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Phase III multiple myelomA

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https://www.readbyqxmd.com/read/28723910/estimating-mono-and-bi-phasic-regression-parameters-using-a-mixture-piecewise-linear-bayesian-hierarchical-model
#1
Rui Zhao, Paul Catalano, Victor G DeGruttola, Franziska Michor
The dynamics of tumor burden, secreted proteins or other biomarkers over time, is often used to evaluate the effectiveness of therapy and to predict outcomes for patients. Many methods have been proposed to investigate longitudinal trends to better characterize patients and to understand disease progression. However, most approaches assume a homogeneous patient population and a uniform response trajectory over time and across patients. Here, we present a mixture piecewise linear Bayesian hierarchical model, which takes into account both population heterogeneity and nonlinear relationships between biomarkers and time...
2017: PloS One
https://www.readbyqxmd.com/read/28685863/efficacy-and-tolerability-of-the-histone-deacetylase-inhibitor-panobinostat-in-clinical-practice
#2
Marc-Andrea Baertsch, Jens Hillengass, Joanna Blocka, Stefan Schönland, Ute Hegenbart, Hartmut Goldschmidt, Marc S Raab
The histone deacetylase inhibitor panobinostat has shown efficacy in phase-II and phase-III trials for multiple myeloma and has recently received market approval in combination with bortezomib and dexamethasone. Here, we retrospectively report our single center experience with panobinostat/bortezomib/dexamethasone (FVD) in a heavily pretreated patient population (n = 24) with a high degree of refractoriness to proteasome inhibitors (PI) and immunomodulatory drugs (IMiD). Median age was 67 years (range 49-87) and the median number of prior therapies was 5 (range 2-17)...
July 7, 2017: Hematological Oncology
https://www.readbyqxmd.com/read/28683766/randomized-double-blind-placebo-controlled-phase-iii-study-of-ixazomib-plus-lenalidomide-dexamethasone-in-patients-with-relapsed-refractory-multiple-myeloma-china-continuation-study
#3
Jian Hou, Jie Jin, Yan Xu, Depei Wu, Xiaoyan Ke, Daobin Zhou, Jin Lu, Xin Du, Xiequn Chen, Junmin Li, Jing Liu, Neeraj Gupta, Michael J Hanley, Hongmei Li, Zhaowei Hua, Bingxia Wang, Xiaoquan Zhang, Hui Wang, Helgi van de Velde, Paul G Richardson, Philippe Moreau
BACKGROUND: The China Continuation study was a separate regional expansion of the global, double-blind, placebo-controlled, randomized phase III TOURMALINE-MM1 study of ixazomib plus lenalidomide-dexamethasone (Rd) in patients with relapsed/refractory multiple myeloma (RRMM) following one to three prior therapies. METHODS: Patients were randomized (1:1) to receive ixazomib 4.0 mg or placebo on days 1, 8, and 15, plus lenalidomide 25 mg on days 1-21 and dexamethasone 40 mg on days 1, 8, 15, and 22, in 28-day cycles...
July 6, 2017: Journal of Hematology & Oncology
https://www.readbyqxmd.com/read/28677826/elotuzumab-plus-lenalidomide-dexamethasone-for-relapsed-or-refractory-multiple-myeloma-eloquent-2-follow-up-and-post-hoc-analyses-on-progression-free-survival-and-tumour-growth
#4
Meletios A Dimopoulos, Sagar Lonial, Darrell White, Philippe Moreau, Antonio Palumbo, Jesus San-Miguel, Ofer Shpilberg, Kenneth Anderson, Sebastian Grosicki, Ivan Spicka, Adam Walter-Croneck, Hila Magen, Maria-Victoria Mateos, Andrew Belch, Donna Reece, Meral Beksac, Eric Bleickardt, Valerie Poulart, Jennifer Sheng, Oumar Sy, Jessica Katz, Anil Singhal, Paul Richardson
The randomized phase III ELOQUENT-2 study (NCT01239797) evaluated the efficacy and safety of elotuzumab + lenalidomide/dexamethasone (ELd) versus lenalidomide/dexamethasone (Ld) in relapsed/refractory multiple myeloma. ELd reduced the risk of disease progression/death by 30% versus Ld (hazard ratio [HR] 0·70). Median time from diagnosis was 3·5 years. We present extended 3-year follow-up data. Endpoints included progression-free survival (PFS), overall response rate (ORR) and interim overall survival (OS)...
July 5, 2017: British Journal of Haematology
https://www.readbyqxmd.com/read/28661711/safety-of-ixazomib-for-the-treatment-of-multiple-myeloma
#5
Antoine Bonnet, Philippe Moreau
Despite a major positive impact of proteasome inhibitors (PI), such as bortezomib and carfilzomib, on the survival of patients with multiple myeloma (MM) over the last few years, their use in clinical practice is limited by the development of drug resistance, significant side-effects or constraining administration schedules. Ixazomib is the first, and for now the only, oral PI, which was approved by the US Food and Drug Administration in 2015 and by the European Medicines Agency in 2016. Areas covered: In this review, we provide an overview of the preclinical and early-phase studies of ixazomib used as single-agent and in combination...
July 12, 2017: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/28596644/highlights-of-multiple-myeloma-at-the-annual-meeting-of-american-society-of-hematology-2016
#6
REVIEW
Nidhi Tandon, Shaji K Kumar
This review discusses the landmark studies in the field of multiple myeloma (MM) which were presented at American society of hematology annual meeting, 2016. There were contrary results from two large phase III trials (one from US and one from Europe) that evaluated the role of additional interventions like tandem autologous transplant (ASCT) and consolidation after induction therapy followed by ASCT in newly diagnosed MM (NDMM) patients, but there were critical differences between the two studies. Novel agents like carfilzomib and ixazomib proved to be of benefit when used as induction and post ASCT consolidation and maintenance in NDMM...
June 2017: Indian Journal of Hematology & Blood Transfusion
https://www.readbyqxmd.com/read/28573902/cost-effectiveness-of-on-demand-plerixafor-added-to-chemotherapy-and-granulocyte-colony-stimulating-factor-for-peripheral-blood-stem-cell-mobilization-in-multiple-myeloma
#7
Giuseppe Milone, Massimo Martino, Salvatore Leotta, Andrea Spadaro, Valentina Zammit, Alessandra Cupri, Giuseppe Avola, Maria Grazia Camuglia, Annalia Di Marco, Potito Scalzulli, Mara Morelli, Attilio Olivieri, Giovanni Tripepi
We here report final results of a phase II/III prospective study that evaluated in Multiple Myeloma the use of on-demand plerixafor (PLX) added to mobilizing chemotherapy for patients showing predictive signs of mobilization failure. A total of 111 patients with MM were registered, all received cyclophosphamide 4 g/m(2) and granulocyte colony-stimulating factor (G-CSF). Overall, a successful CD34+ cell mobilization was achieved in 97.2% (108/111) of patients. Minimum harvest (≥2.0 × 10(6) CD34+ cells/kg) was achieved in 97...
June 2, 2017: Leukemia & Lymphoma
https://www.readbyqxmd.com/read/28573439/using-pharmacy-management-systems-for-research-survival-outcomes-for-lenalidomide-in-multiple-myeloma-in-the-clinical-setting
#8
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...
June 1, 2017: International Journal of Clinical Pharmacy
https://www.readbyqxmd.com/read/28485007/management-of-adverse-events-associated-with-ixazomib-plus-lenalidomide-dexamethasone-in-relapsed-refractory-multiple-myeloma
#9
Shaji Kumar, Philippe Moreau, Parameswaran Hari, Maria-Victoria Mateos, Heinz Ludwig, Chaim Shustik, Tamas Masszi, Andrew Spencer, Roman Hájek, Kenneth Romeril, Irit Avivi, Anna M Liberati, Monique C Minnema, Hermann Einsele, Sagar Lonial, Deborah Berg, Jianchang Lin, Neeraj Gupta, Dixie-Lee Esseltine, Paul G Richardson
The oral proteasome inhibitor ixazomib is approved in the United States, European Union and other countries, in combination with oral lenalidomide and dexamethasone (Rd), for the treatment of patients with multiple myeloma who have received at least one prior therapy. Approval was based on the global, randomised, double-blind, placebo-controlled Phase III TOURMALINE-MM1 study of ixazomib-Rd (IRd) versus placebo-Rd in patients with relapsed/refractory multiple myeloma. IRd resulted in a significant improvement in progression-free survival versus placebo-Rd (median: 20·6 vs...
May 9, 2017: British Journal of Haematology
https://www.readbyqxmd.com/read/28427514/triplet-versus-doublet-combination-regimens-for-the-treatment-of-relapsed-or-refractory-multiple-myeloma-a-meta-analysis-of-phase-iii-randomized-controlled-trials
#10
COMPARATIVE STUDY
Zhiqiang Sun, Fang Zheng, Suwan Wu, Yanjuan Liu, Hehe Guo, Yichen Liu
During the past decades, several prospective trials had been conducted to assess the efficacy and toxicities of triplet versus doublet combination regimens for the treatment of relapsed or refractory multiple myeloma (RRMM), but the results were controversial. We thus performed a systematic literature search to identify relevant trials. Summary hazard ratios (HRs), relative risks (RRs), and 95% confidence intervals (95%CIs) were calculated. A total of 3197 RRMM patients were included for analysis. The pooled results demonstrated that triplet combination therapies significantly improve OS (HR 0...
May 2017: Critical Reviews in Oncology/hematology
https://www.readbyqxmd.com/read/28423741/lenalidomide-and-the-risk-of-serious-infection-in-patients-with-multiple-myeloma-a-systematic-review-and-meta-analysis
#11
REVIEW
Li Ying, Tong YinHui, Zheng Yunliang, Haozhen Sun
The immunomodulatory drug lenalidomide is highly effective against newly diagnosed and relapsed/refractory multiple myeloma (MM), but serious and even fatal infections have been associated with its use. In this meta-analysis, we assessed the overall risk of infection to MM patients treated with lenalidomide. Eleven phase II or III clinical trials, comprising 3,210 subjects, were selected from the Embase, Pubmed, and Cochrane Library databases, from the Clinical Trial Registration website, and from meeting abstracts and virtual presentations at the American Society of Clinical Oncology...
July 11, 2017: Oncotarget
https://www.readbyqxmd.com/read/28370401/cyclophosphamide-based-stem-cell-mobilization-in-relapsed-multiple-myeloma-patients-a-subgroup-analysis-from-the-phase-iii-trial-relapse
#12
Marc-Andrea Baertsch, Jana Schlenzka, Katharina Lisenko, Julia Krzykalla, Natalia Becker, Katja Weisel, Richard Noppeney, Hans Martin, Hans W Lindemann, Mathias Haenel, Axel Nogai, Christof Scheid, Hans Salwender, Roland Fenk, Ullrich Graeven, Peter Reimer, Martin Schmidt-Hieber, Martin Goerner, Ingo G H Schmidt-Wolf, Stefan Klein, Anthony D Ho, Hartmut Goldschmidt, Patrick Wuchter
OBJECTIVE: Analysis of the efficiency and toxicity of cyclophosphamide-based stem cell mobilization in patients with relapsed multiple myeloma (RMM). METHODS: Peripheral blood stem cells (PBSCs) were mobilized with high dose cyclophosphamide (2 g/m(2) daily on days 1 and 2) and G-CSF plus pre-emptive/rescue plerixafor in RMM patients (first to third relapse) treated within the ReLApsE trial of the German-Speaking Myeloma Multicenter Group (GMMG). RESULTS: Mobilization was initiated with high-dose cyclophosphamide (HD-CY) and G-CSF in 30 patients...
March 31, 2017: European Journal of Haematology
https://www.readbyqxmd.com/read/28290121/population-pharmacokinetic-analysis-of-ixazomib-an-oral-proteasome-inhibitor-including-data-from-the-phase-iii-tourmaline-mm1-study-to-inform-labelling
#13
Neeraj Gupta, Paul M Diderichsen, Michael J Hanley, Deborah Berg, Helgi van de Velde, R Donald Harvey, Karthik Venkatakrishnan
Ixazomib is an oral proteasome inhibitor, approved in USA, Canada, Australia and Europe in combination with lenalidomide and dexamethasone, for the treatment of patients with multiple myeloma who have received at least one prior therapy. We report a population pharmacokinetic model-based analysis for ixazomib that was pivotal in describing the clinical pharmacokinetics of ixazomib, to inform product labelling. Plasma concentration-time data were collected from 755 patients who received oral or intravenous ixazomib in once- or twice-weekly schedules in ten trials, including the global phase III TOURMALINE-MM1 study...
March 13, 2017: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/28240968/systematic-literature-review-and-network-meta-analysis-of-treatment-outcomes-in-relapsed-and-or-refractory-multiple-myeloma
#14
REVIEW
Chrissy H Y van Beurden-Tan, Margreet G Franken, Hedwig M Blommestein, Carin A Uyl-de Groot, Pieter Sonneveld
Purpose Since 2000, many new treatment options have become available for relapsed and/or refractory multiple myeloma (R/R MM) after a long period in which dexamethasone and melphalan had been the standard treatment. Direct comparisons of these novel treatments, however, are lacking. This makes it extremely difficult to evaluate the relative added value of each new treatment. Our aim was to synthesize all efficacy evidence, enabling a comparison of all current treatments for R/R MM. Methods We performed a systematic literature review to identify all publicly available phase III randomized controlled trial evidence...
April 20, 2017: Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology
https://www.readbyqxmd.com/read/28197996/upfront-lower-dose-lenalidomide-is-less-toxic-and-does-not-compromise-efficacy-for-vulnerable-patients-with-relapsed-refractory-multiple-myeloma-final-analysis-of-the-phase-ii-revlite-study
#15
MULTICENTER STUDY
Hang Quach, Liam Fernyhough, Ross Henderson, Gillian Corbett, Bart Baker, Peter Browett, Hilary Blacklock, Cecily Forsyth, Craig Underhill, Paul Cannell, Judith Trotman, Annette Neylon, Simon Harrison, Emma Link, Arlene Swern, Linda Cowan, Meletios A Dimopoulos, H Miles Prince
The combination of lenalidomide and dexamethasone is an established treatment for patients with multiple myeloma (MM). Increasingly, treatment attenuation is advocated for frail/elderly patients to minimize toxicity even though there have been no prospective studies to demonstrate whether lenalidomide dose attenuation impacts on response and survival outcome. This prospective multicentre phase II study assessed the efficacy and tolerability of lower dose lenalidomide (15 mg) and dexamethasone (20 mg) in 149 eligible patients with relapsed/refractory MM aged over 59 years and/or with renal impairment...
May 2017: British Journal of Haematology
https://www.readbyqxmd.com/read/28176904/plitidepsin-design-development-and-potential-place-in-therapy
#16
REVIEW
Sara Alonso-Álvarez, Emilia Pardal, Diego Sánchez-Nieto, Miguel Navarro, Maria Dolores Caballero, Maria Victoria Mateos, Alejandro Martín
Plitidepsin is a cyclic depsipeptide that was first isolated from a Mediterranean marine tunicate (Aplidium albicans) and, at present, is manufactured by total synthesis and commercialized as Aplidin(®). Its antitumor activity, observed in preclinical in vitro and in vivo studies has prompted numerous clinical trials to be conducted over the last 17 years, alone or in combination with other anticancer agents. Single-agent plitidepsin has shown limited antitumor activity and a tolerable safety profile in several malignancies, such as noncutaneous peripheral T-cell lymphoma, melanoma, and multiple myeloma...
2017: Drug Design, Development and Therapy
https://www.readbyqxmd.com/read/28169231/palbociclib-a-new-hope-in-the-treatment-of-breast-cancer
#17
REVIEW
R Priyadharsini Palanisamy
Breast cancer being one of the common cancers has high morbidity and mortality. Despite the conventional treatment, the burden of the disease increases year after year. There is a need for newer drugs that target the different mechanisms in the pathogenesis. The interaction of cyclins with cyclin dependent kinases (CDKs) plays a major role in the abnormal cell cycle in cancer and it is considered to be an important target. Palbociclib is a CDK inhibitor currently approved for the treatment of breast cancer...
October 2016: Journal of Cancer Research and Therapeutics
https://www.readbyqxmd.com/read/28116920/safety-issues-and-management-of-toxicities-associated-with-new-treatments-for-multiple-myeloma
#18
REVIEW
Annamaria Brioli, Lars-Olof Mügge, Andreas Hochhaus, Marie Von Lilienfeld-Toal
In the last decade, the availability of new drugs for the treatment of Multiple Myeloma (MM) significantly improved patients' outcomes, but also raised attention towards a new spectrum of adverse events. Recently, four novel agents with different mechanisms of action (carfilzomib, elotuzumab, daratumumab and panobinostat) have been approved for the treatment of MM. This review aims at providing physicians with the tools to recognize and handle toxicity issues related with these new treatments. Areas covered: This review focuses on the management of drug related adverse events of the latest approved drug combinations...
March 2017: Expert Review of Hematology
https://www.readbyqxmd.com/read/28111466/bortezomib-and-thalidomide-maintenance-after-stem-cell-transplantation-for-multiple-myeloma-a-pethema-gem-trial
#19
L Rosiñol, A Oriol, A I Teruel, A L de la Guía, MaJ Blanchard, J de la Rubia, M Granell, MaA Sampol, L Palomera, Y González, MaA Etxebeste, R Martínez-Martínez, M T Hernández, F de Arriba, A Alegre, MaT Cibeira, MaV Mateos, J Martínez-López, J J Lahuerta, J San Miguel, J Bladé
The phase III trial GEM05MENOS65 randomized 390 patients 65 years old or younger with newly diagnosed symptomatic multiple myeloma (MM) to receive induction with thalidomide/dexamethasone, bortezomib/thalidomide/dexamethasone and Vincristine, BCNU, melphalan, cyclophosphamide, prednisone/vincristine, BCNU, doxorubicin, dexamethasone bortezomib (VBMCP/VBAD/B) followed by autologous stem cell transplantation (ASCT) with MEL-200. After ASCT, a second randomization was performed to compare thalidomide/bortezomib (TV), thalidomide (T) and alfa-2b interferon (alfa2-IFN)...
February 14, 2017: Leukemia: Official Journal of the Leukemia Society of America, Leukemia Research Fund, U.K
https://www.readbyqxmd.com/read/28110581/triplet-combinations-in-relapsed-refractory-myeloma-update-on-recent-phase-3-trials
#20
REVIEW
Jean-Samuel Boudreault, Cyrille Touzeau, Philippe Moreau
Multiple myeloma (MM) is a rare hematologic disease of antibody-secreting plasma cells. Our understanding of the pathogenesis of this malignancy has improved greatly, and at the same time, we have access to new and more effective treatments options. Over the last 5 years, a spectrum of novel therapies with different mechanisms of action, including third-generation immunomodulatory drugs (pomalidomide), second generation proteasome inhibitors (carfilzomib and ixazomib), a histone deacetylase inhibitor (panobinostat) and monoclonal antibodies (mAbs) (elotuzumab and daratumumab) has transformed our approach to the treatment of patients with relapsed/refractory MM (RRMM)...
March 2017: Expert Review of Hematology
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