Evaluating the use of Selinexor in patients with relapsed or refractory Multiple Myeloma
A Non-interventional Study of Selinexor (Nexpovio®) in Combination With Bortezomib and Dexamethasone (SVd) in Patients With Relapsed or Refractory Multiple Myeloma (R/RMM)
This study is trying to see how well Selinexor works with other medications for adults with relapsed or refractory multiple myeloma and how it affects their quality of life.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | iOMEDICO AG Industry-sponsored |
| Locations | 2 sites (Wien and 1 other locations) |
| Trial ID | NCT05954780 on ClinicalTrials.gov |
What this trial studies
The SEATTLE study is a non-interventional observational study aimed at gathering real-world evidence on the quality of life, tolerability, safety, and effectiveness of Selinexor in combination with bortezomib and dexamethasone for patients with relapsed or refractory multiple myeloma. This study will assess adult patients who are receiving this treatment in a clinical routine setting, focusing on patient-reported outcomes and adverse event management. By collecting data from various treatment centers, the study seeks to provide insights that complement existing pivotal studies on Selinexor.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with relapsed or refractory multiple myeloma who are starting their second-line treatment with Selinexor, bortezomib, and dexamethasone.
Not a fit: Patients who are contraindicated for Selinexor or those participating in other interventional clinical trials may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the understanding of Selinexor's impact on quality of life and treatment outcomes for patients with multiple myeloma.
How similar studies have performed: While there have been studies on Selinexor, this observational approach focusing on real-world data in a clinical routine setting is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Relapsed or refractory multiple myeloma * Indication and decision for ≥2nd-line treatment with selinexor in combination with bortezomib and dexamethasone according to current selinexor SmPC as assessed by the treating physician * Treatment decision before inclusion into this non-interventional study * Willingness and ability to participate in the electronic patient-reported outcome (ePRO) module and answering of questionnaires * Age ≥18 years * Signed and dated informed consent form * Inclusion before start of treatment (prospective inclusion) Exclusion Criteria: * Contraindications according to selinexor SmPC for patients with MM * Participation in an interventional clinical trial
Where this trial is running
Wien and 1 other locations
- Medizinische Universität Wien, Universitätsklinik für Innere Medizin I — Wien, Austria (Not_yet_recruiting)
- Gemeinschaftspraxis für Hämatologie und Onkologie GbR — Ravensburg, Baden-Württemberg, Germany (Recruiting)
Study contacts
- Study coordinator: Daniel Kummer, Dr.
- Email: seattle@iomedico.com
- Phone: +49761-152420
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.