EUCTR2016-003957-14-DE进行中（未招募）1 期
A Phase 3 Randomized, Controlled, Open-label Study of Selinexor, Bortezomib, and Dexamethasone (SVd) versus Bortezomib and Dexamethasone (Vd) in Patients with Relapsed or Refractory Multiple Myeloma (RRMM) - BOSTO
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 364
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Histologically confirmed MM with measurable disease per IMWG guidelines as defined by at least 1 of the following:
- •a.Serum M-protein = 0.5 g/dL (> 5 g/L) by serum protein electrophoresis (SPEP) or for immunoglobulin (Ig) A myeloma, by quantitative serum IgA levels; or
- •b.Urinary M-protein excretion at least 200 mg/24 hours; or
- •c.Serum FLC = 100 mg/L, provided that the serum FLC ratio is abnormal (normal FLC ratio: 0.26 to 1.65).
- •2.Had at least 1 prior anti-MM regimen and no more than 3 prior anti-MM regimens. Induction therapy followed by stem cell transplant and consolidation/maintenance therapy will be considered as 1 anti-MM regimen.
- •3.Documented evidence of progressive MM (based on the Investigator's determination according to the IMWG response criteria) on or after their most recent regimen.
- •4.Prior treatment with bortezomib or other PI is allowed, provided all of the following criteria are met:
- •Best response achieved with prior bortezomib at any time was = PR and with the last PI therapy (alone or in combination) was = PR, AND
- •Participant did not discontinue bortezomib due to Grade = 3 related toxicity, AND
- •Must have had at least a 6 month PI-treatment-free interval prior to C1D1 of study treatment.
- •5.Must have an ECOG Status score of 0, 1, or 2.
- •6.Written informed consent in accordance with federal, local, and institutional guidelines.
- •7.Age = 18 years.
- •8.Resolution of any clinically significant non-hematological toxicities (if any) from previous treatments to Grade = 1 by C1D1. Patients with chronic, stable Grade 2 non hematological toxicities may be included following approval from the Medical Monitor.
- •9.Adequate hepatic function within 28 days prior to C1D1:
- •a.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
- •b.Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) normal to < 2 × ULN.
- •10.Adequate renal function within 28 days prior to C1D1 (estimated creatinine clearance [CrCl] of = 20 mL/min, calculated using the formula of Cockroft and Gault):
- •(140-Age) × Mass (kg)/(72 × creatinine mg/dL)
- •Multiply by 0.85 if the patient is female, or if CrCl is = 20 mL/min as measured by 24 hour urine collection.
- •11.Adequate hematopoietic function within 7 days prior to C1D1: total white blood cell (WBC) count = 1500/mm3, absolute neutrophil count = 1000/mm3, hemoglobin =8.5 g/dL and platelet count = 75,000/mm3 (patients for whom < 50% of bone marrow nucleated cells are plasma cells) or = 50,000/mm3 (patients for whom = 50% of bone marrow nucleated cells are plasma cells).
- •a.Patients receiving hematopoietic growth factor support, including erythropoietin, darbepoetin, granulocyte-colony stimulating factor (G-CSF), granulocyte macrophage-colony stimulating factor (GM-CSF), and platelet stimulators (eg, eltrombopag, romiplostim, or interleukin-11) must have a 2-week interval between growth factor support and the Screening assessments, but they may receive growth factor support during the study.
- •b.Patients must have:
- •At least a 2-week interval from the last red blood cell (RBC) transfusion prior to the Screening hemoglobin assessment, and
- •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.
- •12. Female patients of childbear
排除标准
- •1.Prior exposure to a SINE compound, including selinexor.
- •2.Prior malignancy that required treatment, or has shown evidence of recurrence (except for non-melanoma skin cancer or adequately treated cervical carcinoma in situ) during the 5 years prior to randomization. Cancer treated with curative intent for > 5 years previously and without evidence of recurrence will be allowed.
- •3.Has any concurrent medical condition or disease (eg, uncontrolled active hypertension, uncontrolled active diabetes, active systemic infection, etc.) that is likely to interfere with study procedures.
- •4.Uncontrolled active infection requiring parenteral antibiotics, antivirals, or antifungals within 1 week prior to C1D1. Patients on prophylactic antibiotics or with a controlled infection within 1 week prior to C1D1 are acceptable.
- •5.Active plasma cell leukemia.
- •6.Documented systemic light chain amyloidosis.
- •7.MM involving the central nervous system.
- •8.Polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin changes (POEMS) syndrome.
- •9.Spinal cord compression.
- •10.Greater than Grade 2 peripheral neuropathy or Grade = 2 peripheral neuropathy with pain at baseline, regardless of whether or not the patient is currently receiving medication.
- •11.Known intolerance, hypersensitivity, or contraindication to glucocorticoids or any of the other ingredients in the glucocorticoid formulations.
- •12.Known intolerance to bortezomib, selinexor, or any of the other ingredients in the study treatment formulations.
- •13.Radiation, chemotherapy, or immunotherapy or any other anticancer therapy (including investigational therapies) = 2 weeks prior to C1D1. Localized radiation to a single site at least 1 week before C1D1 is permitted. Glucocorticoids within 2 weeks of C1D1 are permitted. Patients on long-term glucocorticoids during Screening do not require a washout period but must be able to tolerate the specified dexamethasone dose in this study.
- •14.Prior autologous stem cell transplantation < 1 month or allogeneic stem cell transplantation < 4 months prior to C1D1.
- •15.Active graft versus host disease (after allogeneic stem cell transplantation) at C1D1.
- •16.Pregnant or breastfeeding females.
- •17.Eligibility for stem cell transplantation. Patients who are eligible for stem cell transplantation but who elect not to have the procedure are allowed.
- •18.BSA < 1.4 m2 at baseline, calculated by the Dubois (Dubois, 1916) or Mosteller (Mosteller, 1987) method.
- •19.Life expectancy of < 4 months.
- •20.Major surgery within 4 weeks prior to C1D1.
- •21.Active, unstable cardiovascular function:
- •a.Symptomatic ischemia, or
- •b.Uncontrolled clinically significant conduction abnormalities (eg, 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 3 months prior to C1D1.
- •22.Known active human immunodeficiency virus (HIV) infection or HIV seropositivity.
- •23.Known active hepatitis A, B, or C infection; or known to be positive for hepatitis C virus ribonucleic acid (RNA) or hepatitis B virus surface antigen.
- •24.Any active gastrointestinal dysfunction interfering with the patient’s ability to swallow tablets, or any active gastrointestinal dysfunction tha
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