OBJECTIVES: Monoclonal antibodies (MABs) have become the mainstay of multiple myeloma (MM) treatment. Randomized controlled trials (RCTs) have confirmed the efficacy of MABs for treating MM, but real-world evidence (RWE) on the effectiveness of MABs is limited. This systematic literature review (PROSPERO 2022 CRD42022375979) aims to investigate and synthesize the RWE of the effectiveness of MABs in MM.

METHODS: Systematic searches were performed to identify relevant literature from 2012-2022 from electronic databases (PubMed, Web of Science, CINAHL, and Google Scholar) and conferences. Search terms combined “monoclonal antibodies,” “multiple myeloma,” and five individual US Food and Drug Administration-approved MABs, including daratumumab, elotuzumab, isatuximab, belantamab mafodotin-blmf, and teclistamab-cqyv. Studies were included if they applied one type of RWE research design and examined at least one MAB. RCTs, case reports, animal studies, and correspondence without data were excluded. Primary outcomes were progression-free survival, overall survival, and overall response rate. COSMOS-E guideline and ROBINS-I tool were used to assess the risk of bias.

RESULTS: Database searches resulted in 6,301 citations. After de-duplication, 4,232 articles were screened, and 111 were included in the final analysis. In total, the average number of included patients was around 389 patients per study (range: 3-12,987; median: 69). Most studies were cross-sectional (n=72), followed by cohort studies (n=33). The real-world effectiveness of MABs could not be synthesized due to lack of control groups and vastly different treatment regimens and comparators; however, most controlled studies (nearly 30%) reported improvements in overall response rate and survival among MM patients treated with MABs as compared to other MM treatments.

CONCLUSIONS: This review is the first study to summarize the RWE for the effectiveness of MABs in treating MM. Additional real-world studies using sufficient sample size and proper designs are needed to assess the effectiveness of MABs for treating MM.