NL-OMON48856招募中2 期
Anakinra: safety and efficacy of interleukin-1 pathway inhibitor anakinra for the management of fever during neutropenia and mucositis in patients with multiple myeloma receiving an autologous hematopoietic stem cell transplantation after high-dose melphalan - A randomized controlled trial - HEMSC42 / AFFECT-2
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 90
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
- •- Aged >=18 years
- •- Diagnosed with multiple myeloma
- •- Scheduled to receive an autologous SCT after myeloablative therapy with high-dose melphalan
- •- Managed with a central venous catheter (triple- or quadruple lumen)
- •- Is able and willing to participate
- •- Has provided written informed consent
- •- Has negative serology for active hepatitis B and C
- •- Has negative serology for HIV
- •- Has no known hypersensitivity to Escherichia coli derived products or any components of anakinra
- •- Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation (during treatment with study medication), and for 30 days after the last dose.
排除标准
- •- Inability to understand the nature and extent of the trial and the procedures required
- •- Enrolment in any other investigational treatment study or use of an investigational agent during the stem cell transplantation (this means studies in multiple myeloma regarding induction or maintenance treatment are permitted).
- •- Women who are pregnant or nursing
- •- Diagnosed with amyloidosis or light-chain deposition disease
- •- ALT or AST greater than 2.0 x upper limit of normal (ULN) of the local laboratories values.
- •- Bilirubin levels greater than 2.0 x upper limit of normal (ULN) of the local laboratories values, except for benign non-malignant indirect hyperbilirubinemia such as Gilbert syndrome
- •- Impaired renal function with eGFR <40 ml/min
- •- Received a live vaccine during the 3 months prior to baseline visit
- •- Recent use of IL-1 antagonist, such as anakinra, rilonacept or canakinumab, within three months prior to baseline visit
- •- Treatment with TNFa inhibiting agents (such as etanercept, adalimumab, infliximab, certolizumab and golimumab).
- •- Uncontrolled bacterial or viral infections, or fungal infections, at the start of therapy
- •- Documented colonization with methicillin-resistant Staphylococcus aureus (MRSA), carbapenemase-producing Enterobacteriaceae (CPE) or vancomycin-resistant enterococci (VRE) prior to registration
- •- Gram-negative colonization resistant to prophylaxis with ciprofloxacin or colistin/cotrimoxazole
- •- Subjects who are not able to receive antibacterial prophylaxis with ciprofloxacin or colistin/cotrimoxazole (because of hypersensitivity or drug interactions)
- •- Subjects with an active solid malignancy prior to registration, with the exception of cutaneous basal or squamous cell carcinomas
- •- History of mycobacterial infection.
- •- Subjects with intrinsic disorders of the gastro-intestinal (GI) tract, including, but not limited to: Crohn*s disease, ulcerative colitis, celiac disease, short bowel syndrome.
- •- Subject has any concurrent medical or psychiatric condition or disease that is likely to interfere with the study procedures or results, or that in the opinion of the investigator, would constitute a hazard for participating in this study.
研究者
相似试验
进行中（未招募）
1 期
Anakinra as prevention of fever and mucositis in patients with a stem cell transplantatioFebrile neutropenia and mucositisMedDRA version: 20.0Level: LLTClassification code 10028127Term: MucositisSystem Organ Class: 100000004867MedDRA version: 20.0Level: PTClassification code 10016288Term: Febrile neutropeniaSystem Organ Class: 10005329 - Blood and lymphatic system disordersEUCTR2018-005046-10-NLRadboud university medical center90
进行中（未招募）
1 期
Anakinra as prevention of mucositis and fever in patients with a stem cell transplantatioMucositis and febrile neutropeniaMedDRA version: 19.0Level: LLTClassification code 10028127Term: MucositisSystem Organ Class: 100000004867MedDRA version: 19.0Level: PTClassification code 10016288Term: Febrile neutropeniaSystem Organ Class: 10005329 - Blood and lymphatic system disordersEUCTR2016-004419-11-NLRadboud university medical center18
已完成
2 期
Safety and efficacy of interleukin-1 inhibitor anakinra for the amelioration of fever during neutropenia and mucositis in patients with multiple myeloma receiving an autologous hematopoietic stem cell transplantation after high-dose melphalaand fever during neutropenia)mucositis and febrile neutropenia(inflammation of the lining of the digestive system100188651001796910005908NL-OMON43066Radboud Universitair Medisch Centrum18
已完成
不适用
Effect of anakinra (soluble interleukin-1 receptor antagonist) as combination therapy: second UK combination therapy in early rheumatoid arthritisMusculoskeletal DiseasesRheumatoid arthritisISRCTN15819795King's College London (UK)158
进行中（未招募）
不适用
Anakinra to treat a gout attackEUCTR2014-000173-39-NLJan van Breemen Research Institute Reade and VU University Medical Centre