Multiple MyelomaNCT06095752
Multiple Myeloma Prognostic Indices
An observational study of Multiple Myeloma and Hematologic Diseases, run by Assiut University at 1 site in Egypt.
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 Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Multiple Myeloma, Hematologic Diseases
- What is being tested?
- blood viscosity , albumin / fibrinogen ratio and red cell distribution
- How many people
- 48 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2023to 30 Apr 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: based on study methodology , the studied population (who are the newly diagnosed cases ) will be followed up to one year after diagnosis to report outcomes . the researcher will recruit the newly diagnosed cases who seek care at internal medicine department, assiut university hospital in completed one year duration and then follow up the case for one year. After reviewing medical record , average flow rate of MM at internal medicine department is 2 cases per month , nearly 25 cases will be included in this study
Who may be able to join
- Patients newly diagnosed with MM according to International Myeloma Working Group criteria 2016.
Who cannot join
- Patient previously diagnosed MM and started treatment or in post treatment follow up
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Spectrum of Blood Viscosity , Albumin / Fibrinogen Ratio and Red Cell Distribution Width in Newly Diagnosed Multiple Myeloma Patients. Observation Study
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
Read the 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.
- Conditions
- Multiple Myeloma, Hematologic Diseases
- Being tested
- blood viscosity , albumin / fibrinogen ratio and red cell distribution
- Medical subject headings
- Multiple Myeloma, Hematologic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood viscosity , albumin / fibrinogen ratio and red cell distributionOther
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
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: One year
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
Measured: One year
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
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2023
- Study start1 Apr 2023
- Primary completion30 Apr 2025
- Study completion30 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Radwan Abdelhakim, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06095752
- Sponsor's protocol ID
- MM prognosis
- Status last verified
- Apr 2025
- First submitted
- 27 Sep 2023
- Last updated
- 2 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spectrum of Blood Viscosity , Albumin / Fibrinogen Ratio and Red Cell Distribution Width in Newly Diagnosed Multiple Myeloma Patients. Observation Study
- ClinicalTrials.gov ID
- NCT06095752
- Acronym / sponsor ID
- MM prognosis
- Conditions
- Multiple Myeloma, Hematologic Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 30 Apr 2025 (actual)
- Study completion
- 30 Apr 2025 (actual)
- First posted
- 23 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- based on study methodology , the studied population (who are the newly diagnosed cases ) will be followed up to one year after diagnosis to report outcomes . the researcher will recruit the newly diagnosed cases who seek care at internal medicine department, assiut university hospital in completed one year duration and then follow up the case for one year. After reviewing medical record , average flow rate of MM at internal medicine department is 2 cases per month , nearly 25 cases will be included in this study
Key inclusion criteria (1 listed)
- Patients newly diagnosed with MM according to International Myeloma Working Group criteria 2016.
Key exclusion criteria (1 listed)
- Patient previously diagnosed MM and started treatment or in post treatment follow up
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood viscosity , albumin / fibrinogen ratio and red cell distributionIn 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 | Other | – |
Primary outcome
Determine the prognosis of newly diagnosed multiple myeloma patients in survival for one year.
Time frame: 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
Determine the prognosis of newly diagnosed multiple myeloma patients in survival for one year.
Time frame: 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
Determine the prognosis of newly diagnosed multiple myeloma patients in survival for one year.
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Myeloma and Hematologic Diseases, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine the prognosis of newly diagnosed multiple myeloma patients in survival for one year. (time frame: One year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2025.