NL-OMON39975已完成2 期
A multicenter, phase II study of bortezomib and dexamethasone as induction treatment followed by high dose melphalan (HDM) and autologous stem cell transplantation (SCT) in patients with de novo amyloid light chain (AL) amyloidosis - HOVON 104 AL amyloidosis
HOVO0 个研究点目标入组 40 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
研究概览
简要总结
Trial is onging in other countries
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •* Biopsy proven, systemic, untreated AL amyloidosis requiring systemic chemotherapy,
- •* Age 18 -70 years inclusive at the time of signing the informed consent form,
- •* Measurable plasma cell dyscrasia, defined as a detectable M-protein with serum electrophoresis and/or level of involved FLC> 50 mg/L,
- •* Life expectancy > 3 months,
- •* WHO performance status 0-2,
- •* NYHA stage 1-2,
- •* Negative pregnancy test at inclusion for women of childbearing potential,
- •* Written informed consent.
排除标准
- •* Multiple Myeloma stage II and III (Durie and Salmon),
- •* Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form,
- •* Any psychological, familial, sociological and geographical condition potentially hampering compliance with the study protocol and follow-up schedule,
- •* Previous treatment for plasma cell dyscrasia
- •* Pregnant or breast feeding females.
- •* Presence of other active malignancy or a history of active malignancy during the past 5 years, with the exception of nonmelanoma skin cancer, stage 0 cervical carcinoma, or treated early-stage prostate cancer provided that prostate-specific antigen is within normal limits,
- •* Hypersensitivity to boron or mannitol,
- •* Uncontrolled infection,
- •* Symptomatic othostatic hypotension defined as a decrease in systolic blood pressure on standing of >20mmHg combined with symptoms like dizziness, cerebral and/or cardial ischemia,
- •*NT pro BNP level > 5000 pg/ml and Troponin T> 0.06 microgram/l (not high senstitivity assay) or NT proBNP level > 5000 pg/ml and Troponin I > 2 times ULN
- •* Symptomatic effusions, defined as pleural effusion or ascites needing drainage therapy,
- •* Positive for HIV or infectious hepatitis, B or C,
- •* Bilirubin > 2x upper limit of normal,
- •* Creatinin clearance < 30 ml/min (after rehydration),
- •* Absolute neutrophil count < 1.0 × 109/L,
- •* NCI CTCAE grade peripheral sensory neuropathy > grade 2,
- •* NCI CTCAE grade peripheral sensory neuropathy > grade 1 in the presence of neuropathic pain,
- •*NCI CTCAE grade peripheral motor neuropathy > grade 2
- •* Concurrent diagnosis of B-cel NHL or B-CLL,
- •* Previous organ transplantation.
- •* Unwilling or unable to use adequate contraception
研究者
相似试验
已完成
3 期
A prospective, multicenter, randomised, double-blind, placebo-controlled, parallel groups, phase 2/3 study to compare the efficacy and safety of masitinib versus placebo in the treatment of patients suffering from Amyotrophic Lateral Sclerosis (ALS)ALSAmyotrophic Lateral Sclerosis10011305NL-OMON44970AB Science10
已完成
2 期
A Phase 2b Multicentre, Randomised, Double-Blind, Active Controlled, Parallel Group Dose-Ranging Study to Assess the Efficacy, Safety and Tolerability of Zibotentan and Dapagliflozin in Patients with Chronic Kidney Disease with Estimated Glomerular Filtration Rate (eGFR) Between 20 and 60 mL/min/1.73 m2Chronic Kidney DiseaseNL-OMON52170Astra Zeneca9
已完成
2 期
A Phase IIb double-blind, randomised, placebo-controlled, multi-centre, confirmative three-way cross-over study on cognitive function with two doses of KH176 in subjects with a genetically confirmed mitochondrial DNA tRNALeu(UUR) m.3243A>G mutation.NL-OMON49029Khondrion B.V.9
已完成
2 期
A multicentre randomized, double-blind, placebo-controlled Phase 2 study to evaluate the safety, tolerability, efficacy, dose-response, pharmacokinetics and pharmacodynamics of repeat dosing of an anti-LAG3 cell depleting monoclonal antibody (GSK2831781) in patients with active ulcerative colitisUlcerative colitisinflamatory bowel disease10017969NL-OMON49796GlaxoSmithKline3
已完成
2 期
A phase IIa, placebo-controlled, double blind, randomised multicentre pilot study to investigate the efficacy, safety and tolerability of the monoclonal antibody ATH3G10 in patients with ST-elevation myocardial infarctioNL-OMON48214Athera Biotechnologies AB16