Phase 1/2 Investigator Sponsored Study of Selinexor in Combination With High-Dose Melphalan Before Autologous Hematopoietic Cell Transplantation for Multiple Myeloma
Phase of Trial: Phase I/II
Latest Information Update: 30 Jun 2017
At a glance
- Drugs Selinexor (Primary) ; Dexamethasone; Dexamethasone; Melphalan
- Indications Multiple myeloma
- Focus Adverse reactions; Therapeutic Use
- Sponsors Karyopharm Therapeutics
- 26 Jun 2017 Status changed from suspended to recruiting.
- 26 Jun 2017 Planned End Date changed from 31 Aug 2019 to 31 Aug 2020.
- 10 Mar 2017 According to a Karyopharm Therapeutics media release, the FDA has placed selinexor (KPT-330) trials on partial clinical hold due to incomplete information in the existing version of the investigator's brochure (IB), Karyopharm has amended the IB and updated the informed consent documents accordingly and submitted to the FDA as requested.