Selinexor (Nexpovio®) (SVd) in Patients With Relapsed or Refractory Multiple Myeloma

NCT ID: NCT05954780

Last Updated: 2026-01-14

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 75 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-06-28
• Study Completion Date: 2026-10-30

Brief 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.

Detailed Description

Multiple myeloma (MM) accounts for approximately 10% of hematological malignancies. Since MM patients are elderly and often comorbid patients, risk-adapted treatment strategies to further improve outcome in is crucial.Selinexor, a potent, oral, SINE (selective inhibitors of nuclear exports) binds reversibly to XPO. This leads to nuclear localization and functional activation of tumor suppressor proteins, which further leads to suppression of nuclear factor κB activity, and reduction in oncoprotein mRNA translation. All this induces apoptosis of tumor cells. Since treatment options for MM are various and the most important factor is to keep or improve quality of life (QoL) of the patients, there is an urge for real-world clinical data of MM patients treated with selinexor in clinical routine. The objective of this non-interventional study is to evaluate QoL and tolerability/safety and AE management as well as effectiveness and dosing in adult patients with relapsed or refractory MM, which receive selinexor in combination with bortezomib and dexamethasone in the 2nd or later therapy line in a real-world setting.

Conditions

Multiple Myeloma

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

second line and later lines therapy

Patients enrolled for second line or later lines therapy with selinexor in combination with bortezomib and dexamethasone.

Selinexor

Intervention Type: DRUG

Selinexor/bortezomib/dexamethasone according to Nexpovio® SmPC

Interventions

Selinexor

Selinexor/bortezomib/dexamethasone according to Nexpovio® SmPC

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Menarini Stemline

UNKNOWN

Sponsor Role: collaborator

Climedo Health GmbH

UNKNOWN

Sponsor Role: collaborator

iOMEDICO AG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tobias Dechow, Prof. Dr.

Role: STUDY_CHAIR

Gemeinschaftspraxis für Hämatologie und Onkologie GbR

Maria Krauth, Assoc. Prof. PD Dr.

Role: STUDY_CHAIR

Universitätsklinikum AKH Wien

Locations

Medizinische Universität Wien, Universitätsklinik für Innere Medizin I

Vienna, , Austria

Gemeinschaftspraxis für Hämatologie und Onkologie GbR

Ravensburg, Baden-Wurttemberg, Germany

Countries

Austria; Germany

Other Identifiers

IOM-090494

Identifier Type: -

Identifier Source: org_study_id