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

NCT05954780 | Active Not Recruiting

• 1 other identifier: IOM-090494
• Study Type: observational
• Target: 75
• Locations: 2 countries
• Sites: 2

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.

Conditions

Multiple Myeloma

Keywords

Multiple Myeloma; Selinexor; Bortezomib; Dexamethasone

Outcome Measures

Primary Outcomes (1)

• Change from baseline of EORTC global health scale

  Change from baseline quality of life (QoL) over time for the global health scale of the EORTC QLQ- C30 questionnaire.

  Baseline, up to 40 months

Secondary Outcomes (41)

• Change from baseline of EORTC QLQ-C30 further scales

  Baseline, up to 40 months

• Change from baseline of EORTC QLQ-MY20 further scales

  Baseline, up to 30 days after selinexor treatment

• Assessment of drug tolerability and safety

  Baseline, up to 40 months

• Adverse events (AEs) and serious adverse events (SAEs) according to NCI CTCAE

  Baseline, up to 30 days after end of selinexor treatment

• Adverse drug reaction (ADR) and serious adverse drug reactions (SADR)

  Baseline, up to 30 days after end of selinexor treatment

Study Arms (1)

second line and later lines therapy

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

Drug: Selinexor

Interventions

Selinexor DRUG

Selinexor/bortezomib/dexamethasone according to Nexpovio® SmPC

second line and later lines therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients (≥18 years old) with relapsed or refractory multiple myeloma and decision for treatment with selinexor in combination with bortezomib and dexamethasone (SVd) in ≥2nd therapy line

You may qualify if:

• 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
• 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

You may not qualify if:

• Contraindications according to selinexor SmPC for patients with MM
• Participation in an interventional clinical trial

Sponsors & Collaborators

• iOMEDICO AG: lead
• Menarini Stemline: collaborator
• Climedo Health GmbH: collaborator

Study Sites (2)

Medizinische Universität Wien, Universitätsklinik für Innere Medizin I

Vienna, 1090, Austria

Location

Gemeinschaftspraxis für Hämatologie und Onkologie GbR

Ravensburg, Baden-Wurttemberg, 88212, Germany

Location

MeSH Terms

Conditions

Multiple Myeloma

Interventions

selinexor

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Tobias Dechow, Prof. Dr.

  Gemeinschaftspraxis für Hämatologie und Onkologie GbR

  STUDY CHAIR

• Maria Krauth, Assoc. Prof. PD Dr.

  Universitätsklinikum AKH Wien

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2023
• First Posted: July 20, 2023
• Study Start: June 28, 2023
• Primary Completion (Estimated): October 30, 2026
• Study Completion (Estimated): October 30, 2026
• Last Updated: January 14, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1); DE (1)