Clinical trial

A Non-interventional Study of Selinexor (Nexpovio®) in Combination With Bortezomib and Dexamethasone (SVd) in Patients With Relapsed or Refractory Multiple Myeloma (R/RMM)

Name

IOM-090494

Description

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.

Trial arms

Trial start

2023-06-28

Estimated PCD

2025-09-15

Trial end

2025-09-15

Status

Recruiting

Treatment

Selinexor

Selinexor/bortezomib/dexamethasone according to Nexpovio® SmPC

Arms:

second line and later lines therapy

Size

100

Primary endpoint

Change from baseline of EORTC global health scale

Baseline, up to 28 months

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

Protocol

{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'CASE_ONLY', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 100, 'type': 'ESTIMATED'}}

Updated at

2023-07-20

1 organization

1 product

1 indication

Organization

iOMEDICO

Product

Selinexor

Indication

Multiple Myeloma