A Phase 2b, Open-Label, Single-Arm Study of Selinexor (KPT-330) Plus Low-‑Dose Dexamethasone (Sd) in Patients With Multiple Myeloma Previously Treated With Lenalidomide, Pomalidomide, Bortezomib, Carfilzomib, and an Anti-CD38 Monoclonal Antibody (mAb) Daratumumab, and Refractory to Prior Treatment With Glucocorticoids, an Immunomodulatory Agent, a Proteasome Inhibitor, and an the Anti-CD38 mAb Daratumumab
Phase of Trial: Phase II
Latest Information Update: 08 Aug 2017
At a glance
- Drugs Dexamethasone (Primary) ; Selinexor (Primary)
- Indications Multiple myeloma
- Focus Registrational; Therapeutic Use
- Acronyms STORM
- Sponsors Karyopharm Therapeutics
- 08 Aug 2017 According to a Karyopharm media release, the company expects to report top-line data from the expanded cohort by April 2018 and assuming a positive outcome, it intends to use the data from the expanded STORM study to support a request for accelerated approval for selinexor in heavily pretreated multiple myeloma.
- 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.
- 06 Dec 2016 Results (n=79) presented at the 58th Annual Meeting and Exposition of the American Society of Hematology.
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Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History