Survival Outcomes of Multiple Myeloma Patients Admitted on Assiut Clinical Hematology Unit

November 14, 2021 updated by: Reham Badr, Assiut University

Study of Survival Outcomes of Multiple Myeloma Patients Admitted on Assiut Clinical Hematology Unit Observational Study

Our study will discuss survival outcomes of multiple myeloma patients admitted on Assiut clinical Hematology and role of neutrophil to lymphocyte and lymphocyte to monocyte ratios as prognostic factors in multiple myeloma.

Study Overview

Status

Not yet recruiting

Conditions

Multiple Myeloma Survival Outcome

Intervention / Treatment

Diagnostic test: Bone marrow biopsy and compete blood count

Detailed Description

What are survival outcomes and the prognostic value of neutrophil to lymphocyte ratio of multiple myeloma patients admitted on Assiut clinical Hematology unit? Multiple myeloma (MM)is a plasma cell neoplasm associated with its characteristic clinical complications: anemia, infections, renal impairment or bone destruction. MM is the second most commonly diagnosed hematological neoplasm, with an incidence rate of 6.2 per 100 000 individuals .

Survival outcomes have remained constant over the past few decades; therefore, MM is still considered incurable. However, the increasing use of autologous stem cell transplantation (SCT) and the introduction of novel therapeutic agents, such as thalidomide and bortezomib, have improved the survival of myeloma patients .

Relationship between inflammation and cancer have been established. Some inflammatory factors from accessory cells in tumor milieu, such as interleukin-1 (IL-1), IL-6, and tumor necrosis factor-alpha (TNF-α), facilitated cancer cells' invasiveness .

Further studies exhibited the reactive oxygen and nitrogen from inflammatory cells induced mutation of some tumor suppressor genes, and inflammatory factors such as IL-6 and prostaglandin E2 (PGE2) caused DNA methylation, which both played an important role in tumorigenesis. Accordingly, neutrophil to lymphocyte ratio (NLR) coinciding with rationales supported by numerous studies, could offer a precise potency in predicting prognosis of cancers. In fact, many studies already demonstrated the prognostic significance of NLR in various cancers Consistently, a number of meta-analyses further confirmed this view in colorectal cancer, lung cancer, ovarian cancer, breast cancer, and lymphoma and others.

Study Type

Observational

Enrollment (Anticipated)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients diagnosed with multiple myeloma in our unit will be included in the study and follow-up will be done to determine the outcome.

Description

Inclusion Criteria: clinical and laboratory diagnosis of multiple myeloma

multiple myeloma patients received chemotherapy in our unit.

Exclusion Criteria:

Waldenstrom macroglobulinemia
MGUS
Amyloidosis
Other plasna cell disorders

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Observational Models: Other
Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Determine the survival outcomes of multiple myeloma patients admitted on Assiut clinical Hematology unit Time Frame: 2 years	Survival time will be measured as time from index date (that is, diagnosis date for MM patients) to the date of death; patients without a date of death were assumed alive at the end of the study period. Survival estimates will be assessed by types of treatment among MM patients. In addition, the proportion of patients who died or survived at least 2, 3 or 5 years after diagnosis will be also described.	2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

January 1, 2022

Primary Completion (Anticipated)

January 1, 2024

Study Completion (Anticipated)

September 1, 2024

Study Registration Dates

First Submitted

November 2, 2021

First Submitted That Met QC Criteria

November 2, 2021

First Posted (Actual)

November 15, 2021

Study Record Updates

Last Update Posted (Actual)

November 22, 2021

Last Update Submitted That Met QC Criteria

November 14, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

assiut5000

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.