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Article ; Online: Highlights of the 11th International Workshop on Waldenstrom's Macroglobulinemia: What we learned, and how it will impact scientific discovery and patient care.

Treon, Steven P / Patterson, Christopher J / Sanz, Ramon Garcia / Miguel, Jesus San

2023 Volume 60, Issue 2, Page(s) 59–64

MeSH term(s)	Humans ; Waldenstrom Macroglobulinemia/therapy ; Patient Care
Language	English
Publishing date	2023-05-10
Publishing country	United States
Document type	Editorial
ZDB-ID	206923-4
ISSN	1532-8686 ; 0037-1963
ISSN (online)	1532-8686
ISSN	0037-1963
DOI	10.1053/j.seminhematol.2023.05.001
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Article ; Online: Isatuximab-pomalidomide-dexamethasone

Richardson, Paul G / Perrot, Aurore / Miguel, Jesus San / Beksac, Meral / Spicka, Ivan / Leleu, Xavier / Schjesvold, Fredrik / Moreau, Philippe / Dimopoulos, Meletios A / Huang, Shang-Yi / Minarik, Jiri / Cavo, Michele / Prince, H Miles / Macé, Sandrine / Zhang, Rick / Dubin, Franck / Morisse, Mony Chenda / Anderson, Kenneth C

Haematologica

2024

Abstract: The primary and pre-specified updated analyses of ICARIA-MM (NCT02990338) demonstrated improved progression-free survival and a benefit in overall survival (OS) was reported with the addition of isatuximab, an anti-CD38 monoclonal antibody, to ... ...

Abstract	The primary and pre-specified updated analyses of ICARIA-MM (NCT02990338) demonstrated improved progression-free survival and a benefit in overall survival (OS) was reported with the addition of isatuximab, an anti-CD38 monoclonal antibody, to pomalidomide-dexamethasone (Pd) in patients with relapsed/refractory multiple myeloma. Here, we report the final OS analysis. This multicenter, randomized, open-label, phase 3 study included patients who had received and failed ≥2 previous therapies, including lenalidomide and a proteasome inhibitor. Between January 10, 2017, and February 2, 2018, 307 patients were randomized (1:1) to isatuximab-pomalidomide- dexamethasone (Isa-Pd; n = 154) or Pd (n = 153), stratified based on age (3). At data cutoff for the final OS analysis after 220 OS events (January 27, 2022), median follow-up duration was 52.4 months. Median OS (95% confidence interval) was 24.6 months (20.3-31.3 months) with Isa-Pd and 17.7 months (14.4-26.2 months) with Pd (hazard ratio = 0.78; 95% CI, 0.59-1.02; 1-sided P = 0.0319). Despite subsequent daratumumab use in the Pd group and its potential benefit on PFS in the first subsequent therapy line, median PFS2 was significantly longer with Isa-Pd vs. Pd (17.5 vs. 12.9 months; log-rank 1-sided P = 0.0091). In this analysis, Isa-Pd continued to be efficacious and well tolerated after follow-up of approximately 52 months, contributing to a clinically meaningful, 6.9-month improvement in median overall survival in patients with relapsed/refractory multiple myeloma.
Language	English
Publishing date	2024-02-01
Publishing country	Italy
Document type	Journal Article
ZDB-ID	2333-4
ISSN	1592-8721 ; 0017-6567 ; 0390-6078
ISSN (online)	1592-8721
ISSN	0017-6567 ; 0390-6078
DOI	10.3324/haematol.2023.284325
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Article ; Online: Health-related quality of life with idecabtagene vicleucel in relapsed and refractory multiple myeloma.

Delforge, Michel / Shah, Nina / Miguel, Jesús San F / Braverman, Julia / Dhanda, Devender S / Shi, Ling / Guo, Shien / Yu, Peiwen / Liao, Weiqin / Campbell, Timothy B / Munshi, Nikhil C

Blood advances

2022 Volume 6, Issue 4, Page(s) 1309–1318

Abstract: Idecabtagene vicleucel (ide-cel), a B-cell maturation antigen-directed chimeric antigen receptor T cell therapy, showed deep, durable responses in patients with triple-class exposed, relapsed and refractory multiple myeloma (RRMM) in the phase 2 KarMMa ( ... ...

Abstract	Idecabtagene vicleucel (ide-cel), a B-cell maturation antigen-directed chimeric antigen receptor T cell therapy, showed deep, durable responses in patients with triple-class exposed, relapsed and refractory multiple myeloma (RRMM) in the phase 2 KarMMa (Efficacy and Safety Study of bb2121 in Subjects With Relapsed and Refractory Multiple Myeloma) trial. We assessed health-related quality of life (HRQoL) among KarMMa patients. The European Organization for Research and Treatment of Cancer Quality of Life C30 Questionnaire and its supplementary 20-item multiple myeloma module, as well as the EuroQol 5-dimension 5-level instrument, were administered at screening, baseline (≤72 hours before or same day as lymphodepletion), day of ide-cel treatment, and after ide-cel treatment. Mean changes from baseline that exceeded the predetermined threshold of minimally important difference were deemed clinically meaningful. The proportions of patients experiencing clinically meaningful changes in HRQoL were assessed using within-patient change thresholds. Time to stable improvement (≥2 consecutive visits with clinically meaningful HRQoL improvements) was analyzed by using the Kaplan-Meier method. A total of 126 (98%) of 128 patients treated with ide-cel were included in the HRQoL analysis. Pretreatment baseline RRMM burden was high and meaningfully worse than that in the age- and sex-weighted general population. Statistically significant and clinically meaningful improvements from baseline were observed by month 1 for pain (-8.9) and disease symptoms (-10.2), and by month 2 for fatigue (-7.2), physical functioning (6.1), cognitive functioning (6.7), and global health status/QoL (8.0). Clinically meaningful improvements in fatigue, pain, and physical functioning were most prominent at months 9, 12, and 18, respectively, and were sustained through 15 to 18 months after ide-cel treatment. For triple-class exposed patients with RRMM with a poor prognosis and few treatment options, a single ide-cel infusion provides early, sustained, statistically significant, and clinically meaningful improvements in HRQoL. This study was registered at Clinicaltrials.gov as #NCT03361748.
MeSH term(s)	Fatigue ; Humans ; Multiple Myeloma/therapy ; Pain ; Quality of Life ; Receptors, Chimeric Antigen/therapeutic use
Chemical Substances	Receptors, Chimeric Antigen ; idecabtagene vicleucel (8PX1X7UG4D)
Language	English
Publishing date	2022-01-28
Publishing country	United States
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	2915908-8
ISSN	2473-9537 ; 2473-9529
ISSN (online)	2473-9537
ISSN	2473-9529
DOI	10.1182/bloodadvances.2021005913
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Article ; Online: AG5 is a potent non-steroidal anti-inflammatory and immune regulator that preserves innate immunity.

Botella-Asunción, Pablo / Rivero-Buceta, Eva M / Vidaurre-Agut, Carla / Lama, Raquel / Rey-Campos, Magalí / Moreno, Alejandro / Mendoza, Laura / Mingo-Casas, Patricia / Escribano-Romero, Estela / Gutierrez-Adan, Alfonso / Saiz, Juan Carlos / Smerdou, Cristian / Gonzalez, Gloria / Prosper, Felipe / Argemí, Josepmaría / Miguel, Jesus San / Sanchez-Cordón, Pedro J / Figueras, Antonio / Quesada-Gomez, Jose Manuel /

Novoa, Beatriz / Montoya, María / Martín-Acebes, Miguel A / Pineda-Lucena, Antonio / Benlloch, Jose María

Biomedicine & pharmacotherapy = Biomedecine & pharmacotherapie

2023 Volume 169, Page(s) 115882

Abstract: An archetypal anti-inflammatory compound against cytokine storm would inhibit it without suppressing the innate immune response. AG5, an anti-inflammatory compound, has been developed as synthetic derivative of andrographolide, which is highly absorbable ...

Abstract	An archetypal anti-inflammatory compound against cytokine storm would inhibit it without suppressing the innate immune response. AG5, an anti-inflammatory compound, has been developed as synthetic derivative of andrographolide, which is highly absorbable and presents low toxicity. We found that the mechanism of action of AG5 is through the inhibition of caspase-1. Interestingly, we show with in vitro generated human monocyte derived dendritic cells that AG5 preserves innate immune response. AG5 minimizes inflammatory response in a mouse model of lipopolysaccharide (LPS)-induced lung injury and exhibits in vivo anti-inflammatory efficacy in the SARS-CoV-2-infected mouse model. AG5 opens up a new class of anti-inflammatories, since contrary to NSAIDs, AG5 is able to inhibit the cytokine storm, like dexamethasone, but, unlike corticosteroids, preserves adequately the innate immunity. This is critical at the early stages of any naïve infection, but particularly in SARS-CoV-2 infections. Furthermore, AG5 showed interesting antiviral activity against SARS-CoV-2 in humanized mice.
MeSH term(s)	Humans ; Mice ; Animals ; Cytokine Release Syndrome ; Immunity, Innate ; COVID-19 ; SARS-CoV-2 ; Anti-Inflammatory Agents, Non-Steroidal/pharmacology ; Anti-Inflammatory Agents, Non-Steroidal/therapeutic use
Chemical Substances	Anti-Inflammatory Agents, Non-Steroidal
Language	English
Publishing date	2023-11-18
Publishing country	France
Document type	Journal Article
ZDB-ID	392415-4
ISSN	1950-6007 ; 0753-3322 ; 0300-0893
ISSN (online)	1950-6007
ISSN	0753-3322 ; 0300-0893
DOI	10.1016/j.biopha.2023.115882
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Article: Towards a pan-European burnt scar mapping methodology based on single date medium resolution optical remote sensing data

Sedano, Fernando / Kempeneers, Pieter / Miguel, Jesús San / Strobl, Peter / Vogt, Peter

ITC journal. 2013 Feb., v. 20

2013

Abstract: A two stage approach for burnt scar detection from single date multispectral medium spatial resolution optical remote sensing data (AWIFS) has been developed. The approach includes first an identification of burnt scar seeds based on a learning algorithm ...

Abstract	A two stage approach for burnt scar detection from single date multispectral medium spatial resolution optical remote sensing data (AWIFS) has been developed. The approach includes first an identification of burnt scar seeds based on a learning algorithm followed by a region growing process. An Artificial Neural Network (ANN) and a Classification tree (CT) were tested as learning algorithms. Both learning algorithms were coupled with a bootstrap aggregation. Training data for the classifiers were obtained from MODIS-based polygons generated by the Rapid Damage Assessment (RDA) module of the European Forest Fire Information System (EFFIS), to which different levels of filtering were applied. The outcomes were validated against datasets generated from visual interpretation of ETM+ scenes. The method was tested in two locations of Portugal and Greece. Both ANN and CT alternatives produced similar results, with kappa coefficients close to 0.80 in the Greek location and higher than 0.70 in the Portuguese location. In test sites, more than 80% and 90% of burnt areas larger than 10ha and 50ha respectively were detected. The results show that filtering the training dataset reduces the overestimation of burnt areas and produce higher accuracies.
Keywords	algorithms ; data collection ; forest fires ; information systems ; neural networks ; seeds ; spatial data ; Greece ; Portugal
Language	English
Dates of publication	2013-02
Size	p. 52-59.
Publishing place	Elsevier B.V.
Document type	Article
ZDB-ID	2097960-5
ISSN	0303-2434 ; 0303-2434
ISSN (online)	0303-2434
ISSN	0303-2434
DOI	10.1016/j.jag.2011.08.003
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Article ; Online: 2021 European Myeloma Network review and consensus statement on smoldering multiple myeloma: how to distinguish (and manage) Dr. Jekyll and Mr. Hyde.

Musto, Pellegrino / Engelhardt, Monika / Caers, Jo / Bolli, Niccolo' / Kaiser, Martin / Van de Donk, Niels / Terpos, Evangelos / Broijl, Annemiek / De Larrea, Carlos Fernández / Gay, Francesca / Goldschmidt, Hartmut / Hajek, Roman / Vangsted, Annette Juul / Zamagni, Elena / Zweegman, Sonja / Cavo, Michele / Dimopoulos, Meletios / Einsele, Hermann / Ludwig, Heinz /

Barosi, Giovanni / Boccadoro, Mario / Mateos, Maria-Victoria / Sonneveld, Pieter / Miguel, Jesus San

Haematologica

2021 Volume 106, Issue 11, Page(s) 2799–2812

Abstract: 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 <60%, and absence of ... ...

Abstract	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 <60%, and absence of any myeloma-defining event. Active multiple myeloma is preceded by SMM, with a median time to progression of approximately 5 years. Cases of SMM range from the extremes of "monoclonal gammopathy of undetermined significance-like", in which patients never progress during their lifetimes, to "early multiple myeloma", in which transformation into symptomatic disease, based on genomic evolution, may be rapid and devastating. Such a "split personality" makes the prognosis and management of individual patients challenging, particularly with regard to the identification and possible early treatment of high-risk SMM. Outside of clinical trials, the conventional approach to SMM generally remains close observation until progression to active multiple myeloma. However, two prospective, randomized trials have recently demonstrated a significant clinical benefit in terms of time to progression, and of overall survival in one of the two studies, for some patients with higher-risk SMM treated with lenalidomide ± dexamethasone, raising the question of whether such an approach should be considered a new standard of care. In this paper, experts from the European Myeloma Network describe current biological and clinical knowledge on SMM, focusing on novel insights into its molecular pathogenesis, new prognostic scoring systems proposed to identify SMM patients at higher risk of early transformation, and updated results of completed or ongoing clinical trials. Finally, some practical recommendations for the real-life management of these patients, based on Delphi consensus methodology, are provided.
MeSH term(s)	Disease Progression ; Humans ; Monoclonal Gammopathy of Undetermined Significance/diagnosis ; Monoclonal Gammopathy of Undetermined Significance/therapy ; Multiple Myeloma/drug therapy ; Multiple Myeloma/therapy ; Prospective Studies ; Risk Factors ; Smoldering Multiple Myeloma/diagnosis ; Smoldering Multiple Myeloma/therapy
Language	English
Publishing date	2021-11-01
Publishing country	Italy
Document type	Journal Article ; Review
ZDB-ID	2333-4
ISSN	1592-8721 ; 0017-6567 ; 0390-6078
ISSN (online)	1592-8721
ISSN	0017-6567 ; 0390-6078
DOI	10.3324/haematol.2021.278519
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Article ; Online: A novel nano-immunoassay method for quantification of proteins from CD138-purified myeloma cells: biological and clinical utility.

Misiewicz-Krzeminska, Irena / Corchete, Luis Antonio / Rojas, Elizabeta A / Martínez-López, Joaquín / García-Sanz, Ramón / Oriol, Albert / Bladé, Joan / Lahuerta, Juan-José / Miguel, Jesús San / Mateos, María-Victoria / Gutiérrez, Norma C

Haematologica

2018 Volume 103, Issue 5, Page(s) 880–889

Abstract: Protein analysis in bone marrow samples from patients with multiple myeloma has been limited by the low concentration of proteins obtained after ... ...

Abstract	Protein analysis in bone marrow samples from patients with multiple myeloma has been limited by the low concentration of proteins obtained after CD138
MeSH term(s)	Biomarkers, Tumor/genetics ; Biomarkers, Tumor/metabolism ; Humans ; Immunoassay/methods ; Multiple Myeloma/diagnosis ; Multiple Myeloma/genetics ; Multiple Myeloma/metabolism ; Nanotechnology/methods ; Prognosis ; RNA, Messenger/genetics ; Survival Rate ; Syndecan-1/metabolism
Chemical Substances	Biomarkers, Tumor ; RNA, Messenger ; SDC1 protein, human ; Syndecan-1
Language	English
Publishing date	2018-03-15
Publishing country	Italy
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	2333-4
ISSN	1592-8721 ; 0017-6567 ; 0390-6078
ISSN (online)	1592-8721
ISSN	0017-6567 ; 0390-6078
DOI	10.3324/haematol.2017.181628
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Article ; Online: Consensus guidelines and recommendations for infection prevention in multiple myeloma: a report from the International Myeloma Working Group.

Raje, Noopur S / Anaissie, Elias / Kumar, Shaji K / Lonial, Sagar / Martin, Thomas / Gertz, Morie A / Krishnan, Amrita / Hari, Parameswaran / Ludwig, Heinz / O'Donnell, Elizabeth / Yee, Andrew / Kaufman, Jonathan L / Cohen, Adam D / Garderet, Laurent / Wechalekar, Ashutosh F / Terpos, Evangelos / Khatry, Navin / Niesvizky, Ruben / Yi, Qing /

Joshua, Douglas E / Saikia, Tapan / Leung, Nelson / Engelhardt, Monika / Mothy, Mohamad / Branagan, Andrew / Chari, Ajai / Reiman, Anthony J / Lipe, Brea / Richter, Joshua / Rajkumar, S Vincent / Miguel, Jesús San / Anderson, Kenneth C / Stadtmauer, Edward A / Prabhala, Rao H / McCarthy, Phillip L / Munshi, Nikhil C

The Lancet. Haematology

2022 Volume 9, Issue 2, Page(s) e143–e161

Abstract: Infection remains the leading cause of morbidity and mortality in patients with multiple myeloma because of the cumulative effect of disease, treatment, and host-related factors. Given that infectious risk is cumulative through the course of the disease, ...

Abstract	Infection remains the leading cause of morbidity and mortality in patients with multiple myeloma because of the cumulative effect of disease, treatment, and host-related factors. Given that infectious risk is cumulative through the course of the disease, preventing infections is paramount. Optimal preventive strategies include vaccination against common pathogens, antimicrobial prophylaxis, infection control measures, and immunoglobulin replacement in a small subset of patients; however, there are no universally accepted guidelines for infection prevention. This Review provides a consensus statement from a panel of 36 experts with global representation, which was convened by The International Myeloma Society to review existing literature and current guidelines, address issues associated with the risk of infection and prevention of infectious complications in multiple myeloma in the context of emerging therapies, and offer recommendations for preventing these complications.
MeSH term(s)	Consensus ; Humans ; Infections/complications ; Multiple Myeloma/complications ; Multiple Myeloma/drug therapy
Language	English
Publishing date	2022-01-20
Publishing country	England
Document type	Journal Article ; Review
ISSN	2352-3026
ISSN (online)	2352-3026
DOI	10.1016/S2352-3026(21)00283-0
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Article ; Online: Clinical predictors of long-term survival in newly diagnosed transplant eligible multiple myeloma - an IMWG Research Project.

Usmani, Saad Z / Hoering, Antje / Cavo, Michele / Miguel, Jesus San / Goldschimdt, Hartmut / Hajek, Roman / Turesson, Ingemar / Lahuerta, Juan Jose / Attal, Michel / Barlogie, Bart / Lee, Jae Hoon / Kumar, Shaji / Lenhoff, Stig / Morgan, Gareth / Rajkumar, S Vincent / Durie, Brian G M / Moreau, Philippe

Blood cancer journal

2018 Volume 8, Issue 12, Page(s) 123

Abstract: Purpose: multiple myeloma is considered an incurable hematologic cancer but a subset of patients can achieve long-term remissions and survival. The present study examines the clinical features of long-term survival as it correlates to depth of disease ... ...

Abstract	Purpose: multiple myeloma is considered an incurable hematologic cancer but a subset of patients can achieve long-term remissions and survival. The present study examines the clinical features of long-term survival as it correlates to depth of disease response. Patients & methods: this was a multi-institutional, international, retrospective analysis of high-dose melphalan-autologous stem cell transplant (HDM-ASCT) eligible MM patients included in clinical trials. Clinical variable and survival data were collected from 7291 MM patients from Czech Republic, France, Germany, Italy, Korea, Spain, the Nordic Myeloma Study Group and the United States. Kaplan-Meier curves were used to assess progression-free survival (PFS) and overall survival (OS). Relative survival (RS) and statistical cure fractions (CF) were computed for all patients with available data. Results: achieving CR at 1 year was associated with superior PFS (median PFS 3.3 years vs. 2.6 years, p < 0.0001) as well as OS (median OS 8.5 years vs. 6.3 years, p < 0.0001). Clinical variables at diagnosis associated with 5-year survival and 10-year survival were compared with those associated with 2-year death. In multivariate analysis, age over 65 years (OR 1.87, p = 0.002), IgA Isotype (OR 1.53, p = 0.004), low albumin < 3.5 g/dL (OR = 1.36, p = 0.023), elevated beta 2 microglobulin ≥ 3.5 mg/dL (OR 1.86, p < 0.001), serum creatinine levels ≥ 2 mg/dL (OR 1.77, p = 0.005), hemoglobin levels < 10 g/dL (OR 1.55, p = 0.003), and platelet count < 150k/μL (OR 2.26, p < 0.001) appeared to be negatively associated with 10-year survival. The relative survival for the cohort was ~0.9, and the statistical cure fraction was 14.3%. Conclusions: these data identify CR as an important predictor of long-term survival for HDM-ASCT eligible MM patients. They also identify clinical variables reflective of higher disease burden as poor prognostic markers for long-term survival.
MeSH term(s)	Aged ; Aged, 80 and over ; Biomarkers ; Cancer Survivors/statistics & numerical data ; Combined Modality Therapy ; Female ; Humans ; Kaplan-Meier Estimate ; Male ; Multiple Myeloma/diagnosis ; Multiple Myeloma/epidemiology ; Multiple Myeloma/mortality ; Multiple Myeloma/therapy ; Neoplasm Staging ; Odds Ratio ; Population Surveillance ; Prognosis ; Treatment Outcome
Chemical Substances	Biomarkers
Language	English
Publishing date	2018-11-23
Publishing country	United States
Document type	Journal Article
ZDB-ID	2600560-8
ISSN	2044-5385 ; 2044-5385
ISSN (online)	2044-5385
ISSN	2044-5385
DOI	10.1038/s41408-018-0155-7
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Article ; Online: Recommendations for acquisition, interpretation and reporting of whole body low dose CT in patients with multiple myeloma and other plasma cell disorders: a report of the IMWG Bone Working Group.

Moulopoulos, Lia A / Koutoulidis, Vassilis / Hillengass, Jens / Zamagni, Elena / Aquerreta, Jesus D / Roche, Charles L / Lentzsch, Suzanne / Moreau, Philippe / Cavo, Michele / Miguel, Jesus San / Dimopoulos, Meletios A / Rajkumar, S Vincent / Durie, Brian G M / Terpos, Evangelos / Delorme, Stefan

Blood cancer journal

2018 Volume 8, Issue 10, Page(s) 95

Abstract: Whole Body Low Dose CT (WBLDCT) has important advantages as a first-line imaging modality for bone disease assessment in patients with plasma cell disorders and has been included in the 2014 International Myeloma Working Group (IMWG) criteria for ... ...

Abstract	Whole Body Low Dose CT (WBLDCT) has important advantages as a first-line imaging modality for bone disease assessment in patients with plasma cell disorders and has been included in the 2014 International Myeloma Working Group (IMWG) criteria for multiple myeloma (MM) definition. Nevertheless, standardization guidelines for the optimal use of WBLDCT in MM patients are still lacking, preventing its more widespread use, both in daily practice and clinical trials. The aim of this report by the Bone Group of the IMWG is to provide practical recommendations for the acquisition, interpretation and reporting of WBLDCT in patients with multiple myeloma and other plasma cell disorders.
MeSH term(s)	Aged ; Female ; Humans ; Image Interpretation, Computer-Assisted ; Image Processing, Computer-Assisted ; Male ; Multiple Myeloma/diagnostic imaging ; Multiple Myeloma/pathology ; Osteolysis ; Plasma Cells/pathology ; Tomography, X-Ray Computed/methods ; Whole Body Imaging/methods
Language	English
Publishing date	2018-10-04
Publishing country	United States
Document type	Case Reports ; Journal Article
ZDB-ID	2600560-8
ISSN	2044-5385 ; 2044-5385
ISSN (online)	2044-5385
ISSN	2044-5385
DOI	10.1038/s41408-018-0124-1
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