Multiple Myeloma Prognostic Indices

Multiple Myeloma Clinical Trial

Official title:

Spectrum of Blood Viscosity , Albumin / Fibrinogen Ratio and Red Cell Distribution Width in Newly Diagnosed Multiple Myeloma Patients. Observation Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06095752
• Other study ID #: MM prognosis
• Status: Recruiting
• Start date: November 1, 2023
• Est. completion date: November 5, 2024

Study information

• Verified date: October 2023
• Source: Assiut University
• Contact: Ahmed Radwan Rostom, Resident Dr
• Phone: 01156900472
• Email: Ahmedrostomyy[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The aim of this study was to evaluate the impact of albumin / fibrinogen ratio, blood viscosity and RDW on the prognosis of a newly diagnosed MM patients

Description:

Multiple myeloma (MM) is a hematologic neoplasm of plasma cells that arises in the bone marrow, manifest by bone pain, pathologic fractures, anemia, renal insufficiency and recurrent infections. Treatment options include chemotherapy (proteosome inhibitors), targeted therapy, autologous stem cell transplantation and supportive care. MM has numerous prognostic factors affecting patient outcomes, some of the most important prognostic factors include age, stage of disease, levels of certain proteins like Beta -2 microglobulin, albumin, chromosomal abnormalities and renal function tests. In addition to albumin / fibrinogen ratio, blood viscosity and hematologic indices which are mainly focused on through this research .

The albumin / fibrinogen ratio has been recently studied as a potential prognostic factor for newly diagnosed MM patients, fibrinogen is the protein that plays a role in blood clotting, while albumin helps regulate fluid balance in the body. Studies show that a higher albumin/ fibrinogen ratio is associated with a better prognosis of MM, However, further studies is necessary to fully understand the impact of this ratio on MM prognosis.

Blood viscosity is the measure of the thickness and stickiness of the blood, which can impact blood flow and oxygen delivery to vital organs. Newly diagnosed MM patients, higher whole blood viscosity is associated with a poorer prognosis and shorter survival times. increased viscosity may contribute to the development of blood clots and impaired circulation, leading to tissue damage and organ failure, However, further studies is needed to better understand the mechanism underlying this relationship and develop targeted interventions to improve outcomes.

Several studies have shown that radial distribution width (RDW) can serve as a prognostic factor in the newly diagnosed MM patients. This index can provide important information about patients' immune response, inflammation and overall health status. A high RDW are associated with poor prognosis. However, further studies is necessary to fully understand the impact of these indices on MM prognosis.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: November 5, 2024
• Est. primary completion date: October 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients newly diagnosed with MM according to International Myeloma Working Group criteria 2016.

Exclusion Criteria:

• Patient previously diagnosed MM and started treatment or in post treatment follow up

Related Conditions & MeSH terms

• Hematologic Diseases
• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Other:
• blood viscosity , albumin / fibrinogen ratio and red cell distribution
In multiple myeloma patients ,we get blood viscosity , albumin / fibrinogen ratio and red cell distribution directly after confirmed diagnosis to determine the prognosis of the disease in association with these tests results

Locations

Country	Name	City	State
Egypt	Assiut University hospital	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine the prognosis of newly diagnosed multiple myeloma patients in survival for one year.	After initial diagnosis of a patient to have multiple myeloma , blood viscosity is obtained and within a year , a relation is established between the prognosis of the disease and the initial results of blood viscosity	One year
Primary	Determine the prognosis of newly diagnosed multiple myeloma patients in survival for one year.	After initial diagnosis of a patient to have multiple myeloma , albumin / fibrinogen ratio is obtained and within a year , a relation is established between the prognosis of the disease and the initial results of albumin /fibrinogen ratio	One year
Primary	Determine the prognosis of newly diagnosed multiple myeloma patients in survival for one year.	After initial diagnosis of a patient to have multiple myeloma , red cell distribution is obtained and within a year , a relation is established between the prognosis of the disease and the initial results of red cell distribution	One year