Observational Study on the Combination of Selinexor With Bortezomib and Dexamethasone for the Treatment of MM Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Multiple Myeloma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Observational Study on the Combination of Selinexor With Bortezomib and Dexamethasone (SVd) for the Treatment of Multiple Myeloma Patients
Overview
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.
Primary outcome measures
- SdV therapy effectiveness in terms of Progression Free Survival [Time frame: at 12 months]
Eligibility 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Case-only
Study locations
Italy · 1 center
- Aou Careggi - Sod Ematologia — Florence
Identifiers
NCT: NCT06933277 · MM0225