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Research protocols for myeloma

Carol Keen, Julie Skilbeck, Helen Ross, Lauren Smith, Karen Collins, Joanne Dixey, Stephen Walters, Diana M Greenfield, John A Snowden, Susan Mawson
INTRODUCTION: While myeloma is an incurable malignancy, developments in disease management have led to increased life expectancy in recent years. Treatment typically involves stem-cell transplantation. Increased survival rates equate to more patients living with the burden of both the disease and its treatment for increasing number of years, rendering myeloma a long-term condition.Evidence exists to demonstrate the benefits of exercise for patients recovering from stem-cell transplantation, and prehabilitation-exercise before treatment-has been shown to be effective in other disease areas...
March 9, 2018: BMJ Open
Alina Striha, A John Ashcroft, Anna Hockaday, David A Cairns, Karen Boardman, Gwen Jacques, Cathy Williams, John A Snowden, Mamta Garg, Jamie Cavenagh, Kwee Yong, Mark T Drayson, Roger Owen, Mark Cook, Gordon Cook
BACKGROUND: Multiple myeloma (MM) is a plasma cell tumour with an approximate annual incidence of 4500 in the UK. Therapeutic options for patients with MM have changed in the last decade with the arrival of proteasome inhibitors and immunomodulatory drugs. Despite these options, almost all patients will relapse post first-line autologous stem cell transplantation (ASCT). First relapse management (second-line treatment) has evolved in recent years with an expanding portfolio of novel agents, driving response rates influencing the durability of response...
March 7, 2018: Trials
Yu-Qian Sun, Ying-Jun Chang, Xiao-Jun Huang
Haploidentical stem cell transplantation (Haplo-SCT) is currently a suitable alternative worldwide for patients with hematological diseases, who lack human leukocyte antigen (HLA)-matched siblings or unrelated donors. Areas covered: This review summarizes the advancements in Haplo-SCT in recent years, primarily focusing on the global trends of haploidentical allograft, the comparison of outcomes between Haplo-SCT and other transplantation modalities, strategies for improving clinical outcomes, including donor selection, hematopoietic reconstitution promotion, and graft-versus-host disease, and relapse prevention/management, as well as the expanded indications of Haplo-SCT, such as severe aplastic anemia, myeloma and lymphoma...
March 6, 2018: Expert Review of Hematology
D Bazyka
After the creation of the Academy of Medical Sciences of Ukraine in 1993 the Research Center for Radiation Medicine was among the first institutions to join the Academy (fig. 1). Estab lishing the Academy was among the first steps of the independent Ukrainian government and aimed to provide a high level health care for population. It was extremely needed for the minimization of Chornobyl medical consequences. This choice was related to a growing recognition of the scientific research in fulfilling the Сenter's mission - study of the effects of low dose radiation on human body and radiation protection of the exposed population...
December 2017: Problemy Radiat︠s︡iĭnoï Medyt︠s︡yny Ta Radiobiolohiï
L Rihova, P Vsianska, R Bezdekova, R Kralova, M Penka, M Krejci, L Pour, R Hájek
BACKGROUND: Progress in treatment of multiple myeloma extensively increased patient remission rates, so minimal residual disease (MRD) detection becomes essential to assess the effectivity of treatment and depth of complete response. Nowadays, multiparametric flow cytometry (MFC) is the most used method for monitoring of MRD presence in the bone marrow of multiple myeloma patients; however, detection on molecular level can be used as well. It is evident that choice of protocol used for MFC-MRD assessment can significantly affect required results; nevertheless, standardized and highly sensitive approach of "next generation flow" is already available...
2017: Klinická Onkologie: Casopis Ceské a Slovenské Onkologické Spolecnosti
Megan M Sharkey, Daniel McKavanagh, Euan Walpole, Peter Mollee, Samantha A Hollingworth
Background Health records can be used to measure medicine use and health outcomes. The public subsidy of lenalidomide in Australia was based on two phase III trials showing improved survival. Objective To use hospital pharmacy information management systems to determine survival outcomes for lenalidomide as a second line treatment in relapsed or refractory multiple myeloma (RRMM) patients. Setting Five public hospitals in Queensland, Australia. Method We extracted data on medicine use and survival for RRMM patients planned to start lenalidomide from pharmacy management and pathology databases...
August 2017: International Journal of Clinical Pharmacy
Patricia Melo Aguiar, Tácio de Mendonça Lima, Gisele Wally Braga Colleoni, Sílvia Storpirtis
This overview summarizes evidence for the efficacy and safety of bortezomib, thalidomide, and lenalidomide in patients with multiple myeloma. We searched the Medline, Scopus, and LILACS databases through August 2016, including systematic reviews with meta-analyses of randomized controlled trials assessing the efficacy and/or safety of bortezomib, thalidomide, or lenalidomide in patients with multiple myeloma. Two authors performed study selection, data extraction, and quality assessment using AMSTAR and GRADE instruments...
May 2017: Critical Reviews in Oncology/hematology
T Ševčíková, K Growková, Z Kufová, J Filipová, P Vrublová, T Jelínek, Z Kořístek, F Kryukov, E Kryukova, R Hájek
AIMS: Some types of monoclonal gammopathies are typified by a very limited availability of aberrant cells. Modern research use high throughput technologies and an integrated approach for detailed characterisation of abnormal cells. This strategy requires relatively high amounts of starting material which cannot be obtained from every diagnosis without causing inconvenience to the patient. The aim of this methodological paper is to reflect our long experience with laboratory work and describe the best protocols for sample collection, sorting and further preprocessing in terms of the available number of cells and intended downstream application in monoclonal gammopathies research...
October 2017: Journal of Clinical Pathology
Deepa Harichandran, Kavitha Radhakrishnan Dinesh
BACKGROUND/PURPOSE: Typhoid and paratyphoid fever continue to be important causes of illness and death in parts of Asia, being associated with poor sanitation and consumption of unsafe food and water. Antimicrobial resistance has emerged to traditional first-line drugs, namely, the fluoroquinolones, as well as to third-generation cephalosporins, posing challenges to treatment. Azithromycin has proven to be an effective alternative for treatment of uncomplicated typhoid fever. The purpose of this study was to determine the antimicrobial susceptibility, clinical outcome and serotype distribution pattern of clinical isolates belonging to Salmonella enterica subspecies enterica...
2017: Infection and Drug Resistance
Laurent Garderet, Anita D'Souza, Paulette Jacobs, Anja van Biezen, Stefan Schönland, Nicolaus Kroeger, Curly Morris, Parameswaran Hari
The understanding and treatment of multiple myeloma (MM) have dramatically improved in recent years. However, accurate assessment of the response of myeloma to therapy and its subsequent relapse remains a difficult task. Criteria have changed over time and new parameters have recently been incorporated to evaluate minimal residual disease status. We present a practical approach to assess response and relapse/progression in myeloma in the context of its treatment. A robust reporting schema is crucial to correctly evaluate any treatment protocol and compare results across trials...
March 8, 2017: Biology of Blood and Marrow Transplantation
Pamela Holzlöhner, Katja Hanack
Monoclonal antibodies are universal binding molecules and are widely used in biomedicine and research. Nevertheless, the generation of these binding molecules is time-consuming and laborious due to the complicated handling and lack of alternatives. The aim of this protocol is to provide one standard method for the generation of monoclonal antibodies using hybridoma technology. This technology combines two steps. Step 1 is an appropriate immunization of the animal and step 2 is the fusion of B lymphocytes with immortal myeloma cells in order to generate hybrids possessing both parental functions, such as the production of antibody molecules and immortality...
January 2, 2017: Journal of Visualized Experiments: JoVE
Meletios A Dimopoulos, Albert Oriol, Hareth Nahi, Jesus San-Miguel, Nizar J Bahlis, Saad Z Usmani, Neil Rabin, Robert Z Orlowski, Mieczyslaw Komarnicki, Kenshi Suzuki, Torben Plesner, Sung-Soo Yoon, Dina Ben Yehuda, Paul G Richardson, Hartmut Goldschmidt, Donna Reece, Steen Lisby, Nushmia Z Khokhar, Lisa O'Rourke, Christopher Chiu, Xiang Qin, Mary Guckert, Tahamtan Ahmadi, Philippe Moreau
BACKGROUND: Daratumumab showed promising efficacy alone and with lenalidomide and dexamethasone in a phase 1-2 study involving patients with relapsed or refractory multiple myeloma. METHODS: In this phase 3 trial, we randomly assigned 569 patients with multiple myeloma who had received one or more previous lines of therapy to receive lenalidomide and dexamethasone either alone (control group) or in combination with daratumumab (daratumumab group). The primary end point was progression-free survival...
October 6, 2016: New England Journal of Medicine
Viviana Torres, Mauricio Cerda, Petra Knaup, Martin Löpprich
PURPOSE: An important part of the electronic information available in Hospital Information System (HIS) has the potential to be automatically exported to Electronic Data Capture (EDC) platforms for improving clinical research. This automation has the advantage of reducing manual data transcription, a time consuming and prone to errors process. However, quantitative evaluations of the process of exporting data from a HIS to an EDC system have not been reported extensively, in particular comparing with manual transcription...
2016: Studies in Health Technology and Informatics
Gordon Cook, A John Ashcroft, David A Cairns, Cathy D Williams, Julia M Brown, Jamie D Cavenagh, John A Snowden, Christopher Parrish, Kwee Yong, Jim Cavet, Hannah Hunter, Jenny M Bird, Guy Pratt, Sally Chown, Ernest Heartin, Sheila O'Connor, Mark T Drayson, Anna Hockaday, Treen C M Morris
BACKGROUND: The Myeloma X trial previously reported improved durability of response (time to disease progression) in patients with relapsed multiple myeloma with salvage autologous stem-cell transplantation (ASCT) compared with oral cyclophosphamide in patients with multiple myeloma relapsing after a first ASCT. We report the final overall survival results of the trial. METHODS: BSBMT/UKMF Myeloma X was a multicentre, randomised, open-label, phase 3 trial done at 51 centres in the UK...
July 2016: Lancet Haematology
S Girnius, N C Munshi
Although multiple myeloma (MM) remains an incurable disease, the advent of novel treatment paradigms has improved survival outcomes in the past two decades. This includes widespread use of high-dose chemotherapy with autologous stem cell transplantation (HDT-ASCT) and the development of the novel agents thalidomide, lenalidomide and bortezomib. The efficacy and tolerability of these novel agents have allowed for the exploration of continuous therapy approaches. Maintenance therapy after HDT-ASCT, for example, may help prolong progression-free survival by providing sustained control of residual disease...
May 2013: Leukemia Supplements
Tiny van Merode, Silvia Bours, Ben van Steenkiste, Theo Sijbers, Gerard van der Hoek, Cor Vos, Gerard M J Bos, Trudy van der Weijden
BACKGROUND: To ensure true patient-centered care, the urgency of patient participation in research is increasingly recognized. This study takes this one step further and reports on patient participation in describing patients' needs for improving quality of care in the context of research priorities - a challenging partnership with patients in research as we yet lack experience in the Netherlands. OBJECTIVES: 1) To illustrate the process of describing patients' needs in the context of research priorities for patients with blood cancer (multiple myeloma or Waldenstrom's disease) with the purpose to improve the quality of health care...
2016: Zeitschrift Für Evidenz, Fortbildung und Qualität Im Gesundheitswesen
Susanna Busco, Carlotta Buzzoni, Sandra Mallone, Annalisa Trama, Marine Castaing, Francesca Bella, Rosalba Amodio, Sabrina Bizzoco, Tiziana Cassetti, Claudia Cirilli, Rosanna Cusimano, Roberta De Angelis, Mario Fusco, Gemma Gatta, Valerio Gennaro, Adriano Giacomin, Paolo Giorgi Rossi, Lucia Mangone, Salvatore Mannino, Silvia Rossi, Daniela Pierannunzio, Andrea Tavilla, Sandro Tognazzo, Rosario Tumino, Massimo Vicentini, Maria Francesca Vitale, Emanuele Crocetti, Luigino Dal Maso
OBJECTIVES: This collaborative study, based on data collected by the network of Italian Cancer Registries (AIRTUM), describes the burden of rare cancers in Italy. Estimated number of new rare cancer cases yearly diagnosed (incidence), proportion of patients alive after diagnosis (survival), and estimated number of people still alive after a new cancer diagnosis (prevalence) are provided for about 200 different cancer entities. MATERIALS AND METHODS: Data herein presented were provided by AIRTUM population- based cancer registries (CRs), covering nowadays 52% of the Italian population...
January 2016: Epidemiologia e Prevenzione
Sagar Lonial, Brendan M Weiss, Saad Z Usmani, Seema Singhal, Ajai Chari, Nizar J Bahlis, Andrew Belch, Amrita Krishnan, Robert A Vescio, Maria Victoria Mateos, Amitabha Mazumder, Robert Z Orlowski, Heather J Sutherland, Joan Bladé, Emma C Scott, Albert Oriol, Jesus Berdeja, Mecide Gharibo, Don A Stevens, Richard LeBlanc, Michael Sebag, Natalie Callander, Andrzej Jakubowiak, Darrell White, Javier de la Rubia, Paul G Richardson, Steen Lisby, Huaibao Feng, Clarissa M Uhlar, Imran Khan, Tahamtan Ahmadi, Peter M Voorhees
BACKGROUND: New treatment options are needed for patients with multiple myeloma that is refractory to proteasome inhibitors and immunomodulatory drugs. We assessed daratumumab, a novel CD38-targeted monoclonal antibody, in patients with refractory multiple myeloma. METHODS: In this open-label, multicentre, phase 2 trial done in Canada, Spain, and the USA, patients (age ≥18 years) with multiple myeloma who were previously treated with at least three lines of therapy (including proteasome inhibitors and immunomodulatory drugs), or were refractory to both proteasome inhibitors and immunomodulatory drugs, were randomly allocated in a 1:1 ratio to receive intravenous daratumumab 8 mg/kg or 16 mg/kg in part 1 stage 1 of the study, to decide the dose for further assessment in part 2...
April 9, 2016: Lancet
Katja Weisel, Meletios Dimopoulos, Kevin W Song, Philippe Moreau, Antonio Palumbo, Andrew Belch, Stephen Schey, Pieter Sonneveld, Lars Sternas, Xin Yu, Ramesh Amatya, Craig J Gibson, Mohamed Zaki, Christian Jacques, Jesus San Miguel
BACKGROUND: Health-related quality of life (HRQoL) is an important element for consideration in treatment decisions in patients with relapsed/refractory multiple myeloma (RRMM). The pivotal MM-003 (A Phase 3, Multicenter, Randomized, Open-Label Study to Compare the Efficacy and Safety of Pomalidomide in Combination With Low-Dose Dexamethasone vs. High-Dose Dexamethasone in Patients With Refractory Multiple Myeloma or Relapsed and Refractory Multiple Myeloma and Companion Study [NIMBUS]) randomized, open-label, multicenter, phase III trial demonstrated improved progression-free survival (PFS) and prolonged overall survival (OS) with pomalidomide (POM) plus low-dose dexamethasone (POM + LoDEX) versus high-dose dexamethasone (HiDEX) in patients with RRMM in whom lenalidomide (LEN) and bortezomib (BORT) had failed...
September 2015: Clinical Lymphoma, Myeloma & Leukemia
Paul G Richardson, Jacob P Laubach, Nikhil C Munshi, Kenneth C Anderson
For the last 20 years, high-dose therapy with autologous stem cell transplantation (ASCT) for multiple myeloma has been considered a standard frontline treatment for younger patients with adequate organ function. With the introduction of novel agents, specifically thalidomide, bortezomib, and lenalidomide, the role of ASCT has changed in several ways. First, novel agents have been incorporated successfully as induction regimens, increasing the response rate before ASCT, and are now being used as part of both consolidation and maintenance with the goal of extending progression-free and overall survival...
December 5, 2014: Hematology—the Education Program of the American Society of Hematology
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