Multiple MyelomaNCT06933277
Observational Study on the Combination of Selinexor With Bortezomib and Dexamethasone for the Treatment of MM Patients
An observational study of Multiple Myeloma, run by Gruppo Italiano Malattie EMatologiche dell'Adulto at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma
- How many people
- 159 participants
- Where
- 1 siteItaly
- Study dates
- 29 Aug 2025to Aug 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Previous exposure to selinexor.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Aou Careggi - Sod Ematologia
Florence
Elisabetta Antonioli
About this study
Official title: 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.
Read the 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.
- Conditions
- Multiple Myeloma
- Keywords
- selinexor, bortezomib, dexamethasone
- Medical subject headings
- Multiple Myeloma
What is being measured
The primary outcome is the main question the study is designed to answer.
SdV therapy effectiveness in terms of Progression Free Survival
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
Measured: at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2025
- Study start29 Aug 2025
- Primary completionAug 2028 (estimated)
- Study completionAug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 159 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gruppo Italiano Malattie EMatologiche dell'Adulto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elena Zamagni, Principal investigator, UOC di Ematologia Policlinico S.Orsola AOU di Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06933277
- Sponsor's protocol ID
- MM0225
- Status last verified
- Sep 2025
- First submitted
- 3 Apr 2025
- Last updated
- 10 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study on the Combination of Selinexor With Bortezomib and Dexamethasone (SVd) for the Treatment of Multiple Myeloma Patients
- ClinicalTrials.gov ID
- NCT06933277
- Acronym / sponsor ID
- MM0225
- Conditions
- Multiple Myeloma
- Keywords
- selinexor, bortezomib, dexamethasone
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 159 participants (estimated)
- Lead sponsor
- Gruppo Italiano Malattie EMatologiche dell'AdultoUniversity, hospital or other
- Study start
- 29 Aug 2025 (actual)
- Primary completion
- Aug 2028 (estimated)
- Study completion
- Aug 2028 (estimated)
- First posted
- 18 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (1 listed)
- Previous exposure to selinexor.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Elena Zamagni principal investigator
UOC di Ematologia Policlinico S.Orsola AOU di Bologna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Myeloma, run by Gruppo Italiano Malattie EMatologiche dell'Adulto at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Paola Fazi (0670390528, p.fazi@gimema.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SdV therapy effectiveness in terms of Progression Free Survival (time frame: at 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2025.