Real-World Registry on the Pharmacotherapy of Multiple Myeloma and Associated Renal and Pulmonary Impairments in the Greater Gulf Region: Protocol for a Retrospective Real-World Data Study.

Autor: Nourallah A; Hematology/Medical Oncology Department, Almana General Hospital, Alkhobar, Saudi Arabia., Alshehri A; Hematology / Oncology Department, Aseer Central Hospital, Abha, Saudi Arabia., Alhejazi A; Division of Adult Hematology and Hematopoietic Stem Cell Transplantation, Department of Oncology, King Abdulaziz Medical City, Riyadh, Saudi Arabia., Usman B; Department of Oncology, King Faisal Specialist Hospital and Research Center, Jeddah, Saudi Arabia., ElGohary G; Department of Medicine, Division of Oncology/Hematology, College of Medicine, King Saud University Medical City, Riyadh, Saudi Arabia., Malhan H; Department of Adult Hematology, Prince Mohammed bin Nasser Hospital, Jazan, Saudi Arabia., Motabi I; Adult Hematology & Bone Marrow Transplant Department, Comprehensive Cancer Center at King Fahad Medical City, Riyadh, Saudi Arabia.; Alfaisal University, Riyadh, Saudi Arabia., Al Farsi K; Department of Hematology, Sultan Qaboos University Hospital, Muscat, Oman., Alshuaibi M; Adult Hematology and Oncology Divisions, Department of Medicine, King Abdul-Aziz Hospital, Alahsa, Saudi Arabia., Siddiqui M; Hematology & Oncology Division at Sheikh Shakhbout Medical City (SSMC), Abu Dhabi, Saudi Arabia., Ghonema R; Department of Hematology, Kuwait Cancer Control Center, Kuwait, Kuwait., Taha RY; Department of Hematology-Bone Marrow Transplantation, National Centre for Cancer Care and Research (NCCCR), Hamad Medical Corporation (HMC), Doha, Qatar., Abouzeid T; Internal Medicine Department, Almouwasat Hospital, Dammam, Saudi Arabia., Ahmed W; Cleveland Clinic Abu Dhabi, Oncology Institute, Abu Dhabi, United Arab Emirates.; Cleveland Clinic Florida, Oncology Institute, Florida, FL, United States., Diab M; Hemato-oncology Department, Burjeel Hospital, Abu Dhabi, United Arab Emirates., Alhuraiji A; Department of Hematology, Kuwait Cancer Control Center, Kuwait, Kuwait., Rabea M; Medical Affairs Department, Sanofi, Jeddah, Saudi Arabia., Chouikrat MZ; Medical Affairs Department, Sanofi, Dubai, United Arab Emirates.
Jazyk: angličtina
Zdroj: JMIR research protocols [JMIR Res Protoc] 2024 Apr 24; Vol. 13, pp. e49861. Date of Electronic Publication: 2024 Apr 24.
DOI: 10.2196/49861
Abstrakt: Background: Multiple myeloma (MM) is the second-most common cancer among hematological malignancies. Patients with active disease may experience several comorbidities, including renal insufficiency and asthma, which may lead to treatment failure. The treatment of relapsed or refractory MM (RRMM) has been associated with multiple factors, causing a decline in progression-free survival as well as overall survival with subsequent lines of therapy. Data about the characteristics of this group of patients in the Greater Gulf region are lacking.
Objective: The primary objective of this study is to describe the disease characteristics and various treatment approaches or regimens used in the management of patients with RRMM in the Greater Gulf region.
Methods: We will conduct a regional, retrospective study collecting real-world and epidemiological data on patients with MM in countries of the Greater Gulf region. Medical records will be used to obtain the required data. Around 150 to 170 patients' records are planned to be retrospectively reviewed over 6 months without any cross-sectional or prospective intervention. Cases will be collected from Saudi Arabia, the United Arab Emirates, Kuwait, Oman, and Qatar. Descriptive as well as analytical statistics will be performed on the extracted data. The calculated sample size will allow us to estimate the percentages of RRMM cases with acceptable precision while complying with the challenges in light of data scarcity. We will obtain a comprehensive description of the demographic profile of patients with MM; treatment outcomes; the proportion of patients with MM with renal impairment and asthma, chronic obstructive pulmonary disease, or both at the time of diagnosis and any subsequent point; and data related to treatment lines, regimens, and MM-associated morbidities.
Results: Patient medical records were reviewed between June 2022 and January 2023 for eligibility and data extraction. A total of 148 patients were eligible for study inclusion, of whom 64.2% (n=95) were male and 35.8% (n=53) were female. The study is currently in its final stages of data analysis. The final manuscript is expected to be published in 2024.
Conclusions: Although MM is a predominant hematological disease, data on its prevalence and patients' characteristics in the Greater Gulf region are scarce. Therefore, this study will give us real-world insights into disease characteristics and various management approaches of patients with MM in the Greater Gulf region.
International Registered Report Identifier (irrid): DERR1-10.2196/49861.
(©Abdulnaser Nourallah, Abdulrahman Alshehri, Ayman Alhejazi, Binyam Usman, Ghada ElGohary, Hafiz Malhan, Ibraheem Motabi, Khalil Al Farsi, Mohammed Alshuaibi, Mustaqeem Siddiqui, Rasha Ghonema, Ruba Yasin Taha, Tarek Abouzeid, Wesam Ahmed, Mohanad Diab, Ahmad Alhuraiji, Magdy Rabea, Mohamed Zahir Chouikrat. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 24.04.2024.)
Databáze: MEDLINE