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Bortezomib, Selinexor, and Dexamethasone in Patients With Multiple Myeloma

NCT03110562 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 402

Last updated 2024-08-21

Study results available
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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

Interventions

DRUG

Selinexor

oral 100 mg dose

DRUG

Bortezomib

subcutaneous dose of 1.3 mg/m2

DRUG

Dexamethasone

oral dose of 20mg

Sponsors & Collaborators

  • Karyopharm Therapeutics Inc

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-05-24
Primary Completion
2020-02-18
Completion
2022-05-12
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Austria
  • Belgium
  • Bulgaria
  • Canada
  • Czechia
  • France
  • Germany
  • Greece
  • Hungary
  • India
  • Israel
  • Italy
  • Poland
  • Romania
  • Russia
  • Serbia
  • Spain
  • Ukraine
  • United Kingdom

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03110562 on ClinicalTrials.gov