Observational Study on the Combination of Selinexor With Bortezomib and Dexamethasone for the Treatment of MM Patients

Not yet recruiting

• Conditions: Multiple Myeloma

• Registration Number: NCT06933277
• Lead Sponsor: Gruppo Italiano Malattie EMatologiche dell'Adulto

Brief Summary

This is an observational study aiming at collecting efficacy and safety data on the use of SVd outside clinical trials, for the treatment of adult patients with MM who have received 1-3 prior line of therapy.

A minimum of 159 patients is required. Overall study duration is estimated in 36 months.

Detailed Description

This is a non-interventional, national, multicenter prospective and retrospective observational study aiming at collecting efficacy and safety data on the use of SVd outside clinical trials, for the treatment of adult patients with MM who have received 1-3 prior line of therapy.

All the sites participating in the study are using SVd in clinical practice. According to sample size calculation, a minimum of 159 patients is required.

Overall study duration is estimated in 36 months: 24 months on enrolment and at least 12 months of observation.

Study Timeline

• Status Verified: 2025-04
• Study First Submitted: 2025-04-03
• Study First Submitted QC: 2025-04-11
• Study First Posted: 2025-04-18
• Last Update Submitted: 2025-04-28
• Last Update Posted: 2025-04-30
• Study Start: 2025-07
• Primary Completion: 2028-07
• Study Completion: 2028-07

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 159

Inclusion Criteria

• Age equal to or greater than 18 years old at the time of SVd initiation
• Signed informed consent (if applicable).
• Diagnosis of symptomatic MM, as defined by the International Myeloma Working Group (IMWG) criteria.
• Relapse after one to three lines of therapy.
• Treatment with SVd, (i.e., having already received at least one dose) at the time the combination has entered clinical practice in Italy (AIFA authorization)
• Prior treatment with and refractoriness to lenalidomide.

Exclusion Criteria

• Previous exposure to selinexor.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
SdV therapy effectiveness in terms of Progression Free Survival	at 12 months	to describe the effectiveness of the use of SVd therapy outside clinical trials in terms of Progression free survival after 12 months from the start of treatment