Serum NGAL IN Patients With Multiple Myeloma
Serum Neutrophil Gelatinase-associated Lipocalin (NGAL) as a Predictor of Renal Injury in Patients With Multiple Myeloma
1 other identifier
observational
60
0 countries
N/A
Brief Summary
The aim of this study was to evaluate SERUM neutrophil gelatinase-associated lipocalin, emerging indicator of tubular damage and examine their relationship with established measures of renal function (serum creatinine, and estimated glomerular filtration rate, eGFR) among MM patients with and without renal impairment (RI), and at various stages of MM progression.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Oct 2022
Typical duration for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 23, 2022
CompletedFirst Posted
Study publicly available on registry
June 30, 2022
CompletedStudy Start
First participant enrolled
October 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2025
CompletedJune 30, 2022
June 1, 2022
2 years
June 23, 2022
June 26, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
serum Neutrophil Gelatinase-associated Lipocalin in patients with multiple myeloma
Role of serum Neutrophil Gelatinase-associated Lipocalin in early detection of renal impairment in patients with multiple myeloma
baseline to 3 months
Interventions
Study the sensitivity and the specificity of serum NGAL to detect AKI in myeloma
Eligibility Criteria
Patients will be recruited during admission and visits to Clinical Hematology Unit and outpatients clinic, Assiut university hospital, from October 2022 to October 2023. Sample size is 60 patients diagnosed MM with or without renal impairment
You may qualify if:
- Adult patients (\>18 years) with SMM or overt multiple myeloma (MM will be confirmed based on the WHO diagnostic criteria; the presence of at least 10% plasma cells in bone marrow biopsies, presence of momoclonal protein in serum and /or urine and one of the following disorders (CRAB): hypercalcemia, renal failure, anemia, or lytic bone lesions).
You may not qualify if:
- ( other causes affect NAGAL level )
- Patients with other plasma cell disorders (eg. Waldenstrom macroglobulinuria, MGUS, amyloidosis )
- Recent active infection;
- History of hepatitis B, C, or HIV
- Neoplasms other than myeloma
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (8)
Turesson I, Bjorkholm M, Blimark CH, Kristinsson S, Velez R, Landgren O. Rapidly changing myeloma epidemiology in the general population: Increased incidence, older patients, and longer survival. Eur J Haematol. 2018 Apr 20:10.1111/ejh.13083. doi: 10.1111/ejh.13083. Online ahead of print.
PMID: 29676004BACKGROUNDRajkumar SV, Dimopoulos MA, Palumbo A, Blade J, Merlini G, Mateos MV, Kumar S, Hillengass J, Kastritis E, Richardson P, Landgren O, Paiva B, Dispenzieri A, Weiss B, LeLeu X, Zweegman S, Lonial S, Rosinol L, Zamagni E, Jagannath S, Sezer O, Kristinsson SY, Caers J, Usmani SZ, Lahuerta JJ, Johnsen HE, Beksac M, Cavo M, Goldschmidt H, Terpos E, Kyle RA, Anderson KC, Durie BG, Miguel JF. International Myeloma Working Group updated criteria for the diagnosis of multiple myeloma. Lancet Oncol. 2014 Nov;15(12):e538-48. doi: 10.1016/S1470-2045(14)70442-5. Epub 2014 Oct 26.
PMID: 25439696BACKGROUNDLudwig H, Novis Durie S, Meckl A, Hinke A, Durie B. Multiple Myeloma Incidence and Mortality Around the Globe; Interrelations Between Health Access and Quality, Economic Resources, and Patient Empowerment. Oncologist. 2020 Sep;25(9):e1406-e1413. doi: 10.1634/theoncologist.2020-0141. Epub 2020 May 7.
PMID: 32335971BACKGROUNDMohty M, Cavo M, Fink L, Gonzalez-McQuire S, Leleu H, Mateos MV, Raab MS, Schoen P, Yong K. Understanding mortality in multiple myeloma: Findings of a European retrospective chart review. Eur J Haematol. 2019 Aug;103(2):107-115. doi: 10.1111/ejh.13264. Epub 2019 Jun 18.
PMID: 31112311BACKGROUNDRafae A, Malik MN, Abu Zar M, Durer S, Durer C. An Overview of Light Chain Multiple Myeloma: Clinical Characteristics and Rarities, Management Strategies, and Disease Monitoring. Cureus. 2018 Aug 15;10(8):e3148. doi: 10.7759/cureus.3148.
PMID: 30345204BACKGROUNDGonsalves WI, Milani P, Derudas D, Buadi FK. The next generation of novel therapies for the management of relapsed multiple myeloma. Future Oncol. 2017 Jan;13(1):63-75. doi: 10.2217/fon-2016-0200. Epub 2016 Aug 11.
PMID: 27513456BACKGROUNDEvison F, Sangha J, Yadav P, Aung YS, Sharif A, Pinney JA, Drayson MT, Cook M, Cockwell P. A population-based study of the impact of dialysis on mortality in multiple myeloma. Br J Haematol. 2018 Feb;180(4):588-591. doi: 10.1111/bjh.14394. Epub 2016 Oct 21. No abstract available.
PMID: 27766629BACKGROUNDClerico A, Galli C, Fortunato A, Ronco C. Neutrophil gelatinase-associated lipocalin (NGAL) as biomarker of acute kidney injury: a review of the laboratory characteristics and clinical evidences. Clin Chem Lab Med. 2012 Feb 15;50(9):1505-17. doi: 10.1515/cclm-2011-0814.
PMID: 22962216BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Essam Abdel Monem El-beih,, professor
Assiut Univ
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
June 23, 2022
First Posted
June 30, 2022
Study Start
October 1, 2022
Primary Completion
October 1, 2024
Study Completion
January 1, 2025
Last Updated
June 30, 2022
Record last verified: 2022-06