An interventional study of - Serum Uromodulin level quantitative test by ELISA technique at day 0, day 21 of 1st cycle and at the end of 2nd cycle of bortezomib based protocol of chemotherapy. in Multiple Myloma, sponsored by Assiut University. Not yet recruiting at 1 site in Egypt. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-03-14.
Sponsored by Assiut University · Not applicable, Interventional, and Diagnostic
Multiple myeloma (MM) is a malignant plasma cell disorder . It is the second most common hematologic malignancy worldwide . It accounts for 15%-20% of all hematologic malignancies and has a 5-year survival rate of 60% .
About 31% of newly diagnosed MM patients presented with renal impairment and about 6% to 13% need dialysis , which significantly increases morbidity and mortality, and limits treatment strategies . Most common renal disease in MM is myeloma cast nephropathy that derived from secreted free light chains that combined with uromodulin to form cast which obstructs the distal tubules and presented with severe acute kidney injury . Renal biopsy is the only method to accurately diagnose myeloma cast nephropathy.
Uromodulin, also known as Tamm-Horsfall protein, is a kidney specific glycoprotein which is produced only by the epithelial cells lining the thick ascending limb (85%-90%) and early distal convoluted tubule (10%-15%), and is released to urine and blood . About 200 mg/day of uromodulin is normally excreted in urine . Recently, uromodulin being involved in many pathological processes as hypertension, urinary tract infections, nephrolithiasis, chronic and acute kidney disease.
Limited is known about role of uromodulin in management of myeloma. Measurement of serum uromodulin in patients that newly diagnosed multiple myeloma with and without renal impairment and follow up these patients for 1 year may provide a useful non-invasive predictor of cast nephropathy and may has a prognostic value in myeloma.
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Exclusion Criteria:
Measurement of serum uromodulin in patients that newly diagnosed multiple myeloma with and without renal impairment and follow up these patients for 1 year. * All patients will be included within certain inclusion criteria after written consent will be subjected to; * Full medical history and clinical examination * Imaging: * abdominal ultrasound. * bone scan or low dose CT for lytic lesions. * Laboratory tests: * complete blood count with blood film * serum creatinine and urea and estimated GFR according to CKD-EPI * urine analysis * C-reactive protein (CRP) * serum calcium * serum total proteins and serum albumin * serum uric acid * 24 hours urinary protein. * Urine and\\or protein electrophoresis with Immunofixation. * Serum Free light chains * Beta 2 microglobulin. * LDH * Serum Uromodulin level quantitative test by ELISA technique at day 0, day 21 of 1st cycle and at the end of 2nd cycle of bortezomib based protocol of chemotherapy. * Renal biopsy if indicated.
Diagnostic Test: - Serum Uromodulin level quantitative test by ELISA technique at day 0, day 21 of 1st cycle and at the end of 2nd cycle of bortezomib based protocol of chemotherapy.
- Serum Uromodulin level quantitative test by ELISA technique at day 0, day 21 of 1st cycle and at the end of 2nd cycle of bortezomib based protocol of chemotherapy.
Also known as: • All patients will be included within certain inclusion criteria after written consent will be subjected to; • Full medical history and clinical examination • Imaging: - abdominal ultrasound. - bone
To assess the predictive value of serum uromodulin level in newly diagnosed patients with multiple myeloma with and without renal impairment as non-invasive marker for myeloma cast nephropathy..
measurement of serum uromodulin level by ELISA technique in newly diagnosed patients with multiple myeloma with and without renal impairment at 3 times during course Bortizomib based chemotherapy to assess if serum uromodulin level is higher in patients with multiple myloma and renal impairment than in those without renal impairment and to detect the most accurate time to measure serum uromodulin during the treatment course.
Time frame: 1 year
To detect correlation between serum uromodulin level and risk stratification, staging and prognosis of newly diagnosed patients with multiple myeloma.
To detect the correlation between serum uromodulin level and risk stratification, staging and prognosis of newly diagnosed patients with multiple myelom during follow up of these patients for 1 year.
Time frame: 1 year
Plan to share: No
This study is not yet recruiting, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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Assiut University