跳至主要内容
临床试验/NCT05093153
NCT05093153招募中不适用

Spanish Registry of Patients With Diagnosis of IgM-MGUS, Asymptomatic & Symptomatic Waldenström Macroglobulinemia. Analysis of Clinical and Laboratory Features, Treatment and Outcomes.

Fundación Española de Hematología y Hemoterapía51 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2021年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
1,000
试验地点
51
主要终点
Overall survival

研究概览

简要总结

Waldenström's macroglobulinemia (WM) is a B-cell lymphoproliferative disorder which is defined by bone marrow infiltration by small lymphocytes, lymphoplasmacytoid and plasma cells together with the presence of a detectable monoclonal immunoglobulin M (IgM).The clinical presentation of WM is variable. Symptoms can be related to tumor infiltration, or they can be related to the monoclonal IgM component. The therapeutic options are heterogeneous and there are no well-established in both first line or relapse/refractory settings. In Spain, the incidence of MGUS-IgM and WM in the last decade is unknown.

The aims of this retrospective, observational, multicentric study is:

  • To develop a national registry of patients diagnosed with Waldenström's Macroglobulinemia and Monoclonal Gammopathy of uncertain significance -IgM in Spain in the past 30years.
  • To evaluate the most relevant clinical characteristics, long-term safety and efficacy of different therapeutic schemes and long-term prognosis of patients with WM
  • To help in the design of future therapeutic strategies, risk prognostic factors and clinical trials in Spain.

Methods:

The investigators will collect data from the patient clinical files after prior Informed Consent providing from patients with diagnosis of MGUS-IgM and WM in the past 30 years in Spain, according to the WHO classification of lymphoid tumors (2008) revised in 2016. Data from patients not able to provide IC (i.e., already dead patients) will be included only after the permission of the ethics review board.

The collected data will be included in a database of the Spanish Myeloma and Lymphoma Intergroup (SMALI) team created ad-hoc by the Spanish Society of Hematology and Hemotherapy (SEHH). Each principal investigator in each center will conduct their technical supervision. The evaluation of the treatment protocols will be done following the indications of the intergroup committee according to the guidelines of the International Waldenström's Macroglobulinemia Group.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Other

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age ≥18 years
  • Patients having a confirmed diagnosis of either in the las 30 years:
  • Monoclonal Gammopathy of uncertain significance -IgM
  • Asymptomatic Waldenström's macroglobulinemia
  • Symptomatic Waldenström's macroglobulinemia

排除标准

  • Other subtypes of Lymphoproliferative diseases.

研究组 & 干预措施

Waldenström's macroglobulinemia cohort patient

Adult patients diagnosed with Waldenström's Macroglobulinemia

结局指标

主要结局

Overall survival

时间窗: through study completion, an average of 4 years

Overall survival evaluation from the date of diagnosis to the death of the patient due to any cause

次要结局

未报告次要终点

研究者

发起方
Fundación Española de Hematología y Hemoterapía
申办方类型
Other
责任方
Sponsor

研究点 (51)

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