Selinexor: Selinexor/bortezomib/dexamethasone according to Nexpovio® SmPC
Study summary
The non-interventional study SEATTLE aims to answer open scientific questions regarding QoL and tolerability/safety and AE management of selinexor as well as effectiveness and dosing in clinical routine. Thus, SEATTLE will provide real-world evidence complementary to pivotal studies.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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
Primary outcome measure(s)
Change from baseline of EORTC global health scale — Baseline, up to 40 months Change from baseline quality of life (QoL) over time for the global health scale of the EORTC QLQ- C30 questionnaire.
Trial sites (2)
Facility
City
Region
Status
Medizinische Universität Wien, Universitätsklinik für Innere Medizin I
Vienna
Austria
Gemeinschaftspraxis für Hämatologie und Onkologie GbR
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time.