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

Sponsors and collaborators