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
Phase of Trial: Phase II
Latest Information Update: 09 Aug 2018
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At a glance
- Drugs Melphalan (Primary)
- Indications Multiple myeloma
- Focus Adverse reactions; Registrational
- Sponsors Ligand Pharmaceuticals; Spectrum Pharmaceuticals
- 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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Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History