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

Gruppo Italiano Malattie EMatologiche dell'Adulto

Status: Enrolling

Conditions: Multiple Myeloma

Study type: Observational

Funder types: Other

Identifiers

NCT06933277

MM0225

Details and patient eligibility

About

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.

Full 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.

Enrollment: 159 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.