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Research protocols for myeloma

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 have dramatically improved in the last 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 the 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 do cross trial comparisons...
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. Results At a median follow-up of 13...
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 DalMaso
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
Xu-Hua Qiu, Yong-Ping Zhai
Clarithromycin is a 14-membered ring macrolide antibiotics that is widely used in the treatment of infectious disease. Several clinical investigations showed that clarithromycin was highly efficient for multiple myeloma in improving response rate and survival when used in combination with the conventional chemotherapy since 1997. This finding highlights the importance of clarithromycin on the treatment of multiple myeloma. It offers a new regimen for the relapsed/refractory multiple myeloma patients, and provids a new thought for the treatment of multiple myeloma...
February 2015: Zhongguo Shi Yan Xue Ye Xue za Zhi
Sham Mailankody, Neha Korde, Alexander M Lesokhin, Nikoletta Lendvai, Hani Hassoun, Maryalice Stetler-Stevenson, Ola Landgren
Outcomes for patients with multiple myeloma (MM) have improved substantially in the past decade, with improvements in both progression-free survival and overall survival. Many patients are now achieving a complete response to treatment, and consequently highly sensitive assays are needed for detection of minimal residual disease (MRD) in patients with MM. Results of multicolour flow cytometry and deep-sequencing studies suggest that among patients achieving a complete response, MRD-negative status is associated with significant improvements in progression-free survival and overall survival...
May 2015: Nature Reviews. Clinical Oncology
Kanako Katayama, Sonoko Misawa, Yasunori Sato, Gen Sobue, Ichiro Yabe, Osamu Watanabe, Masatoyo Nishizawa, Susumu Kusunoki, Seiji Kikuchi, Ichiro Nakashima, Shu-Ichi Ikeda, Nobuo Kohara, Takashi Kanda, Jun-Ichi Kira, Hideki Hanaoka, Satoshi Kuwabara
INTRODUCTION: Polyneuropathy, organomegaly, endocrinopathy, M-protein and skin changes (POEMS) syndrome is a fatal systemic disorder associated with plasma cell dyscrasia and the overproduction of the vascular endothelial growth factor (VEGF). Recently, the prognosis of POEMS was substantially improved by introduction of therapeutic intervention for myeloma. However, no randomised clinical trial has been performed because of the rarity and severity of the disease. METHODS AND ANALYSIS: The Japanese POEMS syndrome with Thalidomide (J-POST) Trial is a phase II/III multicentre, double-blinded, randomised, controlled trial that aims to evaluate the efficacy and safety of a 24-week treatment with thalidomide in POEMS syndrome, with an additional 48-week open-label safety study...
2015: BMJ Open
Deanna J Fall, Holly Stessman, Sagar S Patel, Zohar Sachs, Brian G Van Ness, Linda B Baughn, Michael A Linden
Multiple myeloma (MM) is an incurable malignant neoplasm hallmarked by a clonal expansion of plasma cells, the presence of a monoclonal protein in the serum and/or urine (M-spike), lytic bone lesions, and end organ damage. Clinical outcomes for patients with MM have improved greatly over the last decade as a result of the re-purposing of compounds such as thalidomide derivatives, as well as the development of novel chemotherapeutic agents including first and second generation proteasome inhibitors, bortezomib (Bz) and carfilzomib...
2014: Journal of Cancer
E S Urnova, O S Pokrovskaia, M A Gracheva, S A Vasil'ev, É G Gemdzhian, I D Tarandovskiĭ, L P Mendeleeva
AIM: To determine the frequency and pattern of blood clotting disorders in patients with multiple myeloma (MM) and to evaluate the adequacy of preventive anticoagulant or antiaggregant therapy. SUBJECTS AND METHODS: The prospective study conducted at the Department for High-Dose Chemotherapy and Bone Marrow Transplantation, Hematology Research Center, Ministry of Health of the Russian Federation, in March 2012 to May 2013, enrolled 25 patients (13 men and 12 women) aged 29-72 years (median age 54 years) with new-onset MM...
2014: Terapevticheskiĭ Arkhiv
A L Melikian, T I Kolosheĭnova, S R Goriacheva, I N Subortseva, M V Vakhrusheva, E N Kolosova, A B Sudarikov, A O Abdullaev, V N Dvirnyk, E Iu Varlamova, A M Kovrigina, A G Turkina
AIM: To determine the clinical features of multiple primary tumors (MPT) in patients with hemoblastoses, to develop treatment policy for synchronous and metachronous tumors, and to determine the impact of chemotherapy for one disease on the course and prognosis of another one. SUBJECTS AND METHODS: The investigation included 20 patients with multiple primary synchronous and metachronous myeloid and lymphoid tumors, who had been followed up at the Outpatient Department of the Hematology Research Center, Ministry of Health of the Russian Federation...
2014: Terapevticheskiĭ Arkhiv
Gordon Cook, Cathy Williams, Julia M Brown, David A Cairns, Jamie Cavenagh, John A Snowden, A John Ashcroft, Marie Fletcher, Chris Parrish, Kwee Yong, Jim Cavet, Hanna Hunter, Jenny M Bird, Anna Chalmers, Sheila O'Connor, Mark T Drayson, Treen C M Morris
BACKGROUND: Relapsed multiple myeloma has no standard treatment, and the role of autologous stem-cell transplantation (ASCT) has not been fully defined. We aimed to compare high-dose melphalan plus salvage ASCT with cyclophosphamide in patients with relapsed multiple myeloma who had previously undergone ASCT. METHODS: This multicentre, randomised, open-label, phase 3 study recruited patients aged at least 18 years with multiple myeloma who needed treatment for first progressive or relapsed disease at least 18 months after a previous ASCT from 51 centres across the UK...
July 2014: Lancet Oncology
Gordan Srkalovic, Mohamad A Hussein, Antje Hoering, Jeffrey A Zonder, Leslie L Popplewell, Harsha Trivedi, Sandy Mazzoni, Rachel Sexton, Robert Z Orlowski, Bart Barlogie
The authors assessed the overall response rate, including confirmed complete response (CR) and partial response, in patients with relapsed/refractory multiple myeloma treated with sorafenib. Qualitative and quantitative toxicities associated with this regimen were evaluated. Patients were eligible if they had a confirmed diagnosis of refractory or relapsed (RR) multiple myeloma (MM) with measurable monoclonal protein. Patients had to have adequate renal, hepatic, hematologic, and cardiac function with a Zubrod performance status of 0-2...
October 2014: Cancer Medicine
Torsten Steinbrunn, Manik Chatterjee, Ralf C Bargou, Thorsten Stühmer
Cell lines represent the everyday workhorses for in vitro research on multiple myeloma (MM) and are regularly employed in all aspects of molecular and pharmacological investigations. Although loss-of-function studies using RNA interference in MM cell lines depend on successful knockdown, no well-established and widely applied protocol for efficient transient transfection has so far emerged. Here, we provide an appraisal of electroporation as a means to introduce either short-hairpin RNA expression vectors or synthesised siRNAs into MM cells...
2014: PloS One
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