Multiple Myeloma Prognostic Indices

Sponsor
Assiut University (Other)
Overall Status
Recruiting
CT.gov ID
NCT06095752
Collaborator
(none)
25
1
12.2
2.1

Study Details

Study Description

Brief 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

Condition or Disease Intervention/Treatment Phase
  • Other: blood viscosity , albumin / fibrinogen ratio and red cell distribution

Detailed 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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
25 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Spectrum of Blood Viscosity , Albumin / Fibrinogen Ratio and Red Cell Distribution Width in Newly Diagnosed Multiple Myeloma Patients. Observation Study
Anticipated Study Start Date :
Nov 1, 2023
Anticipated Primary Completion Date :
Oct 30, 2024
Anticipated Study Completion Date :
Nov 5, 2024

Outcome Measures

Primary Outcome Measures

  1. Determine the prognosis of newly diagnosed multiple myeloma patients in survival for one year. [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

  2. Determine the prognosis of newly diagnosed multiple myeloma patients in survival for one year. [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

  3. Determine the prognosis of newly diagnosed multiple myeloma patients in survival for one year. [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Assiut University hospital Assiut Egypt 88

Sponsors and Collaborators

  • Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ahmed Radwan Abdelhakim, Resident doctor, Ahmed Radwan abdelhakim, Assiut University
ClinicalTrials.gov Identifier:
NCT06095752
Other Study ID Numbers:
  • MM prognosis
First Posted:
Oct 23, 2023
Last Update Posted:
Oct 23, 2023
Last Verified:
Oct 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 23, 2023