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

September 3, 2025 updated by: Gruppo Italiano Malattie EMatologiche dell'Adulto

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

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.

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

159

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Italy
      • Florence, Italy
        • Recruiting
        • Aou Careggi - Sod Ematologia
        • Contact:
          • Elisabetta Antonioli

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

this study will include patients who will start SVD treatment during the study enrolment period or who received at least one dose of the treatment according to AIFA authorization before the study inclusion date.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
SdV therapy effectiveness in terms of Progression Free Survival
Time Frame: 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
at 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gruppo Italiano Malattie EMatologiche dell'Adulto

Investigators

  • Principal Investigator: Elena Zamagni, UOC di Ematologia Policlinico S.Orsola AOU di Bologna

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 29, 2025

Primary Completion (Estimated)

August 1, 2028

Study Completion (Estimated)

August 1, 2028

Study Registration Dates

First Submitted

April 3, 2025

First Submitted That Met QC Criteria

April 11, 2025

First Posted (Actual)

April 18, 2025

Study Record Updates

Last Update Posted (Estimated)

September 10, 2025

Last Update Submitted That Met QC Criteria

September 3, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MM0225

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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