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Phase III multiple myelomA

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https://www.readbyqxmd.com/read/28935772/the-european-medicines-agency-review-of-carfilzomib-for-the-treatment-of-adult-patients-with-multiple-myeloma-who-have-received-at-least-one-prior-therapy
#1
Kyriaki Tzogani, Jorge Camarero Jiménez, Isabel Garcia, Arantxa Sancho-López, Marc Martin, Alexandre Moreau, Pierre Demolis, Tomas Salmonson, Jonas Bergh, Edward Laane, Heinz Ludwig, Christian Gisselbrecht, Francesco Pignatti
On November 19, 2015, a marketing authorization valid through the European Union was issued for carfilzomib in combination with lenalidomide and dexamethasone for the treatment of adult patients with multiple myeloma (MM) who have received at least one prior therapy.In a phase III trial in patients with relapsed MM, median progression-free survival (PFS) for patients treated with carfilzomib in combination with lenalidomide and dexamethasone (CRd) was 26.3 months versus 17.6 months for those receiving lenalidomide and dexamethasone alone (hazard ratio = 0...
September 21, 2017: Oncologist
https://www.readbyqxmd.com/read/28905189/bortezomib-and-low-dose-dexamethasone-with-or-without-continuous-low-dose-oral-cyclophosphamide-for-primary-refractory-or-relapsed-multiple-myeloma-a-randomized-phase-iii-study
#2
Martin Kropff, Martin Vogel, Guido Bisping, Rudolf Schlag, Rudolf Weide, Wolfgang Knauf, Heinrich Fiechtner, Georgi Kojouharoff, Stephan Kremers, Wolfgang E Berdel
This phase III, open-label, randomized, controlled study aimed to evaluate the benefit of adding continuous low-dose oral cyclophosphamide to bortezomib-dexamethasone in patients with primary relapsed/refractory multiple myeloma. Patients were randomized 1:1 to receive up to eight 3-week cycles of bortezomib (1.3 mg/m(2)) and dexamethasone (20 mg; VD; n = 48) or bortezomib-dexamethasone plus oral cyclophosphamide (50 mg; VCD; n = 48). Median time to progression (primary endpoint) was slightly longer in the VD versus VCD group (12...
September 14, 2017: Annals of Hematology
https://www.readbyqxmd.com/read/28885719/post-transplant-consolidation-plus-lenalidomide-maintenance-vs-lenalidomide-maintenance-alone-in-multiple-myeloma-a-systematic-review
#3
REVIEW
Fatimah Al-Ani, Martha Louzada
BACKGROUND: In newly diagnosed multiple myeloma (NDMM), autologous stem cell transplantation (ASCT) remains the standard approach for transplant-eligible patients. To control the inevitable relapse, post-transplant consolidation/maintenance strategies are commonly used. However, the benefit of post-transplant consolidation is still uncertain. METHOD: We conducted a systematic review of phase II/III studies to compare the efficacy of post-ASCT consolidation plus lenalidomide maintenance (CON+LEN) vs...
September 8, 2017: European Journal of Haematology
https://www.readbyqxmd.com/read/28827410/neutral-tumor-evolution-in-myeloma-is-associated-with-poor-prognosis
#4
David C Johnson, Oleg Lenive, Jonathan Mitchell, Graham Jackson, Roger Owen, Mark Drayson, Gordon Cook, John R Jones, Charlotte Pawlyn, Faith E Davies, Brian A Walker, Christopher Wardell, Walter M Gregory, David Cairns, Gareth J Morgan, Richard S Houlston, Martin F Kaiser
Recent studies suggest that the evolutionary history of a cancer is important in forecasting clinical outlook. To gain insight into the clonal dynamics of multiple myeloma (MM) and its possible influence on patient outcome we analysed whole exome sequencing tumor data for 333 patients from Myeloma XI, a UK phase III trial and 434 patients from the CoMMpass study, all of which had received immunomodulatory therapy (IMiD). By analysing mutant allele frequency distributions in tumors we found that 17-20% of MM is under neutral evolutionary dynamics...
August 21, 2017: Blood
https://www.readbyqxmd.com/read/28803351/dose-and-schedule-selection-of-the-oral-proteasome-inhibitor-ixazomib-in-relapsed-refractory-multiple-myeloma-clinical-and-model-based-analyses
#5
Neeraj Gupta, Huyuan Yang, Michael J Hanley, Steven Zhang, Rachael Liu, Shaji Kumar, Paul G Richardson, Tomas Skacel, Karthik Venkatakrishnan
BACKGROUND: The oral proteasome inhibitor ixazomib has been approved by regulatory authorities around the world, including in the United States and the European Union, for the treatment of patients with multiple myeloma (MM) who have received at least one prior therapy, based on the pivotal phase III TOURMALINE-MM1 study. OBJECTIVE: The objective of this study was to quantitatively characterize the benefit-risk profile of ixazomib in relapsed/refractory MM in support of the approved dose and schedule...
August 12, 2017: Targeted Oncology
https://www.readbyqxmd.com/read/28801967/retreatment-and-prolonged-therapy-with-subcutaneous-bortezomib-in-patients-with-relapsed-multiple-myeloma-a-randomized-controlled-phase-iii-study
#6
Evangelos Terpos, Marco Gobbi, Anna Potamianou, Marjolein Lahaye, Catherine Couturier, Michele Cavo
OBJECTIVES: This randomized, international, multicenter, open-label phase III study investigated the effects of experimental retreatment with subcutaneous bortezomib plus dexamethasone (VD) followed by prolonged bortezomib therapy vs. standard VD retreatment in patients with relapsed/refractory multiple myeloma. METHODS: Patients were randomized (2:1) to receive either experimental (n = 53) or standard (n = 27) retreatment, stratified by the number of prior therapy lines...
August 12, 2017: European Journal of Haematology
https://www.readbyqxmd.com/read/28761118/bortezomib-before-and-after-high-dose-therapy-in-myeloma-long-term-results-from-the-phase-iii-hovon-65-gmmg-hd4-trial
#7
H Goldschmidt, H M Lokhorst, E K Mai, B van der Holt, I W Blau, S Zweegman, K C Weisel, E Vellenga, M Pfreundschuh, M J Kersten, C Scheid, S Croockewit, R Raymakers, D Hose, A Potamianou, A Jauch, J Hillengass, M Stevens-Kroef, M S Raab, A Broijl, H W Lindemann, G M J Bos, P Brossart, M van Marwijk Kooy, P Ypma, U Duehrsen, R M Schaafsma, U Bertsch, T Hielscher, Le Jarari, H J Salwender, P Sonneveld
The Dutch-Belgian Cooperative Trial Group for Hematology Oncology Group-65/German-speaking Myeloma Multicenter Group-HD4 (HOVON-65/GMMG-HD4) phase III trial compared bortezomib (BTZ) before and after high-dose melphalan and autologous stem cell transplantation (HDM, PAD arm) compared with classical cytotoxic agents prior and thalidomide after HDM (VAD arm) in multiple myeloma (MM) patients aged 18-65 years. Here, the long-term follow-up and data on second primary malignancies (SPM) are presented. After a median follow-up of 96 months, progression-free survival (censored at allogeneic transplantation, PFS) remained significantly prolonged in the PAD versus VAD arm (hazard ratio (HR)=0...
July 4, 2017: Leukemia: Official Journal of the Leukemia Society of America, Leukemia Research Fund, U.K
https://www.readbyqxmd.com/read/28756084/emerging-therapies-for-multiple-myeloma-application-in-older-adults
#8
REVIEW
Tanya M Wildes
Tremendous advances in the treatment of multiple myeloma have yielded improvements in survival in patients with multiple myeloma. A number of pivotal phase III trials have established the benefit of these newer agents in individuals with relapsed multiple myeloma. Because older adults are under-enrolled in clinical trials, clinical trial data may not be categorically generalizable to more vulnerable older adults. In this review, the applicability to older adults of recent clinical trials of newer agents in older adults with myeloma are examined, with attention to eligibility criteria, dosing of therapy, characteristics of the population, and subgroup analyses of older adults...
July 26, 2017: Journal of Geriatric Oncology
https://www.readbyqxmd.com/read/28723910/estimating-mono-and-bi-phasic-regression-parameters-using-a-mixture-piecewise-linear-bayesian-hierarchical-model
#9
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
#10
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
#11
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
#12
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
#13
REVIEW
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...
August 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
#14
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
#15
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
#16
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
https://www.readbyqxmd.com/read/28485007/management-of-adverse-events-associated-with-ixazomib-plus-lenalidomide-dexamethasone-in-relapsed-refractory-multiple-myeloma
#17
RANDOMIZED CONTROLLED TRIAL
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...
August 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
#18
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
#19
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
#20
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
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