Author
Elena Zamagni
Other affiliations: Utrecht University, Washington University in St. Louis
Bio: Elena Zamagni is an academic researcher from University of Bologna. The author has contributed to research in topics: Multiple myeloma & Transplantation. The author has an hindex of 54, co-authored 212 publications receiving 15725 citations. Previous affiliations of Elena Zamagni include Utrecht University & Washington University in St. Louis.
Topics: Multiple myeloma, Transplantation, Thalidomide, Lenalidomide, Bortezomib
Papers published on a yearly basis
Papers
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Mayo Clinic1, National and Kapodistrian University of Athens2, University of Turin3, Heidelberg University4, Harvard University5, Memorial Sloan Kettering Cancer Center6, University of Navarra7, University of Pennsylvania8, VU University Medical Center9, Emory University10, University of Bologna11, Mount Sinai Hospital12, Memorial Hospital of South Bend13, Karolinska University Hospital14, Carolinas Healthcare System15, Aalborg University16, Ankara University17, Cedars-Sinai Medical Center18
TL;DR: The disease definition of multiple myeloma is updated to include validated biomarkers in addition to existing requirements of attributable CRAB features (hypercalcaemia, renal failure, anaemia, and bone lesions), and specific metrics that new biomarkers should meet for inclusion in the disease definition are provided.
Abstract: This International Myeloma Working Group consensus updates the disease defi nition of multiple myeloma to include validated biomarkers in addition to existing requirements of attributable CRAB features (hypercalcaemia, renal failure, anaemia, and bone lesions). These changes are based on the identifi cation of biomarkers associated with near inevitable development of CRAB features in patients who would otherwise be regarded as having smouldering multiple myeloma. A delay in application of the label of multiple myeloma and postponement of therapy could be detrimental to these patients. In addition to this change, we clarify and update the underlying laboratory and radiographic variables that fulfi l the criteria for the presence of myeloma-defi ning CRAB features, and the histological and monoclonal protein requirements for the disease diagnosis. Finally, we provide specifi c metrics that new biomarkers should meet for inclusion in the disease defi nition. The International Myeloma Working Group recommends the implementation of these criteria in routine practice and in future clinical trials, and recommends that future studies analyse any diff erences in outcome that might occur as a result of the new disease defi nition.
3,049 citations
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Mayo Clinic1, University of Navarra2, Harvard University3, Cedars-Sinai Medical Center4, Memorial Sloan Kettering Cancer Center5, Emory University6, National and Kapodistrian University of Athens7, Mount Sinai Hospital8, University of Turin9, University of Texas MD Anderson Cancer Center10, Heidelberg University11, Alfred Hospital12, University Health System13, Carolinas Healthcare System14, University of Bologna15, Aalborg University16, Dalhousie University17, Erasmus University Rotterdam18, Roswell Park Cancer Institute19, Columbia University20, University of Toulouse21
TL;DR: Several aspects of disease response assessment are clarified, along with endpoints for clinical trials, and future directions for disease response assessments are highlighted, to allow uniform reporting within and outside clinical trials.
Abstract: Treatment of multiple myeloma has substantially changed over the past decade with the introduction of several classes of new effective drugs that have greatly improved the rates and depth of response. Response criteria in multiple myeloma were developed to use serum and urine assessment of monoclonal proteins and bone marrow assessment (which is relatively insensitive). Given the high rates of complete response seen in patients with multiple myeloma with new treatment approaches, new response categories need to be defined that can identify responses that are deeper than those conventionally defined as complete response. Recent attempts have focused on the identification of residual tumour cells in the bone marrow using flow cytometry or gene sequencing. Furthermore, sensitive imaging techniques can be used to detect the presence of residual disease outside of the bone marrow. Combining these new methods, the International Myeloma Working Group has defined new response categories of minimal residual disease negativity, with or without imaging-based absence of extramedullary disease, to allow uniform reporting within and outside clinical trials. In this Review, we clarify several aspects of disease response assessment, along with endpoints for clinical trials, and highlight future directions for disease response assessments.
1,681 citations
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VU University Amsterdam1, Heidelberg University2, University of Barcelona3, Harvard University4, Complutense University of Madrid5, Lille University of Science and Technology6, Marche Polytechnic University7, Mayo Clinic8, Emory University9, Sapienza University of Rome10, University of Bologna11, University of Arkansas for Medical Sciences12, National and Kapodistrian University of Athens13, Cedars-Sinai Medical Center14, Erasmus University Rotterdam15, University of Navarra16, Centre Hospitalier Universitaire de Nantes17
TL;DR: The R-ISS is a simple and powerful prognostic staging system, and it is recommended for use in future clinical studies to stratify patients with NDMM effectively with respect to the relative risk to their survival.
Abstract: Purpose The clinical outcome of multiple myeloma (MM) is heterogeneous. A simple and reliable tool is needed to stratify patients with MM. We combined the International Staging System (ISS) with chromosomal abnormalities (CA) detected by interphase fluorescent in situ hybridization after CD138 plasma cell purification and serum lactate dehydrogenase (LDH) to evaluate their prognostic value in newly diagnosed MM (NDMM). Patients and Methods Clinical and laboratory data from 4,445 patients with NDMM enrolled onto 11 international trials were pooled together. The K-adaptive partitioning algorithm was used to define the most appropriate subgroups with homogeneous survival. Results ISS, CA, and LDH data were simultaneously available in 3,060 of 4,445 patients. We defined the following three groups: revised ISS (R-ISS) I (n = 871), including ISS stage I (serum β2-microglobulin level < 3.5 mg/L and serum albumin level ≥ 3.5 g/dL), no high-risk CA [del(17p) and/or t(4;14) and/or t(14;16)], and normal LDH level (l...
1,350 citations
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TL;DR: Oral MPT is an effective first-line treatment for elderly patients with multiple myeloma and anticoagulant prophylaxis reduces frequency of thrombosis.
792 citations
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TL;DR: VTD induction therapy before double autologous stem-cell transplantation significantly improves rate of complete or near complete response, and represents a new standard of care for patients with multiple myeloma who are eligible for transplant.
783 citations
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01 Jan 2000
3,536 citations
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Mayo Clinic1, National and Kapodistrian University of Athens2, University of Turin3, Heidelberg University4, Harvard University5, Memorial Sloan Kettering Cancer Center6, University of Navarra7, University of Pennsylvania8, VU University Medical Center9, Emory University10, University of Bologna11, Mount Sinai Hospital12, Memorial Hospital of South Bend13, Karolinska University Hospital14, Carolinas Healthcare System15, Aalborg University16, Ankara University17, Cedars-Sinai Medical Center18
TL;DR: The disease definition of multiple myeloma is updated to include validated biomarkers in addition to existing requirements of attributable CRAB features (hypercalcaemia, renal failure, anaemia, and bone lesions), and specific metrics that new biomarkers should meet for inclusion in the disease definition are provided.
Abstract: This International Myeloma Working Group consensus updates the disease defi nition of multiple myeloma to include validated biomarkers in addition to existing requirements of attributable CRAB features (hypercalcaemia, renal failure, anaemia, and bone lesions). These changes are based on the identifi cation of biomarkers associated with near inevitable development of CRAB features in patients who would otherwise be regarded as having smouldering multiple myeloma. A delay in application of the label of multiple myeloma and postponement of therapy could be detrimental to these patients. In addition to this change, we clarify and update the underlying laboratory and radiographic variables that fulfi l the criteria for the presence of myeloma-defi ning CRAB features, and the histological and monoclonal protein requirements for the disease diagnosis. Finally, we provide specifi c metrics that new biomarkers should meet for inclusion in the disease defi nition. The International Myeloma Working Group recommends the implementation of these criteria in routine practice and in future clinical trials, and recommends that future studies analyse any diff erences in outcome that might occur as a result of the new disease defi nition.
3,049 citations
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Cedars-Sinai Medical Center1, University of Salamanca2, University of Arkansas for Medical Sciences3, Mayo Clinic4, Alexandra Hospital5, Lund University6, Karolinska Institutet7, Ankara University8, Washington University in St. Louis9, Cross Cancer Institute10, University of Turin11, Royal Prince Alfred Hospital12, University of Texas MD Anderson Cancer Center13, University of Pavia14, Harvard University15, University of Bologna16, The Royal Marsden NHS Foundation Trust17
TL;DR: The European Group for Blood and Bone Marrow Transplant/International Bone Marrows Transplant Registry criteria have been expanded, clarified and updated to provide a new comprehensive evaluation system to adequately assess clinical outcomes in myeloma.
Abstract: New uniform response criteria are required to adequately assess clinical outcomes in myeloma. The European Group for Blood and Bone Marrow Transplant/International Bone Marrow Transplant Registry criteria have been expanded, clarified and updated to provide a new comprehensive evaluation system. Categories for stringent complete response and very good partial response are added. The serum free light-chain assay is included to allow evaluation of patients with oligo-secretory disease. Inconsistencies in prior criteria are clarified making confirmation of response and disease progression easier to perform. Emphasis is placed upon time to event and duration of response as critical end points. The requirements necessary to use overall survival duration as the ultimate end point are discussed. It is anticipated that the International Response Criteria for multiple myeloma will be widely used in future clinical trials of myeloma.
2,411 citations
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TL;DR: Bortezomib is superior to high-dose dexamethasone for the treatment of patients with multiple myeloma who have had a relapse after one to three previous therapies.
Abstract: background This study compared bortezomib with high-dose dexamethasone in patients with relapsed multiple myeloma who had received one to three previous therapies. methods We randomly assigned 669 patients with relapsed myeloma to receive either an intravenous bolus of bortezomib (1.3 mg per square meter of body-surface area) on days 1, 4, 8, and 11 for eight three-week cycles, followed by treatment on days 1, 8, 15, and 22 for three five-week cycles, or high-dose dexamethasone (40 mg orally) on days 1 through 4, 9 through 12, and 17 through 20 for four five-week cycles, followed by treatment on days 1 through 4 for five four-week cycles. Patients who were assigned to receive dexamethasone were permitted to cross over to receive bortezomib in a companion study after disease progression. results Patients treated with bortezomib had higher response rates, a longer time to progression (the primary end point), and a longer survival than patients treated with dexamethasone. The combined complete and partial response rates were 38 percent for bortezomib and 18 percent for dexamethasone (P<0.001), and the complete response rates were 6 percent and less than 1 percent, respectively (P<0.001). Median times to progression in the bortezomib and dexamethasone groups were 6.22 months (189 days) and 3.49 months (106 days), respectively (hazard ratio, 0.55; P<0.001). The oneyear survival rate was 80 percent among patients taking bortezomib and 66 percent among patients taking dexamethasone (P=0.003), and the hazard ratio for overall survival with bortezomib was 0.57 (P=0.001). Grade 3 or 4 adverse events were reported in 75 percent of patients treated with bortezomib and in 60 percent of those treated with dexamethasone. conclusions Bortezomib is superior to high-dose dexamethasone for the treatment of patients with multiple myeloma who have had a relapse after one to three previous therapies.
2,333 citations
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TL;DR: Guidelines summarize and evaluate all available evidence at the time of the writing process, on a particular issue with the aim of assisting health professionals in selecting the best management strategies for an individual patient, with a given condition, taking into account the impact on outcome.
Abstract: ACS
: acute coronary syndrome
AMPLIFY
: Apixaban for the Initial Management of Pulmonary Embolism and Deep-Vein Thrombosis as First-line Therapy
aPTT
: activated partial thromboplastin time
b.i.d.
: bis in diem (twice daily)
b.p.m.
: beats per minute
BNP
: brain natriuretic peptide
BP
: blood pressure
CI
: confidence interval
CO
: cardiac output
COPD
: chronic obstructive pulmonary disease
CPG
: Committee for Practice Guidelines
CRNM
: clinically relevant non-major
CT
: computed tomographic/tomogram
CTEPH
: chronic thromboembolic pulmonary hypertension
CUS
: compression venous ultrasonography
DSA
: digital subtraction angiography
DVT
: deep vein thrombosis
ELISA
: enzyme-linked immunosorbent assay
ESC
: European Society of Cardiology
H-FABP
: heart-type fatty acid-binding protein
HIT
: heparin-induced thrombocytopenia
HR
: hazard ratio
ICOPER
: International Cooperative Pulmonary Embolism Registry
ICRP
: International Commission on Radiological Protection
INR
: international normalized ratio
iPAH
: idiopathic pulmonary arterial hypertension
IVC
: inferior vena cava
LMWH
: low molecular weight heparin
LV
: left ventricle/left ventricular
MDCT
: multi-detector computed tomographic (angiography)
MRA
: magnetic resonance angiography
NGAL
: neutrophil gelatinase-associated lipocalin
NOAC(s)
: Non-vitamin K-dependent new oral anticoagulant(s)
NT-proBNP
: N-terminal pro-brain natriuretic peptide
o.d.
: omni die (every day)
OR
: odds ratio
PAH
: pulmonary arterial hypertension
PE
: pulmonary embolism
PEA
: pulmonary endarterectomy
PEITHO
: Pulmonary EmbolIsm THrOmbolysis trial
PESI
: pulmonary embolism severity index
PH
: pulmonary hypertension
PIOPED
: Prospective Investigation On Pulmonary Embolism Diagnosis
PVR
: pulmonary vascular resistance
RIETE
: Registro Informatizado de la Enfermedad Thromboembolica venosa
RR
: relative risk
rtPA
: recombinant tissue plasminogen activator
RV
: right ventricle/ventricular
SPECT
: single photon emission computed tomography
sPESI
: simplified pulmonary embolism severity index
TAPSE
: tricuspid annulus plane systolic excursion
Tc
: technetium
TOE
: transoesophageal echocardiography
TTR
: time in therapeutic range
TV
: tricuspid valve
UFH
: unfractionated heparin
V/Q scan
: ventilation–perfusion scintigraphy
VKA
: vitamin K antagonist(s)
VTE
: venous thromboembolism
Guidelines summarize and evaluate all available evidence at the time of the writing process, on a particular issue with the aim of assisting health professionals in selecting the best management strategies for an individual patient, with a given condition, taking into account the impact on outcome, as well as the risk-benefit-ratio of particular diagnostic or therapeutic means. Guidelines and recommendations should help the health professionals to make decisions in their daily practice. However, the final decisions concerning an individual patient must be made by the responsible health professional(s) in consultation with the patient and caregiver as appropriate.
A great number of Guidelines have …
2,113 citations