Clinical trial NCT05954780: Selinexor (Nexpovio®) (SVd) in Patients With Relapsed or Refractory Multiple Myeloma
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)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Multiple Myeloma
Keywords: Multiple Myeloma
Selinexor
Bortezomib
Dexamethasone
Lead sponsor: iOMEDICO AG
Sponsor class: INDUSTRY
Collaborators: name: Stemline Switzerland GmbH
name: Climedo Health GmbH
First posted: 2023-07-20
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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

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.

Detailed 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.

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

Primary outcomes:
measure: Change from baseline of EORTC global health scale
timeFrame: Baseline, up to 40 months
Secondary outcomes:
measure: Change from baseline of EORTC QLQ-C30 further scales
timeFrame: Baseline, up to 40 months
measure: Change from baseline of EORTC QLQ-MY20 further scales
timeFrame: Baseline, up to 30 days after selinexor treatment
measure: Assessment of drug tolerability and safety
timeFrame: Baseline, up to 40 months
measure: Adverse events (AEs) and serious adverse events (SAEs) according to NCI CTCAE
timeFrame: Baseline, up to 30 days after end of selinexor treatment
measure: Adverse drug reaction (ADR) and serious adverse drug reactions (SADR)
timeFrame: Baseline, up to 30 days after end of selinexor treatment
measure: Adverse events of special interest (AESI)
timeFrame: Baseline, up to 30 days after end of selinexor treatment
measure: Changes in selinexor therapy
timeFrame: From date of selinexor treatment start, up to 40 months
measure: Effectiveness in routine treatment: Best response
timeFrame: Baseline, up to 40 months
measure: Effectiveness in routine treatment: Overall response rate (ORR)
timeFrame: Baseline, up to 40 months
measure: Effectiveness in routine treatment: Disease control rate (DCR)
timeFrame: Baseline, up to 40 months
measure: Effectiveness in routine treatment: Progression-free survival (PFS)
timeFrame: Baseline, up to 40 months
measure: 6 months PFS rate
timeFrame: Baseline, until 6 months after start of selinexor treatment
measure: 12 months PFS rate
timeFrame: Baseline, until 12 months after start of selinexor treatment
measure: Effectiveness in routine treatment: Overall survival (OS)
timeFrame: Baseline, up to 40 months
measure: 6 months OS rate
timeFrame: Baseline, until 6 months after start of selinexor treatment
measure: 12 months OS rate
timeFrame: Baseline, until 12 months after start of selinexor treatment
measure: Selinexor therapy: Dosing
timeFrame: Baseline, up to end of selinexor treatment
measure: Selinexor therapy: Frequency
timeFrame: Cycle 1, day 1
measure: Selinexor therapy: Dose reduction of starting dose
timeFrame: Cycle 1, day 1
measure: Selinexor therapy: Dose changes
timeFrame: From date of second selinexor application, up to 40 months
measure: Previous therapies
timeFrame: Baseline
measure: Daratumumab-based previous therapies
timeFrame: Baseline
measure: Treatment duration
timeFrame: From date of selinexor treatment start, up to 40 months
measure: Subsequent antineoplastic therapies
timeFrame: From Date of end of selinexor treatment up to 40 months
measure: Subsequent antineoplastic transplantations
timeFrame: From Date of end of selinexor treatment up to 40 months
measure: Subsequent antineoplastic radiations
timeFrame: From Date of end of selinexor treatment up to 40 months
measure: Frequency of concomitant medication
timeFrame: Baseline up to 30 days after end of selinexor therapy
measure: Anti-emetic substances for AE treatment
timeFrame: Baseline up to 30 days after end of selinexor treatment
measure: Anti-emetic substances for prophylaxis
timeFrame: From date of selinexor treatment start, up to 40 months
measure: Anti-diarrhea substances for AE treatment
timeFrame: Baseline up to 30 days after end of selinexor treatment
measure: Anti-diarrhea substances for prophylaxis
timeFrame: From date of selinexor treatment start, up to 40 months
measure: Anti-emetic and anti-diarrhea substances for AE treatment
timeFrame: From date of selinexor treatment start, up to date of end of selinexor treatment
measure: Anti-emetic and anti-diarrhea substances for prophylaxis
timeFrame: From date of selinexor treatment start, up to date of end of selinexor treatment
measure: Administration of Glucocorticoids and NK1 antagonist for prophylaxis
timeFrame: From date of selinexor treatment start, up to 40 months
measure: Administration of NK1 + 5HT3 antagonist for prophylaxis
timeFrame: From date of selinexor treatment start, up to 40 months
measure: Administration of Glucocorticoids and 5HT3 antagonist for prophylaxis
timeFrame: From date of selinexor treatment start, up to 40 months
measure: Administration of Glucocorticoids, NK1 and 5HT3 antagonist for prophylaxis
timeFrame: From date of selinexor treatment start, up to 40 months
measure: Therapy decision
timeFrame: Baseline
measure: Therapy choice
timeFrame: Baseline
measure: Assessment of myeloma comorbidity index R-MCI
timeFrame: Baseline
measure: R-MCI risk groups
timeFrame: Baseline
Other outcomes:
Locations:
city: Wien
country: Austria
facility: Medizinische Universität Wien, Universitätsklinik für Innere Medizin I
city: Ravensburg
country: Germany
facility: Gemeinschaftspraxis für Hämatologie und Onkologie GbR
state: Baden-Württemberg
Study officials:
affiliation: Gemeinschaftspraxis für Hämatologie und Onkologie GbR
name: Tobias Dechow, Prof. Dr.
role: STUDY_CHAIR
affiliation: Universitätsklinikum AKH Wien
name: Maria Krauth, Assoc. Prof. PD Dr.
role: STUDY_CHAIR
References: