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1.
Preprint in English | medRxiv | ID: ppmedrxiv-21265158

ABSTRACT

BackgroundMyeloma patients frequently respond poorly to bacterial and viral vaccination. A few studies have reported poor humoral immune responses in myeloma patients to COVID-19 vaccination. MethodsUsing a prospective study of myeloma patients in UK Rudy Study cohort, we assessed humoral and Interferon gamma release assay (IGRA) cellular immune responses to COVID-19 vaccination post second COVID-19 vaccine administration. FindingsWe report data from 214 adults with myeloma (n=204) or smouldering myeloma (n=10) who provided blood samples at least 3 weeks after second vaccine dose. Positive Anti-Spike antibody levels (> 50 IU/ml) were detected in 189/203 (92.7%), positive IGRA responses were seen in 97/158 (61.4%) myeloma patients. Only 10/158 (6.3%) patients were identified to have both a negative IGRA and negative Anti-Spike protein antibody response. 95/158 (60.1%) patients produced positive results for both anti-Spike protein serology and IGRA. After adjusting for disease severity and myeloma therapy, poor humoral immune response was predicted by male gender. Predictors of poor IGRA included anti-CD38/ anti-BCMA therapy and Pfizer-BioNTech (PB) vaccination. InterpretationSignificant majority of myeloma patients elicit Anti-Spike protein antibody responses to COVID-19 vaccine with 60% of myeloma patients showing both humoral and T cell response. Predictors of a poor immune response included male gender, myeloma therapy regimen and administration of Pfizer-BioNTech vaccination. Further work is required to understand the clinical significance of divergent cellular response to vaccination. FundingFunding for this study has been received from Blood Cancer Vaccine Consortium and Janssen UK. RUDY platform has been funded by NIHR.

2.
Preprint in English | medRxiv | ID: ppmedrxiv-21257379

ABSTRACT

ObjectiveMultiple myeloma (MM)-related morbidity has a profound effect on quality of life (QoL), and immune function, but few studies have prospectively examined the impact of COVID-19 pandemic and attendant vaccination on both immunity and QoL of patients with MM. We aimed to characterise these effects in a prospective cohort study. DesignWe initiated a prospective national cohort study of patients with MM from start of the second wave of SARS CoV-2 infections in December 2020 and resultant COVID lockdown in the United Kingdom. We assessed current myeloma status, history of COVID19 symptoms, testing and vaccination including response using the rudystudy.org platform. In addition, healthcare resource use, mental and social well being and loneliness (Lubben scale) from the start of the COVID-19 pandemic were assessed. ParticipantsWe report data from the first one hundred and nine adults with MM who completed the questionnaires and the first round of blood testing in the cohort. ResultsFive patients (4.5%) had COVID-19 infection confirmed by history and/or testing (Nucleocapsid antibody). Up to 98% of patients shielded completely or partially during both waves of the pandemic, with 18% of patients consequently changing antimyeloma therapy in the shielding period. Using the Lubben scale, 21/99 (21.2 %) reported social isolation. Using HADS scale 23.1% of patients reported symptoms of mild to moderate anxiety or mild to moderate depression during this period. Humoral immune response (spike ab) tested 3 weeks after first vaccination was detected in 17/28 (60%) patients. ConclusionMyeloma patients shielded during waves of the pandemic with significant change to therapy, low level natural COVID-19 infection (4%) and social isolation. Humoral response following the first dose of COVID-19 vaccine is lower than that reported in non-myeloma cohorts. What is already known on this topicLimited published data exist on the effect of the COVID-19 pandemic on myeloma patients. Post first vaccine response in myeloma patients has been reported in a small number of patients from two studies ranging from 25 % to 56%. What this study addsThis study reports myeloma patients shielded during waves of the pandemic and demonstrates consequent significant social isolation and changes to therapy. Low level natural COVID-19 infection (4%) was noted in the study and humoral response following first dose of COVID-19 vaccine was lower than that reported in non-myeloma cohorts.

3.
Preprint in English | medRxiv | ID: ppmedrxiv-20177576

ABSTRACT

The primary cause of morbidity and mortality in patients with multiple myeloma (MM) is an infection. Therefore there is great concern about the susceptibility to the outcome of COVID-19 infected patients with multiple myeloma. This retrospective study describes the baseline characteristics and outcome data of COVID-19 infection in 650 patients with plasma cell disorders (98 outpatinets and 538 hospitilized patinets), collected from 10 countries by the International Myeloma Society to understand the initial challenges faced by Myeloma patients during COVID-19 pandemic. Descriptive statistics, univariate logistic regression, and multivariate analysis were performed for hospitalized MM patinets. The median age was 69 years, and nearly all patients (96%) had MM. Approximately 36% were recently diagnosed (2019-2020), and 54% of patients were receiving first-line therapy. Thirty-three percent of patients have died, with significant geographic variability, ranging from 27% to 57% of hospitalized patients. Univariate analysis identified age, ISS3, high-risk disease, renal disease, suboptimal myeloma control (active or progressive disease), and one or more comorbidities as risk factors for higher rates of death. Neither history of transplant, including within a year of COVID-19 diagnosis nor other anti-MM treatments were associated with outcomes. Multivariate analysis found that only age, high-risk MM, renal disease, and suboptimal MM control remained independent predictors of adverse outcome with COVID-19 infection. The management of MM in the era of COVID-19 requires careful consideration of patient and disease-related factors to decrease the risk of acquiring COVID-19 infection, while not compromising the disease control through appropriate MM treatment. This study provides the data to develop recommendations for the management of MM patients at risk of COVID-19 infection. Key PointsO_LIHigh but variable mortality for hospitalized MM patients (27% to 57%) C_LIO_LIOptimal MM control was associated with COVID-19 associated death for MM patinets C_LI Explanation of noveltyThis study investigated the risk and outcome of COVID-19 infection in MM patients globally (10 countries)

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