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Introduction: Despite several studies, the impact of coronavirus disease 2019 on patients with multiple myeloma remains uncertain. Material(s) and Method(s): We performed a survey that covered the period of the first and second waves of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic in 23 centers inseven countries. Out of 352 patients with myeloma and SARS-CoV-2, 23% died. Results/Conclusions: Logistic regression showed a lower risk of death among patients treated with proteasome inhibitor and a higher risk of death for those who had a severe or a very severe course of disease.Copyright © 2023 Sciendo. All rights reserved.
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BACKGROUND: The COVID-19 pandemic has created enormous challenges for the clinical management of patients with hematological malignancies (HMs), raising questions about the optimal care of this patient group. METHODS: This consensus manuscript aims at discussing clinical evidence and providing expert advice on statements related to the management of HMs in the COVID-19 pandemic. For this purpose, an international consortium was established including a steering committee, which prepared six working packages addressing significant clinical questions from the COVID-19 diagnosis, treatment, and mitigation strategies to specific HMs management in the pandemic. During a virtual consensus meeting, including global experts and lead by the European Society for Medical Oncology and the European Hematology Association, statements were discussed and voted upon. When a consensus could not be reached, the panel revised statements to develop consensual clinical guidance. RESULTS AND CONCLUSION: The expert panel agreed on 33 statements, reflecting a consensus, which will guide clinical decision making for patients with hematological neoplasms during the COVID-19 pandemic.
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COVID-19 , Hematologic Neoplasms , COVID-19 Testing , Consensus , Hematologic Neoplasms/epidemiology , Hematologic Neoplasms/therapy , Humans , PandemicsABSTRACT
Aim: The novel coronavirus (SARS-CoV-2) is a highly contagious disease with a significant mortality rate. Haematological patients are among those most at risk. We evaluate here the disease course, association between comorbidities and COVID-19 severity and seroconversion potential in 50 positive patients at our clinic. Methods: We performed 1,600 diagnostic PCR nasopharyngeal swabs over a period of 8 months. We introduced a set of preventive measures so as to protect our patients and personnel. In 50 COVID-19 positive patients, we closely evaluated the course of the disease, the impact of underlying risk factors and the principal haematological diagnoses. We also evaluated the potential for seroconversion in 15 COVID-19 positive patients. Results: Strict barrier measures, especially in patients undergoing autologous stem cell transplantation, have been shown as being crucial for reducing the spread of disease.We did not record any disease outbreak and registered only one positive case during the peri-transplant period at our facility. The most common comorbidities were arterial hypertension or other cardiovascular disease, type 2 diabetes and renal impairment. Two-thirds of positive patients were on first line treatment. Hypogammaglobulinemia did not prove to be a risk factor for a severe COVID-19 course and we did not observe it to be an obstacle for seroconversion. Conclusion: Preventive measures are significant for reducing the spread of disease, especially in haematology centres. In our single centre experience, we report a mortality of 14%. Although we report a relatively small cohort and much remains yet to be clarified, our results can even now be implemented in daily practice.
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Background: Proteasome inhibitors (PIs) & monoclonal antibodies are backbones of RRMM treatment;Ixa is approved with lenalidomide-dex for pts with ≥1 prior therapy, & Dara is approved in various regimens, including with bortezomib-dex (DVd). In CASTOR (DVd vs Vd), Vd was limited to 8 cycles;however, prolonged PI therapy is associated with improved outcomes. The IDd regimen with oral Ixa may enable longer-term PI therapy than with DVd. We evaluate IDd using a treat-to-progression approach. Methods: Ixa/Dara-naive RRMM pts receive Ixa 4 mg (days 1, 8, 15), Dara 16 mg/kg (days 1, 8, 15, 22, cycles 1–2;days 1, 15, cycles 3–6;day 1, cycles 7+), & dex 20 mg (days 1, 2, 8, 9, 15, 16, 22, 23) in 28-day cycles. The primary endpoint is ≥ very good partial response (VGPR) rate;secondary endpoints include overall response rate (ORR), progression-free survival (PFS), time to progression (TTP), overall survival (OS), & safety. We report data from the 2nd IA, conducted after ~50% of PFS events had occurred (data cutoff: 1/1/2021). Results: 61 pts were enrolled (median age 69 y, 19.7% aged ≥75 y;19.7% International Staging System stage III;26.2% high-risk cytogenetics [del(17p), t(4;14), t(14;16)], 42.6% expanded high-risk cytogenetics [high-risk &/or amp1q21]);59.0/26.2/14.8% of pts had received 1/2/3 prior lines. At data cutoff, pts had received a median of 16 IDd cycles;37.7% were ongoing. Relative dose intensity (RDI) of Ixa, Dara, & dex was 20%) TEAEs were diarrhea (39.3%), anemia (27.9%), thrombocytopenia (26.2%), & fatigue (21.3%);common (>5%) G≥3 TEAEs were pneumonia (11.5%), thrombocytopenia (11.5%), & anemia (8.2%). Infections & Infestations TEAEs were seen in 57.4% of pts (G≥3 24.6%) and were serious in 26.2%, including pneumonia (9.8%) and COVID-19/pneumonia (4.9%). Rate of peripheral neuropathy (PN) was 18.0% (1.6% G≥3). PN was 28.6% & 12.5%in pts with & without history of PN, respectively. Study drug dose modifications, reductions & discontinuations due to TEAEs were required in 57.4% (Ixa 36.1%, Dara 34.4%, dex 41.0%), 32.8%, & 9.8%of pts, respectively. Four pts died on study due to sudden death, COVID-19 pneumonia, septic shock, & COVID-19 (none were considered study drug-related). Conclusion: These IA data suggest IDd has a positive risk-benefit profile in RRMM pts, with a ≥VGPR rate of 30.5%, median PFS of 17.0 m, & a low rate of discontinuation due to TEAEs. The final analysis of this ongoing study is expected in 2022.
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Background: COVID-19 disease caused by SARS-CoV-2 coronavirus has affected millions of people worldwide. The mortality of this infection varies with age and comorbidities up to more than 10% in very elderly population. The aim of our study was to determine the mortality rate and healthcare utilization among multiple myeloma patients and describe the potential risk factors for death. Aims: The aim of our study was to determine the mortality rate and healthcare utilization among multiple myeloma patients and describe the potential risk factors for death. Methods: We retrospectively analyzed entries in the Czech Registry of Monoclonal Gammopathies from patients who were infected with SARS-CoV-2 from March 2020 until January 2021. Demographic data, treatment patterns, comorbidities, symptoms of COVID-19, treatment modalities and healthcare utilization was compared in survivors and non-survivors. Results: Overall, 158 patients with MM and COVID-19 with known outcome of the infection were identified. There were 72.8% (115/158) survivors and 27.2% (43/158) deceased patients. Both groups were balanced in gender, ECOG, M protein isotype, ISS stage and comorbidities. Non-survivors were significantly older (median 71.5 years vs 67.9 years, p=0.046). There were no differences between previous treatment lines in either group. Patients received median one prior line of therapy (range 0-6, p=0.994). 95% of patients were exposed to IMiDs (150/158), 89.9% to proteasome inhibitors (142/158) and 18.4% (29/158) to anti-CD38 antibody. Autologous stem cell transplantation was used in 36.7% (58/158) of patients. There were no differences in administered treatment in both groups. Inpatient treatment due to COVID-19 was required in 46.8% (74/158) of patients. Survivors hospitalization rate was 31.3% (36/115) and 88.4% (38/43) in non-survivors. In-hospital mortality was 51.4% (38/74). Non-survivors had more intensive care unit stays (4.3% vs 55.8%, p<0.0001) and needed more ventilation support (0.9 % vs 23.3%, p<0.0001). Mortality of patients who needed ICU was 82.8% (24/29 ICU stays) and 32.7% (16/49 ward stays) in patients who needed standard ward inpatient therapy. Mortality of patients needing artificial ventilation was 90.9% (1/11). Mortality of patients needing non-invasive ventilation or high flow nasal oxygen and 85.0% (17/20). Mortality of patients needing Summary/Conclusion: The mortality of MM patients with COVID-19 was very high especially in patients in need of any type of ventilation support. Healthcare utilization was high with almost half of the infected myeloma patients needing inpatient treatment. No apparent risk factors in terms of disease status or previous treatment were identified. Supported by MH CZ - DRO (UHHK, 00169906) and by the program PROGRES Q40/8.