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Front-line treatment of multiple myeloma.

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… All these triplets showed superior efficacy in comparison with MP and were approved by EMA for the treatment of patients who are not candidates for ASCT. … Phase 3, randomized, study establishing that a triplet bortezomib-IMiD-based induction therapy is a standard-of-care in NDMM patients who are candidates for ASCT. 21146205 10.1016/S0140-6736(10)61424-9 6. Moreau P San Miguel J Sonneveld P . …

New developments in the management of relapsed/refractory multiple myeloma - the role of ixazomib.

Ixazomib is the first oral proteasome inhibitor to be approved, in combination with lenalidomide and dexamethasone, for the treatment of patients with multiple myeloma who have received at least one prior therapy. Approval was on the basis of results from the phase 3, double-blind, placebo-controlled TOURMALINE-MM1 study, which demonstrated a 35% improvement in progression-free survival with the all-oral combination of ixazomib plus lenalidomide-dexamethasone versus lenalidomide-dexamethasone alone (median: 20.6 vs 14.7 months; hazard ratio: 0.74, p=0.012; median follow-up 14.7 months). The ad

The Role of Monoclonal Antibodies in the First-Line Treatment of Transplant-Ineligible Patients with Newly Diagnosed Multiple Myeloma.

Elderly transplant-ineligible (NTE) patients represent the majority of patients affected by multiple myeloma (MM). Elderly patients are a highly heterogeneous population, with large variability in health and functional status. Thus, choosing their optimal treatment is challenging. A wide range of first-line treatments is available, and novel-agent combinations, including monoclonal antibodies (mAbs), have recently entered clinical practice. The combination of the anti-CD38 mAb daratumumab with bortezomib, melphalan and prednisone (Dara-VMP) or lenalidomide and dexamethasone (Dara-Rd) demonstra

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… Fit patients should receive full-dose triplets/quadruplets including novel agents. ASCT can be considered in selected cases with good organ function [ 17 ] ( Figure 1 ). Figure 1 Frailty Assessment. … Another important issue is the choice of treatment in elderly patients who are not fit enough to receive full-dose mAb-based triplets/quadruplets. …

Multiple myeloma current treatment algorithms.

The treatment of multiple myeloma (MM) continues to evolve rapidly with arrival of multiple new drugs, and emerging data from randomized trials to guide therapy. Along the disease course, the choice of specific therapy is affected by many variables including age, performance status, comorbidities, and eligibility for stem cell transplantation. In addition, another key variable that affects treatment strategy is risk stratification of patients into standard and high-risk MM. High-risk MM is defined by the presence of t(4;14), t(14;16), t(14;20), gain 1q, del(17p), or p53 mutation. In this paper

Efficacy and safety of once weekly selinexor 40 mg versus 60 mg with pomalidomide and dexamethasone in relapsed and/or refractory multiple myeloma.

ObjectiveTo identify the optimal dose of selinexor in combination with pomalidomide and dexamethasone (SPd).MethodsAn analysis of efficacy and safety of 2 once-weekly selinexor regimens (60 mg and 40 mg) with pomalidomide and dexamethasone (SPd-60 and SPd-40, respectively) given to patients with relapsed/refractory multiple myeloma (RRMM) in the STOMP (NCT02343042) and XPORT-MM-028 (NCT04414475) trials.ResultsTwenty-eight patients (60.7% males, median age 67.5 years) and 20 patients (35.0% males, median age 65.5 years) were analyzed in the SPd-40 and SPd-60 cohorts, respectively. Overall respo

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… One of the triplet combinations being evaluated in this study is selinexor, pomalidomide and dexamethasone (SPd). … There are limited data on the effectiveness of pomalidomide and low-dose dexamethasone (Pd)-based triplets in the evolving post-anti CD38 mAb treatment landscape, in which there is no standard of care ( 8 , 9 ). …

Daratumumumab, Bortezomib и Dexamethasone для лечения пациентов с повторной или рефрактной множественной миеломой и тяжелыми реанимациями: результаты фазы 2 Испытание GMG-DANTE.

Деформация функции real (RI) — обычное осложнение в множестве миеломы (MM). Вместе с тем имеются ограниченные данные о безопасности и эффективности антиММ-режимов у пациентов с тяжелым RI, поскольку эти пациенты часто исключаются из клинических испытаний. Этот эксперимент, инициированный следователем по многоцентрическому этапу II GMG-DANTE, позволил оценить даратумумаб, бортезомиб и дексаметасон (DVd) в случае рецидива или рецидива (r/r) пациентов MM с тяжелыми пациентами RI. r/RMM ≥1 предыдущая линия обработки и ГФР <30 мл/мин.1.73 m2 или гемодиализ имели право на получение eight циклы DVd,

Current and Novel Alkylators in Multiple Myeloma.

A large number of novel treatments for myeloma have been developed and approved; however, alkylating drugs continue to be part of standard regimens. Additionally, novel alkylators are currently being developed. We performed a non-systematized literary search for relevant papers and communications at large conferences, as well as exploiting the authors' knowledge of the field, to review the history, current use and novel concepts around the traditional alkylators cyclophosphamide, bendamustine and melphalan and current data on the newly developed pro-drug melflufen. Even in the era of targeted

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… Reimbursement issues make the use of these two triplet regimens difficult in many countries. In such cases, the use of triplets with the generic drug bendamustine may be considered as long as they prove efficacious and safe in phase 2 trials. … It is our opinion that salvage transplant should not be used as an alternative to the approved relapse triplets, but could be considered after a limited number of cycles of triplet therapy and always followed by continuous therapy. …

2019 ASCO Annual Meeting Highlights for the Advanced Practitioner: Hematologic Malignancies.

Amy Pierre, MSN, ANP-BC, of the Memorial Sloan Kettering Cancer Center, and Nancy M. Nix, PharmD, BCPS, BCOP of St. Joseph's/Candler Health System offer an advanced practitioner perspective on trials assessing the efficacy and safety of novel agents in smoldering and relapsed/refractory multiple myeloma, chronic lymphocytic leukemia, and acute myeloid leukemia.

Approaches and Challenges in the Management of Multiple Myeloma in the Very Old: Future Treatment Prospects.

The increasing incidence of geriatric patients with multiple myeloma has elevated concerns in clinical practice. While the introduction of novel therapeutic agents has substantially improved outcomes in younger patients with myeloma, poorer outcomes remain in older patients. Managing older patients requires a multidisciplinary team approach to consider factors that may influence both treatment selection and outcomes. Aging is associated with remodeling of vital organs, physiological downregulations of basal metabolism, susceptibility to multiple comorbidities with ultimate frailty, thereby con

Long term responders in frontline multiple myeloma-exception vs expectation of the modern era.

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Evidence-based Korean guidelines for the clinical management of multiple myeloma: addressing 12 key clinical questions.

Multiple myeloma (MM), a hematological malignancy, is characterized by malignant plasma cell proliferation in the bone marrow. Recent treatment advances have significantly improved patient outcomes associated with MM. In this study, we aimed to develop comprehensive, evidence-based guidelines for the diagnosis, prognosis, and treatment of MM. We identified 12 key clinical questions essential for MM management, guiding the extensive literature review and meta-analysis of the study. Our guidelines provide evidence-based recommendations by integrating patient preferences with survey data. These r

High-Cutoff Hemodialysis Therapy for Patients with Light Chain Cast Nephropathy and AKI Requiring Dialysis: PRO.

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… achieve dialysis independence in 48% of patients. 8 In EuLite, all patients received triplet chemotherapy and 51% of the HD group achieved dialysis independence versus 25% as expected in the statistical plan. … Bortezomib-based triplets are associated with a high probability of dialysis independence and rapid renal recovery in newly diagnosed myeloma patients with severe renal failure or those requiring dialysis . Am J Hematol. 2016 ; 91 ( 5 ): 499 – 502 . doi: 10.1002/ajh.24335 26890495 9. …

Hematologic response assessment in monoclonal gammopathy of renal significance: critical appraisal of current criteria.

INTRODUCTION: Current recommendations for hematologic response (HemR) assessment in monoclonal gammopathies of renal significance (MGRS) are based on the monoclonal immunoglobulin (MIg) component responsible for renal damage. Light-chain (LC) amyloidosis criteria are recommended when renal lesions are due to LC, whereas multiple myeloma (MM) criteria are proposed when due to an intact monoclonal immunoglobulin. However, the nephrotoxic MIg is frequently not measurable either by the International Myeloma Working Group (IMWG) or the International Society of Amyloidosis (ISA) criteria. METHODS: I

Real-world treatment trends and triple class exposed status in newly diagnosed multiple myeloma patients in Japan: A retrospective claims database study.

Treatment trends for newly diagnosed multiple myeloma (NDMM) are not fully evaluated in real-world settings in the Japanese population. Triple-class exposed (TCE) patients with relapsed or refractory MM have a poor prognosis and limited treatment options. To clarify characteristics, treatment trends, and TCE status in Japanese patients with MM, we conducted a retrospective, non-interventional study. Data from patients with MM were extracted from a Japanese claims database between 2015 and 2022: this study identified patients with NDMM prescribed daratumumab (D), lenalidomide (R), and/or bortez

Клинический консенсус в отношении лечения санитарной трансплантации, недавно диагностировавшийся множественным миэлома: двойной склейка Делфи.

Цель: Получение клинического консенсуса в отношении факторов, влияющих на установление первой линии для пациентов, имеющих право на трансплантацию (TIE), с недавно поставленным диагнозом множественной миеломы (NDMM). В качестве экспертов были выбраны базирующиеся в США гематологи/онкологи, которые лечат пациентов ТИЭ с NDMM. Все участники дискуссии согласились с тем, что в первую очередь важно использовать наиболее эффективное обращение; 88% По мнению участников дискуссии, наиболее эффективными являются дератумумаб-содержащие режимы. Группировщики согласились с тем, что лечение следует продолж

Улучшение выживаемости в миеломе после предварительного обнаружения состояния прекурсоров: общенациональное исследование реального мира.

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Gaps and opportunities in the treatment of relapsed-refractory multiple myeloma: Consensus recommendations of the NCI Multiple Myeloma Steering Committee.

A wide variety of new therapeutic options for Multiple Myeloma (MM) have recently become available, extending progression-free and overall survival for patients in meaningful ways. However, these treatments are not curative, and patients eventually relapse, necessitating decisions on the appropriate choice of treatment(s) for the next phase of the disease. Additionally, an important subset of MM patients will prove to be refractory to the majority of the available treatments, requiring selection of effective therapies from the remaining options. Immunomodulatory agents (IMiDs), proteasome inhi

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… Two studies have shown increasing depth of response with salvage ASCT after reinduction with modern triplet or quadruplet therapy. … Conventional wisdom has been to use triplet therapies when possible based on multiple Phase 3 trials that have demonstrated an overall survival improvement with triplets compared to doublet therapies. …

The Role of Monoclonal Antibodies in Smoldering and Newly Diagnosed Transplant-Eligible Multiple Myeloma.

The recent introduction of monoclonal antibodies (MoAbs), with several cellular targets, such as CD-38 (daratumumab and isatuximab) and SLAM F7 (elotuzumab), differently combined with other classes of agents, has significantly extended the outcomes of patients with multiple myeloma (MM) in different phases of the disease. Initially used in advanced/refractory patients, different MoAbs combination have been introduced in the treatment of newly diagnosed transplant eligible patients (NDTEMM), showing a significant improvement in the depth of the response and in survival outcomes, without a signi

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… Moreover, given the mechanism of action and safety profile of MoAbs, the shift from triplets to quadruplets has not resulted in a worsening of patients’ quality of life [ 2 , 3 ]. … The combination of MoAb and a triplet (proteasome inhibitor (PI)-IMiD-dex) will probably become the new standard of care. 2.5. Anti-CD-38 Monoclonal Antibodies 2.5.1. …

Treatment of relapsed and refractory multiple myeloma.

The therapeutic strategy for relapsed and refractory multiple myeloma (RRMM) integrates a holistic approach regarding patient, disease, and drug-related factors. Patient-related factors include age, frailty status, and underlying comorbidities, especially cardiovascular and renal diseases and peripheral neuropathies that affect tolerability to multiple drug combinations or transplantations. Disease-related factors encompass these multiple patient-related factors, particularly the aggressiveness of the disease and cytogenetics. Regarding drug-related factors, the approval of novel proteasome in

Update on elotuzumab for the treatment of relapsed/refractory multiple myeloma: patients' selection and perspective.

Monoclonal antibodies (mAbs) targeting antigens expressed by plasma cells demonstrated major clinical activity in multiple myeloma patients and therefore became a new major class of drug for these patients. Elotuzumab is a humanized mAb targeting the cell surface signaling lymphocytic activation molecule family member 7, a glycoprotein highly expressed on plasma cells, that is the second mAb approved for the treatment of myeloma patients. The mechanism of action of elotuzumab includes natural killer cell (NK) mediated antibody-dependent cellular cytotoxicity and direct activation of NK-cells.