Role of Uromodulin in Management of Multiple Myloma

March 12, 2025 updated by: Usra Mohamed Farag, Assiut University
• To Evaluate the role of uromodulin level in early diagnosis of cast nephropathy and to detect its prognostic value in multiple myeloma patients

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Usra Mohamed Farrag Ahmed farrag Usra Mohamed Farrag Ahmed, assistant lecturer
  • Phone Number: 002- 010134605 002- 01013460518
  • Email: usramohamed24@gmail.com

Study Locations

  • Egypt
    • Eygpt
      • Assiut, Eygpt, Egypt, 71525
        • Assiut University
        • Contact:
          • assuit university medicine assuit university,faculty of medicine
          • Phone Number: 01020462809 0882411900
          • Email: med@aun.edu.eg
        • Contact:
          • Usra Mohamed Farrag Ahmed farrag Usra Mohamed Farrag Ahmed, master degree
        • Contact:
          • Mohsen Mohammed Hussein El Kossi hussein Mohsen Mohammed Hussein El Kossi, professor
        • Contact:
          • Maha Mohammed Abdel-Aziz Abdel-Aziz Maha Mohammed Abdel-Aziz, lecturer

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: patients that newly diagnosed multiple myeloma with and without renal impairment

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.
Other Names:
  • • 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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..
Time Frame: 1 year
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.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To detect correlation between serum uromodulin level and risk stratification, staging and prognosis of newly diagnosed patients with multiple myeloma.
Time Frame: 1 year
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.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 25, 2025

Primary Completion (Estimated)

March 25, 2027

Study Completion (Estimated)

March 25, 2027

Study Registration Dates

First Submitted

March 2, 2025

First Submitted That Met QC Criteria

March 12, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 12, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • multiple myloma

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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