Primary)
  • Indications Multiple myeloma
  • Focus Adverse reactions; Registrational
  • Sponsors Ligand Pharmaceuticals; Spectrum Pharmaceuticals
  • Most Recent Events

    • 23 Oct 2015 According to a Spectrum Pharmaceuticals media release, the company has received a Complete Response Letter from the U.S. FDA for propylene glycol-free melphalan formulation [Evomela]. The FDA has not identified any clinical deficiency in Spectrum's NDA submission and the company plans to meet with the FDA and seek clarification on the Complete Response Letter.
    • 02 Sep 2015 According to a Spectrum Pharmaceuticals media release, results from this trial were published in the Biology of Blood and Marrow Transplantation (BBMT) journal.
    • 02 Sep 2015 Results were published in a Spectrum Pharmaceuticals media release.
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