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

NCT ID: NCT06933277

Last Updated: 2025-09-10

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 159 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-08-29
• Study Completion Date: 2028-08-31

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.

Conditions

Multiple Myeloma

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gruppo Italiano Malattie EMatologiche dell'Adulto

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Elena Zamagni

Role: PRINCIPAL_INVESTIGATOR

UOC di Ematologia Policlinico S.Orsola AOU di Bologna

Locations

Aou Careggi - Sod Ematologia

Florence, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Paola Fazi

Role: CONTACT

p.fazi@gimema.it

0670390528

Enrico Crea

Role: CONTACT

e.crea@gimema.it

0670390514

Facility Contacts

Elisabetta Antonioli

Role: primary

Other Identifiers

MM0225

Identifier Type: -

Identifier Source: org_study_id