Multiple MylomaNCT06876298
Role of Uromodulin in Management of Multiple Myloma
A study testing - 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 people with Multiple Myloma, run by Assiut University at 1 site in Egypt.
Trial summary
To Evaluate the role of uromodulin level in early diagnosis of cast nephropathy and to detect its prognostic value in multiple myeloma patients Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myloma
- What is being tested?
- - 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.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 25 Mar 2025to 25 Mar 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Usra Mohamed Farrag Ahmed farrag Usra Mohamed Farrag Ahmed, assistant lecturer contact
Egypt1 site
Assiut University
Asyut, Eygpt, 71525
assuit university medicine assuit university,faculty of medicine, 0882411900 ext. 01020462809, med@aun.edu.eg
Usra Mohamed Farrag Ahmed farrag Usra Mohamed Farrag Ahmed, master degree
About this study
- To Evaluate the role of uromodulin level in early diagnosis of cast nephropathy and to detect its prognostic value in multiple myeloma patients
Read the 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.
- Conditions
- Multiple Myloma
- Being tested
- - 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.
- Keywords
- uromodulin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
- 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
Also called • 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
- 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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2025
- Study start25 Mar 2025 (estimated)
- Primary completion25 Mar 2027 (estimated)
- Study completion25 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Multiple MylomaStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Usra Mohamed Farag, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06876298
- Sponsor's protocol ID
- multiple myloma
- Status last verified
- Mar 2025
- First submitted
- 2 Mar 2025
- Last updated
- 14 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 19414839Rajkumar 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.
PubMed 38943315Kipp 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.
PubMed 32839194Pruijm 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.
PubMed 26683888LaFavers 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.
PubMed 35959659Rusing 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.
PubMed 38329272Dimopoulos 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.
PubMed 37414019Fermand 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.
PubMed 30012636He 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.
PubMed 33211297Sperling 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.
PubMed 33771856Rajkumar SV. Multiple myeloma: Every year a new standard? Hematol Oncol. 2019 Jun;37 Suppl 1(Suppl 1):62-65. doi: 10.1002/hon.2586.
PubMed 31187526