A Non-interventional Study of Selinexor (Nexpovio®) in Combination With Bortezomib and Dexamethasone (SVd) in Patients With Relapsed or Refractory Multiple Myeloma (R/RMM)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- iOMEDICO AG
- 入组人数
- 75
- 试验地点
- 3
- 主要终点
- Change from baseline of EORTC global health scale
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •Contraindications according to selinexor SmPC for patients with MM
- •Participation in an interventional clinical trial
研究组 & 干预措施
second line and later lines therapy
Patients enrolled for second line or later lines therapy with selinexor in combination with bortezomib and dexamethasone.
干预措施: Selinexor (Drug)
结局指标
主要结局
Change from baseline of EORTC global health scale
时间窗: 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.
次要结局
- Therapy choice(Baseline)
- Selinexor therapy: Dosing(Baseline, up to end of selinexor treatment)
- Effectiveness in routine treatment: Best response(Baseline, up to 40 months)
- Daratumumab-based previous therapies(Baseline)
- Treatment duration(From date of selinexor treatment start, up to 40 months)
- Selinexor therapy: Frequency(Cycle 1, day 1)
- Change from baseline of EORTC QLQ-MY20 further scales(Baseline, up to 30 days after selinexor treatment)
- 12 months PFS rate(Baseline, until 12 months after start of selinexor treatment)
- 6 months PFS rate(Baseline, until 6 months after start of selinexor treatment)
- Selinexor therapy: Dose reduction of starting dose(Cycle 1, day 1)
- Frequency of concomitant medication(Baseline up to 30 days after end of selinexor therapy)
- Anti-emetic substances for prophylaxis(From date of selinexor treatment start, up to 40 months)
- Administration of Glucocorticoids and NK1 antagonist for prophylaxis(From date of selinexor treatment start, up to 40 months)
- Administration of Glucocorticoids and 5HT3 antagonist for prophylaxis(From date of selinexor treatment start, up to 40 months)
- Change from baseline of EORTC QLQ-C30 further scales(Baseline, up to 40 months)
- Assessment of drug tolerability and safety(Baseline, up to 40 months)
- Adverse events of special interest (AESI)(Baseline, up to 30 days after end of selinexor treatment)
- Changes in selinexor therapy(From date of selinexor treatment start, up to 40 months)
- Effectiveness in routine treatment: Progression-free survival (PFS)(Baseline, up to 40 months)
- Adverse events (AEs) and serious adverse events (SAEs) according to NCI CTCAE(Baseline, up to 30 days after end of selinexor treatment)
- Adverse drug reaction (ADR) and serious adverse drug reactions (SADR)(Baseline, up to 30 days after end of selinexor treatment)
- Effectiveness in routine treatment: Overall response rate (ORR)(Baseline, up to 40 months)
- Effectiveness in routine treatment: Disease control rate (DCR)(Baseline, up to 40 months)
- 6 months OS rate(Baseline, until 6 months after start of selinexor treatment)
- 12 months OS rate(Baseline, until 12 months after start of selinexor treatment)
- Effectiveness in routine treatment: Overall survival (OS)(Baseline, up to 40 months)
- Previous therapies(Baseline)
- Subsequent antineoplastic therapies(From Date of end of selinexor treatment up to 40 months)
- Anti-diarrhea substances for AE treatment(Baseline up to 30 days after end of selinexor treatment)
- Assessment of myeloma comorbidity index R-MCI(Baseline)
- R-MCI risk groups(Baseline)
- Selinexor therapy: Dose changes(From date of second selinexor application, up to 40 months)
- Subsequent antineoplastic radiations(From Date of end of selinexor treatment up to 40 months)
- Anti-emetic substances for AE treatment(Baseline up to 30 days after end of selinexor treatment)
- Anti-diarrhea substances for prophylaxis(From date of selinexor treatment start, up to 40 months)
- Anti-emetic and anti-diarrhea substances for AE treatment(From date of selinexor treatment start, up to date of end of selinexor treatment)
- Administration of NK1 + 5HT3 antagonist for prophylaxis(From date of selinexor treatment start, up to 40 months)
- Therapy decision(Baseline)
- Subsequent antineoplastic transplantations(From Date of end of selinexor treatment up to 40 months)
- Anti-emetic and anti-diarrhea substances for prophylaxis(From date of selinexor treatment start, up to date of end of selinexor treatment)
- Administration of Glucocorticoids, NK1 and 5HT3 antagonist for prophylaxis(From date of selinexor treatment start, up to 40 months)