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NCT Number: NCT05954780

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Medizinische Universität Wien, Universitätsklinik für Innere Medizin I, Vienna, Austria

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About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Selinexor

Drug

Selinexor/bortezomib/dexamethasone according to Nexpovio® SmPC

Primary outcomes

  1. Change from baseline of EORTC global health scale

    Time frame: 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.

Secondary outcomes

  1. Change from baseline of EORTC QLQ-C30 further scales

    Time frame: Baseline, up to 40 months

    Change from baseline in further scales of the EORTC QLQ-C30 questionnaire

  2. Change from baseline of EORTC QLQ-MY20 further scales

    Time frame: Baseline, up to 30 days after selinexor treatment

    Change from baseline in further scales of the EORTC QLQ-MY20 questionnaire

  3. Assessment of drug tolerability and safety

    Time frame: Baseline, up to 40 months

    Frequency of specific (serious) adverse drug reactions ((S)ADRs) (nausea, weight loss, diarrhea, vomiting, fatigue)

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

    Time frame: Baseline, up to 30 days after end of selinexor treatment

    Incidence of (serious) AEs ((S)AEs) as characterized by type, frequency, severity and seriousness.

  5. Adverse drug reaction (ADR) and serious adverse drug reactions (SADR)

    Time frame: Baseline, up to 30 days after end of selinexor treatment

    Incidence of (serious) adverse drug reactions ((S)ADRs) as characterized by type, frequency, severity and seriousness.

  6. Adverse events of special interest (AESI)

    Time frame: Baseline, up to 30 days after end of selinexor treatment

    Incidence of AEs of special interest defined as cataracts (new-onset cataracts and worsening of cataracts) and Acute cerebellar syndrome.

  7. Changes in selinexor therapy

    Time frame: From date of selinexor treatment start, up to 40 months

    Frequency of treatment delays, no administrations (skips), discontinuation (withdrawn) of selinexor due to safety reasons

  8. Effectiveness in routine treatment: Best response

    Time frame: Baseline, up to 40 months

    Frequencies of best response during selinexor therapy will be calculated using descriptive statistics.

  9. Effectiveness in routine treatment: Overall response rate (ORR)

    Time frame: Baseline, up to 40 months

    ORR of patients will be calculated. ORR is defined as the proportion of patients achieving a complete response, very good partial response or partial response as best overall response. Patients without response measurement are considered non-responders.

  10. Effectiveness in routine treatment: Disease control rate (DCR)

    Time frame: Baseline, up to 40 months

    DCR is defined as the proportion of patients achieving complete response, very good partial response, partial response, or stable disease as best response. Patients without response measurement are considered non-responders.

  11. Effectiveness in routine treatment: Progression-free survival (PFS)

    Time frame: Baseline, up to 40 months

    PFS is defined as the time interval measured from the day of first selinexor administration to first progression or death, whichever comes first.

  12. 6 months PFS rate

    Time frame: Baseline, until 6 months after start of selinexor treatment

    PFS rates will be analysed 6 months after treatment start of selinexor

  13. 12 months PFS rate

    Time frame: Baseline, until 12 months after start of selinexor treatment

    PFS rates will be analysed 12 months after treatment start of selinexor

  14. Effectiveness in routine treatment: Overall survival (OS)

    Time frame: Baseline, up to 40 months

    OS is defined as the time interval measured from the day of first selinexor administration to time of death from any cause.

  15. 6 months OS rate

    Time frame: Baseline, until 6 months after start of selinexor treatment

    OS rates will be analysed 6 and 12 months after treatment start of selinexor

  16. 12 months OS rate

    Time frame: Baseline, until 12 months after start of selinexor treatment

    OS rates will be analysed 6 and 12 months after treatment start of selinexor

  17. Selinexor therapy: Dosing

    Time frame: Baseline, up to end of selinexor treatment

    Dose intensity during treatment (mg/m2 per week) will be analysed

  18. Selinexor therapy: Frequency

    Time frame: Cycle 1, day 1

    Frequency of starting dose of selinexor (100 mg, 80 mg, 60 mg, other) will be analysed

  19. Selinexor therapy: Dose reduction of starting dose

    Time frame: Cycle 1, day 1

    Reasons for reduced starting dose compared to SmPC will be analysed

  20. Selinexor therapy: Dose changes

    Time frame: From date of second selinexor application, up to 40 months

    Reasons for dose reductions and dose re-escalation during treatment compared to previous dose

  21. Previous therapies

    Time frame: Baseline

    Frequency of distinct previous therapies (systemic / radiation / transplantation)

  22. Daratumumab-based previous therapies

    Time frame: Baseline

    Frequency of patients with daratumumab-based previous therapies

  23. Treatment duration

    Time frame: From date of selinexor treatment start, up to 40 months

    Treatment duration of selinexor therapy

  24. Subsequent antineoplastic therapies

    Time frame: From Date of end of selinexor treatment up to 40 months

    Frequency of distinct subsequent antineoplastic therapies.

  25. Subsequent antineoplastic transplantations

    Time frame: From Date of end of selinexor treatment up to 40 months

    Frequency of distinct subsequent antineoplastic transplantations.

  26. Subsequent antineoplastic radiations

    Time frame: From Date of end of selinexor treatment up to 40 months

    Frequency of distinct subsequent antineoplastic radiations.

  27. Frequency of concomitant medication

    Time frame: Baseline up to 30 days after end of selinexor therapy

    Frequency of concomitant medication administered

  28. Anti-emetic substances for AE treatment

    Time frame: Baseline up to 30 days after end of selinexor treatment

    Use of anti-emetic substances for AE treatment

  29. Anti-emetic substances for prophylaxis

    Time frame: From date of selinexor treatment start, up to 40 months

    Use of anti-emetic substances for prophlaxis

  30. Anti-diarrhea substances for AE treatment

    Time frame: Baseline up to 30 days after end of selinexor treatment

    Use of anti-diarrhea substances for AE treatment

  31. Anti-diarrhea substances for prophylaxis

    Time frame: From date of selinexor treatment start, up to 40 months

    Use of anti-diarrhea substances for prophylaxis

  32. Anti-emetic and anti-diarrhea substances for AE treatment

    Time frame: From date of selinexor treatment start, up to date of end of selinexor treatment

    Use of anti-emetic and anti-diarrhea substances for AE treatment

  33. Anti-emetic and anti-diarrhea substances for prophylaxis

    Time frame: From date of selinexor treatment start, up to date of end of selinexor treatment

    Use of anti-emetic and anti-diarrhea substances for prophylaxis

  34. Administration of Glucocorticoids and NK1 antagonist for prophylaxis

    Time frame: From date of selinexor treatment start, up to 40 months

    Frequency of glucocorticoids (i.e., dexamethasone given in addition to study medication) + NK1 antagonist administration used for prophylaxis.

  35. Administration of NK1 + 5HT3 antagonist for prophylaxis

    Time frame: From date of selinexor treatment start, up to 40 months

    Frequency of NK1 + 5HT3 antagonist administration used for prophylaxis

  36. Administration of Glucocorticoids and 5HT3 antagonist for prophylaxis

    Time frame: From date of selinexor treatment start, up to 40 months

    Frequency of glucocorticoids (i.e., dexamethasone given in addition to study medication) + 5HT3 antagonist administration used for prophylaxis.

  37. Administration of Glucocorticoids, NK1 and 5HT3 antagonist for prophylaxis

    Time frame: From date of selinexor treatment start, up to 40 months

    Frequency of glucocorticoids (i.e., dexamethasone given in addition to study medication) + NK1 + 5HT3 antagonist administration used for prophylaxis.

  38. Therapy decision

    Time frame: Baseline

    Assessment of parameters of therapy decision making.

  39. Therapy choice

    Time frame: Baseline

    Frequency of distinct parameters affecting therapy choice.

  40. Assessment of myeloma comorbidity index R-MCI

    Time frame: Baseline

    Assessment of R-MCI in all patients and patients with different starting doses

  41. R-MCI risk groups

    Time frame: Baseline

    Frequency of R-MCI risk groups in all patients and according to different selinexor starting dosages (100 mg vs. 80 mg vs. 60 mg).

Sponsors and collaborators

Lead sponsor

iOMEDICO AG

Industry

Collaborators

  • Climedo Health GmbH
  • Menarini Group

Registry information

Official study title

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

Acronym: SEATTLE

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Jul 20, 2023
Registry last updated
Jan 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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