CTRI/2017/11/010561进行中（未招募）3 期
A Phase 3 Randomized, Controlled, Open-LabelStudy Of Selinexor, Bortezomib, ANDDexamethasone (SVD) Versus Bortezomib ANDDexamethasone (VD) In Patients With Relapsed OrRefractory Multiple Myeloma (RRMM) - BOSTO
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
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.
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 (e.g., 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 (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 and 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 (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 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 patientâ??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/situ
研究者
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