Updated Meta-Analysis of Phase III Randomized Controlled Trials (RCTs) to Evaluate the Incidence of Pneumonia, Upper Respiratory Tract Infections (URTIs) and Venous Thromboembolism (VTE) in Patients with Multiple Myeloma Treated with Isatuximab
Abstract
Introduction
Multiple myeloma is a hematologic malignancy characterized by the clonal proliferation of malignant plasma cells in the bone marrow, constituting approximately 13% of all hematologic malignancies. Isatuximab is a monoclonal antibody targeting the CD38 protein on myeloma cells, causing cell death through various immune-mediated mechanisms. Clinical trials have shown that adding Isatuximab to standard regimens for multiple myeloma significantly enhances efficacy but introduces some notable toxicities. The purpose of this study is to determine the risk of pneumonia, URTIs, and VTE in patients with MM treated with isatuximab.
Methods
We conducted a comprehensive literature search using MEDLINE, EMBASE, and COCHRANE databases from inception through July 22nd, 2024. Phase III RCTs utilizing isatuximab in newly diagnosed MM (NDMM) and relapsed/refractory MM (RRMM) mentioning pneumonia, URTIs, and VTE as adverse effects were included. Mantel-Haenszel (MH) method was used to calculate the estimated pooled risk ratio (RR) with 95% confidence interval (CI). Heterogeneity was assessed with Cochran's Q- statistic. Random effects model was applied.
Results
A total of 1044 patients from 3 Phase III RCTs (ICARIA-MM, IKEMA, IMROZ) were eligible for evaluation of pneumonia and URTIs incidence. A total of 1403 patients from 3 phase III RCTs (IKEMA, IMROZ, GMMG-HD7) were eligible for evaluation of VTE incidence. ICARIA-MM and IKEMA involved RRMM patients, while IMROZ and GMMG-HD7…
How strong is the evidence?
Evidence Hub reads this as a meta-analysis, done in people. Its evidence level is 1 of 5 (Highest · pooled evidence). Pooled evidence from several studies sits at the top of the evidence pyramid. Reported size: 1,403 participants or records.
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