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    Treatment of Newly Diagnosed Myeloma (excluding t-cell redirection therapy)

    Serious and hematological adverse effects of daratumumab plus triple therapy vs triple therapy alone for Multiple Myeloma: A Systematic Review and Meta-Analysis

    P-365: Serious and hematological adverse effects of daratumumab plus triple therapy vs triple therapy alone for Multiple Myeloma: A Systematic Review and Meta-Analysis

    Thursday, September 26, 2024
    Introduction: The anti CD-38 monoclonal antibody Daratumumab was recently included in multiple protocols for treatment of Newly diagnosed Multiple Myeloma, either alone or in addition to standard care. Some Systematic Reviews with Meta Analysis have already evaluated effectiveness and survival of daratumumab treatment, strengthening the comprehension of the impact of this therapy. Nevertheless, there is still no such study evaluating the adverse effects and toxicities related to the addition of daratumumab to triple therapy as primary outcome, even though data have been and are being released. The goal of this study is to evaluate the Serious adverse effects of daratumumab plus triple therapy in comparison to triple therapy alone for newly diagnosed Multiple Myeloma.

    Methods: This is a Systematic review with Meta-Analysis of randomized controlled data comparing triple therapy plus daratumumab versus triple therapy alone. Our primary outcome was serious adverse events (SAE). Secondary outcomes included Grade 3 and 4 (G3-4) adverse events, infection and secondary malignancies.

    Results: We included 4 randomized controlled trials, totalizing 1139 patients. The occurrence of SAE was not significantly affected by the addition of daratumumab to triple therapy (Risk Ratio [RR] 1.03; 95%; confidence interval [CI] 0.90-1.18) and a lower rate of treatment-emergent adverse event leading to death was found, tough not statistically significant (RR 0.51; 95%; CI 0.14-1.83). Serious treatment-emergent pneumonia was increased and statistically significant in the daratumumab group (RR 1.66; 95%; CI 1.15-2.38), serious pyrexia had no significant difference (RR 0.81; 95%; CI 0.53-1.22). Grade 3 and 4 neutropenia was significantly increased in the quadruplet therapy group (RR 1.69; 95%; CI 1.24-2.32), such as thrombocytopenia (RR 1.51; 95%; CI 1.24-1.85), but lymphopenia had no significative difference (RR 1.50; 95%; CI 0.84-2.69). G3-4 Infections were increased in the daratumumab group (RR 1.25; 95%; CI 1.03-1.52) and G3-4 pneumonia was increased, though not statistically significantly different (RR 1.50; 95%; CI 0.93-2.42), as serious treatment-emergent pneumonia was. Secondary malignancy was not statistically different between groups (RR 1.39; 95%; CI 0.88-2.19).

    Conclusions: Our Meta-Analysis suggests that including daratumumab to triple therapy regimens increases the risk of serious treatment-emergent pneumonia, G3-4 neutropenia, G3-4 thrombocytopenia and G3-4 infections. Furthermore, additional studies are needed to strengthen our comprehension of long term safety.