Evaluation of the Impact of the Update Multiple Myeloma Criteria on the Natural History of Smoldering Myeloma in Order to Establish New Recommendations About Follow-up and Prognostic Evaluation of Smoldering Myeloma (CARRISMM)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 395
- 试验地点
- 96
- 主要终点
- Assess the annual risk estimated at 2 years of progression from SMM to MM
研究概览
简要总结
This study is a prospective open label interventional multicenter study evaluating the impact of the update multiple myeloma criteria on the natural history of smoldering myeloma in order to establish new recommendations about follow up and prognostic evaluation of smoldering myeloma.
详细描述
In 2014, the International Myeloma Working Group (IMWG) proposed a revised classification of multiple myeloma (MM) and smoldering myeloma (SMM). Since the new definition of SMM proposed excludes "ultra-high risk SMM", the evolution profile of SMM will change. Therefore, investigators need to update their knowledge of SMM to optimize the management of patients. This project is expected to describe more precisely the new landscape of SMM.
The results will help to establish new recommendations for the standard care of SMM and especially for defining accurate follow-up and risk stratifying.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years.
- •SMM defined by IMWG 2014 criteria
- •Serum monoclonal protein (IgG or IgA) ≥30 g/L and/or urinary monoclonal protein ≥500 mg per 24 h and/or clonal bone marrow plasma cells 10-60%
- •Absence of myeloma defining events or amyloidosis
- •Diagnosed less than 1 year before the inclusion
- •Able and willing to give valid written informed consent. Patients must give written informed consent (IC) in accordance with institutional and local guidelines.
排除标准
- •Previous antimyeloma treatment including bisphosphonates
- •Second Primary Malignancy and/or auto-immune disease treated by immunosuppressive drugs.
- •Evidence of end organ damage that can be attributed to the underlying SMM:
- •Hypercalcaemia: serum calcium >0.25 mmol/L (>10 mg/L) higher than the upper limit of normal or >2.75 mmol/L (>110 mg/L)
- •Renal insufficiency: creatinine clearance <40 mL/min or serum creatinine >177 μmol/L (>20 mg/L)
- •Anaemia: haemoglobin value of >2 g/dL below the lower limit of normal, or a haemoglobin value <10 g/dL
- •Bone lesions: one or more osteolytic lesions on skeletal radiography, CT, or Positron Emission Tomography-Computed Tomography (PET-CT)
- •Presence of one of the following biomarkers of malignancy:
- •Clonal bone marrow plasmocytosis ≥60%
- •Involved/uninvolved serum Free Light Chain (FLC) ratio ≥ 100 (The involved free light chain must be ≥100 mg/L)
- •Presence of one or more focal lesions on MRI studies (each focal lesion must be 5 mm or more in size)
- •History of malignancy other than SMM within 3 years before inclusion
- •Amyloidosis
- •POEMS syndrome
- •Contraindication to MRI
- •Pregnancy
- •Nursing mother
- •Legally protected adults (under judicial protection, guardianship, or supervision)
结局指标
主要结局
Assess the annual risk estimated at 2 years of progression from SMM to MM
时间窗: 2 years
Progression to MM will be defined, according to IMWG 2014 revised classification, by the apparition of one or more myeloma defining events: * Evidence of end organ damage that can be attributed to the underlying MM (CRAB criteria) * Presence of one of the following biomarkers of malignancy (new criteria of MM introduced in 2014 IMWG recommendations)
次要结局
- Assess the risk of progression to MM evaluating biological factors(5 years)
- Assess the risk of progression to MM evaluating radiological markers(5 years)
- Describe the clonal and sub-clonal evolution of SMM(5 years)
- Describe annual risk of progression from SMM to MM at 5 years(5 years)