Haematologica. 2020;105(12):2872-2878. of its high effectiveness in apparently healthy adults.7 Recently, it was reported the 1st BNT162b2 dose provided some safety against COVID-19 among nursing facility residents.8,9 However, there is no Ankrd1 information in the literature about its efficacy in patients with MM or with other malignant diseases. Herein, we report the development of neutralizing antibodies (NAbs) against SARS-CoV-2 in patients with MM after the first dose of the BNT162b2 vaccine. Major inclusion criteria for the participation of patients with MM in this study included age >18 years; presence or smoldering myeloma or active MM, irrespective of the treatment given or the line of therapy; and eligibility for vaccination, according to International Myeloma Society recommendations.8 Volunteers of similar age and sex, who served as controls, were included in this analysis. Major exclusion criteria for myeloma patients and controls PTC-209 included the presence of autoimmune disorders or active malignant disease, HIV or active hepatitis B and C contamination, or end-stage renal disease. Herein, we report a sub-analysis of a prospective study (“type”:”clinical-trial”,”attrs”:”text”:”NCT04743388″,”term_id”:”NCT04743388″NCT04743388) evaluating the kinetics of antiCSARS-CoV-2 antibodies following COVID-19 vaccination in healthy subjects and patients with hematological malignancies or solid tumors. After PTC-209 vein puncture, serum of patients and controls was collected on day 1 (D1; before the first BNT162b2 dose) and on day 22 (D22; before the second dose of the vaccine). Serum was separated within 4 hours of blood collection and stored at ?80C until the day of measurement. NAbs against SARS-CoV-2 were measured using methodology approved by the US Food and Drug Administration (enzyme-linked immunosorbent assay; cPass SARS-CoV-2 Neutralizing Antibody Detection Kit; GenScript, Piscataway, NJ)10 at the above time points. Samples from the same patient or control were measured in the same enzyme-linked immunosorbent assay PTC-209 plate. The study was approved by the institutional Ethical Committees in accordance with the Declaration of Helsinki and the International Conference on Harmonization for Good Clinical Practice. All patients and controls provided informed consent before entering into the study. The current study populace included 48 patients with MM (29 males/19 females; median age, 83 years; range, 59-92 years) and 104 controls (57 males/47 females; median age, 83 years; range, 65-95 years), who were vaccinated during the same period at the same vaccination center (Alexandra Hospital, Athens, Greece). The advanced age of the participants was the result of the Greek vaccination program that prioritizes octogenarians and health care workers for COVID-19 immunization. The characteristics of the patients with myeloma are depicted in Table 1. In summary, at the time of vaccination, 35 (72.9%) patients were receiving antimyeloma therapy, 4 were in remission after prior therapy and did not receive any therapy at the time of vaccination, and 9 had smoldering myeloma. Table 1. Characteristics of patients with MM Total patients (males/females), n48 (29/19)Age, median (range), y83 (59-92)Smoldering myeloma/active myeloma9 (18.7)/39 (81.2)Receiving treatment for active myeloma, yes/no, n35/4 Line of therapy, if on treatment (n = 35) ?First15 (42.9)?Second10 (28.6)?Third4 (11.4)Greater than third6 (17.1) Type of therapy ?PI+IMiD combos9 (25.7)??VRD6??IRD2??PomVD1?IMiD-based regimens14 (40.0)??Rd10??R maintenance2??RCd1??PomCd1?PI-based regimens2 (5.7)??VD1??ICD1?Anti-CD38 mAb-based PTC-209 therapies8 (22.8)??Daratumumab monotherapy4??Daratumumab-Rd2??Daratumumab-PomDex1??Isatuximab-Rd1?Belantamab mafodotin monotherapy2 (5.7) Open in a separate windows Unless otherwise noted, data are n (%). ICD, ixazomib, cyclophosphamide and dexamethasone; IMiD, immunomodulatory drug; IRD, ixazomib, lenalidomide, and dexamethasone; mAb, monoclonal antibody; PI, proteasome inhibitor; PomCd, pomalidomide, cyclophosphamide, and dexamethasone; PomVD, pomalidomide, bortezomib, and dexamethasone; PomDex, pomalidomide and dexamethasone; R, lenalidomide; RCd, lenalidomide, cyclophosphamide, and dexamethasone; Rd, lenalidomide and dexamethasone; VD, bortezomib and dexamethasone; VRD, bortezomib, lenalidomide and dexamethasone. On D1, no patient or control had NAb titers 30% (the cutoff defining positivity); similarly, there was no difference with regard to NAb titers between patients with MM and controls on D1. After the first dose of the vaccine, on D22, patients with MM had lower NAb titers compared with controls: median NAb-inhibition titers was 20.6% (range, 0-96.7%) PTC-209 for patients with MM vs 32.5% (range, 5.2-97.3%) for controls (< .01; Physique 1). More.