日本人の再発または難治性多発性骨髄腫におけるDaratumumabの安全性に関する後方視的検討とInfusion Related Reaction発現リスク因子の探索

抄録

Daratumumab (DARA) is a treatment for relapsed or refractory multiple myeloma. The MMY 3003 trial compared DARA, lenalidomide, and dexamethasone combination therapy (DLd therapy) with lenalidomide and dexamethasone combination therapy (Ld therapy). There were 283 cases in which DARA is included in the group, among which there are only 20 cases in Japan, with limited information on efficacy and safety in the Japanese population. Another characteristic of DARA adverse events is the Infusion Related Reaction (IRR). The risk factors associated with DARA's IRR have not been identified yet, and there are concerns about their impact on treatment.

Therefore, we retrospectively examined the safety of DARA in Japanese patients who received DARA and investigated the risk factors for IRR expression in multiple myeloma patients at our hospital. With regard to adverse events, we have experienced cases in which hematologic toxicity is Grade 3 or higher, but in non-hematologic toxicity, no case has resulted in serious outcomes of Grade 3 or higher. Any adverse event that occurred during the survey period could be managed with coping therapy, and safety was secured when DARA was administered. Although IRR has frequently occurred in DARA administration, there have been no reports on the risk factors for IRR expression to date. However, in this study, cases with “IMiDs refractory” as a risk factor for IRR were significantly affected. It is shown that “IMiDs refractory” cases can cope with IRR earlier by responding to risk factors.