Introduction: With the recent advancement in multiple myeloma, Daratumumab a monoclonal antibody against CD38 has been shown promising results especially in those with who were refractory to other treatments. In this meta-analysis, we aimed to analyze the efficacy of daratumumab in newly diagnosed patients with multiple myeloma who were or were not eligible for transplant therapy.

Methods: A thorough search was conducted in PubMed, Cochrane, and Clinicaltrials.gov using the MeSH terms “daratumumab” or “Darzalex” and “multiple myeloma” covering the period from 2000 to 2024. Studies that compared daratumumab combined with other therapies versus combination therapy alone were included. The Mantel-Haenzel formula was employed to calculate the pooled risk ratio (RR), and the Generic Inverse Variance method was used to determine the pooled hazard ratio for disease progression, using RevMan version 5.4 with a 95% confidence interval (CI). A P value of less than 0.05 was deemed significant.

Results: A total of 6 phase-III RCTs 3664 patients were analyzed. The use of daratumumab was associated with 39% fewer events of progression of disease or deaths in TE group (RR= 0.61; 95% CI= 0.39 to 0.93; p=0.02) and 29% lower in TIE group (RR= 0.71; 95% CI= 0.53 to 0.94; p=0.02). The hazard ratio for progression or death with daratumumab group versus control in both transplant eligible (TE) (HR= 0.44; 95% CI= 0.35 to 0.57; p<0.00001) or transplant ineligible (TIE) (HR= 0.47; 95% CI= 0.38 to 0.59; p<0.00001) group was significantly lower. Daratumumab significantly increased overall response rate (ORR) (RR= 1.20; 95% CI= 1.11 to 1.30 ; p<0.00001) and complete response (CR) (RR= 1.34; 95% CI= 1.02 to 1.76; p=0.04) in the TIE group only. Interestingly, the rate of minimal residual disease (MRD)-negative was increased only in the TIE group (RR= 4.09; 95% CI= 2.81 to 5.94; p<0.00001) with the use of daratumumab compared to the TE group.

Conclusion: Use of daratumumab showed benefits in both TE and TIE patients with newly diagnosed multiple myeloma (NDMM). It significantly reduced the risk for disease progression or deaths and improved clinical outcomes in terms of ORR and CR. The most notable improvements were observed in the TIE-NDMM group, suggesting an effective treatment option in these patient groups.

Disclosures

No relevant conflicts of interest to declare.

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2024
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