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临床试验/NCT05439538
NCT05439538尚未招募不适用

Serum Neutrophil Gelatinase-associated Lipocalin (NGAL) as a Predictor of Renal Injury in Patients With Multiple Myeloma

Assiut University0 个研究点目标入组 60 人开始时间: 2022年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
60
主要终点
serum Neutrophil Gelatinase-associated Lipocalin in patients with multiple myeloma

研究概览

简要总结

The aim of this study was to evaluate SERUM neutrophil gelatinase-associated lipocalin, emerging indicator of tubular damage and examine their relationship with established measures of renal function (serum creatinine, and estimated glomerular filtration rate, eGFR) among MM patients with and without renal impairment (RI), and at various stages of MM progression.

详细描述

Multiple myeloma (MM), Being one of the most common hematologic malignancies, particularly in the elderly patient, MM represents a devastating disease that occurs due to uncontrolled proliferation of a plasma cell in bone marrow , MM Presents itself with characteristic features of organ involvement: bone lesions, anemia, renal insufficiency, infections, hypercalcemia and specific malignancy biomarkers (plasma cell clonality ≥60%, involved to uninvolved serum free light chains (FLCs) ≥100 and >1 focal lesion on magnetic resonance imaging) . Additionally , Evidence of clonal plasma cell percentage of ≥10% in bone marrow or biopsy-proven plasmacytoma is necessary to define a case of MM .

MM is the second most commonly diagnosed hematological neoplasm, with an incidence rate of 5.3 per 100 000 individuals ,its incidence in Egypt 1.5 per 100 000 individuals Early mortality may not only be associated with disease progression, but also with concomitant organ involvement (i.e., renal failure) and therapy side-effects (i.e., infections) .

Production of monoclonal paraproteins, immunoglobulins (MIg) or free light chains (FLCs), is a characteristic feature of myeloma that is tied to its clinical manifestations,Although non-functional, paraproteins may be produced in excess, which alongside their physicochemical properties may precipitate the formation of lesions in vasculature and variably affect organ function. Owing to the differences between individual clones and associated MIg, kidney pathology is highly heterogeneous, with renal tubular injury associated with light chain cast nephropathy as the dominant presentation .

Renal impairment (RI) is one of the most common complications of symptomatic MM(close to one fourth of patients at the time of diagnosis). RI, defined as a serum creatinine (sCr) level > 2 mg/dL, is one of the diagnostic criteria of symptomatic MM, and it constitutes 1 of the 4 "CRAB" features (calcium level elevation, renal impairment, anemia, and bone lesions) that indicate myeloma-related organ dysfunction .. RI can carry a poor prognosis, particularly if renal function does not recover , Irreversible renal failure is less frequent, but may be present in up to 8% of patients .

The use of novel antimyeloma agents such as proteasome inhibitors (PIs) and immunomodulatory drugs (IMiDs) as well as the improvement in supportive care has resulted in a substantial increase in patient survival. However, RI reversibility is still closely associated with MM prognosis. The persistence of severe RI is associated with significant morbidity and mortality, and remains one of the factors associated with early death, Effective anti-MM therapy and supportive care can restore renal function in several patients, Therefore, earlier recognition of disease, including its end-organ manifestations, is necessary for timely initiation and optimization of therapy but we lack biomarkers that could predict renal outcomes . Renal insufficiency is considered reversible in about 50% of cases in some reports .

研究设计

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

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult patients (>18 years) with SMM or overt multiple myeloma (MM will be confirmed based on the WHO diagnostic criteria; the presence of at least 10% plasma cells in bone marrow biopsies, presence of momoclonal protein in serum and /or urine and one of the following disorders (CRAB): hypercalcemia, renal failure, anemia, or lytic bone lesions).

排除标准

  • ( other causes affect NAGAL level )
  • Patients with other plasma cell disorders (eg. Waldenstrom macroglobulinuria, MGUS, amyloidosis )
  • Recent active infection;
  • History of hepatitis B, C, or HIV
  • Neoplasms other than myeloma

结局指标

主要结局

serum Neutrophil Gelatinase-associated Lipocalin in patients with multiple myeloma

时间窗: baseline to 3 months

Role of serum Neutrophil Gelatinase-associated Lipocalin in early detection of renal impairment in patients with multiple myeloma

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ehab A. Abdelmenam

Principal Investigator

Assiut University

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