international myeloma working group
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2021 ◽  
pp. 1-2
Author(s):  
Tobias Holderried

KarMMa ist eine offene, einarmige, multizentrische, multinationale Phase-II-Studie zur Bewertung der Wirksamkeit und Sicherheit von Idecabtagen Vicleucel (ide-cel) bei erwachsenen Patienten mit rezidiviertem und refraktärem Multiplem Myelom (RRMM) in Nordamerika und Europa. Der primäre Endpunkt der Studie ist die Gesamtansprechrate (Overall Response Rate, ORR), die von einem unabhängigen Prüfungsausschuss (IRC) gemäß den Kriterien der International Myeloma Working Group (IMWG) bewertet wird. Ein wichtiger sekundärer Endpunkt ist ein komplettes Ansprechen (complete Response, CR) oder besser. Bei ide-cel handelt es sich um eine BCMA-gerichtete, genetisch modifizierte autologe CAR-T-Zell-Immuntherapie. Ide-cel besteht aus einem murinen extrazellulären einkettigen variablen Fragment (single-chain variable fragment, scFv), das spezifisch für die Erkennung von BCMA ist und an eine humane CD8-α-Gelenk- und Transmembrandomäne gebunden ist. Diese ist im Tandem mit den zytoplasmatischen T-Zell-Signaldomänen CD137 4–1BB und CD3-ζ-Kette fusioniert. Ide-cel erkennt und bindet an BCMA auf der Oberfläche von multiplen Myelom-Zellen, was zur Proliferation von CAR-T-Zellen, zur Ausschüttung von Zytokinen und zur anschließenden zytolytischen Abtötung von BCMA-exprimierenden Zellen führt. Ide-cel führte bei der Mehrheit der stark vorbehandelten Patienten mit refraktärem und rezidivierendem Myelom zu einem Ansprechen; ein MRD-negativer Status wurde bei 26% der behandelten Patienten erreicht. Bei fast allen Patienten traten toxische Wirkungen des Grades 3 oder 4 auf, am häufigsten hämatologische toxische Wirkungen und Zytokin-Freisetzungssyndrome (Cytokine-release syndrome, CRS). (ClinicalTrials.gov Identifier: NCT03361748)


Haematologica ◽  
2021 ◽  
Author(s):  
Pellegrino Musto ◽  
Monika Engelhardt ◽  
Jo Caers ◽  
Niccolo’ Bolli ◽  
Martin Kaiser ◽  
...  

According to the updated International Myeloma Working Group criteria, smoldering multiple myeloma (SMM) is an asymptomatic plasma cell disorder characterized by an M-component >3 g/dL, bone marrow plasma cell infiltration >10% and


2021 ◽  
Author(s):  
L Papageorgiou ◽  
P Vandreden ◽  
L Garderet ◽  
I Elalamy ◽  
G Gerotziafas

2021 ◽  
Vol 22 (3) ◽  
pp. e119-e130 ◽  
Author(s):  
Evangelos Terpos ◽  
Elena Zamagni ◽  
Suzanne Lentzsch ◽  
Matthew T Drake ◽  
Ramón García-Sanz ◽  
...  

2021 ◽  
Vol 22 (3) ◽  
pp. e105-e118
Author(s):  
Philippe Moreau ◽  
Shaji K Kumar ◽  
Jesús San Miguel ◽  
Faith Davies ◽  
Elena Zamagni ◽  
...  

2021 ◽  
Vol 2 (1) ◽  
pp. 33
Author(s):  
Maria Ingrid Ferreira Dias Gregório ◽  
Lívia Maria Alves de Souza ◽  
Sarah Buarque Gomes de Moura

Introdução: O mieloma múltiplo (MM) é uma gamopatia monoclonal incurável caracterizada pela proliferação maligna e clonal de plasmócitos na medula óssea, produzindo proteína M. A terapia do MM evoluiu na última década, com taxas de resposta geral > 90% e resposta completa > 50%. Entretanto, a recaída permanece alta, sugerindo que subclones resistentes persistem e que podem não ser medidos pelas técnicas atuais. Tradicionalmente, as taxas de resposta foram definidas pela urina e eletroforese de proteínas séricas, imunofixação e ausência de clones no exame histopatológico da medula óssea. Atualmente, existem vários ensaios sensíveis validados para estimar doença residual mínima (DRM). Objetivo: Descrever os novos métodos e técnicas utilizadas para detecção de DRM no MM. Material e métodos: Tratou-se de uma revisão narrativa, utilizando os descritores: Mieloma Múltiplo; Diagnóstico; Doença Residual Mínima. Foram realizadas buscas nas bases de dados Lilacs, Scielo e Pubmed, referentes ao período de 2015 a 2020. Foi incluído um total de 10 artigos neste estudo. Resultados: Os artigos analisados avaliaram os níveis de doença mínima verificáveis com sequenciamento e citometria de fluxo, ambos de última geração. A FDA aprovou esse teste de fluxo de 8 cores como o padrão para medir o grau de resposta em estudos clínicos de mieloma nos EUA. Além disso, o teste de isotipo de cadeia pesada + leve (Hevylite®), será incorporado aos critérios de resposta como marcador sanguíneo de baixo nível de atividade da doença. Em 2016, a Lancet Oncology publicou os critérios do International Myeloma Working Group para avaliação de resposta e doença residual mínima no MM com citometria de fluxo de última geração (NGF) e/ou sequenciamento de última geração (NGS). Conclusão: Novos métodos de detecção de DRM por NGF e NGS são técnicas promissoras para a avaliação da resposta ao tratamento do MM quando comparado às mais antigas.


2021 ◽  
Vol 11 (2) ◽  
Author(s):  
David L. Murray ◽  
Noemi Puig ◽  
Sigurdur Kristinsson ◽  
Saad Z. Usmani ◽  
Angela Dispenzieri ◽  
...  

AbstractPlasma cell disorders (PCDs) are identified in the clinical lab by detecting the monoclonal immunoglobulin (M-protein) which they produce. Traditionally, serum protein electrophoresis methods have been utilized to detect and isotype M-proteins. Increasing demands to detect low-level disease and new therapeutic monoclonal immunoglobulin treatments have stretched the electrophoretic methods to their analytical limits. Newer techniques based on mass spectrometry (MS) are emerging which have improved clinical and analytical performance. MS is gaining traction into clinical laboratories, and has replaced immunofixation electrophoresis (IFE) in routine practice at one institution. The International Myeloma Working Group (IMWG) Mass Spectrometry Committee reviewed the literature in order to summarize current data and to make recommendations regarding the role of mass spectrometric methods in diagnosing and monitoring patients with myeloma and related disorders. Current literature demonstrates that immune-enrichment of immunoglobulins coupled to intact light chain MALDI-TOF MS has clinical characteristics equivalent in performance to IFE with added benefits of detecting additional risk factors for PCDs, differentiating M-protein from therapeutic antibodies, and is a suitable replacement for IFE for diagnosing and monitoring multiple myeloma and related PCDs. In this paper we discuss the IMWG recommendations for the use of MS in PCDs.


Folia Medica ◽  
2020 ◽  
Vol 62 (4) ◽  
pp. 730-735
Author(s):  
Vasko Graklanov ◽  
Veselin Popov ◽  
Ralitsa Raycheva

Aim: &#1058;&#1086; investigate the serum levels of vitamin D in newly diagnosed patients with multiple myeloma. Patients and methods: In this study we measured the serum levels of vitamin D in 37 patients (19 women, 18 men) at a median age of 68 years and a diagnosis of MM according to the International Myeloma Working Group (IMWG) criteria. The immunoassay tests used for the quantification of 25 (OH) &ndash; Vitamin D were original ELISA kits Immundiagnostic and the measurement was done before starting the treatment. Results: Serum levels below the optimum (<30 ng/ml) were recorded in all 37 patients. The median value of vitamin D was 4.3&plusmn;6.5 mg/ml, the maximum value measured was 24.7 mg/ml, which is below the lower limit of the reference value for deficiency. Conclusions: In this study, we found extremely low serum vitamin D levels in most of the newly diagnosed MM patients.


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