- Active, not recruiting
NCT03110562 : Phase 3 - Bortezomib, Selinexor, and Dexamethasone in Patients With Myeloma (BOSTON)
Updated: Sep 22, 2022
BOSTON Study
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.
Sponsor
Multiple Locations
International Study
ClinicalTrials.gov Identifier: NCT03110562
Official Title: 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)
First Posted: April 12, 2017
Click here for details on ClinicalTrials.gov
Dexamethasone : National Cancer Institute
Dexamethasone : MedlinePlus Drug Information
Bortezomib : National Cancer Institute
Bortezomib : MedlinePlus Drug Information