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1 4 th Heidelberg Myeloma Workshop Current status and developments in diagnosis and therapy of Multiple Myeloma Congress venue: Lecture hall, Klinik für Innere Medizin Universitätsklinikum Heidelberg Friday, April 26 th 2013 (Meeting language English) and Saturday, April 27 th 2013 (Meeting language German) Prof. Dr. med. Hartmut Goldschmidt PD Dr. med. Kai Neben Prof. Dr. med. Anthony D. Ho Prof. Dr. med. Dirk Jäger Prof. Dr. med. Christof von Kalle Prof. Dr. med. Otmar D. Wiestler UniversitätsKlinikum Heidelberg

2 4 th 4 th Heidelberg Myeloma Workshop Current status and and developments in in diagnosis and and therapy of of Multiple Myeloma Greeting Dear colleagues, we are glad to welcome you to the 4 th Heidelberg Myeloma Workshop. It continues the series of events on new developments of diagnosis and improved treatment strategies of Multiple Myeloma. Myeloma patients are benefiting from many fundamental innovations in diagnosis and therapy in recent years. High response rates by the combination of new drugs and blood stem cell transplantation prolong the disease-free period as well as the overall survival to more than ten years. Also the quality of life has increased for patients with Multiple Myeloma. Several new substances are already in Phase III trials. Studies on the intensification of the therapy and the results on how the depth of remission influences the overall survival, offer new chances to further prolong the life of the patients. A precise classification of the prognosis of different patient groups can be achieved by analysis of genetic changes and characteristic clinical and molecular markers. This allows a targeted and effective therapy. Methods of imaging and of molecular medicine will continuously extend and improve our understanding of the disease. These advances are only possible due to continuous medical research. The approved SFB Transregio 79 on the sites Gießen, Dresden and Heidelberg also contributes to the development of new bone substitutes and implant materials. We very much hope that the planned Myeloma Workshop in Heidelberg will inform you comprehensively about current results of research and the progress in the diagnosis and treatment of Multiple Myeloma. We are convinced that the scientific exchange will contribute to a more rapid translation of approaches from cancer research into patient care and that thereby the success of the therapy for patients with Myeloma will be improved. A warm welcome to Heidelberg! Prof. Dr. Hartmut Goldschmidt and PD Dr. Kai Neben Seite 2 Seite 3

3 Grußwort Sehr geehrte Kolleginnen und Kollegen, wir freuen uns sehr, Sie zum 4 th Heidelberg Myeloma Workshop begrüßen zu dürfen. Dieser setzt die Reihe von Veranstaltungen zu neuen Entwicklungen der Diagnostik und verbesserten Therapiestrategien beim Multiplen Myelom fort. Patienten mit Multiplem Myelom profitieren von vielfältigen grundlegenden Neuerungen in Diagnostik und Therapie der letzten Jahre. Hohe Ansprechraten durch die Kombination aus neuen Medikamenten und Blutstammzelltransplantation verlängern sowohl den krankheitsfreien Zeitraum, als auch das Gesamtüberleben auf über zehn Jahre. Auch die Lebensqualität der Patienten mit Multiplem Myelom ist gestiegen. Mehrere neue Wirkstoffe befinden sich bereits in Phase III Studien. Untersuchungen zur Therapieintensivierung und Ergebnisse darüber, wie die Tiefe der Remission das Gesamtüberleben beeinflussen, bieten neue Chancen, das Leben der Patienten weiter zu verlängern. Eine präzise Abgrenzung der Prognose von verschiedenen Patientengruppen kann über den Nachweis von genetischen Veränderungen und charakteristischen klinischen und molekularen Markern erfolgen und ermöglicht eine gezielte und effektivere Therapie für die Patienten. Richtungsweisend sind hier die Verfahren der Bildgebung und der molekularen Medizin zu nennen, welche unser Verständnis der Erkrankung kontinuierlich erweitern und verbessern. Nur durch stetige medizinische Forschung sind solche Fortschritte möglich. Dazu trägt auch der im Jahre 2010 an den Standorten Gießen, Dresden und Heidelberg bewilligte SFB Transregio 79 zur Entwicklung von neuen Knochenersatzstoffen und Implantatwerkstoffen bei. Wir hoffen sehr, dass Sie die geplante Veranstaltung umfassend über aktuelle Forschungsergebnisse und die Fortschritte in der Diagnostik und Behandlung des Multiplen Myeloms informieren wird. Wir sind davon überzeugt, dass der Austausch vor Ort dazu beiträgt, richtungsweisende Entwicklungen schneller in die klinische Anwendung zu überführen und dadurch die Therapieerfolge bei Myelompatienten zu verbessern. Herzlich willkommen in Heidelberg! Prof. Dr. Hartmut Goldschmidt und PD Dr. Kai Neben Seite 4 Seite 5

4 Friday, 26 th April 2013 Meeting Language English / Seminarsprache Englisch Lecture hall, Klinik für Innere Medizin, Universitätsklinikum Heidelberg Until 11:00 a.m. arrival 10:30 a.m. 11:00 a.m. Coffee and breakfast 10:30 a.m. 11:00 a.m. Registration 11:00 11:15 Welcome, Introduction 4 th Heidelberg Myeloma Workshop Hartmut Goldschmidt, Heidelberg Peter Dreger, Heidelberg Otmar D. Wiestler, Heidelberg CV Abstract Slides 11:15 11:45 Key note lecture Paul Richardson Introducing Paul Richardson (Peter Dreger) The emerging role of novel therapies in the management of Multiple Myeloma Paul Richardson, Boston 11:45 12:15 Key note lecture Gareth Morgan 16 Introducing Gareth Morgan (Hartmut Goldschmidt) Molecular development of Multiple Myeloma role of Cereblon Gareth Morgan, London 12:15 12:45 Key note lecture Richard Houlston 18 Introducing Richard Houlston (Kari Hemminki) Genome wide association studies (GWAS) and prediction of cancer Richard Houlston, London 12:45 1:45 Lunch 1:45 3:05 Session I Diagnosis, prognosis and biological background of Multiple Myeloma Chairmen: Dirk Hose, Heidelberg, Hervé Avet-Loiseau, Toulouse CV Abstract Slides 1:45 2:05 Role of new imaging techniques in diagnosing and staging of patients with Multiple Myeloma Stefan Delorme, Heidelberg Questions and answers 2:05 2:25 Role for genomics in Multiple Myeloma Hervé Avet-Loiseau, Toulouse Questions and answers 2:25 2:45 From myeloma precursor disease to Multiple Myeloma Maria-Victoria Mateos, Salamanca Questions and answers 2:45 3:05 Familial risks and germline genetics of Myeloma Kari Hemminki, Heidelberg Questions and answers 3:05 3:30 Coffee break 3:30 4:50 Session II Therapy of Multiple Myeloma - drugs and treatment strategies Chairmen: Nicolaus Kröger, Hamburg, Marc-Steffen Raab, Heidelberg CV Abstract Slides 3:30 3:50 Immunmodulatory drugs in the treatment of Multiple Myeloma: focus on maintenance treatment Philippe Moreau, Nantes Questions and answers 3:50 4:10 Bone targeting agents in the treatment of Multiple Myeloma 42 Gareth Morgan, London Questions and answers 4:10 4:30 Monoclonal antibody-based therapy as a new treatment strategy in Multiple Myeloma Sundar Jagannath, New York Questions and answers 4:30 4:50 Autologous stem cell transplantation in the era of new drugs Pieter Sonneveld, Rotterdam Questions and answers 4:50 5:30 Coffee break Seite 6 Seite 7

5 5:30 6:45 Session III Treatment paradigm of Multiple Myeloma Chairmen: Hartmut Goldschmidt, Heidelberg, Peter Dreger, Heidelberg CV Abstract Slides Samstag, 27. April 2013 Seminarsprache Deutsch / Meeting Language German Hörsaal, Klinik für Innere Medizin, Universitätsklinikum Heidelberg 5:30 5:40 Introduction: Cure or chronification? Hartmut Goldschmidt, Heidelberg 5:40 6:00 Pro Cure Nicolaus Kröger, Hamburg 8:30 9:30 Sitzung IV Neues aus den Studiengruppen Vorsitzende: Dirk Jäger, Heidelberg, Martin Kropff, Münster CV Abstract Slides 6:00 6:20 Pro Chronification Morie A. Gertz, Rochester :20 6:35 Debate All 6:35 6:45 Summary Hartmut Goldschmidt, Heidelberg 8:30 9:00 DSMM (Deutsche Studiengruppe Multiples Myelom) 62 Hermann Einsele, Würzburg Fragen zum Vortrag 9:00 9:30 GMMG (German-Speaking Myeloma Multicenter Group) Hartmut Goldschmidt, Heidelberg Fragen zum Vortrag 9:30 9:50 Kaffeepause 9:50 11:10 Sitzung V Myelomdiagnostik im Jahr 2013: Was sind Standards in Deutschland? Vorsitzende: Christof Scheid, Köln, Christof von Kalle, Heidelberg CV Abstract Slides 9:50 10:10 Bildgebung beim Multiplen Myelom Jens Hillengaß, Heidelberg Fragen zum Vortrag 10:10 10:30 Molekulare Diagnostik beim Multiplen Myelom Dirk Hose, Heidelberg Fragen zum Vortrag 10:30 10:50 Standards der Kontroll- und Verlaufsuntersuchungen beim Multiplen Myelom Christof Scheid, Köln Fragen zum Vortrag 10:50 11:10 Multiples Myelom Therapierealität in Deutschland Hartmut Goldschmidt, Heidelberg Fragen zum Vortrag 11:10 13:30 Mittagspause mit Lunchsession Seite 8 Seite 9

6 11:30 12:40 Lunch Session Scientific Workshop Werkstoffe für die Geweberegeneration im systemisch erkrankten Knochen (SFB Transregio 79) Vorsitzende: Dirk Hose, Heidelberg, Christian Heiß, Gießen 13:30 14:30 Sitzung VI Therapieempfehlungen bei Patienten mit Multiplem Myelom I Vorsitzende: Stefan Fuxius, Heidelberg, Igor Blau, Berlin 11:30 11:40 Einführung Hartmut Goldschmidt, Heidelberg CV Abstract Slides 11:40 12:00 Entwicklung von Knochenersatzstoffen für die Behandlung von benignen und malignen Knochendefekten Die klinische Sicht Christian Heiß, Gießen Fragen zum Vortrag 12:00 12:20 Entwicklung von Knochenersatzstoffen für die Behandlung von benignen und malignen Knochendefekten Die pathophysiologische Sicht Dirk Hose, Heidelberg Fragen zum Vortrag 12:20 12:40 Entwicklung von Knochenersatzstoffen für die Behandlung von benignen und malignen Knochendefekten Die materialwissenschaftliche Sicht Michael Gelinsky, Dresden Fragen zum Vortrag 13:30 13:50 Die Primärtherapie von Patienten mit Multiplem Myelom 96 Martin Kropff, Münster Fragen zum Vortrag CV Abstract Slides 13:50 14:10 Die Rezidivtherapie von Patienten mit Multiplem Myelom Kai Neben, Heidelberg Fragen zum Vortrag 14:10 14:30 Therapie der myelombedingten Nierenerkrankung Katja Weisel, Tübingen Fragen zum Vortrag 14:30 14:50 Kaffeepause 14:50 15:30 Sitzung VII Therapieempfehlungen bei Patienten mit Multiplem Myelom II Vorsitzende: Katja Weisel, Tübingen, Kai Neben, Heidelberg CV Abstract Slides 14:50 15:10 Die Therapie der Knochenerkrankung beim Multiplen Myelom Franz Jakob, Würzburg Fragen zum Vortrag 15:10 15:30 Neue Therapieoptionen für das Multiple Myelom welche Fortschritte erwarten wir innerhalb der nächsten Jahre? Marc-Steffen Raab, Heidelberg Fragen zum Vortrag 15:30 16:00 Resümee des 14 th International Myeloma Workshop : 114 Welche diagnostischen und therapeutischen Konsequenzen ergeben sich für die Patientenversorgung in Deutschland? Hartmut Goldschmidt, Heidelberg, Hermann Einsele, Würzburg Seite 10 Seite 11

7 CURRICULUM VITAE The Emerging Role of Novel Therapies in the Management of Multiple Myeloma (MM) Paul Richardson, Boston, MA, USA Paul Richardson Paul Richardson MD is the RJ Corman Professor of Medicine at Harvard Medical School and Clinical Director of the Jerome Lipper Multiple Myeloma Center, Dana-Farber Cancer Institute (DFCI), Boston, USA. Dr Richardson obtained his medical degree from St Bartholomew s Hospital Medical College, London, UK, before completing residencies at Newcastle University School of Medicine, UK, the Royal Marsden Hospital (London and Surrey) and then the Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, USA. His fellowships in haematology/oncology and medical oncology were completed at Tufts University School of Medicine, Baystate Medical Center, Springfield, USA, and Harvard Medical School, DFCI. Dr Richardson s primary research interest is in novel therapies for myeloma, including bortezomib, lenalidomide and pomalidomide, and he is currently a clinical leader for multiple studies on the use of combination therapies in the treatment of this disease. He is serving as Principal or Co Principal Investigator and Study Chair for several pivotal trials, including the international Intergroupe Francophone du Myélome/DFCI 2009 study in newly diagnosed patients eligible for stem cell transplantation using the combination of lenalidomide, bortezomib and dexamethasone (RVD). His role in the development of defibrotide for the treatment of veno-occlusive disease began with its very inception, when he treated the first patient and then led the first clinical study for this indication. Since then Dr Richardson has had a central role in all the US prospective clinical trials performed to date, with a number of orphan product drug grants awarded by the FDA to facilitate and support the evaluation of the drug as part of his investigator-initiated studies, as well as an early phase development grant from the American Cancer Society. Among other honours, Dr Richardson was awarded an honorary Fellowship of the Royal College of Physicians (UK) in recognition of his international contributions in multiple myeloma and stem cell transplantation. He is the past Chair of the Multiple Myeloma Research Consortium (USA) Clinical Trials Core, a position he held for 5 years as a founding member and as part of a rotating tenure, and for which he currently serves on the Steering Committee and Project Review Committee. He is Chair of the newly formed Alliance Myeloma Committee (USA), formerly known as the Cancer and Leukemia Group B. The last decade has seen remarkable progress in the therapy of MM with the development of combination regimens that incorporate the proteasome inhibitor Bortezomib and the immunomodulatory agents Thalidomide and Lenalidomide, as well as the recent approval of Carfilzomib and Pomalidomide. Advances have been predicated on greater understanding of MM biology and the interaction with the marrow microenvironment as well as cortical bone. With the incorporation of novel agents as targeted therapy, median survival has significantly improved. Furthermore, with the integration of novel therapies around established standards of care, further improvements have been achieved. Specifically, the use of novel treatments around autologous stem cell transplantation (ASCT) and the emerging treatment paradigm of induction, intensification, consolidation and maintenance applied across both transplant eligible and ineligible patients has emerged as a key treatment algorithm. However, in spite of these advances, nearly all patients relapse, as reflected by the lack of any plateau in survival curves from clinical trials evaluating currently available treatment options. Substantial challenges thus remain, and MM remains incurable. The optimal sequencing and integration of treatment strategies has become increasingly important as survival has improved. Both acute and long-term toxicities include peripheral neuropathy, thromboembolic disease, myelosuppression, and the interaction of traditional genotoxic treatment with immunomodulatory agents which may result in rare complications such as second new primaries. Further research including pharmacogenetic analysis of patient DNA and trials to assess the efficacy of interventions to minimize toxicity are thus essential to further improve patient outcome. Novel combination therapies which are rationally designed and derived from bench research utilizing informative models have proven central to progress. Second generation small molecules are under development as part of combination strategies, which build upon the therapeutic backbone of immunomodulatory therapy and proteasome inhibition. Monoclonal antibodies are now finding their place in the therapeutic armamentarium. Further refinement of ASCT and its utilization in selected patients, versus sparing this in others and keeping ASCT in reserve, is currently under study. Allogeneic SCT remains investigational, but will also hopefully benefit from the integration of novel therapies, making it a modality associated with less toxicity and greater efficacy. In summary, improvements to help understand heterogeneity in MM and the complexities of its biology through genomics and proteomics should enhance the ability to pursue more tailored treatments. This, together with continued new drug development, offers the potential of yet further clinical benefit and the increased probability of making MM a chronic illness in the majority of patients. Dr Richardson is an editorial board member of several journals, including the Journal of Clinical Oncology and the British Journal of Haematology, and has authored or co-authored over 350 articles published in international, peerreviewed journals, including several original papers in the New England Journal of Medicine. Seite 12 Seite 13

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9 CURRICULUM VITAE Molecular development of Multiple Myeloma role of Cereblon Gareth Morgan, London, UK Gareth Morgan Gareth Morgan is Professor of Haematology at The Institute of Cancer Research (ICR) and Consultant Haematologist at the Royal Marsden NHS Foundation Trust. After attending medical school at the University Hospital of Wales, he completed a PhD and trained in the molecular genetics and management of blood cell cancers at the ICR. He left the ICR to join the University of Leeds where he set up his own research group studying the molecular genetics of non-hodgkin s lymphoma and myeloma. During this time, he developed his interest and expertise in the treatment and management of leukaemias, lymphomas and myeloma. He is an internationally respected clinician and researcher who has published extensively on the genetics and treatment of these diseases. His research has focussed on the translation of information derived from the molecular analysis of the pathogenesis of malignant cells into the clinic using novel targeted treatment strategies based on innovative diagnostic approaches. One of the major aims of his research group is the development of personalised medicine strategies for myeloma with the aim of overcoming treatment resistance. In particular, he is interested in the use of new drugs in the context of standard treatment approaches. He is a committed clinician and trialist and is currently Principal Investigator of the Myeloma XI study and a number of Phase I and II studies, as well as serving on Independent Data Monitoring Committees. He is actively involved in research into the genetic basis of myeloma and how this can be used in the clinical environment. He receives programme funding from Myeloma UK as well as project support from the Kay Kendall Leukaemia Fund, the Bud Flanagan Leukemia Fund and Cancer Research UK. He is widely published with over 400 high impact factor peer reviewed articles. He is recognised nationally and internationally as a clinician and researcher and has been Scientific Secretary for the British Society of Haematology. He is currently Scientific Secretary for the UK Myeloma Forum. He reviews for a number of journals and sits on grant giving bodies both in the UK and internationally. He has been instrumental in the establishment of the European Myeloma Network. He is a Director for Myeloma UK, Scientific Advisor to the International Myeloma Foundation and is on the Board of the UK Stem Cell Bank. Seite 16 Seite 17

10 CURRICULUM VITAE Genome wide association studies (GWAS) and prediction of cancer Richard Houlston, London, UK Richard Houlston Current Post Professor of Molecular and Population Genetics, Division of Genetics and Epidemiology, Institute of Cancer Research; Honorary Consultant in Clinical Genetics, Royal Marsden NHS Trust, UK Education Imperial College, London BSc (Biochemistry), MB BS (Distinction Pathology); MRC Studentship, Dermatology Prize Institute of Psychiatry, University of London; MSc University of London; MD, PhD (Genetics) Further Qualifications MRCPath 1988, FRCPath 1997, MRCP 1992, FRCP 1997 Specialist accreditation in pathology 1988 Specialist accreditation in genetics (JCHMT) 1992 Publications Over 370 articles in peer-reviewed journals Over 60 book chapters and review articles Employment Reader in Molecular and Population Genetics, Institute of Cancer Research Senior Lecturer in Genetics, Institute of Cancer Research Clinical Scientist, Institute of Cancer Research 1992 Specialist Registrar in Clinical Genetics, Southampton University Clinical Research Fellow, Imperial Cancer Research Fund Lecturer UMDS, London Wellcome Trust Clinical Fellow, Institute of Psychiatry, London House Officer and Registrar Posts Memberships of Academic Committees and Boards 2012 present Academy of Medical Sciences: Sectional Committee Membership ; Cancer family study group 2006 present UkCCS steering committee 2001 present Institute of Cancer Research, Academic Board 2002 present Institute of Cancer Research-Royal Mardsen Hospitals NHS Trust, Joint Research Committee Seite 18 Seite 19

11 CURRICULUM VITAE Role of new imaging techniques in diagnosing and staging of patients with Multiple Myeloma Stefan Delorme, Heidelberg, Germany In our center, plain films are obsolete, and have been replaced by whole-body CT for detecting destruction of mineralized bone. Nevertheless, new open questions have arisen. First, the imaging criteria for staging are still divergent. Second, there is disagreement which imaging techniques should be used in future, and in which combination. Third, using more sensitive techniques will inevitably cause patients to be staged higher than they would if only plain films were used, but the consequences with regard to treatment are unclear. In particular, the relevance of diffuse infiltration patterns seen with MRI only is open. Stefan Delorme 1987 Graduated from Medical School in Hannover, Approbation, Assumed German citizenship Resident in Internal Medicine, I. Medizinische Universitätsklinik Heidelberg 1988 Medical Dissertation (Dr. med.) Resident in Radiology, DKFZ Working group leader in CT and Ultrasonography Resident, Department of Radiology, Heidelberg University Resident in Radiology, DKFZ 1996 Board certification in Radiology, supervising physician and research fellow, DKFZ Since 1998 Deputy chairman of the Derpartment of Radiology, DKFZ 1999 Habilitation and appointment as Associate Professor in Radiology (Heidelberg University) 1999 Appointment as Senior Teacher in the German Society of Ultrasound in Medicine (DEGUM) Working group leader in MRI Acting chairman of the Department of Oncological Diagnostics and Therapy, DKFZ Since 2003 Working group leader in Body and Musculoskeletal imaging Chairman of the Radiological section of the German Society of Ultrasound in Medicine (DEGUM) Acting chairman of the Department of Radiology, DKFZ Since 2010 Vice chairman of the Department of Radiology, DKFZ President elect of the German Society of Ultrasound in Medicine (DEGUM) Since 2010 President of the German Society of Ultrasound in Medicine (DEGUM) New imaging techniques whole-body computed tomography (CT), whole-body magnetic resonance imaging (MRI), positron emission tomography (PET) with 18-F-deoxyglucose (FDG) - have proven advantageous for imaging multiple myeloma: 1. All lesions leading to bone destructions visible on plain films will also be seen with CT or MRI. 2. CT and MRI will also show lesions which have not yet caused a destruction of mineralized bone, which extend beyond the confines of the bone, or which are primarily extraskeletal. While MRI will show intraosseous lesions irrespective of their location, CT will detect lesions mainly if they lie within fatty but not hematopoietic bone marrow. 3. MRI but not CT or plain films will reliably show a diffuse myeloma infiltration in the bone marrow, even if the cancellous bone is still preserved. This will only be depicted by CT if the bone is very osteoporotic. 4. CT of the entire skeleton can be performed within one minute in low-dose technique without effort for the patient, and with a radiation dose comparable to plain films. 5. MRI is highly sensitive to any lesion, and a normal MRI excludes lytic lesions which could possibly be detected with CT or plain films. However, once a lesion is found with MRI, additional CT or plain films may be needed to assess alterations of mineralized bone and their impact on its stability. 6. Diffusion-weighted MRI (DWI) with background suppression will sensitively detect areas of increased cellular density within the bone marrow, particularly bone marrow infiltrates. DWI is being evaluated as a possible tool for assessing local aggressiveness and treatment response. 7. FDG-PET is less sensitive in detecting myeloma infiltrates than MRI. It is insensitive to diffuse bone marrow involvement but may show solid nodules if they are metabolically active. Despite its low sensitivity its value may lie in the detection of mainly active nodules. It is not clear yet, however whether these are more clinically relevant than those with a lower uptake. A treatment response is mirrored in a reduction in FDG uptake, which occurs earlier than a morphological shrinkage of lesions. Seite 20 Seite 21

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13 CURRICULUM VITAE Role for genomics in Multiple Myeloma Hervé Avet-Loiseau, Toulouse, France Hervé Avet-Loiseau Hervé Avet-Loiseau has been Head of the Laboratory for Genomics in Myeloma at the University Cancer Center of Toulouse, France since September Previously, he was Head of the Hematology Laboratory at the University Hospital of Nantes, France, a position he held from He received his medical degree with a specialization in pediatric hematology in After pursuing a postdoctoral fellowship in the laboratory of Dr Joe Gray in San Francisco, USA, he moved into the area of biological hematology in 1995 and subsequently specialized in cytogenetics. He received his PhD in 1998 and became Professor of Hematology in Professor Avet-Loiseau is highly involved in the Intergroupe Francophone du Myélome (IFM), where he leads all biological studies. Most of these studies are based on the analysis of genetic abnormalities observed in malignant plasma cells using different technologies, including fluorescence in situ hybridization (FISH), gene expression profiling, and single nucleotide polymorphism (SNP) arrays. In March 2011, Professor Avet-Loiseau was elected President of the IFM. Seite 24 Seite 25

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15 CURRICULUM VITAE From myeloma precursor disease to Multiple Myeloma Maria-Victoria Mateos, Salamanca, Spain Should we treat Smoldering Multiple Myeloma? Smoldering Multiple Myeloma (SMM) is an asymptomatic precursor disease of MM for which the standard of care is observation until progression to symptomatic disease occurs. Maria-Victoria Mateos Dr. María-Victoria Mateos, MD and PhD, is an Associated Professor and Consultant Physician of the Haematology Department at the University Hospital of Salamanca, Spain. She studied Medicine at the University of Valladolid, Spain ( ) and completed her residency in Haematology at the University Hospital of Salamanca. In 2000, she obtained her PhD (Methylation of the p16 gene in Multiple Myeloma). Currently, she works as clinician physician and coordinates all clinical trials developed in the Haematology Department, collaborating in the design together with their development. She is a member of the PETHEMA board in Spain due to her active participation in the clinical trials and also she is a member of the IMWG due to her participation in clinical trials focused on Multiple Myeloma. She has published over 100 original papers in international journals. Her areas of interest include multiple myeloma, the biology of plasma cells and the news drugs development. However, SMM is a heterogeneous disease and although there are SMM patients at low or standard risk of progression who won t obtain any benefit from an early treatment, there is a high-risk subgroup of patients in whom the median time to progression to active disease is of approximately 2 years and these should really be the target for an early intervention. All attempts to early treat SMM patients, including alkylators agents, thalidomide, or bisphosphonates, failed to obtain a benefit but no discrimination according to the risk of progression was done. Currently, several trials are ongoing in high risk SMM patients with different drugs (lenalidomide, siltuximab, elotuzumab, MLN9708) and we have already consolidated results from a trial conducted by the Spanish Myeloma Group in this selected patient population comparing lenalidomide-based therapy vs. observation. The early treatment with lenalidomide-dexamethasone followed by lenalidomide maintenance significantly delayed the time to progression to symptomatic disease, and resulted into a benefit in overall survival. In addition, the oral administration of this regimen was convenient for the patients with a good toxicity profile. We conclude that, at the present time, we are in the optimal way to change the paradigm of treatment of SMM patients at high risk of progression to active disease. Seite 28 Seite 29

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17 CURRICULUM VITAE Familial risks and germline genetics of Myeloma Kari Hemminki, Heidelberg, Germany Kari Hemminki Position Title Professor of Molecular Genetic Epidemiology Education/Training 1973 University of Helsinki, Finland, MD, Medicine 1973 University of Helsinki, Finland, PhD, Medical biochemistry 1975 University of Helsinki, Finland, Assist. Prof, Medical biochemistry Johns Hopkins University, Baltimore, USA, Postdoc, Molecular biology Positions Research Professor, Institute of Occupational Health, Helsinki Professor of Epidemiology, Karolinska Institute, Huddinge, Sweden (from at 20%) since 2002 Professor of Molecular Genetic Epidemiology, German Cancer Research Center (DKFZ) and since 2006 University of Heidelberg, Heidelberg, Germany German Cancer Research Center, chairperson of research area C, Cancer Risk Factors and Prevention and member of the scientific council Foreign Adjunct Professor, molecular genetic epidemiology, Karolinska Institute, Sweden since 2009 Guest Professor, molecular genetic epidemiology, Lund University Little is known about genetic susceptibility to multiple myeloma (MM). According to the Swedish Family-Cancer Database, the familial risk of MM is close 3.0 which is among the highest of common malignancies. The likelihood of finding significant genetic effects is grossly related to the magnitude of the familial risk, which is a surrogate of heritability. The familial risk is thus a roadmap into disease genetics, which would thus suggest that susceptibility genes exist for MM. Indeed, the first genome wide association study (GWAS), conducted as a UK-German collaboration by Broderick and coworkers (Nature Genet 2012), identified risk loci at 3p22.1 (rs in ULK4; odds ratio (OR) = 1.32; P = ) and 7p15.3 (rs , OR = 1.38; P = ). In addition, we observed a promising association at 2p23.3 (rs , OR = 1.29; P = ). The G-to-A transition at rs of the ULK 4 gene results in an alanine to threonine alteration, which is predicted to be benign. The gene encodes a serine/threonine protein kinase, which is a key regulator of mtor-mediated autophagy. The rs SNP at chromosome 7 maps to an intron of the DNAH11 gene, which encodes a dynein heavy chain microtubuledependent ATPase motor, involved in respiratory cilia movement. Germline DNAH11 mutations cause Kartagener syndrome. However, the SNP is in linkage disequilibrium with the CDCA7L gene, encoding a MYC interacting protein. The risks for MM conferred by these three loci collectively accounting for only ~4% of the familial risk of MM. However, because of the high carrier frequencies of risk alleles, the loci make a significant contribution to MM etiology in terms of the population attributable fraction of ~37%. The chromosome 3 locus was recently associated with the risk of monoclonal gammopathy of undetermined significance (Greenberg et al, Leukemia 2012). MM shows many types of cytogenetic changes, some of which have prognostic implications. However, little is known about the possible genetic control of these changes. We have addressed this question in our joint UK-German MM population. Common cytogenetetic abnormalities were assessed by interphase fluorescence in situ hybridization (FISH) and the frequencies were associated with SNP data from the joint GWAS. According to the preliminary results, some significant associations were discovered. Support: German Cancer Aide. Seite 32 Seite 33

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19 CURRICULUM VITAE Immunomodulatory drugs incorporated into maintenance strategies Philippe Moreau, Nantes, France 1 - Maintenance with IMiDs following high-dose therapy (HDT) and autologous stem cell transplantation (ASCT) Philippe Moreau Prof. Philippe Moreau, MD, is Head of the Hematology Department at the University Hospital of Nantes, France. He specializes in clinical hematology, with a particular focus on multiple myeloma and its treatment with high-dose therapy and novel agents. Prof. Moreau was appointed University Professor of Clinical Hematology at Nantes Faculty of Medicine in As leading researcher in multiple myeloma, Prof. Moreau is head of the unit for early phase 1 and phase 2 trials in clinical hematology at the University Hospital of Nantes. Additionally, he was a member of the organizing committee for the 2011 International Myeloma Workshop, in Paris. Prof. Moreau is currently a member of the administration council f the Intergroupe Francophone du Myélome (IFM), and he was chairman of the IFM from 2006 through Prof. Moreau is widely published, with more than 200 per-reviewed articles and reviews that have appeared in high impact factor journals including Journal of Clinical Oncology, Lancet Oncology, and Blood. He is frequently invited speaker at international hematologic oncology meetings. In most countries, thalidomide was the first novel agent to become available. This oral drug was soon examined ASCT in the maintenance setting, with the objective of prolonging the duration of response. Six randomized phase III studies from various countries have since been published. Taken together, all 6 trials have shown a significant benefit for thalidomide in terms of response and progression-free survival (PFS), while overall survival (OS) was improved in two of these studies. The safety profile of thalidomide may hinder its use as long-term maintenance therapy. Notably, peripheral neuropathy (PN) observed with thalidomide is cumulative and related to treatment duration. The incidence of PN was high across all trials, and was the main cause of discontinuation of maintenance therapy. The possible emergence of tumor-resistant clones in patients with prolonged exposure to thalidomide has also led to concerns about its lack of efficacy in patients with adverse cytogenetic abnormalities. Lenalidomide is currently considered the best candidate for use as maintenance therapy. Results from two randomized trials evaluating lenalidomide maintenance following ASCT have recently been published. In the IFM study, 614 patients received lenalidomide consolidation treatment after ASCT and were then randomized to receive either placebo (Arm A) or lenalidomide maintenance (10 15 mg/day until relapse; Arm B). After a median follow-up of 30 months, patients who received lenalidomide maintenance had improved median PFS by 18 months (median 23 months in Arm A versus 41 months in Arm B). A benefit in terms of OS has not yet been demonstrated. Second primary malignancies (SPMs) were observed in 26 patients (3,1 %) treated with lenalidomide and 11 (1,2%) treated with placebo. The Cancer and Leukemia Group B (CALGB) group reported the results of a similar phase III randomized trial of lenalidomide or placebo following HDT and ASCT (CALGB study). Patients (N = 460) aged <70 years with non-progressive multiple myeloma were randomized post-asct to receive placebo (n = 229) or lenalidomide 10 mg/day (n = 231) until progression. The study was stopped prematurely because of the significant superiority observed with lenalidomide maintenance, which resulted in a 63% reduction in the risk of progression compared with placebo. The median time-to-progression (TTP) was 46 months for the lenalidomide arm versus 27 months for the placebo arm at a median follow-up of 34 months. Interestingly, despite a crossover of patients with disease progression from the placebo arm to the lenalidomide arm, an improvement in OS was observed favoring the lenalidomide arm (3-year OS rate: 88% versus 80%; P=0.03). Eighteen of the 231 patients treated with lenalidomide developed SPMs (7.8%), whereas 6 of the 229 patients (2.6%) treated with placebo developed SPMs. 2 - Maintenance with IMiDs in patients non eligible for ASCT Maintaining response to induction treatment and preventing tumor progression are important goals also in elderly patients. Thalidomide maintenance may be an option, although thalidomide tolerance decreases with aging. Three of the six Melphalan-Prednisone-Thalidomide (MPT) studies included thalidomide maintenance, but no OS advantage was observed. Two other trials explored the role of thalidomide maintenance after conventional therapy, demonstrating an improvement in PFS, but not in OS, probably due to a slight increase in toxicity. Lenalidomide is another attractive drug in the maintenance setting. However, its routine use is controversial, given the concerns about the risk of SPMs observed following ASCT. In a pre-specified landmark analysis of the MM015 trial, lenalidomide maintenance significantly extended median PFS from the start of maintenance (26 months) as compared with placebo (7 months), regardless of age and with acceptable adverse-event rates. The results of the trial confirm the importance of continuous treatment with lenalidomide. The data available so far suggest that maintenance treatment has the potential to improve PFS. However, longer follow-up is needed to assess the survival benefit, to define the appropriate duration, and the impact of maintenance treatment on survival at relapse. Seite 36 Seite 37

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