Selinexor plus bortezomib and dexamethasone for relapsed multiple myeloma after 1–3 prior therapies
Official title: Observational Study on the Combination of Selinexor With Bortezomib and Dexamethasone (SVd) for the Treatment of Multiple Myeloma Patients
Run by Gruppo Italiano Malattie EMatologiche dell'Adulto · NCT06933277 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 159 (estimated) |
| Sponsor | Gruppo Italiano Malattie EMatologiche dell'Adulto Academic / other |
| Locations | 1 site (Florence) |
| Status | Recruiting |
| Started | August 29, 2025 |
| Main results expected | August 2028 |
| Study ends | August 2028 |
| Registry record updated | September 10, 2025 |
| Trial ID | NCT06933277 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
6MW5311 in adults with relapsed or refractory blood cancers
This study tests increasing doses of 6MW5311 in adults with multiple myeloma, AML, or CMML to see if it is safe and tolerable and to find a suitable dose for later studies.
-
Tailored exercise program to improve quality of life for adults with hematologic cancers
This pilot trial tests a personalized 16-week exercise program to see if it’s feasible and helpful for adults with acute myeloid leukemia, lymphoma, or multiple myeloma after first-line treatment.
-
Aspirin vs. rivaroxaban for blood clot prevention in newly diagnosed multiple myeloma
In newly diagnosed multiple myeloma patients on IMiD-based therapy, this study tests whether aspirin or rivaroxaban is better at preventing blood clots.
-
Exercise phenotyping before chemotherapy in newly diagnosed multiple myeloma
This observational study tests whether some newly diagnosed multiple myeloma patients with normal resting heart function already show limited exercise capacity, and whether that limitation relates to subtle heart tissue changes and future heart-related outcomes.
-
SMS text check-ins to track symptoms for people with plasma cell disorders
This study tests whether daily SMS symptom prompts are feasible and acceptable for adults starting treatment for multiple myeloma or AL amyloidosis.
-
Cevostamab with Pomalidomide and Dexamethasone after BCMA-directed CAR T therapy in multiple myeloma
This study tests if Cevostamab combined with pomalidomide and dexamethasone can help people with multiple myeloma who have already had CAR T therapy and several prior treatments.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.