NL-OMON44193招募中2 期
A Phase II study of Selinexor (KPT-330) combined with bortezomib and dexamethasone (SVd) for induction and consolidation for patients with progressive or refractory Multiple Myeloma. - The Selvedex trial
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 49
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
- 18 至 99（—）
入选标准
- •The subject must understand and voluntarily sign an informed consent document prior to any study related assessments/procedures are conducted.
- •Age >= 18 years at the time of signing the informed consent form.
- •Able to adhere to the study visit schedule and other protocol requirements.
- •Documented diagnosis of multiple myeloma and measurable disease (serum M-protein >= 5 g/L or urine M-protein >= 200 mg/24 hours or abnormal FLC ratio with involved free light chain (FLC) > 100 mg/L);
- •Documented progression as per the IMWG uniform response criteria (Durie, 2006) during or after the anti-myeloma regimen; or never achieved a response better than PD after at least 2 cycles of their previous anti-myeloma regimen.
- •At lease one prior anti-myeloma regimen. Induction therapy followed by autologous stem cell transplant (ASCT) and consolidation/ maintenance will be considered as one regimen.
- •Normal renal function with a Creatinine Clearance > 30mL/min according to the Modification of Diet in Renal Disease (MDRD) equation for estimation of Glomerular Filtration Rate (GFR)
- •WHO performance status score of 0, 1 or 2
- •Female patients of child-bearing potential must agree to use dual methods of contraception and have a negative serum pregnancy test at screening, and male patients must use an effective barrier method of contraception if sexually active with a female of child-bearing potential. Acceptable methods of contraception are condoms with contraceptive foam, oral, implantable or injectable contraceptives, contraceptive patch, intrauterine device, diaphragm with spermicidal gel, or a sexual partner who is surgically sterilized or post-menopausal. For both male and female patients, effective methods of contraception must be used throughout the study and for three months following the last dose.
- •All subjects must agree to refrain from donating blood while on study drug and for 28 days after discontinuation from this study treatment.
- •All subjects must agree not to share medication.
排除标准
- •Prior resistance/refractory disease to bortezomib, defined as progression during or within 60 days of completing bortezomib therapy.
- •Systemic AL amyloidosis
- •Non secretory myeloma
- •Known CNS involvement
- •Absolute neutrophil count (ANC) <1.0 x 109/L, unless related to MM.
- •Platelet count < 50 x 109/L.
- •Corrected serum calcium > 14 mg/dL (> 3.5 mmol/L).
- •Hemoglobin < 8 g/dL (< 4.9 mmol/L; prior RBC transfusion or recombinant human erythropoietin use is permitted).
- •Significant hepatic dysfunction (Serum SGOT/AST or SGPT/ALT > 3.0 x upper limit of normal (ULN) or serum total bilirubin > 2 x ULN unless due to inheritable syndrome such as Gilbert*s)
- •Prior history of malignancies, other than MM, unless the subject has been free of the disease
- •for >= 5 years. Exceptions include the following:
- •oBasal or squamous cell carcinoma of the skin.
- •oCarcinoma in situ of the cervix or breast.
- •oIncidental histological finding of prostate cancer (TNM stage of T1a or T1b).
- •Hypersensitivity to bortezomib or dexamethasone (this includes >= Grade 3 rash during prior bortezomib therapy).
- •Peripheral neuropathy >= Grade 2 at time of registration.
- •Subjects who received an allogeneic bone marrow or allogeneic peripheral blood stem cell transplant less than 12 months prior to initiation of study treatment
- •Congestive heart failure (NY Heart Association Class III or IV).
- •Myocardial infarction within 12 months prior to starting study treatment
- •Unstable or poorly controlled angina pectoris, including Prinzmetal variant angina pectoris.
- •Subjects who received any of the following within the last 14 days of initiation of study treatment:
- •Major surgery (kyphoplasty is not considered major surgery).
- •Use of any anti-myeloma drug therapy at the time of registration in the trial.
- •Use of any investigational agents within 28 days or five half-lives (whichever is longer) of treatment.
- •Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subjects from signing the informed consent form.
- •Any active uncontrolled infections
- •Pregnant or breastfeeding females.
- •Known human immunodeficiency virus (HIV) positivity, active infectious hepatitis A, B or C or chronic hepatitis B or C.
- •Any psychological, familial, sociological and geographical condition potentially hampering compliance with the study protocol and follow-up schedule.
研究者
相似试验
进行中（未招募）
1 期
A Phase II study of Selinexor (KPT-330) combined with bortezomib and dexamethasone (SVd) for induction and consolidation for patients with progressive or refractory Multiple Myeloma.A Phase II study of Selinexor (KPT-330) combined with bortezomib and dexamethasone (SVd) for induction and consolidation for patients with progressive or refractory Multiple Myeloma.EUCTR2014-002444-40-NLErasmus MC37
尚未招募
不适用
A Phase II study of Selinexor (KPT-330) combined with bortezomib and dexamethasone (SVd) for induction andconsolidation for patients with progressive or refractory Multiple Myeloma.Multiple MyelomaMultipel MyeloomProgressive or RefractoryProgressief of refractairsafety and tolerability of selinexorNL-OMON25937Erasmus University Medical Center49
进行中（未招募）
1 期
Selinexor in patients with advanced thymoma and thymic carcinomaadvanced thymic epithelial tumour (TET) progressing after primary chemotherapyMedDRA version: 21.1Level: PTClassification code 10055108Term: Thymic cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: PTClassification code 10043670Term: ThymomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: PTClassification code 10043674Term: Thymoma malignant recurrentSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: PTClassification code 10061031Term: Thymoma malignantSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2016-002612-40-DKDepartment of Oncology Rigshospitalet50
进行中（未招募）
1 期
A Phase 2b Open-label Study of Selinexor (KPT-330) in Patients with Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL)Relapsed/Refractory DLBCLMedDRA version: 20.0Level: HLTClassification code 10012819Term: Diffuse large B-cell lymphomasSystem Organ Class: 100000004851EUCTR2014-001977-15-GRKaryopharm Therapeutics, Inc.110
进行中（未招募）
1 期
A Phase 2b Open-label Study of Selinexor (KPT-330) in Patients withRelapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL)Relapsed/Refractory DLBCLMedDRA version: 20.0Level: HLTClassification code 10012819Term: Diffuse large B-cell lymphomasSystem Organ Class: 100000004851EUCTR2014-001977-15-BEKaryopharm Therapeutics, Inc.320