A Phase IIA Open-Label, Randomized, Pharmacokinetic Comparative, Cross-Over Study of Melphalan HCL for Injection (Propylene Glycol-Free) and Alkeran for Injection for Myeloablative Conditioning in Multiple Myeloma Patients Undergoing Autologous Transplantation

Trial Profile

A Phase IIA Open-Label, Randomized, Pharmacokinetic Comparative, Cross-Over Study of Melphalan HCL for Injection (Propylene Glycol-Free) and Alkeran for Injection for Myeloablative Conditioning in Multiple Myeloma Patients Undergoing Autologous Transplantation

Completed
Phase of Trial: Phase II

Latest Information Update: 15 Mar 2016

At a glance

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

    • 15 Mar 2016 According to a Spectrum Pharmaceuticals media release, EVOMELA was approved by the FDA based on its bioequivalence to the standard melphalan formulation (Alkeran) via the 505(b)(2) regulatory pathway.
    • 15 Mar 2016 According to a Ligand Pharmaceuticals media release, based on the results of this trial, company has received approval from the U.S. Food and Drug Administration (FDA) of melphalan (EVOMELA) for use in two indications: 1) as a high-dose conditioning treatment prior to hematopoietic progenitor (stem) cell transplantation (ASCT) in patients with multiple myeloma, and 2) for the palliative treatment of patients with multiple myeloma for whom oral therapy is not appropriate.
    • 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.
Restricted Access

Oops, it looks like you don’t have a valid subscription to this content. To gain full access to the content and functionality of the AdisInsight database try one of the following.

  • with a username/password associated to an account with a valid subscription
  • Contact your organization’s admin about adding this content to your AdisInsight subscription
  • Request a trial

If you are a subscriber to this content then contact us at AsktheExpert.AdisInsight@springer.com so we can help.

Back to top