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Руководящие принципы и консенсус в отношении минимально адаптированной к остаточным болезням терапии в множестве миеломы, выработанные Рабочей группой по миеломе в Пантихоокеанском регионе.

Лечение множественной миеломы (ММ) вступило в эру терапии, ориентированной на глубокую ремиссию, где минимальные остаточные заболевания (МВД) стали ключевым показателем реакции на лечение и долгосрочного прогнозирования, превосходя обычные критерии полной ремиссии. Однако оптимальная интеграция МРТ в процесс принятия клинических решений еще не достигнута. Этот экспертный консенсус предлагает основанные на фактических данных руководящие указания относительно пересмотра целей лечения в эпоху лечения на основе CD38, включения статуса MRD в терапевтические решения, стандартизации обнаружения MRD и

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… Two years after stopping therapy, less than 15% of these patients had disease progression or needed retreatment for MRD resurgence. This study shows that patients with deep MRD negativity can safely defer additional consolidation without affecting outcomes. … intervention for patients with biochemical progression, potentially improving long-term disease control. 13 Evidence from the phase II MRD2STOP study showed that patients who experienced MRD resurgence (10 -6 ) during maintenance therapy discontinuation were able to regain MRD negativity after successful retreatment …

Выбрать первоначальную терапию MS; факторы личного характера, болезни и лекарственные средства.

Инициирование болезни, изменяющей терапию у пациента с недавно поставленным диагнозом повторного склероза, в настоящее время предоставляет наилучшую возможность повлиять на их последующий курс лечения. В этой статье рассматриваются личные факторы, характеристики представления заболеваний и данные о текущих заболеваниях, изменяющих терапию, с точки зрения выбора первоначального лечения в этой среде. Хотя показатели для прогнозирования на индивидуальном уровне остаются ненадежными, особенно для тех, кто имеет мягкие представления, имеющиеся в настоящее время данные об относительной эффективности

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… In an extension study over 5 years which allowed retreatment for emergent disease activity, 68.5 ​% received no additional therapy. At five years, 60 ​% had stable disability scores, 18 ​% were worse, and 22 ​% were improved compared to baseline [ 124 ]. … Alemtuzumab is a highly potent DMT with prolonged suppression of inflammatory MS activity in many patients, however, breakthrough disease occurs in a substantial number of individuals following initial therapy, requiring either retreatment with the agent or an alternate DMT, and serious adverse effects …

Isatuximab in combination with cemiplimab in patients with relapsed/refractory multiple myeloma: A phase 1/2 study.

BACKGROUND: Given the incurable nature of multiple myeloma (MM), efforts are made to improve the efficacy of anti-CD38 monoclonal antibodies via combinations with other potentially synergistic therapies. This Phase 1/2 trial (NCT03194867) was designed to determine whether cemiplimab (anti-PD-1) enhances the anti-myeloma activity of isatuximab (anti-CD38) in patients with relapsed and refractory multiple myeloma (RRMM), to confirm the feasibility of the combination, determine its efficacy, and further evaluate its safety. METHODS: Patients received isatuximab 10 mg/kg once weekly for 4 weeks f

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… Whether benefit can be gained from an alternate anti‐CD38 agent (or even retreatment with the same anti‐CD38 agent) and the appropriate timing of reintroduction of CD38 inhibition remain important clinical questions, particularly as anti‐CD38 therapy moves into earlier lines of treatment. … patient had minor response‐stable disease, and one patient had a partial response. 32 Results from the present study add to the available data on the appropriate use and timing of subsequent anti‐CD38 therapy, but this important clinical question should be addressed further in prospective crossover or retreatment …

Bortezomib, thalidomide and dexamethasone, with or without cyclophosphamide, for patients with previously untreated multiple myeloma: 5-year follow-up.

This follow-up extension of a randomised phase II study assessed differences in long-term outcomes between bortezomib-thalidomide-dexamethasone (VTD) and VTD-cyclophosphamide (VTDC) induction therapy in multiple myeloma. Newly diagnosed patients (n = 98) were randomised 1:1 to intravenous bortezomib (1·3 mg/m(2); days 1, 4, 8, 11), thalidomide (100 mg; days 1-21), and dexamethasone (40 mg; days 1-4, 9-12), with/without cyclophosphamide (400 mg/m(2); days 1, 8), for four 21-day cycles before stem-cell mobilisation/transplantation. After a median follow-up of 64·8 months, median time-to-next the

Uncertainties about the benefit-risk balance of oncology medicines assessed by the European Medicines Agency.

BackgroundDrug regulators assess and describe uncertainties regarding treatment outcomes and the benefit-risk balance of newly authorised medicines. We aimed to evaluate the type and number of uncertainties described in the benefit-risk assessment for initial marketing authorisations of oncology medicines assessed by the European Medicines Agency (EMA). We also aimed to develop a systematic classification of uncertainties to contribute to improved communication about uncertainties.Materials and methodsWe included all medicines containing a new active substance assessed by the EMA and granted a

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… “The B/R of retreatment with ide-cel is uncertain, as the responses reported in the re-treated population were infrequent (5 PR and one VGPR reported in 29 retreated patients in study MM-001), and a limited PFS was observed.” …

Managing treatment-related peripheral neuropathy in patients with multiple myeloma.

Peripheral neuropathy is one of the most important complications of multiple myeloma treatment. Neurological damage can be observed at the onset of the disease, due to the effect of monoclonal protein or radicular compression, but more often is treatment related. Vinca alkaloids in the past era, and more recently, thalidomide and bortezomib are mainly responsible. Degeneration of dorsal root ganglion is common, prevalently related to angiogenesis inhibition and cytokine modulation in the case of thalidomide and inhibition of the ubiquitin proteasome system in the case of bortezomib. Sensory ne

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… It is important to note that once BiPN has resolved, there is no increased risk for cumulative BiPN upon retreatment with bortezomib. 80 New generation PIs have been developed in an effort to overcome resistance to bortezomib and side effects. … A prospective, international phase 2 study of bortezomib retreatment in patients with relapsed multiple myeloma. Br J Haematol. 2013;160(5):649–659. doi: 10.1111/bjh.12198. 81. Siegel D, Martin T, Nooka A, et al. …

Резюме книги: Тема: 13th Международный симпозиум на тему " Ходжкин лимфома " ; октябрь 2024

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Gemcitabine and carfilzomib induced thrombotic microangiopathy: eculizumab as a life-saving treatment.

Drug-induced aHUS is rare; however, early diagnosis is vital to reduce morbidity and mortality. With confirmation of the diagnosis, eculizumab appears to be a viable treatment option to suppress the pro-inflammatory surge. Furthermore, adverse side effects of medications such as carfilzomib and gemcitabine should be considered in the appropriate settings.

INSIGHT MM: a large, global, prospective, non-interventional, real-world study of patients with multiple myeloma.

With the introduction of new drugs with different mechanisms of action, multiple myeloma (MM) patients' outcomes have improved. However, the efficacy seen in clinical trials is often not seen in real-world settings and data on the effectiveness of MM therapies are needed. INSIGHT MM is a prospective, global, non-interventional, observational study that is enrolling approximately 4200 patients with newly diagnosed or relapsed/refractory MM, making it the largest study of its kind to date. The study aims to describe contemporary, real-world patterns of patient characteristics, clinical disease p

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… These include documentation of treatment combinations prescribed, duration of treatment, sequencing of therapies, retreatment and use of continuous versus fixed-duration therapy, and if a patient has received therapy as part of a clinical trial. … each line, prior SCT or consolidation/maintenance therapy, use of investigational therapy as part of a clinical trial, response, MRD † | Retrospective Disease management | Baseline and quarterly | – Current therapy: type of regimens and drugs (including duration of treatment, sequencing of therapies, retreatment …

Evolving paradigms in the treatment of relapsed/refractory multiple myeloma: increased options and increased complexity.

The use of modern therapies such as thalidomide, bortezomib and lenalidomide coupled with upfront high-dose therapy and autologous stem cell transplant (ASCT) has resulted in improved survival in patients with newly diagnosed multiple myeloma (MM). However, patients with relapsed/refractory multiple myeloma (RRMM) often have poorer clinical outcomes and might benefit from novel therapeutic strategies. Emerging therapies, such as deacetylase inhibitors, monoclonal antibodies and new proteasome inhibitors, appear promising and may change the therapeutic landscape in RRMM. A limited number of stu

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… Efficacy of retreatment with immunomodulatory drugs (IMiDs) in patients receiving IMiDs for initial therapy of newly diagnosed multiple myeloma . … A prospective, international phase 2 study of bortezomib retreatment in patients with relapsed multiple myeloma . Br J Haematol 2013 ; 160 : 649 –659. 23293914 10.1111/bjh.12198 Mikhael JR, Dingli D, Roy V, Reeder CB, Buadi FK, Hayman SR et al. …

The Society for Immunotherapy of Cancer consensus statement on immunotherapy for the treatment of multiple myeloma.

Outcomes in multiple myeloma (MM) have improved dramatically in the last two decades with the advent of novel therapies including immunomodulatory agents (IMiDs), proteasome inhibitors and monoclonal antibodies. In recent years, immunotherapy for the treatment of MM has advanced rapidly, with the approval of new targeted agents and monoclonal antibodies directed against myeloma cell-surface antigens, as well as maturing data from late stage trials of chimeric antigen receptor CAR T cells. Therapies that engage the immune system to treat myeloma offer significant clinical benefits with durable

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… Trials are ongoing investigating dara as maintenance therapy after autologous stem cell transplant ( NCT03901963 and NCT03346135 ). 67 There is insufficient data to establish efficacy for retreatment with dara. … A consensus could not be reached to recommend retreatment with dara in patients relapsing on monthly dosing. Patients on dara should receive seasonal influenza vaccines. …

Comprehensive Single-Cell Immune Profiling Defines the Patient Multiple Myeloma Microenvironment Following Oncolytic Virus Therapy in a Phase Ib Trial.

PurposeOur preclinical studies showed that the oncolytic reovirus formulation pelareorep (PELA) has significant immunomodulatory anti-myeloma activity. We conducted an investigator-initiated clinical trial to evaluate PELA in combination with dexamethasone (Dex) and bortezomib (BZ) and define the tumor immune microenvironment (TiME) in patients with multiple myeloma treated with this regimen.Patients and methodsPatients with relapsed/refractory multiple myeloma (n = 14) were enrolled in a phase Ib clinical trial (ClinicalTrials.gov: NCT02514382) of three escalating PELA doses administered on D

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… The response to PELA/BZ/Dex treatment in these patients lasted far longer than would be expected for BZ retreatment alone (Patient 11: PFS of 45 months; Patient 10: PFS 52 months for PELA/BZ/Dex vs. 6.4 months expected for BZ retreatment; ref. 39 ). … Bortezomib retreatment for relapsed and refractory multiple myeloma in real-world clinical practice. Health Sci Rep 2019;2:e104. 40. Ravirala D, Pei G, Zhao Z, Zhang X. Comprehensive characterization of tumor immune landscape following oncolytic virotherapy by single-cell RNA sequencing. …

От диагностики к лечению: изучение механизмов, лежащих в основе оптического неврата в множестве склерозов.

Множественный склероз (MS) — хроническое аутоиммунное заболевание, воздействующее на центральную нервную систему, которое, как правило, вызывает сенсорные расстройства, моторную слабость, слабую походку, несогласованность и оптический неуриит (ON). Согласно статистическим данным, до 50% пациентов, страдающих синдромом MS, испытывают проблемы со зрением в период болезни, страдающие от нечеткого зрения, боли, недостатка зрения и даже слепоты. Лечение перешло от кортикостероидов к лечению, ориентированному на клетки В/Т. В рамках этого обзора проводится всеобъемлющая и систематическая оценка диаг

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… Retreatment every 24 weeks In PPMS, 1000 mg every 24 weeks for 96 weeks (4 cycles) For relapse in SPMS, 1000 mg weekly for 4 weeks A study of 69 patients afflicted with relapsing–remitting MS received two infusions of rituximab at 1000 mg with a fortnight's interval. … Retreatment every 24 weeks In PPMS, 1000 mg every 24 weeks for 96 weeks (4 cycles) For relapse in SPMS, 1000 mg weekly for 4 weeks A study of 69 patients afflicted with relapsing–remitting MS received two infusions of rituximab at 1000 mg with a fortnight's interval. …

Clinical Management of Triple-Class Refractory Multiple Myeloma: A Review of Current Strategies and Emerging Therapies.

Major progress has been made in the upfront treatment of multiple myeloma, but the disease ultimately relapses and leads to death in the vast majority of those afflicted. New treatment strategies and modalities are necessary to treat myeloma in relapse, particularly in cases of triple-refractory status defined by disease progression during or shortly after treatment with immunomodulatory agents, proteasome inhibitors, and anti-CD38 monoclonal antibody therapy. In this manuscript, we review recent promising developments in the treatment of triple-class refractory myeloma including bispecific an

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… Cytogenic abnormalities or other disease-related factors, treatment-related factors, such as prior drug exposures and toxicities, longevity of prior remission, and retreatment, and patient-related factors, such as renal insufficiency, hepatic impairment, comorbidities, and patient preference, should … A prospective, international phase 2 study of bortezomib retreatment in patients with relapsed multiple myeloma Br. J. Haematol. 2013 160 649 659 10.1111/bjh.12198 23293914 11. Mikhael J.R. …

Propranolol: A "Pick and Roll" Team Player in Benign Tumors and Cancer Therapies.

Research on cancer therapies focuses on processes such as angiogenesis, cell signaling, stemness, metastasis, and drug resistance and inflammation, all of which are influenced by the cellular and molecular microenvironment of the tumor. Different strategies, such as antibodies, small chemicals, hormones, cytokines, and, recently, gene editing techniques, have been tested to reduce the malignancy and generate a harmful microenvironment for the tumor. Few therapeutic agents have shown benefits when administered alone, but a few more have demonstrated clear improvement when administered in combin

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… Of the patients who achieved success, 68% continued for 3 months without treatment, and 24% required retreatment. Adverse events, reported by 80% of the patients, were mild and expected in this population related to known side effects of propranolol. … Retreatment was effective, and the safety profile was satisfactory. …

Lenalidomide maintenance for diffuse large B-cell lymphoma patients responding to R-CHOP: quality of life, dosing, and safety results from the randomised controlled REMARC study.

Lenalidomide maintenance therapy prolonged progression-free survival (PFS) versus placebo in elderly patients with diffuse large B-cell lymphoma (DLBCL) responding to induction chemotherapy in the phase 3 REMARC study. This subpopulation analysis assessed the impact of lenalidomide maintenance and treatment-emergent adverse events (TEAEs) on health-related quality of life (HRQOL). Global health status (GHS), and physical functioning and fatigue subscales were evaluated in patients who completed the European Organisation for Research and Treatment of Cancer quality-of-life questionnaire-C30 v3.

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… However, around one‐third of patients relapse or require retreatment within the first 24 months post first‐line induction (Maurer et al. , 2014 ). This is associated with poor outcome and a median survival after relapse or retreatment of 10 months (McMillan et al. , 2016 ). …

New developments in the treatment of multiple myeloma - clinical utility of daratumumab.

Multiple myeloma is a clonal disorder of plasma cells that is currently considered incurable. CD38 is a 46 kDa type II transmembrane glycoprotein that is highly expressed on myeloma cells. Daratumumab is a first in-class human IgG1 monoclonal antibody that targets CD38, and has antimyeloma effects through several mechanisms. Single-agent trials show surprising activity in heavily pretreated myeloma patients. Trials in the relapsed setting, where daratumumab is added to lenalidomide and dexamethasone or bortezomib and dexamethasone, have demonstrated significantly improved progression-free surv

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… These authors also demonstrate the return of CD38 to baseline levels, 6 months after treatment cessation, which could provide a rationale for retreating selected patients. Resistance of myeloma cells following progressive lines of therapy is therapeutically challenging. … with at least 2 lines of prior therapy and relapsed or relapsed and refractory multiple myeloma Blood 2015 126 23 508 508 40 Nooka AK Joseph N Boise LH Gleason C Kaufman JL Lonial S Clinical efficacy of daratumumab, pomalidomide and dexamethasone in relapsed, refractory myeloma patients: utility of retreatment …

SEOM Clinical Guideline for bone metastases from solid tumours (2016).

Bone metastases are common in many advanced solid tumours, being breast, prostate, thyroid, lung, and renal cancer the most prevalent. Bone metastases can produce skeletal-related events (SREs), defined as pathological fracture, spinal cord compression, need of bone irradiation or need of bone surgery, and hypercalcaemia. Patients with bone metastases experience pain, functional impairment and have a negative impact on their quality of life. Several imaging techniques are available for diagnosis of this disease. Bone-targeted therapies include zoledronic acid, a potent biphosfonate, and denosu

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… SBRT may be particularly useful in selected cases with radio-resistant tumours, spinal cord compression, where there is a significant concern about normal tissue toxicity and for those who need retreatment for previously spinal metastases. … Single fraction radiotherapy is efficacious: a further analysis of the Dutch Bone Metastasis Study controlling for the influence of retreatment. Int J Radiat Oncol Biol Phys. 2004;59(2):528–537. doi: 10.1016/j.ijrobp.2003.10.006. 58. Hoskin P, Price P, Eason D, Regan J, Austin D, Palmer S, et al. …

A predictive tool particularly designed for elderly myeloma patients presenting with spinal cord compression.

BackgroundThis study was performed to design a predictive tool that allows the estimation of overall survival (OS) of elderly myeloma patients (aged ≥ 65 years) presenting with myeloma-induced spinal cord compression (SCC).MethodsOne-hundred-and-sixteen patients irradiated for motor deficits of the legs due to myeloma-induced spinal cord compression were retrospectively evaluated. Ten characteristics were analyzed for OS including age, interval between myeloma diagnosis and radiotherapy, other osseous myeloma lesions, myeloma type, gender, time developing motor deficits, number of affected ver

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… Milker-Zabel S Zabel A Thilmann C Schlegel W Wannenmacher M Debus J Clinical results of retreatment of vertebral bone metastases by stereotactic conformal radiotherapy and intensity-modulated radiotherapy Int J Radiat Oncol Biol Phys 2003 55 162 167 10.1016/S0360-3016(02)03864-6 12504049 9. …

Risk factors for relapse in non-infectious cryoglobulinemic vasculitis, including type I cryoglobulinemia: a systematic review.

BackgroundData on non-infectious cryoglobulinemic vasculitis (NICV) is scarce, especially concerning the management of relapses, which are troublesome. We aimed to investigate risk factors for relapse in NICV.MethodsA systematic literature search of CINAHL, Embase, MEDLINE, Scopus, and the Web of Science databases was implemented until April 2023. Eligible studies included randomized control trials, observational studies, and case series with ≥4 patients. Two reviewers independently extracted data and assessed the quality of the eligible studies.ResultsA total of 3,724 articles were retrieved

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… 49.9 ± 45.5 months | Noted in 60% | Noted in 31.3% | RTX + CS severe infections 29.1%, BCL/WM 8.9%, Increased early mortality when used first line | Relapse 42.7% with renal flare 75%; Death 24% Colantuono 2017 ( * n = 2) | EMC 5% | Cutaneous 89% Neuropathy 78% Nephropathy 41% | Not described | RTX ± retreatment … De Vita et al. discussed the superiority of RTX to conventional treatment (consisting of CS, AZA, CYC, or PLEX) in refractory cases where subsequent responses were achieved on RTX retreatment. …