drugset / Trial / NCT02389543

Study of Selinexor (KPT- 330), Lenalidomide, & Dexamethasone in Relapsed/Refractory Multiple Myeloma Patients

NCT02389543

Phase 1/2 Withdrawn Karyopharm Therapeutics Inc
RandomizedParallel-groupOpen-labelTreatment

Summary

This is an open-label, randomized clinical study with two stages to assess the maximum tolerated dose (MTD), efficacy, and safety of selinexor, lenalidomide, and dexamethasone (SLd) in patients with relapsed/refractory (RR) multiple myeloma (MM). The stages are dose escalation (Phase 1) and expansion (Phase 2).

Timeline

Start
2015-07
Primary completion
2018-01
Completion
2018-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Dexamethasone Small molecule 20 mg
Subject Dexamethasone Small molecule 40 mg
Subject Lenalidomide Other / unclassified 15 mg
Subject Lenalidomide Other / unclassified 25 mg
Subject Selinexor Other / unclassified 60 mg
Subject Selinexor Other / unclassified 80 mg
Subject Selinexor Other / unclassified 100 mg

Indications