EUCTR2016-003957-14-AT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
适应症
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 stud
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.
- •12. Radiation, chemotherapy, or immunotherapy or any other anticancer therapy = 2 (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.
- •13. Prior autologous stem cell transplantation < 1 month or allogeneic stem cell
- •transplantation < 4 months prior to C1D1.
- •14. Active graft versus host disease (after allogeneic stem cell transplantation) at C1D1.
- •15. Pregnant or breastfeeding females.
- •16. BSA < 1.4 m2 at baseline, calculated by the Dubois (Dubois 1916) or Mosteller (Mosteller, 1987) method.
- •17. Life expectancy of < 4 months.
- •18. Major surgery within 4 weeks prior to C1D1.
- •19. 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.
- •20. Known active human immunodeficiency virus (HIV) infection or HIV seropositivity.
- •21. 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.
- •22. 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.
- •23. 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.
- •24. Contraindication to any of the r
研究者
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