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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.
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.
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | at 12 months |
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Inclusion Criteria:
Exclusion Criteria:
- Previous exposure to selinexor.
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Paola Fazi | Contact | 0670390528 | p.fazi@gimema.it | |
| Enrico Crea | Contact | 0670390514 | e.crea@gimema.it |
| Name | Affiliation | Role |
|---|---|---|
| Elena Zamagni | UOC di Ematologia Policlinico S.Orsola AOU di Bologna | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aou Careggi - Sod Ematologia | Recruiting | Florence | Italy |
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| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
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| D014652 |
| Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |