Role of Uromodulin in Management of Multiple Myloma

NCT06876298 | Not Yet Recruiting

• 1 other identifier: multiple myloma
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Multiple Myloma

Keywords

uromodulin

Outcome Measures

Primary Outcomes (1)

• 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.

  1 year

Secondary Outcomes (1)

• To detect correlation between serum uromodulin level and risk stratification, staging and prognosis of newly diagnosed patients with multiple myeloma.

  1 year

Study Arms (1)

patients that newly diagnosed multiple myeloma with and without renal impairment

OTHER

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.

Interventions

- 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. 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.

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

patients that newly diagnosed multiple myeloma with and without renal impairment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut University

Asyut, Eygpt, 71525, Egypt

Location

Related Publications (11)

• Levey AS, Stevens LA, Schmid CH, Zhang YL, Castro AF 3rd, Feldman HI, Kusek JW, Eggers P, Van Lente F, Greene T, Coresh J; CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration). A new equation to estimate glomerular filtration rate. Ann Intern Med. 2009 May 5;150(9):604-12. doi: 10.7326/0003-4819-150-9-200905050-00006.

  PMID: 19414839 BACKGROUND

• Rajkumar SV. Multiple myeloma: 2024 update on diagnosis, risk-stratification, and management. Am J Hematol. 2024 Sep;99(9):1802-1824. doi: 10.1002/ajh.27422. Epub 2024 Jun 28.

  PMID: 38943315 BACKGROUND

• Kipp A, Olinger E. What Does Uromodulin Do? Clin J Am Soc Nephrol. 2020 Dec 31;16(1):150-153. doi: 10.2215/CJN.06390420. Epub 2020 Aug 24. No abstract available.

  PMID: 32839194 BACKGROUND

• Pruijm M, Ponte B, Ackermann D, Paccaud F, Guessous I, Ehret G, Pechere-Bertschi A, Vogt B, Mohaupt MG, Martin PY, Youhanna SC, Nagele N, Vollenweider P, Waeber G, Burnier M, Devuyst O, Bochud M. Associations of Urinary Uromodulin with Clinical Characteristics and Markers of Tubular Function in the General Population. Clin J Am Soc Nephrol. 2016 Jan 7;11(1):70-80. doi: 10.2215/CJN.04230415. Epub 2015 Dec 18.

  PMID: 26683888 BACKGROUND

• LaFavers KA, Micanovic R, Sabo AR, Maghak LA, El-Achkar TM. Evolving Concepts in Uromodulin Biology, Physiology, and Its Role in Disease: a Tale of Two Forms. Hypertension. 2022 Nov;79(11):2409-2418. doi: 10.1161/HYPERTENSIONAHA.122.18567. Epub 2022 Aug 12.

  PMID: 35959659 BACKGROUND

• Rusing LZ, Kozakowski N, Jeryczynski G, Vospernik L, Riedl J, Reiter T, Gisslinger H, Agis H, Krauth MT. Renal outcome in multiple myeloma patients with cast nephropathy: a retrospective analysis of potential predictive values on clinical and renal outcome. Hematology. 2024 Dec;29(1):2311600. doi: 10.1080/16078454.2024.2311600. Epub 2024 Feb 8.

  PMID: 38329272 BACKGROUND

• Dimopoulos MA, Merlini G, Bridoux F, Leung N, Mikhael J, Harrison SJ, Kastritis E, Garderet L, Gozzetti A, van de Donk NWCJ, Weisel KC, Badros AZ, Beksac M, Hillengass J, Mohty M, Ho PJ, Ntanasis-Stathopoulos I, Mateos MV, Richardson P, Blade J, Moreau P, San-Miguel J, Munshi N, Rajkumar SV, Durie BGM, Ludwig H, Terpos E; International Myeloma Working Group. Management of multiple myeloma-related renal impairment: recommendations from the International Myeloma Working Group. Lancet Oncol. 2023 Jul;24(7):e293-e311. doi: 10.1016/S1470-2045(23)00223-1.

  PMID: 37414019 BACKGROUND

• Fermand JP, Bridoux F, Dispenzieri A, Jaccard A, Kyle RA, Leung N, Merlini G. Monoclonal gammopathy of clinical significance: a novel concept with therapeutic implications. Blood. 2018 Oct 4;132(14):1478-1485. doi: 10.1182/blood-2018-04-839480. Epub 2018 Jul 16.

  PMID: 30012636 BACKGROUND

• He J, Schmerold L, Van Rampelbergh R, Qiu L, Potluri R, Dasgupta A, Li L, Li Y, Hu P, Nemat S, Smugar SS, Zeltzer P, Appiani C, Li Q, Mehra M, Richarz U. Treatment Pattern and Outcomes in Newly Diagnosed Multiple Myeloma Patients Who Did Not Receive Autologous Stem Cell Transplantation: A Real-World Observational Study : Treatment pattern and outcomes in patients with multiple myeloma. Adv Ther. 2021 Jan;38(1):640-659. doi: 10.1007/s12325-020-01546-0. Epub 2020 Nov 19.

  PMID: 33211297 BACKGROUND

• Sperling AS, Anderson KC. Facts and Hopes in Multiple Myeloma Immunotherapy. Clin Cancer Res. 2021 Aug 15;27(16):4468-4477. doi: 10.1158/1078-0432.CCR-20-3600. Epub 2021 Mar 26.

  PMID: 33771856 BACKGROUND

• Rajkumar SV. Multiple myeloma: Every year a new standard? Hematol Oncol. 2019 Jun;37 Suppl 1(Suppl 1):62-65. doi: 10.1002/hon.2586.

  PMID: 31187526 BACKGROUND

Central Study Contacts

Usra Mohamed Farrag Ahmed farrag Usra Mohamed Farrag Ahmed, assistant lecturer

CONTACT

002- 01013460518; usramohamed24@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Usra Mohamed farrag Ahmed

Study Record Dates

• First Submitted: March 2, 2025
• First Posted: March 14, 2025
• Study Start: March 25, 2025
• Primary Completion (Estimated): March 25, 2027
• Study Completion (Estimated): March 25, 2027
• Last Updated: March 14, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)