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

Multiple Myeloma Clinical Trial

— SEATTLE  

Official 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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05954780
• Other study ID #: IOM-090494
• Status: Recruiting
• Start date: June 28, 2023
• Est. completion date: September 15, 2025

Study information

• Verified date: July 2023
• Source: iOMEDICO AG
• Contact: Daniel Kummer, Dr.
• Phone: +49761-152420
• Email: seattle[@]iomedico.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: September 15, 2025
• Est. primary completion date: September 15, 2025
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Drug:
• Selinexor
Selinexor/bortezomib/dexamethasone according to Nexpovio® SmPC

Locations

Country	Name	City	State
Austria	Medizinische Universität Wien, Universitätsklinik für Innere Medizin I	Wien
Germany	Gemeinschaftspraxis für Hämatologie und Onkologie GbR	Ravensburg	Baden-Württemberg

Sponsors (3)

Lead Sponsor	Collaborator
iOMEDICO AG	Climedo Health GmbH, Stemline Switzerland GmbH

Countries where clinical trial is conducted

Austria,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 28 months
Secondary	Change from baseline of EORTC QLQ-C30 further scales	Change from baseline in further scales of the EORTC QLQ-C30 questionnaire	Baseline, up to 28 months
Secondary	Change from baseline of EORTC QLQ-MY20 further scales	Change from baseline in further scales of the EORTC QLQ-MY20 questionnaire	Baseline, up to 30 days after selinexor treatment
Secondary	Assessment of drug tolerability and safety	Frequency of specific (serious) adverse drug reactions ((S)ADRs) (nausea, weight loss, diarrhea, vomiting, fatigue)	Baseline, up to 28 months
Secondary	Adverse events (AEs) and serious adverse events (SAEs) according to NCI CTCAE	Incidence of (serious) AEs ((S)AEs) as characterized by type, frequency, severity and seriousness.	Baseline, up to 30 days after end of selinexor treatment
Secondary	Adverse drug reaction (ADR) and serious adverse drug reactions (SADR)	Incidence of (serious) adverse drug reactions ((S)ADRs) as characterized by type, frequency, severity and seriousness.	Baseline, up to 30 days after end of selinexor treatment
Secondary	Adverse events of special interest (AESI)	Incidence of AEs of special interest defined as cataracts (new-onset cataracts and worsening of cataracts) and Acute cerebellar syndrome.	Baseline, up to 30 days after end of selinexor treatment
Secondary	Changes in selinexor therapy	Frequency of treatment delays, no administrations (skips), discontinuation (withdrawn) of selinexor due to safety reasons	From date of selinexor treatment start, up to 28 months
Secondary	Effectiveness in routine treatment: Best response	Frequencies of best response during selinexor therapy will be calculated using descriptive statistics.	Baseline, up to 28 months
Secondary	Effectiveness in routine treatment: Overall response rate (ORR)	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.	Baseline, up to 28 months
Secondary	Effectiveness in routine treatment: Disease control rate (DCR)	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.	Baseline, up to 28 months
Secondary	Effectiveness in routine treatment: Progression-free survival (PFS)	PFS is defined as the time interval measured from the day of first selinexor administration to first progression or death, whichever comes first.	Baseline, up to 28 months
Secondary	6 months PFS rate	PFS rates will be analysed 6 months after treatment start of selinexor	Baseline, until 6 months after start of selinexor treatment
Secondary	12 months PFS rate	PFS rates will be analysed 12 months after treatment start of selinexor	Baseline, until 12 months after start of selinexor treatment
Secondary	Effectiveness in routine treatment: Overall survival (OS)	OS is defined as the time interval measured from the day of first selinexor administration to time of death from any cause.	Baseline, up to 28 months
Secondary	6 months OS rate	OS rates will be analysed 6 and 12 months after treatment start of selinexor	Baseline, until 6 months after start of selinexor treatment
Secondary	12 months OS rate	OS rates will be analysed 6 and 12 months after treatment start of selinexor	Baseline, until 12 months after start of selinexor treatment
Secondary	Selinexor therapy: Dosing	Dose intensity during treatment (mg/m2 per week) will be analysed	Baseline, up to end of selinexor treatment
Secondary	Selinexor therapy: Frequency	Frequency of starting dose of selinexor (100 mg, 80 mg, 60 mg, other) will be analysed	Cycle 1, day 1
Secondary	Selinexor therapy: Dose reduction of starting dose	Reasons for reduced starting dose compared to SmPC will be analysed	Cycle 1, day 1
Secondary	Selinexor therapy: Dose changes	Reasons for dose reductions and dose re-escalation during treatment compared to previous dose	From date of second selinexor application, up to 28 months
Secondary	Previous therapies	Frequency of distinct previous therapies (systemic / radiation / transplantation)	Baseline
Secondary	Daratumumab-based previous therapies	Frequency of patients with daratumumab-based previous therapies	Baseline
Secondary	Treatment duration	Treatment duration of selinexor therapy	From date of selinexor treatment start, up to 28 months
Secondary	Subsequent antineoplastic therapies	Frequency of distinct subsequent antineoplastic therapies.	From Date of end of selinexor treatment up to 28 months
Secondary	Subsequent antineoplastic transplantations	Frequency of distinct subsequent antineoplastic transplantations.	From Date of end of selinexor treatment up to 28 months
Secondary	Subsequent antineoplastic radiations	Frequency of distinct subsequent antineoplastic radiations.	From Date of end of selinexor treatment up to 28 months
Secondary	Frequency of concomitant medication	Frequency of concomitant medication administered	Baseline up to 30 days after end of selinexor therapy
Secondary	Anti-emetic substances for AE treatment	Use of anti-emetic substances for AE treatment	Baseline up to 30 days after end of selinexor treatment
Secondary	Anti-emetic substances for prophylaxis	Use of anti-emetic substances for prophlaxis	From date of selinexor treatment start, up to 28 months
Secondary	Anti-diarrhea substances for AE treatment	Use of anti-diarrhea substances for AE treatment	Baseline up to 30 days after end of selinexor treatment
Secondary	Anti-diarrhea substances for prophylaxis	Use of anti-diarrhea substances for prophylaxis	From date of selinexor treatment start, up to 28 months
Secondary	Anti-emetic and anti-diarrhea substances for AE treatment	Use of anti-emetic and anti-diarrhea substances for AE treatment	From date of selinexor treatment start, up to date of end of selinexor treatment
Secondary	Anti-emetic and anti-diarrhea substances for prophylaxis	Use of anti-emetic and anti-diarrhea substances for prophylaxis	From date of selinexor treatment start, up to date of end of selinexor treatment
Secondary	Administration of Glucocorticoids and NK1 antagonist for prophylaxis	Frequency of glucocorticoids (i.e., dexamethasone given in addition to study medication) + NK1 antagonist administration used for prophylaxis.	From date of selinexor treatment start, up to 28 months
Secondary	Administration of NK1 + 5HT3 antagonist for prophylaxis	Frequency of NK1 + 5HT3 antagonist administration used for prophylaxis	From date of selinexor treatment start, up to 28 months
Secondary	Administration of Glucocorticoids and 5HT3 antagonist for prophylaxis	Frequency of glucocorticoids (i.e., dexamethasone given in addition to study medication) + 5HT3 antagonist administration used for prophylaxis.	From date of selinexor treatment start, up to 28 months
Secondary	Administration of Glucocorticoids, NK1 and 5HT3 antagonist for prophylaxis	Frequency of glucocorticoids (i.e., dexamethasone given in addition to study medication) + NK1 + 5HT3 antagonist administration used for prophylaxis.	From date of selinexor treatment start, up to 28 months
Secondary	Therapy decision	Assessment of parameters of therapy decision making.	Baseline
Secondary	Therapy choice	Frequency of distinct parameters affecting therapy choice.	Baseline
Secondary	Assessment of myeloma comorbidity index R-MCI	Assessment of R-MCI in all patients and patients with different starting doses	Baseline
Secondary	R-MCI risk groups	Frequency of R-MCI risk groups in all patients and according to different selinexor starting dosages (100 mg vs. 80 mg vs. 60 mg).	Baseline