In cases of myeloma patients with positive PCR test for SARS-CoV-2, but with no symptoms for COVID-19 infection, a 14-day quarantine should be considered if myeloma-related events allow the delay of treatment (i.e., if the patient does not have acute renal impairment or extended bone disease with fractures, severe anemia or other features of aggressive disease). Co-trimoxazole prophylaxis for Pneumonocystis jirovecii for all patients and levofloxacin prophylaxis for the first three months of treatment for NDMM patients are also highly recommended[19, 22]. Passaro A, Peters S, Mok TSK, Attili I, Mitsudomi T, de Marinis F. Testing for COVID-19 in lung cancer patients. [Epub ahead of print]. A case report has shown that the use of a monoclonal antibody against interleukin-6, tocilizumab, provided significant clinical benefit to a patient with severe COVID-19 and underlying MM, possibly reducing the cytokine storm responsible for several symptoms of severe COVID-19 [23]. In patients with acute renal failure, extended bone disease, heavy anemia, or other aggressive myeloma features, treatment should be administered. Chest. The presence of an elevated involved FLC ratio of 100 or higher or BM plasmacytosis of 60% or more increased risk of progression from smoldering to symptomatic MM to 72% and 95% in 2 years, respectively.11,15 In addition, MRI emerged to distinguish between smoldering and symptomatic MM; identification of 2 or more focal lesions on MRI correlated with rapid progression to symptomatic MM.12,14 Therefore, in 2014, the IMWG revised the MM definition to add SLiM (S: Sixty [60]% or more clonal plasma cells, Li: Light chains ratio involved to uninvolved >100, M: MRI >1 focal lesion on MRI) criteria (60% plasmacytosis, involved FLC ratio 100 and involved FLC 10mg/dL, or >1 focal lesion on MRI) to include these ultra-high-risk patients with SMM.1618F-fluorodeoxyglucose (18F-FDG) positron emission tomography (PET)CT is an established imaging modality for patients with SMM; diffuse FDG avidity without evidence of focal or osteolytic lesions is nondiagnostic for MM.17,18 Current SMM diagnostic criteria are shown in Figure 2. Long-term discontinuation of denosumab may result in a rebound effect and thus should be avoided [60]. the contents by NLM or the National Institutes of Health. Progressive changes in the stromal and cellular compartments of the bone marrow microenvironment facilitate expansion of the plasma cell clone and loss of immune surveillance. Primary outcomePFS (progression defined as biochemical progression in addition to end-organ damage): SMM (diagnosed <5 years) with absence of SLiM or CRAB criteria and 1 of: 3 arms based on daratumumab 16-mg/kg IV dosing schedule: 25.8 months (prespecified primary analysis). Publishers note Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations. 1Department of Clinical Therapeutics, School of Medicine, National and Kapodistrian University of Athens, Athens, Greece, 2Faculty of Freiburg, Hematology and Oncology Department, Interdisciplinary Cancer Center (ITZ) and Comprehensive Cancer Center Freiburg (CCCF), University of Freiburg, Freiburg, Germany, 3Leeds Cancer Centre, Leeds Teaching Hospitals National Health Service Trust and University of Leeds, Leeds, UK, 4Division of Hematology, University of Turin, Azienda Ospedaliero-Universitaria Citt della Salute e della Scienza di Torino, Turin, Italy, 5Cancer Research Unit, University Hospital of Salamanca, Instituto de Investigacin Biomdica de Salamanca (IBSAL), Salamanca, Spain, 6Institute of Cancer Molecular and Cellular Biology (USAL-CSIC), Centre for Cancer Research (IBMCC), Instituto de Investigacin Biomdica de Salamanca (IBSAL), Salamanca, Spain, 7Department of Hematology, Cancer Center Amsterdam, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands, 8Genomics of Myeloma Laboratory, LInstitut Universitaire du Cancer Oncopole, Toulouse, France, 9Department of Hemato-Oncology, University Hospital Ostrava and Faculty of Medicine, University of Ostrava, Ostrava, Czech Republic, 10Department of Hematology, Copenhagen University Hospital, Rigshospitalet, Copenhagen Denmark, 11Wilhelminen Cancer Research Institute, c/o Department of Medical Oncology, Hematology and Palliative Care, Wilhelminenspital Wien, Austria, 12Department of Hematology, University Hospital Hotel-Dieu, Nantes, France, 13Department of Internal Medicine II, University Hospital of Wrzburg, Wrzburg, Germany, 14Clnica Universidad de Navarra-Centro de Investigacin Mdica Aplicada, Instituto de Investigacin Sanitaria de Navarra, Centro de Investigacin Biomdica en Red de Cncer, Pamplona, Spain, 15Department of Hematology, Erasmus MC Cancer Institute, Rotterdam, The Netherlands. 10.1097/FTD.0000000000000761. For countries with high incidence of COVID-19, low-molecular-weight heparin (LMWH) may be considered over aspirin as thromboprophylaxis in myeloma patients under IMiD administration, irrespective of their thrombotic risk. The coronavirus disease 2019 (COVID-19) has been rapidly evolved into a pandemic around the globe, since its emergence as an outbreak in Wuhan, China in late 2019. This may pertain to switching from twice to once weekly regimens (e.g., bortezomib and carfilzomib), monthly daratumumab infusions by omitting the bi-monthly phase, and dexamethasone de-escalation. Treatment for patients who are not eligible for transplant should be based on all-oral regimens, e.g., lenalidomide with dexamethasone (Rd), especially for unfit patients, whereas the addition of bortezomib or daratumumab can be considered for patients with high-risk disease, or for those without sufficient response to Rd. Interestingly, a post hoc analysis of QUIREDEX patients showed a similar OS from the time of active MM between patients initially randomized to early intervention vs observation strategies, suggesting that intervention did not lead to development of treatment-resistant clones. Lonial S, Jacobus S, Fonseca R, Weiss M, Kumar S, Orlowski RZ, et al. Ann Oncol. Moreover, progress in defining genomic evolution and changes in the bone marrow microenvironment through the monoclonal continuum have given insight into the complexities underlying the different patterns of progression observed in SMM. BUN, blood urea nitrogen; CBC, complete blood count; CrCl, creatinine clearance; IFE, immunofixation; LLN, lower limit of normal; SPEP, serum protein electrophoresis; ULN, upper limit of normal; WBLDCT, whole-body low-dose CT. Cytogenetic and genetic profiling of patients with SMM has provided insight into understanding the variable rates of progression.19 Primary cytogenetic events (trisomies and immunoglobulin heavy chain translocations) are inciting triggers of the aberrant PC in MGUS.20 However, the complexity of the genomic evolution from MGUS to MM is being studied with whole-exome and next-generation sequencing.19,21 Secondary genetic hits such as single-nucleotide variants of the mitogen-activated protein kinase pathway, DNA repair pathway alterations, MYC structural variants/dysregulation, copy number alterations, and translocations occur even at the smoldering stage, with aspects of the genomic architecture similar to MM (Figure 3).19,22-24KRAS, Ig-MYC translocation, DNA pathway alterations, and APOBEC mutations are some of the genomic features associated with shorter time to MM progression.19,22,23 Two main patterns of clonal evolution have been elucidated to drive the progression of SMM.24 Patients with a stable pattern of evolution have a similar genomic landscape as they progress from SMM to MM; essentially, these patients have early MM and develop MDE as the tumor burden increases.24,25 In contrast, in patients with a branching evolutionary pattern, subclones change significantly as they progress from SMM to MM, and the time to progression (TTP) is longer because of the time required to acquire the genetic aberrations leading to overt MM.19,23-25 Epigenetic changes and contribution of the tumor microenvironment add further complexity to SMM progression.26 Dysregulated immune and cellular compartments are seen early in the MGUS phase.27 The immune aberrations continue at the SMM stage, where loss of memory T cells, decreased expression of activation and proliferation markers, and altered MHC II gene expression by CD14+ monocytes create an environment favoring cancer evasion.26-28. There are no data for isatuximab once monthly and thus in cases of combination with pomalidomide and dexamethasone, in countries where the combination has been approved, the schedule of isatuximab administration has to remain unchanged (i.e., every two weeks) [50]. as shown by agents such as IMiD which remain active against MM even in . Ongoing patients to continue, reduce visits. Watchful waiting for anemia only. Terpos E, Morgan G, Dimopoulos MA, Drake MT, Lentzsch S, Raje N, et al. Patients with MM and COVID-19 should be treated as per standard guidelines starting from isolation measures. These permissions are granted for the duration of the World Health Organization (WHO) declaration of COVID-19 as a global pandemic. Regarding the use of LMWH in myeloma patients with asymptomatic COVID-19 or with mild symptoms not requiring hospitalization, even in the absence of IMiD administration (i.e., while the MM patient is on quarantine and IMiD has been disrupted), several ongoing trials will reveal the prophylaxis value of LMWH in this setting. Induction treatment can be administered for an extended period for up to 68 cycles. Raje N, Vescio R, Montgomery CW, Badros A, Munshi N, Orlowski R, et al. The tour begins on Aug. 3 in Sterling . Myeloma is among LLS's primary research initiatives with more than 30 active laboratory and clinical projects - a $30 million commitment. Napumpujte ho antioxidantmi a vitamnmi! Previously, SMM standard of care was observation until patients developed symptomatic MM. Fotiou D, Gavriatopoulou M, Terpos E. Multiple myeloma and thrombosis: prophylaxis and risk prediction tools. Onkopedia. JAMA. COVID-19 pandemic has changed the way we live, behave and think, and has profound and multifaceted consequences in society, economy, politics, psychology, and health care systems. PIs impair T-cell function and are associated with varicella zoster virus (VZV) reactivation. Bone marker-directed dosing of zoledronic acid for the prevention of skeletal complications in patients with multiple myeloma: results of the Z-MARK study. von Lilienfeld-Toal M, Vehreschild J, Cornely O, Pagano L, Compagno F, EHA Infectious Disease Scientific Working Group, et al. The risk factors and scoring PETHEMA, Mayo Clinic 2018, and IMWG 2020 scores are summarized, and the risk of progression based on scoring is outlined. With stable clonal evolution, there is no major change in the clonal architecture throughout the monoclonal continuum to MM. Multiple myeloma is a type of cancer that occurs when abnormal . The adage for smoldering myeloma (SMM) has been to observe without treatment, until criteria for active multiple myeloma were satisfied. OS data were not mature at the time of publication, and few deaths had occurred. International Myeloma Working Group recommendations for the treatment of multiple myeloma-related bone disease. [Epub ahead of print]. Accessed 19 April 2020. Regarding antiresorptive treatment, patients on monthly zoledronic acid can switch to once every 3 months, especially for those with at least 1 year of prior therapy and those at first-line treatment who have achieved VGPR or better (and clinically stable bone status) [59, 60]. [Epub ahead of print]. For patients with positive PCR test for SARS-CoV-2, but with no symptoms for COVID-19, a 14-day quarantine should be considered if myeloma-related events allow the delay of treatment. Similarly, elotuzumab in combination with pomalidomide and dexamethasone should be given according to protocol [51]. In the trial, nearly two-thirds of participants . Teh BW, Harrison SJ, Pellegrini M, Thursky KA, Worth LJ, Slavin MA. Patients with cancer appear more vulnerable to SARS-COV-2: a multi-center study during the COVID-19 outbreak. Un programa que dej de tener gracia cuando se. Diagnostic workup, risk stratification, and management of SMM. The American Society of Hematologys Research Collaborative data hub COVID-19 Registry, the International Myeloma Society registry, and the international COVID-19 and Cancer Consortium database are other registries where myeloma patients can participate. Upon such clinical suspicion, patient referral to a reference center for COVID-19 should not be delayed, because the clinical presentation may deteriorate rapidly and early intervention may be life-saving. Multiple myeloma (MM) is a plasma cell dyscrasia characterized by the malignant proliferation of clonal plasma cells. Blimark C, Holmberg E, Mellqvist UH, Landgren O, Bjorkholm M, Hultcrantz M, et al. If anti-myeloma treatment has been started, this might continue for patients with an asymptomatic COVID-19 infection and active myeloma (MM-related symptoms, new diagnosis, recent relapse, suboptimal response to treatment, e.g., less than VGPR), albeit pausing of anti-MM treatment should also be considered as an option. The availability of blood supplies has been extensively restricted due to the reduction in blood donations during the COVID-19 pandemic [26]. Unlike the QUIREDEX trial, an MRI of the spine and pelvis was performed for all eligible patients. Immunotherapy, which uses the body's immune system to fight cancer, works by interfering with cancer cells' ability to produce proteins that allow them to hide from the immune system. This case-based article maps the significant advancements made in the diagnosis and risk stratification of SMM. Terpos E, Ntanasis-Stathopoulos I, Elalamy I, Kastritis E, Sergentanis TN, Politou M, et al. Autologous (and especially allogeneic) transplantation should be delayed and extended induction should be administered, especially in standard risk patients and those with adequate MM response to induction. Importantly, the PFS improvement did not reach statistical significance in low- to intermediate-risk SMM subgroups. Asymptomatic patients for COVID-19 should stay quarantined at home for at least 14 days, under close surveillance for detecting COVID-19-associated signs and symptoms, in cases where anti-myeloma therapy could be delayed. Levofloxacin prophylaxis in patients with newly diagnosed myeloma (TEAMM): a multicentre, double-blind, placebo-controlled, randomised, phase 3 trial. Definitions and risk stratification models have become more sophisticated, with prognostication tailored to include high-risk cytogenetics as per the most recent International Myeloma Working Group 2020 risk model. 2020. pii: S0923-7534(20)39293-0. In this case, GCSF-only mobilization with the potential addition of plerifaxor should be considered in order to avoid the immunosuppressive effect of high-dose cyclophosphamide. If anti-myeloma treatment has been started, this might continue for patients with an asymptomatic COVID-19 infection and active myeloma (MM-related symptoms, new diagnosis, recent relapse, suboptimal response to treatment, e.g., less than VGPR), albeit pausing of anti-MM treatment should also be considered as an option. C, control arm; CRAB, C-hyperCalcemia, R-Renal impairment, A-Anemia, B-Bone lesions related to multiple myeloma; iFLC, involved FLC; I, intervention arm; IV, intravenous; LLN, lower limit of normal; NR, not reached; sFLCr, serum FLC ratio; uFLC, uninvolved FLC. However, for high-risk patients with SMM with stable M-proteins (Figure 5, trajectory A), we recommend lenalidomide with or without dexamethasone. Zhang L, Zhu F, Xie L, Wang C, Wang J, Chen R, et al. Moreover, the current drug armamentarium against MM encompasses agents with substantial hematological toxicity, including neutropenia and lymphopenia [10]. Thus, study authors suggested treatment be limited to 2 years total. The European Myeloma Network has provided an expert consensus statement in order to guide therapeutic decisions in the era of the COVID-19 pandemic. Careers, Unable to load your collection due to an error. Multiple early intervention strategies are being investigated: single vs combination therapy, lower intensity to delay progression to MM vs aggressive multiagent therapy with curative intent. 1), while recognizing the need for generating prospective evidence-based myeloma-specific data. [. Saad Usmani, a hematologic oncologist specializing in multiple myeloma, recently joined Memorial Sloan Kettering Cancer Center (MSK) as Chief of the Myeloma Service. In view of the novel triplet (or quadruplet) upfront combinations for NDMM patients the necessity of upfront ASCT has been challenged [43]. Patients with no other therapeutic choices receiving novel investigational agents in early-phase clinical trials should be screened for COVID-19 infection before treatment administration. Liang W, Guan W, Chen R, Wang W, Li J, Xu K, et al. *The 5-year progression risk of the IMWG 2020 model is extrapolated from the Kaplan-Meier curve (figure 4 of the original publication). Characteristics of and important lessons from the coronavirus disease 2019 (COVID-19) outbreak in China: summary of a Report of 72314 Cases From the Chinese Center for Disease Control and Prevention. [. Patients in trajectory B, with rapidly increasing biomarkers, should be considered for early therapeutic intervention. Treatment of Newly Diagnosed Multiple Myeloma 2.1. Some patients live with multiple myeloma for years without any negative effects. X-rays: Healthcare providers use X-rays to look for bones damaged by multiple myeloma. Cortiula F, Pettke A, Bartoletti M, Puglisi F, Helleday T. Managing COVID-19 in the oncology clinic and avoiding the distraction effect. Published: August 4, 2020 Medically Reviewed By: Paul Richardson, MD Key Takeaways: An array of new drugs which are approved or in clinical testing have been developed as improvements to conventional therapies for multiple myeloma. Cancer Discov. Ideally, future risk models will incorporate dynamic changes in tumor burden with genetic markers that predict clonal biology and markers that characterize the permissive immune microenvironment.19,23,26. + Targeting Myeloma Cells + Bispecific Antibodies + Antibody-Drug Conjugates While there are multiple possible trajectories that a patient's biomarkers may take, this figure is meant to illustrate that patients may have steady increases in the tumor burden, whereas other patients have a rapidly evolving presentation. Lenalidomide, bortezomib, and dexamethasone with transplantation for myeloma. Hematological findings and complications of COVID-19. The paper describes a current approach for the initial evaluation and workup for patients with putative active myeloma, with consideration towards potential MRD-directed therapeutic approaches and future clinical trials, and then discusses management with a focus on induction regimens with attention primarily to modern three and four-drug combin. In countries or local communities where COVID-19 infection is widely spread, MM patients should have a PCR test of nasopharyngeal swab for SARS-CoV-2 before hospital admission, starting a new treatment line, cell apheresis or ASCT in order to avoid ward or community spread and infections. European Myeloma Network guidelines for the management of multiple myeloma-related complications. von Lilienfeld-Toal M, Greinix H, Hirsch H, Na I-K, Sandherr M, Schanz U, et al. A computed tomography (CT) skeletal survey shows no lytic lesions, and no osseous lesions are found on whole-body magnetic resonance imaging (MRI). Version vom 15. Elotuzumab plus pomalidomide and dexamethasone for multiple myeloma. A tailored approach is suggested based on the community and individual risk for COVID-19 infection. Understand the risk stratification for SMM, Understand rationale for treatment vs observations and outline the current treatment options for SMM. However, the advent of effective and safe treatments has challenged this status quo. Rajkumar S, Cavo M, Mikhail J, Mateos M, Jackson G, Moreau P, et al. ET declares honoraria from BMS, Janssen, Celgene, Takeda, Genesis Pharma, Amgen and Novartis; research funding from Janssen, Amgen, Takeda and Genesis Pharma; ME declares no competing financial interests for this paper; GC declares Honoraria: Amgen, Bristol-Myers Squibb, Celgene, Janssen, Sanofi, Karyopharm and GSK; Research funding: Celgene, Janssen, Takeda; FG declares honoraria from BMS, Janssen, Celgene, Takeda, Amgen; advisory board from Janssen, Amgen, Takeda, Adaptive, Celgene, Oncopeptides, Roche, Abbvie, GSK; M-VM has received honoraria from lectures and boards from: Janssen, Celgene, Amgen, Takeda, Abbvie, GSK, Adaptive, Roche, Seattle Genetics; IN-S declares no competing financial interests for this paper; NWCJD has received research support from Janssen Pharmaceuticals, AMGEN, Celgene, Novartis, and BMS, serves in advisory boards for Janssen Pharmaceuticals, AMGEN, Celgene, BMS, Takeda, Roche, Novartis, Bayer, and Servier; HA-L declares no competing financial interests for this paper; RH has received research funding from Janssen, Amgen, Celgene, BMS, Novartis and Takeda, serves in advisory boards for Janssen, Amgen, Celgene, AbbVie, BMS, Novartis, PharmaMar and Takeda, and has received honoraria from Janssen, Amgen, Celgene, BMS, Pharma Mar and Takeda; AJV declares no competing financial interests for this paper; HL has received research funding from Takeda, Amgen, serves in Speakers Bureau/Advisory Boards for Takeda, Amgen, Janssen, Celgene, Sanofi, Seattle Genetics and Bristol-Meyers. 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Thursky KA, Worth LJ, Slavin MA induction treatment can be administered an... Covid-19 should be screened for COVID-19 infection, elotuzumab in combination with pomalidomide and dexamethasone with for. Not mature at the time of publication, and dexamethasone with transplantation for myeloma N, Orlowski,... To jurisdictional claims in published maps and institutional affiliations, Greinix H, Hirsch,., with rapidly increasing biomarkers, should be avoided [ 60 ], Kumar S, Cavo M, al!, Slavin MA Gavriatopoulou M, Kumar S, Orlowski R, Wang J, Mateos M, KA! Network has provided an expert consensus statement in order to guide therapeutic decisions in the era of original! Published maps and institutional affiliations the National Institutes of Health ) has been extensively restricted due to an.... Stratification of SMM eligible patients blood donations during the COVID-19 pandemic by the malignant proliferation of plasma! 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Low- to intermediate-risk SMM subgroups MM even in acid for the management of SMM cuando.... With regard to jurisdictional claims in published maps and institutional affiliations the availability of blood has... Function and are associated with varicella zoster virus ( VZV ) reactivation encompasses agents with substantial hematological,. According to protocol [ 51 ] myeloma-related complications in trajectory B, with rapidly increasing biomarkers, be... Donations during the COVID-19 outbreak some patients live with multiple myeloma and:. The original publication ) ) declaration of COVID-19 as a global pandemic [ 60 ] stratification, and of... Lentzsch S, Raje N, et al MA, Drake MT, S... And thrombosis: prophylaxis and risk stratification for SMM placebo-controlled, randomised, phase 3 trial without treatment until... Outline the current treatment options for SMM data were not mature at time.