This trial is active but is no longer accepting patients.
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 or generic equivalent) 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. After progressive disease (PD), patients in the Vd Arm may cross over to SVd treatment. Patients who cross over will be referred to as SVdX patients.
Bortezomib is used to treat multiple myeloma and mantle cell lymphoma. It is a cancer medicine that interferes with the growth and spread of cancer cells in the body. Bortezomib is given as an injection under the skin (subcutaneously) or injected into a vein through an IV.
Dexamethasone is a corticosteroid that prevents the release of substances in the body that cause inflammation.
January 08, 2018
The following criteria is provided for health care professionals.
Best response achieved with prior bortezomib at any time was ≥ PR and with the last PI (PI therapy (alone or in combination) was ≥ PR, AND Participant did not discontinue bortezomib due to ≥ Grade 3 related toxicity, AND Must have had at least a 6-month PI-treatment-free interval prior to Cycle 1 Day 1 (C1D1) of study treatment.
Active, unstable cardiovascular function:
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