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Selinexor Treatment of Refractory Myeloma


Title 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) and Refractory to Prior Treatment With Glucocorticoids, an Immunomodulatory Agent, a Proteasome Inhibitor and an Anti-CD38 mAb
Therapeutic Area Multiple Myeloma
Principal Investigator Raymond Comenzo, MD
Min Age 18 Years
Gender All
Contact George Mensing
617 636-2683
More Information https://clinicaltrials.gov/ct2/show/NCT02336815

Overview

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).

Study Details

Inclusion Criteria

  • Must have measurable Multiple Myeloma according to IMWG guidelines (as defined by laboratory values)
  • Must have received 3 or more lines of treatment.

Exclusion Criteria

  • Must not have active smoldering MM.
  • Must not have active plasma cell leukemia.

Study Requirements

There is no maximum treatment duration for this study, it will end when all subjects have completed a one-year follow-up period. Bone marrow biopsy or aspirate will be performed at screening, Cycles 2, 3 and at survival follow-up which will occur every 3 months. Blood draws for PK and PD will also be performed. Each PD sample will be 2 mL with pre-dose and multiple post-dose samples done at Cycle 1 Day 1, Cycle 1 Day 8 and Cycle 2 Day 1. Each PK sample will be 2 mL with pre-dose and multiple post-dose samples done at Cycle 1 Day 1, Cycle 1 Day 8, Cycle 1 Day 15 and Cycle 2 Day 1.