KCT0008434尚未招募Unknown
A Prospective Sponsor-investigator Clinical Study for dose-finding of selinexor in Relapsed and/or Refractory Multiple Myeloma (RRMM) Patients with Impaired Renal Function
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 入组人数
- 12
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
- 年龄范围
- 19(Year) 至 o Limit（—）
- 性别
- All
入选标准
- •1) Men or women 19 years of age or older
- •2) Relapsed in accordance with IMWG standards (19. Other matters necessary for safe and scientific conduct of clinical research) or refractory multiple myeloma patients
- •3) Patients with multiple myeloma diagnosis who satisfy the following (all of the following)
- •- Monoclonal plasma cells in the bone marrow %10% or plasma cell species identified by biopsy
- •- Patients with multiple myeloma that can be evaluated and who fall under one or more of the following
- •i. Serum M-protein 0 0.5 g/dL or urine M-protein 200 200 mg/24 hours
- •ii. IgA multiple myeloma: serum M-protein 00.5 g/dL or urine M-protein 200200 mg/24 hours
- •iii. Hard-chain multiple myeloma: Serum glass hard-chain (sFLC) 100100 mg/L and abnormal serum kappa/lambda free hard-chain ratio
- •4) Proteasome inhibitor, immunomodulatory drug, and CD38
- •Patients who have failed at least three systemic treatments, including CD38 targeted monoclonal antibody.
- •5) Patients who have not previously been treated at Cellinex
- •6) Accompanying renal dysfunction: glomerular filtration rate predicted by MDRD formula <20 mL/min
- •7) Proper liver function (satisfied with all of the following)
- •- Serum total bilirubin is less than twice the normal upper limit (however, if you have Gilbert syndrome)
- •less than 3x)
- •- AST/ALT less than 2.5 times the normal upper limit
- •8) (Eastern Cooperative Oncology Group Performance Status) 0-2
- •9) Normal cardiac function (Ejection fracture 45 45%)
- •10) Proper bone marrow function (satisfying all of the following)
- •- Neutral sphere 800/ul or higher
- •- Platelet count above 30,000/ul
- •- - Hemoglobin 7 g/dL
- •11) If the subject is a woman,
- •- If the amenorrhea period is at least 1 year (female after menopause),
- •- Before the start of treatment (at the time of screening), the urine pregnancy test is negative and can maintain contraception during the study period.
- •[Limited to women before menopause or women with menopause within 1 year (within 1 year since menopause)]
- •*During the consent process for women of childbearing age, contraception methods such as natural cycle and abstinence are used according to the Catholic ideology of the present application.
- •Guide the subject.
排除标准
- •1) Asymptomatic multiple myeloma, active plasma cell
- •Selinexor Exploratory PK in MM Patients with Renal Impairment Ver.1.0 / 2022.11.14
- •leukemia), undetermined monoclonal gamma globulinemia (MGUS), or multiple myeloma invading the central nervous system.
- •2) cardiovascular dysfunction of activity
- •3) HIV positive
- •4) Active hepatitis A, B or C
- •5) Accompanying cancer diseases that are currently being treated or that require treatment
- •6) Except for non-melanoma skin cancer and intraepithelial cervical cancer, which has been completely cured within the last five years, a patient with a history of other cancers
- •7) Peripheral neuropathy of severity 3 or higher or neuroinflammatory with pain of severity 2 or higher
- •8) Participating in a clinical study in which another anti-tumor drug is administered within 3 weeks
- •9) Platelet transfusion or red blood cell transfusion is performed within 2 days of the first day of the first cycle.
- •10) If the following hematopoietic promoter is administered within two days of the first day of the first cycle:
- •(G-CSF, GM-CSF, erythropoietin, megakaryocyte growth factor)
- •11) When a SINE compound was previously administered, including Selinexor
- •12) Accompanying mental illness that is difficult to participate in this study
- •13) Pregnant women
研究者
相似试验
招募中
Unknown
Investigator-initiated clinical trial of bradycardia with transvenous vagus nerve stimulation catheters for supraventricular tachyarrhythmiasAtrial fibrillation/Atrial flutter/Atrial tachycardia etc.JPRN-jRCT2072230062Sakamoto Kazuo20
尚未招募
不适用
A study for confirming the functional effects of 3D-printed patient specific orthopedic fixation plates for patients with distal radius fractures or patients in need of corrective osteotomyKCT0005932Asan Medical Center20
招募中
不适用
Prospective observational clinical study to investigate the oral cavity microbiome in patients with depression treated with selective serotonin reuptake inhibitors (SSRIs)F33.8Other recurrent depressive disordersDRKS00031660Mund-Kiefer- und Gesichtschirurgische Klinik, FAU Uniklinik Erlangen68
进行中（未招募）
1 期
Investigator-initiated clinical research trial on the effects of 5% Minoxidil topical foam on gene expression, hair growth and scalp microenvironment in men with androgenetic alopeciaAndrogenetic Alopecia Hamilton-Norwood IIIv-IV male patientsMedDRA version: 16.1Level: PTClassification code 10068168Term: Androgenetic alopeciaSystem Organ Class: 10040785 - Skin and subcutaneous tissue disordersEUCTR2013-004130-15-DECharité-Universitätsmedizin Berlin, Department of Dermatology, Clinical Research Center for Hair and Skin Science12
招募中
2 期
Investigator-initiated clinical trial of Patient-Specific Cardiac Support Net for dilated cardiomyopathydilated cardiomyopathyDilated cardiomyopathy, , Cardiac failure, Cardiac remodelingD002311JPRN-jRCT2042210157Akita Toshiaki5