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临床试验/NCT06457464
NCT06457464尚未招募不适用

Clinical Outcomes and Prognostic Factors in Patients With Multiple Myeloma in Assuit University Hospitals ( Prospective and Retrospective Study)

Assiut University0 个研究点目标入组 100 人开始时间: 2024年7月1日最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
尚未招募
入组人数
100
主要终点
variety of drugs used and their responses, and pateints

研究概览

简要总结

  1. Description of the demographic, clinical, and laboratory characteristics of patients with MM admitted to the hematology unit of Assuit University Hospitals.
  2. Determination of treatment outcomes and prognostic factors associated with survival rates.

详细描述

Multiple Myeloma MM (plasma cell myeloma) represents a malignant proliferation of plasma cells derived from B cells. Its median age of diagnosis is 52-61 years but is less common under 40 years. Males are affected more than females.

Diagnostic criteria for Multiple Myeloma:

  1. Clonal bone marrow plasma cells or biopsy-proven bony or extramedullary plasmacytoma and any one of the following myeloma-defining events.
  2. Evidence of one or more end-organ damage that can be attributed to the underlying plasma cell proliferative disorder specifically:
  • Hypercalcemia: serum calcium > 0.25mmol/l(>1 mg /dl) higher than the upper limit of normal or > 2.75mmol/l (>11mg/dl).

  • Renal insufficiency: creatinine clearance <40 ml per min or serum creatinine >177 µmol (>2 mg/dl) .

  • Anaemia : (hemoglobin value of < 10g/dl or hemoglobin > 2g/dl below the lower limit of normal

  • Bone lesions: one or more osteolytic lesions on skeletal radiography, CT or PET CT ∙ Any one or more of the following biomarkers of malignancy:

  • Clonal bone marrow plasma cells percentage > 60 %.

  • Involved: uninvolved serum-free light chain ratio ≥100.

  • >1 focal lesion on MRI studies. It causes many organ dysfunctions and symptoms such as renal failure, bony pains or fractures, anemia, susceptibility to infection, hypercalcemia, neurologic symptoms, and manifestation of hyperviscosity. It is characterized by the development of osteolytic lesions in the bone and involves the activation of osteoclasts with simultaneous suppression of new bone formation of osteoblast inhibition Bone pain is the most common symptom. Other presentations are anemia, hypercalcemia, renal failure, weight loss. Rare features are cord compression and CNS involvement.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

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

  • Patients ≥ 18 years old diagnostic as MM with Eastern Cooperative Oncology Group performance status(ECOG) Performance Status (0-2)

排除标准

  • Patients with poor performing status unfit to receive chemotherapy with ECOG PS > 2

结局指标

主要结局

variety of drugs used and their responses, and pateints

时间窗: baseline

examine the current state of multiple myeloma management, including the variety of drugs used and their effectiveness, as well as the outcomes for patients undergoing autologous stem cell transplantation (ASCT).

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

Amira Hassan Hassan Bakr

Doctor

Assiut University

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