Selinexor (Nexpovio®) (SVd) in Patients With Relapsed or Refractory Multiple Myeloma
- Registration Number
- NCT05954780
- Lead Sponsor
- iOMEDICO AG
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 100
- 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)
- Contraindications according to selinexor SmPC for patients with MM
- Participation in an interventional clinical trial
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description second line and later lines therapy Selinexor Patients enrolled for second line or later lines therapy with selinexor in combination with bortezomib and dexamethasone.
- Primary Outcome Measures
Name Time Method Change from baseline of EORTC global health scale 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 Outcome Measures
Name Time Method Therapy choice Baseline Frequency of distinct parameters affecting therapy choice.
Selinexor therapy: Dosing Baseline, up to end of selinexor treatment Dose intensity during treatment (mg/m2 per week) will be analysed
Effectiveness in routine treatment: Best response Baseline, up to 40 months Frequencies of best response during selinexor therapy will be calculated using descriptive statistics.
Daratumumab-based previous therapies Baseline Frequency of patients with daratumumab-based previous therapies
Treatment duration From date of selinexor treatment start, up to 40 months Treatment duration of selinexor therapy
Selinexor therapy: Frequency Cycle 1, day 1 Frequency of starting dose of selinexor (100 mg, 80 mg, 60 mg, other) will be analysed
Change from baseline of EORTC QLQ-MY20 further scales Baseline, up to 30 days after selinexor treatment Change from baseline in further scales of the EORTC QLQ-MY20 questionnaire
12 months PFS rate Baseline, until 12 months after start of selinexor treatment PFS rates will be analysed 12 months after treatment start of selinexor
6 months PFS rate Baseline, until 6 months after start of selinexor treatment PFS rates will be analysed 6 months after treatment start of selinexor
Selinexor therapy: Dose reduction of starting dose Cycle 1, day 1 Reasons for reduced starting dose compared to SmPC will be analysed
Frequency of concomitant medication Baseline up to 30 days after end of selinexor therapy Frequency of concomitant medication administered
Anti-emetic substances for prophylaxis From date of selinexor treatment start, up to 40 months Use of anti-emetic substances for prophlaxis
Administration of Glucocorticoids and NK1 antagonist for prophylaxis 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.
Administration of Glucocorticoids and 5HT3 antagonist for prophylaxis 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.
Change from baseline of EORTC QLQ-C30 further scales Baseline, up to 40 months Change from baseline in further scales of the EORTC QLQ-C30 questionnaire
Assessment of drug tolerability and safety Baseline, up to 40 months Frequency of specific (serious) adverse drug reactions ((S)ADRs) (nausea, weight loss, diarrhea, vomiting, fatigue)
Adverse events of special interest (AESI) 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.
Changes in selinexor therapy 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
Effectiveness in routine treatment: Progression-free survival (PFS) 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.
Adverse events (AEs) and serious adverse events (SAEs) according to NCI CTCAE Baseline, up to 30 days after end of selinexor treatment Incidence of (serious) AEs ((S)AEs) as characterized by type, frequency, severity and seriousness.
Adverse drug reaction (ADR) and serious adverse drug reactions (SADR) 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.
Effectiveness in routine treatment: Overall response rate (ORR) 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.
Effectiveness in routine treatment: Disease control rate (DCR) 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.
6 months OS rate Baseline, until 6 months after start of selinexor treatment OS rates will be analysed 6 and 12 months after treatment start of selinexor
12 months OS rate Baseline, until 12 months after start of selinexor treatment OS rates will be analysed 6 and 12 months after treatment start of selinexor
Effectiveness in routine treatment: Overall survival (OS) 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.
Previous therapies Baseline Frequency of distinct previous therapies (systemic / radiation / transplantation)
Subsequent antineoplastic therapies From Date of end of selinexor treatment up to 40 months Frequency of distinct subsequent antineoplastic therapies.
Anti-diarrhea substances for AE treatment Baseline up to 30 days after end of selinexor treatment Use of anti-diarrhea substances for AE treatment
Assessment of myeloma comorbidity index R-MCI Baseline Assessment of R-MCI in all patients and patients with different starting doses
R-MCI risk groups 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).
Selinexor therapy: Dose changes From date of second selinexor application, up to 40 months Reasons for dose reductions and dose re-escalation during treatment compared to previous dose
Subsequent antineoplastic radiations From Date of end of selinexor treatment up to 40 months Frequency of distinct subsequent antineoplastic radiations.
Anti-emetic substances for AE treatment Baseline up to 30 days after end of selinexor treatment Use of anti-emetic substances for AE treatment
Anti-diarrhea substances for prophylaxis From date of selinexor treatment start, up to 40 months Use of anti-diarrhea substances for prophylaxis
Anti-emetic and anti-diarrhea substances for AE treatment 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
Administration of NK1 + 5HT3 antagonist for prophylaxis From date of selinexor treatment start, up to 40 months Frequency of NK1 + 5HT3 antagonist administration used for prophylaxis
Therapy decision Baseline Assessment of parameters of therapy decision making.
Subsequent antineoplastic transplantations From Date of end of selinexor treatment up to 40 months Frequency of distinct subsequent antineoplastic transplantations.
Anti-emetic and anti-diarrhea substances for prophylaxis From date of selinexor treatment start, up to date of end of selinexor treatment Use of anti-emetic and anti-diarrhea substances for prophylaxis
Administration of Glucocorticoids, NK1 and 5HT3 antagonist for prophylaxis 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.
Trial Locations
- Locations (2)
Gemeinschaftspraxis für Hämatologie und Onkologie GbR
🇩🇪Ravensburg, Baden-Württemberg, Germany
Medizinische Universität Wien, Universitätsklinik für Innere Medizin I
🇦🇹Wien, Austria