EUCTR2016-003957-14-IT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 MultipleMyeloma (RRMM) - BOSTON study
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
- •Patients must meet all of the following inclusion criteria to be eligible to enroll in this study:
- •1. Histologically confirmed MM.
- •2. Had at least 1 prior anti-MM regimen and no more than 3 prior anti-MM regimens.
- •3. Documented evidence of progressive MM 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:
- •a) Best response achieved with prior bortezomib at any time was = PR and with the last PI therapy (alone or in combination) was = PR, AND
- •b) Participant did not discontinue bortezomib due to Grade = 3 related toxicity, AND
- •c) 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.
- •9. Adequate hepatic function within 28 days prior to C1D10. Adequate renal function within 28 days prior to C1D1.
- •11. Adequate hematopoietic function within 7 days prior to C1D1.
- •12. Female patients of childbearing potential must agree to use 2 methods of contraception.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 124
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 240
排除标准
- •Patients meeting any of the following exclusion criteria are not eligible to enroll in this study:
- •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
- •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.
- •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 required concomitant drugs or supportive treatments.
- •25. Patients unwilling or unable to comply with the protocol, including providing 24-hour
- •urine samples for urine protein electrophoresis at the required time points.
研究者
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