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

Observational Study on the Combination of Selinexor With Bortezomib and Dexamethasone (SVd) for the Treatment of Multiple Myeloma Patients

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06933277

Enrollment

159

Registered

2025-04-18

Start date

2025-08-29

Completion date

2028-08-31

Last updated

2025-09-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Myeloma

Keywords

selinexor, bortezomib, dexamethasone

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

Italy

Contacts

Primary ContactPaola Fazi

p.fazi@gimema.it0670390528

Backup ContactEnrico Crea

e.crea@gimema.it0670390514

Outcome results