NCT03110562

Bortezomib, Selinexor, and Dexamethasone in Patients With Multiple Myeloma

A Phase 3 Randomized, Controlled, Open-label Study of Selinexor, Bortezomib, and Dexamethasone (SVd) Versus Bortezomib and Dexamethasone (Vd) in Patients With Relapsed or Refractory Multiple Myeloma (RRMM)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 402 (actual)
• Sponsor: Karyopharm Therapeutics Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This Phase 3, 2-arm, randomized, active comparator-controlled, open-label, multicenter study will compare the efficacy and health-related quality of life (HR-QoL) and assess the safety of selinexor plus bortezomib (Velcade) plus low-dose dexamethasone (SVd) versus bortezomib plus low-dose dexamethasone (Vd) in adult patients with RRMM who have received 1 to 3 prior anti-multiple myeloma (MM) regimens. Crossover from the Vd Arm to a treatment that includes selinexor (i.e., SVdX or SdX) will be allowed at the point of IRC-confirmed objective disease progression per the IMWG criteria for patients in the Vd Arm.

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
DRUG	Selinexor	oral 100 mg dose
DRUG	Bortezomib	subcutaneous dose of 1.3 mg/m2
DRUG	Dexamethasone	oral dose of 20mg

Timeline

• Start date: 2017-05-24
• Primary completion: 2020-02-18
• Completion: 2022-05-12
• First posted: 2017-04-12
• Last updated: 2024-08-21
• Results posted: 2021-07-08

Locations

157 sites across 21 countries: United States, Australia, Austria, Belgium, Bulgaria, Canada, Czechia, France, Germany, Greece, Hungary, India, Israel, Italy, Poland, Romania, Russia, Serbia, Spain, Ukraine, United Kingdom

Regulatory

• FDA-regulated drug study