Clinical trial · Observational
Selinexor (Nexpovio®) (SVd) 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)
NCT05954780CI-TRIAL-00100838SEATTLEactive not recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Selinexor | Drug | Selinexor | ALIAS |
Design
Arms and outcomes
Arms (1)
- label
- second line and later lines therapy
- description
- Patients enrolled for second line or later lines therapy with selinexor in combination with bortezomib and dexamethasone.
- interventionNames
- Drug: Selinexor
Primary outcomes (1)
- measure
- Change from baseline of EORTC global health scale
- timeFrame
- Baseline, up to 40 months
- description
- Change from baseline quality of life (QoL) over time for the global health scale of the EORTC QLQ- C30 questionnaire.
Secondary outcomes (41)
- measure
- Change from baseline of EORTC QLQ-C30 further scales
- timeFrame
- Baseline, up to 40 months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.