Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202602521522057 Date of Registration: 26/02/2026
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Multiparameter Flow Cytometry (MPFC) Minimal Residual Disease Status as a Prognostic Factor in Newly Diagnosed Egyptian Multiple Myeloma Patients: A 36-Month Follow-Up Study
Official scientific title Detection of minimal residual disease in Egyptian multiple myeloma patients by multiparametric flowcytometry
Brief summary describing the background and objectives of the trial Background: Multiple Myeloma (MM) is a hematologic malignancy where the depth of response to treatment strongly correlates with long-term survival. Multiparameter Flow Cytometry (MPFC) has emerged as a highly sensitive and standard method for detecting Minimal Residual Disease (MRD). Assessing MRD status is critical for predicting patient outcomes and guiding therapy; however, real-world data highlighting its prognostic value specifically within the Egyptian population is essential to optimize local clinical practices. Objectives: The primary objective of this study is to evaluate the prognostic significance of MRD status, assessed via MPFC, in newly diagnosed Egyptian patients with Multiple Myeloma. Specifically, the study aims to correlate MRD negativity with long-term clinical outcomes, including Progression-Free Survival (PFS) and Overall Survival (OS), over a 36-month follow-up perioيز
Type of trial Observational
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Cancer
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Diagnosis / Prognosis
Anticipated trial start date 21/12/2020
Actual trial start date 21/12/2020
Anticipated date of last follow up 28/02/2022
Actual Last follow-up date
Anticipated target sample size (number of participants) 102
Actual target sample size (number of participants)
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Single Group Non-randomised Allocation Sequence/Code was not concealed Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Minimal Residual Disease assessment 36 months All enrolled newly diagnosed Multiple Myeloma patients received standard-of-care treatment protocols. At the designated time point (post-induction/consolidation), bone marrow aspirate samples were evaluated for Minimal Residual Disease (MRD) status. This assessment was performed using highly sensitive Multiparameter Flow Cytometry (MPFC). Based on the MPFC results, patients were categorized into MRD-negative and MRD-positive groups, and subsequently followed for 36 months to evaluate long-term prognostic outcomes, including Progression-Free Survival (PFS) and Overall Survival (OS). 102
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
• Egyptians • Patients diagnosed as multiple myeloma • Male or female • Any Age group • Non Egyptians • Any other malignancies 80 and over: 80+ Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 30 Year(s) 85 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 20/12/2020 National Cancer Institute IRB
Ethics Committee Address
Street address City Postal code Country
1 Kasr Al-Ainy Street, Fom El-Khalig Square, Cairo, Egypt Cairo 11796 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Outcome Name: Progression-Free Survival (PFS) Timeframe: 36 months Description: The time from the date of diagnosis (or start of treatment) to the date of first documented disease progression or death from any cause, compared between MRD-negative and MRD-positive patient groups as assessed by MPFC. Outcome Name: Overall Survival (OS) Timeframe: 36 months Description: The time from the date of diagnosis to death from any cause, evaluated based on the MPFC MRD status achieved. Up to 36 months of follow-up
Secondary Outcome Outcome Name: Rate of MRD Negativity. Timeframe: At the time of MRD assessment (e.g., post-induction)Description: The percentage of patients who achieved undetectable minimal residual disease (MRD negativity) using Multiparameter Flow Cytometry (MPFC) with a sensitivity of at least 10−4. 36 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
National Cancer Institute Cairo University hospitals Egypt 1 Kasr Al-Ainy Street, Fom El-Khalig Square Cairo 11796 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
National Cancer Institute Cairo University 1 Kasr Al-Ainy Street, Fom El-Khalig Square, Cairo, Egypt Cairo 11796 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor National Cancer Institute Cairo University 1 Kasr Al-Ainy Street, Fom El-Khalig Square Cairo 11796 Egypt University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Sally Ibrahim sally.ibrahim@nci.cu.edu.eg +201007917157 41 Mahmoud El-Shamy st., Hadayek Helwan
City Postal code Country Position/Affiliation
Cairo 11747 Egypt National Cancer Institute Cairo University
Role Name Email Phone Street address
Scientific Enquiries Magda Mahmoud Assem magda.assem@nci.cu.edu.eg +201001030338 Manial El-Roda
City Postal code Country Position/Affiliation
Cairo 11553 Egypt National Cancer Institute Cairo University
Role Name Email Phone Street address
Public Enquiries Sally Ibrahim sally.ibrahim@nci.cu.edu.eg +201007917157 41 Mahmoud El-Shamy st., Hadayek Helwan
City Postal code Country Position/Affiliation
Cairo 11747 Egypt National Cancer Institute Cairo University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes The datasets generated and analyzed during the current study are not publicly available to protect patient privacy and comply with institutional regulations. However, anonymized data are available from the corresponding author upon reasonable request. Informed Consent Form,Study Protocol Immediately following publication Researchers who provide a methodologically sound proposal and whose proposed use of the data has been approved by an independent review committee. To achieve the aims in the approved proposal, such as performing a meta-analysis or validating clinical outcomes in Multiple Myeloma. A signed Data Use Agreement (DUA) and evidence of Institutional Review Board (IRB) approval from the requesting party's institution.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Actual trial start date 26/02/2026 PACTR Admin 21 Dec 2020