NCT03089411Unknown不适用
Collection of Additional Data Followed the Study "A Phase III Study of Velcade (Bortezomib) Thalidomide Dexaméthasone (VTD) Versus Velcade (Bortezomib) Cyclophosphamide Dexaméthasone (VCD) as an Induction Treatment Prior to Autologous Stem Cell Transplantation in Patients With Newly Diagnosed Multiple Myeloma"
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 340
- 试验地点
- 62
- 主要终点
- Number of death
研究概览
简要总结
Collection of retrospective additional data (survival, biological, disease response data) following the study IFM 2013-04.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 66 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Asymptomatic Multiple myeloma
- •Non-secretory Multiple myeloma
- •Proven AL-amyloidosis
- •Age ≥ 66 years old
- •Prior or current systemic therapy for Multiple myeloma, including steroids (except for emergency use of a 4-day block of dexamethasone before randomization, maximum total dose allowed 160 mg)
- •Radiation therapy in the 2 weeks preceding randomization
- •National Cancer Institute grade ≥ 2 peripheral neuropathy
- •Haemoglobin < 8g/dL
- •Absolute neutrophil count < 1,000 cells / µL, platelet count < 50,000 cells / µL
- •Creatinine level > 170 µmol/L or requiring dialysis.
- •Bilirubin, transaminases or GamaGT > 3 UNL (upper normal limit)
- •Positive HIV serology, evidence of active Hepatitis B and C infection
- •Severe active infection
- •Inability to comply with an anti-thrombotic treatment regimen
- •A personal medical history of severe psychiatric disease
- •Uncontrolled diabetes contraindicating the use of high-dose dexamethasone
- •Non-controlled or severe cardiovascular disease (including a myocardial infarction in the 6 months prior to recruitment)
- •A personal medical history of cancer unless the patient has been without relapse after treatment discontinuation > or = 5 years (except for basocellular skin cancer or in situ cervical cancer)
- •Use of any investigational drug in the 30 days preceding randomization 22 - Pregnant or lactating women. 23 - Adults under juridical protection 24 - Known or suspected hypersensitivity to any of the study therapies or excipients 25 - Necessity of vaccination for yellow fever or with any other live vaccines
结局指标
主要结局
Number of death
时间窗: 6 months
To evaluate Overall and Progression-Free Survival
次要结局
未报告次要终点
研究者
研究点 (62)
Loading locations...
相似试验
已完成
不适用
Additional Post Hoc Analysis and Clinical Data CollectionNeurological ObservationsNCT02860416ElMindA Ltd55
已完成
不适用
Follow-Up Study of Patients Previously Treated With Pimecrolimus Tablets for Chronic Plaque-Type PsoriasisPsoriasisNCT00098189Novartis
已完成
不适用
Follow-Up Study of Patients Previously Treated With Pimecrolimus Tablets for Atopic DermatitisAtopic DermatitisNCT00098150Novartis66
已完成
不适用
Post-Market Clinical Follow Up Study to Collect Additional Data and ImagingConnective Tissue DefectNCT04880070Cynosure, Inc.5
已完成
不适用
Cohort Follow-up: Progression and Consequences of Chronic Kidney Disease.Chronic Renal DiseasesRenal Function DisorderNCT04070885University Hospital, Bordeaux210