A Randomized Phase I/II Study of BI-505 in Conjunction With High-dose Melphalan and Autologous Stem Cell Transplantation for Multiple Myeloma

Trial Profile

A Randomized Phase I/II Study of BI-505 in Conjunction With High-dose Melphalan and Autologous Stem Cell Transplantation for Multiple Myeloma

Discontinued
Phase of Trial: Phase I/II

Latest Information Update: 15 Dec 2016

At a glance

  • Drugs BI 505 (Primary) ; Melphalan
  • Indications Multiple myeloma
  • Focus Adverse reactions; Therapeutic Use
  • Sponsors BioInvent International
  • Most Recent Events

    • 07 Jun 2017 Biomarkers information updated
    • 12 Dec 2016 Status changed to discontinued due to full clinical hold from FDA.
    • 08 Nov 2016 According to a BioInvent International media release, company has received verbal notice from the U.S. Food and Drug Administration (FDA) that a full clinical hold (i.e. no further dosing of patients) has been placed on this study;due to an adverse cardiopulmonary event in this clinical study.
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