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https://www.readbyqxmd.com/read/29061534/granulocyte-colony-stimulating-factor-use-after-autologous-peripheral-blood-stem-cell-transplantation-comparison-of-two-practices
#1
Amrita D Singh, Sapna Parmar, Khilna Patel, Shreya Shah, Tsiporah Shore, Usama Gergis, Sebastian Mayer, Adrienne Phillips, Jing-Mei Hsu, Ruben Niesvizky, Tomer M Mark, Roger Pearse, Adriana Rossi, Koen van Besien
Administration of granulocyte colony-stimulating factor (G-CSF) after autologous peripheral blood stem cell transplantation (PBSCT) is generally recommended to reduce the duration of severe neutropenia; however, there is limited and conflicting data regarding the optimal timing of G-CSFs post-transplant. A retrospective study was performed at NewYork-Presbyterian/Weill Cornell Medical Center (NYP/WC) from November 5, 2013 to August 9, 2016 of adult inpatient autologous PBSCT patients who received G-CSF empirically starting on day +5 (early) versus day +12 only if absolute neutrophil count (ANC) was <0...
October 20, 2017: Biology of Blood and Marrow Transplantation
https://www.readbyqxmd.com/read/29051077/cellular-proliferation-by-multiplex-immunohistochemistry-identifies-high-risk-multiple-myeloma-in-newly-diagnosed-treatment-naive-patients
#2
Scott Ely, Peter Forsberg, Ihsane Ouansafi, Adriana Rossi, Alvin Modin, Roger Pearse, Karen Pekle, Arthur Perry, Morton Coleman, David Jayabalan, Maurizio Di Liberto, Selina Chen-Kiang, Ruben Niesvizky, Tomer M Mark
INTRODUCTION: Therapeutic options for multiple myeloma (MM) are growing, yet clinical outcomes remain heterogeneous. Cytogenetic analysis and disease staging are mainstays of risk stratification, but data suggest a complex interplay between numerous abnormalities. Myeloma cell proliferation is a metric shown to predict outcomes, but available methods are not feasible in clinical practice. PATIENTS AND METHODS: Multiplex immunohistochemistry (mIHC), using multiple immunostains simultaneously, is universally available for clinical use...
September 20, 2017: Clinical Lymphoma, Myeloma & Leukemia
https://www.readbyqxmd.com/read/28937327/carfilzomib-dexamethasone-versus-subcutaneous-or-intravenous-bortezomib-in-relapsed-or-refractory-multiple-myeloma-secondary-analysis-of-the-phase-3-endeavor-study
#3
Hartmut Goldschmidt, Philippe Moreau, Heinz Ludwig, Ruben Niesvizky, Wee-Joo Chng, Douglas Joshua, Katja Weisel, Andrew Spencer, Robert Z Orlowski, Shibao Feng, Karim S Iskander, Meletios A Dimopoulos
This is a secondary analysis of the phase 3 ENDEAVOR study comparing relapsed and/or refractory multiple myeloma (RRMM) patients receiving carfilzomib-dexamethasone (Kd) with those receiving subcutaneous (SC) bortezomib with dexamethasone (Vd) or intravenous (IV) Vd. Of Kd-treated patients, 356 Kd were pre-selected (by physician prior to randomization if to be randomized to Vd) for SC Vd (Kd [SC Vd]) and 108 for IV Vd (Kd [IV Vd], respectively. Of Vd-treated patients, 360 received SC Vd and 75 IV Vd. Kd (SC Vd) median PFS was not reached; SC Vd was 9...
September 22, 2017: Leukemia & Lymphoma
https://www.readbyqxmd.com/read/28877078/advances-in-immunotherapy-in-multiple-myeloma
#4
Leora Boussi, Ruben Niesvizky
PURPOSE OF REVIEW: Here, we explore the significant progress made in the treatment of multiple myeloma, focusing on immunotherapy and the promise it has offered to patients suffering from advanced disease. RECENT FINDINGS: Multiple myeloma, a B-cell malignancy, is characterized by unregulated plasma cell growth in the bone marrow as well as strong immunosuppression in the tumor microenvironment. mAbs targeting tumor antigens overcome this, increasing T-cell activation, multiple myeloma cell death, and depth of response...
November 2017: Current Opinion in Oncology
https://www.readbyqxmd.com/read/28843768/carfilzomib-or-bortezomib-in-relapsed-or-refractory-multiple-myeloma-endeavor-an-interim-overall-survival-analysis-of-an-open-label-randomised-phase-3-trial
#5
RANDOMIZED CONTROLLED TRIAL
Meletios A Dimopoulos, Hartmut Goldschmidt, Ruben Niesvizky, Douglas Joshua, Wee-Joo Chng, Albert Oriol, Robert Z Orlowski, Heinz Ludwig, Thierry Facon, Roman Hajek, Katja Weisel, Vania Hungria, Leonard Minuk, Shibao Feng, Anita Zahlten-Kumeli, Amy S Kimball, Philippe Moreau
BACKGROUND: The phase 3 ENDEAVOR trial was a head-to-head comparison of two proteasome inhibitors in patients with relapsed or refractory multiple myeloma. Progression-free survival was previously reported to be significantly longer with carfilzomib administered in combination with dexamethasone than with bortezomib and dexamethasone in an interim analysis. The aim of this second interim analysis was to compare overall survival between the two treatment groups. METHODS: ENDEAVOR was a phase 3, open-label, randomised controlled trial in patients with relapsed or refractory multiple myeloma...
October 2017: Lancet Oncology
https://www.readbyqxmd.com/read/28504647/identification-of-a-nucleoside-analog-active-against-adenosine-kinase-expressing-plasma-cell-malignancies
#6
Utthara Nayar, Jouliana Sadek, Jonathan Reichel, Denise Hernandez-Hopkins, Gunkut Akar, Peter J Barelli, Michelle A Sahai, Hufeng Zhou, Jennifer Totonchy, David Jayabalan, Ruben Niesvizky, Ilaria Guasparri, Duane Hassane, Yifang Liu, Shizuko Sei, Robert H Shoemaker, J David Warren, Olivier Elemento, Kenneth M Kaye, Ethel Cesarman
Primary effusion lymphoma (PEL) is a largely incurable malignancy of B cell origin with plasmacytic differentiation. Here, we report the identification of a highly effective inhibitor of PEL. This compound, 6-ethylthioinosine (6-ETI), is a nucleoside analog with toxicity to PEL in vitro and in vivo, but not to other lymphoma cell lines tested. We developed and performed resistome analysis, an unbiased approach based on RNA sequencing of resistant subclones, to discover the molecular mechanisms of sensitivity...
June 1, 2017: Journal of Clinical Investigation
https://www.readbyqxmd.com/read/28430175/carfilzomib-lenalidomide-dexamethasone-vs-lenalidomide-dexamethasone-in-relapsed-multiple-myeloma-by-previous-treatment
#7
M A Dimopoulos, A K Stewart, T Masszi, I Špička, A Oriol, R Hájek, L Rosiñol, D Siegel, G G Mihaylov, V Goranova-Marinova, P Rajnics, A Suvorov, R Niesvizky, A Jakubowiak, J San-Miguel, H Ludwig, S Ro, S Aggarwal, P Moreau, A Palumbo
Carfilzomib, a proteasome inhibitor, is approved as monotherapy and in combination with dexamethasone or lenalidomide-dexamethasone (Rd) for relapsed or refractory multiple myeloma. The approval of carfilzomib-lenalidomide-dexamethasone (KRd) was based on results from the randomized, phase 3 study ASPIRE (NCT01080391), which showed KRd significantly improved progression-free survival (PFS) vs Rd (median 26.3 vs 17.6 months; hazard ratio (HR)=0.690; P=0.0001). This subgroup analysis of ASPIRE evaluated KRd vs Rd by number of previous lines of therapy and previous exposure to bortezomib, thalidomide or lenalidomide...
April 21, 2017: Blood Cancer Journal
https://www.readbyqxmd.com/read/28383205/igm-myeloma-a-multicenter-retrospective-study-of-134-patients
#8
MULTICENTER STUDY
Jorge J Castillo, Artur Jurczyszyn, Lucie Brozova, Edvan Crusoe, Jacek Czepiel, Julio Davila, Angela Dispenzieri, Marion Eveillard, Mark A Fiala, Irene M Ghobrial, Alessandro Gozzetti, Joshua N Gustine, Roman Hajek, Vania Hungria, Jiri Jarkovsky, David Jayabalan, Jacob P Laubach, Barbara Lewicka, Vladimir Maisnar, Elisabet E Manasanch, Philippe Moreau, Elizabeth A Morgan, Hareth Nahi, Ruben Niesvizky, Claudia Paba-Prada, Tomas Pika, Ludek Pour, John L Reagan, Paul G Richardson, Jatin Shah, Ivan Spicka, Ravi Vij, Anna Waszczuk-Gajda, Morie A Gertz
IgM myeloma is a rare hematologic malignancy for which the clinicopathological features and patient outcomes have not been extensively studied. We carried out a multicenter retrospective study in patients with diagnosis of IgM myeloma defined by >10% marrow involvement by monoclonal plasma cells, presence of an IgM monoclonal paraproteinemia of any size, and anemia, renal dysfunction, hypercalcemia, lytic lesions and/or t(11;14) identified by FISH. A total of 134 patients from 20 centers were included in this analysis...
August 2017: American Journal of Hematology
https://www.readbyqxmd.com/read/28306371/carfilzomib-and-dexamethasone-vs-bortezomib-and-dexamethasone-in-patients-with-relapsed-multiple-myeloma-results-of-the-phase-3-study-endeavor-nct01568866-according-to-age-subgroup
#9
Heinz Ludwig, Meletios A Dimopoulos, Philippe Moreau, Wee-Joo Chng, Hartmut Goldschmidt, Roman Hájek, Thierry Facon, Ludek Pour, Ruben Niesvizky, Albert Oriol, Laura Rosiñol, Aleksandr Suvorov, Gianluca Gaidano, Tomas Pika, Katja Weisel, Vesselina Goranova-Marinova, Antonio Palumbo, Heidi H Gillenwater, Nehal Mohamed, Sanjay Aggarwal, Shibao Feng, Douglas Joshua
No abstract text is available yet for this article.
March 17, 2017: Leukemia & Lymphoma
https://www.readbyqxmd.com/read/28285081/a-phase-i-trial-of-high-dose-lenalidomide-and-melphalan-as-conditioning-for-autologous-stem-cell-transplantation-in-relapsed-or-refractory-multiple-myeloma
#10
Tomer M Mark, Danielle Guarneri, Peter Forsberg, Adriana Rossi, Roger Pearse, Arthur Perry, Karen Pekle, Linda Tegnestam, June Greenberg, Tsiporah Shore, Usama Gergis, Sebastian Mayer, Koen Van Besien, Scott Ely, David Jayabalan, Daniel Sherbenou, Morton Coleman, Ruben Niesvizky
Autologous stem cell transplantation (ASCT) conditioned with high-dose chemotherapy has long been established as the standard of care for eligible patients with newly diagnosed multiple myeloma. Despite recent therapeutic advances, high-dose melphalan (HDM) remains the chemotherapy regimen of choice in this setting. Lenalidomide (LEN) in combination with low-dose dexamethasone is recognized as a standard of care for patients with relapsed or refractory multiple myeloma (RRMM), and there is growing support for the administration of LEN as maintenance therapy post-ASCT...
March 8, 2017: Biology of Blood and Marrow Transplantation
https://www.readbyqxmd.com/read/28211560/carfilzomib-lenalidomide-and-dexamethasone-in-patients-with-relapsed-multiple-myeloma-categorised-by-age-secondary-analysis-from-the-phase-3-aspire-study
#11
RANDOMIZED CONTROLLED TRIAL
Meletios A Dimopoulos, A Keith Stewart, Tamás Masszi, Ivan Špička, Albert Oriol, Roman Hájek, Laura Rosiñol, David Siegel, Georgi G Mihaylov, Vesselina Goranova-Marinova, Péter Rajnics, Aleksandr Suvorov, Ruben Niesvizky, Andrzej Jakubowiak, Jesus San-Miguel, Heinz Ludwig, Antonio Palumbo, Mihaela Obreja, Sanjay Aggarwal, Philippe Moreau
A primary analysis of the ASPIRE study found that the addition of carfilzomib to lenalidomide and dexamethasone (carfilzomib group) significantly improved progression-free survival (PFS) compared with lenalidomide and dexamethasone alone (control group) in patients with relapsed multiple myeloma (RMM). This post hoc analysis examined outcomes from ASPIRE in patients categorised by age. In the carfilzomib group, 103/396 patients were ≥70 years old, and in the control group, 115/396 patients were ≥70 years old...
May 2017: British Journal of Haematology
https://www.readbyqxmd.com/read/28061993/deferring-autologous-stem-cell-transplantation-for-consolidation-of-minimal-residual-disease-in-multiple-myeloma
#12
Marc Braunstein, Ruben Niesvizky
The expanding armamentarium of novel agents used in combination to treat multiple myeloma (MM) can induce clinical responses in most newly diagnosed patients, with encouraging outcomes observed in the relapsed/refractory setting. Highly sensitive techniques to detect minimal residual disease (MRD) are increasingly being employed to gauge the depth of response to modern anti-myeloma therapies and help guide therapeutic decisions. MM patients who have not achieved MRD-negativity, as assessed by one of several available assays, pose a therapeutic dilemma in terms of whether to proceed with high-dose therapy followed by autologous stem cell transplant (ASCT) versus administering additional cycles of chemotherapy...
December 2016: Seminars in Oncology
https://www.readbyqxmd.com/read/28025582/carfilzomib-dexamethasone-vs-bortezomib-dexamethasone-in-relapsed-or-refractory-multiple-myeloma-by-cytogenetic-risk-in-the-phase-3-study-endeavor
#13
RANDOMIZED CONTROLLED TRIAL
W-J Chng, H Goldschmidt, M A Dimopoulos, P Moreau, D Joshua, A Palumbo, T Facon, H Ludwig, L Pour, R Niesvizky, A Oriol, L Rosiñol, A Suvorov, G Gaidano, T Pika, K Weisel, V Goranova-Marinova, H H Gillenwater, N Mohamed, S Feng, S Aggarwal, R Hájek
The randomized phase 3 study ENDEAVOR demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) for carfilzomib and dexamethasone (Kd) vs bortezomib and dexamethasone (Vd) in relapsed or refractory multiple myeloma (MM). We conducted a preplanned subgroup analysis of ENDEAVOR to evaluate Kd vs Vd by cytogenetic risk. Of 785 patients with known cytogenetics, 210 (27%) had high-risk cytogenetics (Kd, n=97 (25%); Vd, n=113 (28%)) and 575 (73%) had standard-risk cytogenetics (Kd, n=284 (75%); Vd, n=291 (72%))...
June 2017: Leukemia: Official Journal of the Leukemia Society of America, Leukemia Research Fund, U.K
https://www.readbyqxmd.com/read/27925676/population-pharmacokinetics-and-exposure-response-relationship-of-carfilzomib-in-patients-with-multiple-myeloma
#14
Ying Ou, Sameer Doshi, Anh Nguyen, Fredrik Jonsson, Sanjay Aggarwal, Kanya Rajangam, Meletios A Dimopoulos, A Keith Stewart, Ashraf Badros, Kyriakos P Papadopoulos, David Siegel, Sundar Jagannath, Ravi Vij, Ruben Niesvizky, Richard Graham, Jenn Visich
A population pharmacokinetic (PK) model and exposure-response (E-R) analysis was developed using data collected from 5 phase 1b/2 and 2 phase 3 studies in subjects with multiple myeloma. Subjects receiving intravenous infusion on 2 consecutive days each week for 3 weeks (days 1, 2, 8, 9, 15, and 16) in each cycle at doses ranging from 15 to 20/56 mg/m(2) (20 mg/m(2) in cycle 1 and, if tolerated, escalated to 56 mg/m(2) on day 8 of cycle 1). The population PK analysis indicated that among all the covariates tested, the only statistically significant covariate was body surface area on carfilzomib clearance; however, this covariate was unlikely to be clinically significant...
May 2017: Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/27682187/characteristics-and-outcomes-of-patients-with-multiple-myeloma-aged-21-40%C3%A2-years-versus-41-60%C3%A2-years-a-multi-institutional-case-control-study
#15
MULTICENTER STUDY
Artur Jurczyszyn, Hareth Nahi, Irit Avivi, Alessandro Gozzetti, Ruben Niesvizky, Sujitha Yadlapati, David S Jayabalan, Paweł Robak, Tomas Pika, Kristian T Andersen, Leo Rasche, Krzysztof Mądry, Dariusz Woszczyk, Małgorzata Raźny, Lidia Usnarska-Zubkiewicz, Wanda Knopińska-Posłuszny, Małgorzata Wojciechowska, Renata Guzicka-Kazimierczak, Monika Joks, Sebastian Grosicki, Hanna Ciepłuch, Marcin Rymko, David H Vesole, Jorge J Castillo
We compared the outcomes of multiple myeloma (MM) patients aged 21-40 and 41-60 years in the novel agent era. This case-control study included 1089 patients between 2000 and 2015. Cases and controls were matched for sex, International Staging System (ISS) stage and institution. There were 173 patients in the younger group and 916 patients in the older group. Younger patients presented with a higher incidence of lytic lesions (82% vs. 72%; P = 0·04) and high-risk cytogenetic abnormalities (83% vs. 68%; P = 0·007), but lower rate of elevated lactate dehydrogenase (21% vs...
December 2016: British Journal of Haematology
https://www.readbyqxmd.com/read/27601539/health-related-quality-of-life-results-from-the-open-label-randomized-phase-iii-aspire-trial-evaluating-carfilzomib-lenalidomide-and-dexamethasone-versus-lenalidomide-and-dexamethasone-in-patients-with-relapsed-multiple-myeloma
#16
A Keith Stewart, Meletios A Dimopoulos, Tamás Masszi, Ivan Špička, Albert Oriol, Roman Hájek, Laura Rosiñol, David S Siegel, Ruben Niesvizky, Andrzej J Jakubowiak, Jesus F San-Miguel, Heinz Ludwig, Jacqui Buchanan, Kim Cocks, Xinqun Yang, Biao Xing, Naseem Zojwalla, Margaret Tonda, Philippe Moreau, Antonio Palumbo
PURPOSE: To determine the effects of carfilzomib, lenalidomide, and dexamethasone (KRd) versus lenalidomide and dexamethasone (Rd) on health-related quality of life (HR-QoL) in the Carfilzomib, Lenalidomide, and Dexamethasone Versus Lenalidomide and Dexamethasone for the Treatment of Patients With Relapsed Multiple Myeloma (ASPIRE) trial. METHODS: Patients with relapsed multiple myeloma were randomly assigned to receive KRd or Rd. The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 and myeloma-specific module were administered at baseline; day 1 of cycles 3, 6, 12, and 18; and after treatment...
September 6, 2016: Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology
https://www.readbyqxmd.com/read/27491641/impact-of-prior-treatment-on-patients-with-relapsed-multiple-myeloma-treated-with-carfilzomib-and-dexamethasone-vs-bortezomib-and-dexamethasone-in-the-phase-3-endeavor-study
#17
RANDOMIZED CONTROLLED TRIAL
P Moreau, D Joshua, W-J Chng, A Palumbo, H Goldschmidt, R Hájek, T Facon, H Ludwig, L Pour, R Niesvizky, A Oriol, L Rosiñol, A Suvorov, G Gaidano, T Pika, K Weisel, V Goranova-Marinova, H H Gillenwater, N Mohamed, S Aggarwal, S Feng, M A Dimopoulos
The randomized phase 3 ENDEAVOR study (N=929) compared carfilzomib and dexamethasone (Kd) with bortezomib and dexamethasone (Vd) in relapsed multiple myeloma (RMM). We performed a subgroup analysis from ENDEAVOR in patients categorized by number of prior lines of therapy or by prior treatment. Median progression-free survival (PFS) for patients with one prior line was 22.2 months for Kd vs 10.1 months for Vd, and median PFS for patients with ⩾2 prior lines was 14.9 months for Kd vs 8.4 months for Vd. For patients with prior bortezomib exposure, the median PFS was 15...
January 2017: Leukemia: Official Journal of the Leukemia Society of America, Leukemia Research Fund, U.K
https://www.readbyqxmd.com/read/27439911/carfilzomib-significantly-improves-the-progression-free-survival-of-high-risk-patients-in-multiple-myeloma
#18
RANDOMIZED CONTROLLED TRIAL
Hervé Avet-Loiseau, Rafael Fonseca, David Siegel, Meletios A Dimopoulos, Ivan Špička, Tamás Masszi, Roman Hájek, Laura Rosiñol, Vesselina Goranova-Marinova, Georgi Mihaylov, Vladimír Maisnar, Maria-Victoria Mateos, Michael Wang, Ruben Niesvizky, Albert Oriol, Andrzej Jakubowiak, Jiri Minarik, Antonio Palumbo, William Bensinger, Vishal Kukreti, Dina Ben-Yehuda, A Keith Stewart, Mihaela Obreja, Philippe Moreau
The presence of certain high-risk cytogenetic abnormalities, such as translocations (4;14) and (14;16) and deletion (17p), are known to have a negative impact on survival in multiple myeloma (MM). The phase 3 study ASPIRE (N = 792) demonstrated that progression-free survival (PFS) was significantly improved with carfilzomib, lenalidomide, and dexamethasone (KRd), compared with lenalidomide and dexamethasone (Rd) in relapsed MM. This preplanned subgroup analysis of ASPIRE was conducted to evaluate KRd vs Rd by baseline cytogenetics according to fluorescence in situ hybridization...
September 1, 2016: Blood
https://www.readbyqxmd.com/read/27071340/clinical-activity-of-carfilzomib-correlates-with-inhibition-of-multiple-proteasome-subunits-application-of-a-novel-pharmacodynamic-assay
#19
Susan J Lee, Konstantin Levitsky, Francesco Parlati, Mark K Bennett, Shirin Arastu-Kapur, Lois Kellerman, Tina F Woo, Alvin F Wong, Kyriakos P Papadopoulos, Ruben Niesvizky, Ashraf Z Badros, Ravi Vij, Sundar Jagannath, David Siegel, Michael Wang, Gregory J Ahmann, Christopher J Kirk
While proteasome inhibition is a validated therapeutic approach for multiple myeloma (MM), inhibition of individual constitutive proteasome (c20S) and immunoproteasome (i20S) subunits has not been fully explored owing to a lack of effective tools. We utilized the novel proteasome constitutive/immunoproteasome subunit enzyme-linked immunosorbent (ProCISE) assay to quantify proteasome subunit occupancy in samples from five phase I/II and II trials before and after treatment with the proteasome inhibitor carfilzomib...
June 2016: British Journal of Haematology
https://www.readbyqxmd.com/read/26366710/the-histone-lysine-methyltransferase-kmt2d-sustains-a-gene-expression-program-that-represses-b-cell-lymphoma-development
#20
Ana Ortega-Molina, Isaac W Boss, Andres Canela, Heng Pan, Yanwen Jiang, Chunying Zhao, Man Jiang, Deqing Hu, Xabier Agirre, Itamar Niesvizky, Ji-Eun Lee, Hua-Tang Chen, Daisuke Ennishi, David W Scott, Anja Mottok, Christoffer Hother, Shichong Liu, Xing-Jun Cao, Wayne Tam, Rita Shaknovich, Benjamin A Garcia, Randy D Gascoyne, Kai Ge, Ali Shilatifard, Olivier Elemento, Andre Nussenzweig, Ari M Melnick, Hans-Guido Wendel
The gene encoding the lysine-specific histone methyltransferase KMT2D has emerged as one of the most frequently mutated genes in follicular lymphoma and diffuse large B cell lymphoma; however, the biological consequences of KMT2D mutations on lymphoma development are not known. Here we show that KMT2D functions as a bona fide tumor suppressor and that its genetic ablation in B cells promotes lymphoma development in mice. KMT2D deficiency also delays germinal center involution and impedes B cell differentiation and class switch recombination...
October 2015: Nature Medicine
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