Selinexor plus bortezomib and dexamethasone for relapsed multiple myeloma after 1–3 prior therapies
Observational Study on the Combination of Selinexor With Bortezomib and Dexamethasone (SVd) for the Treatment of Multiple Myeloma Patients
This study will try to see how the selinexor + bortezomib + dexamethasone (SVd) combination works and how safe it is for adults with multiple myeloma who have had 1–3 prior treatments and are lenalidomide‑refractory.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 159 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Gruppo Italiano Malattie EMatologiche dell'Adulto Academic / other |
| Locations | 1 site (Florence) |
| Trial ID | NCT06933277 on ClinicalTrials.gov |
What this trial studies
This is a national, multicenter, non‑interventional observational study collecting both retrospective and prospective real‑world data on the use of selinexor combined with bortezomib and dexamethasone (SVd) in routine clinical practice in Italy. It will enroll at least 159 adult patients with symptomatic multiple myeloma who relapsed after one to three prior lines of therapy and who are refractory to lenalidomide, excluding those with prior selinexor exposure. Sites will gather safety and efficacy outcomes with a 24‑month enrolment window and at least 12 months of follow‑up per patient. The aim is to describe how SVd performs outside clinical trials in everyday care settings.
Who should consider this trial
Good fit: Adults (≥18 years) with symptomatic multiple myeloma who have relapsed after one to three prior lines of therapy, are refractory to lenalidomide, and have started SVd in routine clinical care are the intended participants.
Not a fit: Patients with prior exposure to selinexor or those who are not lenalidomide‑refractory would not fit the study population and are unlikely to benefit from its specific findings.
Why it matters
Potential benefit: If successful, the study could provide real‑world evidence on effectiveness and safety of SVd that helps clinicians choose treatments for relapsed multiple myeloma.
How similar studies have performed: Randomized clinical trials such as BOSTON have shown benefit for selinexor‑bortezomib‑dexamethasone versus bortezomib‑dexamethasone, and this study aims to corroborate those findings in real‑world practice.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Florence
- Aou Careggi - Sod Ematologia — Florence, Italy (Recruiting)
Study contacts
- Principal investigator: Elena Zamagni — UOC di Ematologia Policlinico S.Orsola AOU di Bologna
- Study coordinator: Paola Fazi
- Email: p.fazi@gimema.it
- Phone: 0670390528
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.