2024-512276-35-00招募中2 期
Selinexor with alternating bortezomib or lenalidomide plus dexamethasone in transplant ineligible newly diagnosed multiple myeloma patients (SABLe): An Investigator Sponsored Trial
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 9
- 主要终点
- ORR at end of induction, with response defined according to IMWG response criteria
研究概览
简要总结
ORR (defined as ≥PR) at end of induction, EoI (16 cycles)
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Age > 18 years
- •Patients must have: At least a 1-week interval from the last platelet transfusion prior to the screening platelet assessment. However, patients may receive RBC and/or platelet transfusions as clinically indicated per institutional guidelines during the study
- •Female patients of childbearing potential must have a negative serum pregnancy test at Screening. Female patients of childbearing potential and fertile male patients who are sexually active with a female of childbearing potential must use highly effective methods of contraception throughout the study and for 3 months following the last dose of study treatment.
- •Patients must be able to take prophylactic anticoagulation as recommended by study
- •Patients with pathologic fractures, infection at diagnosis or symptomatic hyperviscosity must have these conditions attended to prior to registration (i.e., intramedullary rod, I.V. antibiotics, plasmapheresis)
- •Willing and able to provide written informed consent in accordance with national, local, and institutional guidelines. The patient must provide informed consent prior to the first screening procedure
- •Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of ≤
- •ECOG 3 allowed if caused by myeloma
- •Newly diagnosed multiple myeloma with treatment demanding disease as defined by IMWG (Rajkumar, Dimopoulos et al. 2014) and measurable disease defined as
- •as defined IMWG 2016 criteria (Table 5) (Kumar, Paiva et al. 2016)
- •By treating physician considered in-eligible for high-dose therapy with stem-cell transplant
- •Patients must have received no prior chemotherapy for multiple myeloma. Patients must have received no prior radiotherapy to a large area of the pelvis (more than half of the pelvis). Patients must have received no prior steroid treatment for myeloma with the exception of a maximum of 14 days of treatment for symptom control (including dexamethasone 40mg).
- •Adequate hepatic function within 7 days prior to C1D1: Total bilirubin < 1.5 × upper limit of normal (ULN) (except patients with Gilbert’s syndrome who must have a total bilirubin of < 3 × ULN), and Alanine aminotransferase (ALT) normal to <2 × ULN.
- •Adequate renal function within 7 days prior to C1D1 as determined by estimated GFR of ≥ 30 mL/min, calculated using standard formula
- •Adequate hematopoietic function within 7 days prior to C1D1: Absolute neutrophil count ≥1.0x109/L, and platelet count ≥100x109/L (patients for whom <50% of bone marrow nucleated cells are plasma cells). If cytopenias are due a plasma cell infiltration in the bone marrow (biopsy-proven heavy-marrow involvement, as defined by having at least 30% marrow cellularity, with > 50% of the cells being malignant plasma cells (documented marrow results required)); in this case, although there are no required lower limits of normal for the blood counts, the treating physician must use his/her medical judgment as to the appropriateness of this study therapy for these patients. Erythropoietin-analogues are allowed.
排除标准
- •Has received selinexor or another XPO1 inhibitor previously
- •Contraindication to any of the required concomitant drugs or supportive treatments
- •Patients unwilling or unable to comply with the protocol
- •Has any concurrent medical condition or disease (e.g. uncontrolled active hypertension, uncontrolled active diabetes, active systemic infection, etc.) that is likely to interfere with study procedures
- •Known intolerance, hypersensitivity, or contraindication to glucocorticoids, bortezomib, lenalidomide and selinexor.
- •Pregnant or breastfeeding females
- •Life expectancy of less than 6 months
- •Active, unstable cardiovascular function, as indicated by the presence of: a) Symptomatic ischemia, or b) Uncontrolled clinically significant conduction abnormalities (e.g. patients with ventricular tachycardia on anti-arrhythmics are excluded; patients with first degree atrioventricular block or asymptomatic left anterior fascicular block/right bundle branch block will not be excluded), or c) Congestive heart failure of New York Heart Association Class ≥3 or known left ventricular ejection fraction <40%, or d) Myocardial infarction within 6 months prior to C1D1
- •Any active gastrointestinal dysfunction interfering with the patient’s ability to swallow tablets, or any active gastrointestinal dysfunction that could interfere with absorption of study treatment.
- •Inability or unwillingness to take supportive medications such as anti-nausea and anti-anorexia agents as recommended by the National Comprehensive Cancer Network® (NCCN) Clinical Practice Guidelines in Oncology (CPGO) (NCCN CPGO) for antiemesis and anorexia/cachexia (palliative care).
- •Any active, serious psychiatric, medical, or other conditions/situations that, in the opinion of the Investigator, could interfere with treatment, compliance, or the ability to give informed consent
结局指标
主要结局
ORR at end of induction, with response defined according to IMWG response criteria
ORR at end of induction, with response defined according to IMWG response criteria
次要结局
- VGPR rate at end of induction
- MRD negativity by NGS at end of induction
- Time to at least PR from start of treatment
- Time to at least VGPR from start of treatment
- Toxicity rates according to NCI-CTCAE v4.03
- Rates of neuropathy according to NCI-CTCAE
- Rates of documented thrombosis
- Rates of administrated vs planned doses
- Number of patients of patients finalizing all 16 cycles of planned induction
- Toxicity rates (frequency, severity and interference) during treatment according to NCI PRO-CTCAE registrations
- Change from baseline to end of treatment in the key PRO domains of functioning (physical, social and emotional) overall QoL and symptoms of fatigue and nausea
- OS
- PFS
- TNT
- Changes in gene expression at baseline from patients responding and not-responding to selinexor
研究者
Department of Hematology, Odense University Hospital
Scientific
Odense University Hospital
研究点 (9)
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