Multiple Myeloma Survival OutcomeNCT05119205
Survival Outcomes of Multiple Myeloma Patients Admitted on Assiut Clinical Hematology Unit
An observational study of Multiple Myeloma Survival Outcome, run by Assiut University.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Multiple Myeloma Survival Outcome
- What is being tested?
- Bone marrow biopsy and compete blood count
- How many people
- 64 participants
- Where
- No sites listed yet
- Study dates
- Jan 2022to Sep 2024
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
None listed.
Who cannot join
- Waldenstrom macroglobulinemia
- MGUS
- Amyloidosis
- Other plasna cell disorders
About this study
Official title: 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.
Read the 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.
- Conditions
- Multiple Myeloma Survival Outcome
- Being tested
- Bone marrow biopsy and compete blood count
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bone marrow biopsy and compete blood countDiagnostic test
Bone marrow biopsy and compete blood count will be done for follow up in patients with multiple myeloma
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the survival outcomes of multiple myeloma patients admitted on Assiut clinical Hematology unit
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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2021
- Study startJan 2022 (estimated)
- Primary completionJan 2024 (estimated)
- Study completionSep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple Myeloma Survival OutcomeStudies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Reham Badr, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05119205
- Sponsor's protocol ID
- assiut5000
- Status last verified
- Nov 2021
- First submitted
- 2 Nov 2021
- Last updated
- 22 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Survival Outcomes of Multiple Myeloma Patients Admitted on Assiut Clinical Hematology Unit Observational Study
- ClinicalTrials.gov ID
- NCT05119205
- Acronym / sponsor ID
- assiut5000
- Conditions
- Multiple Myeloma Survival Outcome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Jan 2022 (estimated)
- Primary completion
- Jan 2024 (estimated)
- Study completion
- Sep 2024 (estimated)
- First posted
- 15 Nov 2021 (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.
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.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (0 listed)
Key exclusion criteria (4 listed)
- Waldenstrom macroglobulinemia
- MGUS
- Amyloidosis
- Other plasna cell disorders
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 |
|---|---|---|
| Bone marrow biopsy and compete blood countBone marrow biopsy and compete blood count will be done for follow up in patients with multiple myeloma | Diagnostic test | – |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2021.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Myeloma Survival Outcome, run by Assiut University.
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 0 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 22 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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 survival outcomes of multiple myeloma patients admitted on Assiut clinical Hematology unit (time frame: 2 years). 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 22 Nov 2021.