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
Drug: Selinexor
Drug: Bortezomib
Drug: Dexamethasone
Once-per-week selinexor, bortezomib, and dexamethasone versus twice-per-week bortezomib and dexamethasone in patients with multiple myeloma (BOSTON): a randomised, open-label, phase 3 trial
Lancet; Nov. 2020
Selinexor, bortezomib, and dexamethasone versus bortezomib and dexamethasone in previously treated multiple myeloma: Outcomes by cytogenetic risk
Am J Hematol; June 2021
457 Transcriptomic Correlates of Response to Selinexor in Multiple Myeloma Reveal a Predictive Signature
Program: Oral and Poster Abstracts
Type: Oral
Session: 652. Multiple Myeloma and Plasma cell Dyscrasias: Clinical and Epidemiological: Multiple Myeloma and Waldenstrom Macroglobulinemia: Exploring Biomarkers in the Era of Personalized Medicine
Hematology Disease Topics & Pathways:
Translational Research
Sunday, December 12, 2021: 12:00 PM
NEWTON, Mass., Nov. 4, 2021 /PRNewswire/ -- Karyopharm Therapeutics Inc. (Nasdaq:KPTI)
Total of 17 Abstracts Selected for Presentation at the Meeting, Including Five Oral Presentations
Title: Transcriptomic Correlates of Response to Selinexor in Multiple Myeloma Reveal a Predictive Signature
Presenter: Paula Restrepo, Icahn School of Medicine at Mount Sinai
Abstract #: 457
Session Type: Oral Presentation
Session: Multiple Myeloma and Plasma Cell Dyscrasias: Clinical and Epidemiological: Multiple Myeloma and Waldenstrom Macroglobulinemia: Exploring Biomarkers in the Era of Personalized Medicine
Date and Time: Sunday, December 12, 2021 at 12:00 p.m. ET
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