Role of Uromodulin in Management of Multiple Myloma

Assiut University

Status: Not yet enrolling

Conditions: Multiple Myloma

Treatments: 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.

Study type: Interventional

Funder types: Other

Identifiers

NCT06876298

multiple myloma

Details and patient eligibility

About

• To Evaluate the role of uromodulin level in early diagnosis of cast nephropathy and to detect its prognostic value in multiple myeloma patients

Full description

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult patients ≥ 18 years old that newly diagnosed with multiple myeloma according to 2024 updates in diagnosis of multiple myeloma (10) with and without renal impairment at nephrology and haematology unit of internal medicine department.

Exclusion criteria

• any patient have evidence of renal impairment due to any cause other than multiple myeloma as diabetic nephropathy, hypertensive nephropathy or lupus nephritis ... etc.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

patients that newly diagnosed multiple myeloma with and without renal impairment

Other group

Description:

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.

Treatment:

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.