A Study of Selinexor (Seli) + Low-dose Dexamethasone (LDD) in Penta-refractory Multiple Myeloma (MM), Seli and Bortezomib + LDD in Triple-class Refractory MM.

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorKaryopharm Therapeutics Inc

About this trial

The purpose of this study is to assess the efficacy, antitumor activity, safety and tolerability of selinexor plus low-dose dexamethasone in participants with penta-refractory multiple myeloma or selinexor and bortezomib plus low-dose dexamethasone in participants with triple-class refractory multiple myeloma.

Eligibility criteria

Qualifiers

Age greater than or equal to (>=)18 years at the time of signing informed consent.

Written informed consent in accordance with federal, local, and institutional guidelines.

Serum M-protein >= 0.5 gram per deciliter (g/dL) by serum protein electrophoresis (SPEP) or, for Immunoglobulin (Ig) A myeloma, by quantitative IgA.

Urinary M-protein excretion >= 200 mg/24 hours.

Disqualifiers

Active plasma cell leukemia.

Documented systemic amyloid light chain amyloidosis.

Active central nervous system MM.

Only for SVd arm: Greater than Grade 2 peripheral neuropathy or Grade >= 2 peripheral neuropathy with pain at baseline, regardless of whether or not the participant is currently receiving medication.

Trial design

Treatments tested in this trial

  • Selinexor
  • Dexamethasone
  • Bortezomib

Treatment groups

127 Participants
are divided into 4 treatment groups

Locations

16
Greece
University General Hospital of Patras2654, PátraiAchaia, Greece
General Hospital of Athens "Alexandra"11528, AttikiAthens, Greece
General Hospital of Athens "Evangelismos"10676, AthensAttica, Greece
Theageneion Cancer Hospital54007, ThessalonikiThessaloniki, Greece

Sponsors and collaborators

Karyopharm Therapeutics Inc

Lead sponsor