NCT05995808

Brief Summary

Multiple myeloma (MM) is the most common bone marrow malignancy of terminally differentiated plasma cells. It accounts for about 1% of all malignant diseases and 10% of haematological malignancies and takes the second place after non-Hodgkin lymphoma . There are some serological and clinical criteria that help to detect the stage of MM and predict the patients' prognosis. These criteria include the level of M protein, calcium, haemoglobin, albumin, creatinine, β2-microglobulin and glomerular filtration rate (GFR).

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P25-P50 for not_applicable multiple-myeloma

Timeline
Completed

Started Sep 2023

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 9, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 16, 2023

Completed
16 days until next milestone

Study Start

First participant enrolled

September 1, 2023

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2025

Completed
Last Updated

August 16, 2023

Status Verified

August 1, 2023

Enrollment Period

11 months

First QC Date

August 9, 2023

Last Update Submit

August 9, 2023

Conditions

Multiple Myeloma

Outcome Measures

Primary Outcomes (1)

  • Cycline D1 expression in bone marrow biopsy of multiple myeloma patient

    Cycline D1 expression in bone marrow biopsy of multiple myeloma patient

    1 year

Study Arms (1)

diagnostic group

EXPERIMENTAL
Procedure: Bone marow biopsy and aspirationDiagnostic Test: biochemical and heamatological tests

Interventions

Bone marow biopsy and aspirationPROCEDURE

Bone marrow biopsy and biopsy aspiration

diagnostic group
biochemical and heamatological testsDIAGNOSTIC_TEST

complete blood count ,serum urea and creatinine

Also known as: complete blood count ,urea and creatinine in serum
diagnostic group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients older than 18 year with newly diagnosed MM.
  • Approval to sign an informed written consent.

You may not qualify if:

  • \. Patient younger than 18 years. 2.Refusal to sign an informed written consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

Neoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System Diseases

Central Study Contacts

Fainan K EL Kady, spcialist

CONTACT

01063017967fainan_khaled_post@med.sohag.edeu.eg

Douaa M Sayed, professor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
clinical pathology specialist

Study Record Dates

First Submitted

August 9, 2023

First Posted

August 16, 2023

Study Start

September 1, 2023

Primary Completion

August 1, 2024

Study Completion

August 1, 2025

Last Updated

August 16, 2023

Record last verified: 2023-08