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