NCT02336815

Selinexor Treatment of Refractory Myeloma

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 202 (actual)
• Sponsor: Karyopharm Therapeutics Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 2b, single-arm, open-label, multicenter study of selinexor 80 mg plus dexamethasone 20 mg (Sd) dosed twice weekly in four-week cycles, in patients with penta-refractory MM (Parts 1 and 2) or quad refractory MM (Part 1 only).

Detailed description

This is a Phase 2b, single-arm, open-label, multicenter study of selinexor 80 mg plus dexamethasone 20 mg (Sd), both dosed twice weekly in each four-week cycle, in patients with MM previously treated with lenalidomide, pomalidomide, bortezomib, carfilzomib, and daratumumab and refractory to prior treatment with glucocorticoids, an immunomodulatory agent (IMiD), a proteasome inhibitor (PI), and daratumumab. This study consists of two parts: * Part 1 enrolled patients with both quad-refractory MM and penta-refractory MM. * Part 2 will enroll patients with penta-refractory MM only.

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
DRUG	Selinexor	Fixed oral dose of 80 mg twice weekly (e.g., Monday and Wednesday or Tuesday and Thursday, etc.)
DRUG	Dexamethasone	20 mg was given with each dose of Selinexor.

Timeline

• Start date: 2015-05-26
• Primary completion: 2019-07-26
• Completion: 2019-07-26
• First posted: 2015-01-13
• Last updated: 2023-01-26
• Results posted: 2020-08-13

Locations

61 sites across 6 countries: United States, Austria, Belgium, France, Germany, Greece