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Xiaomu Wei, M Nieves Calvo-Vidal, Siwei Chen, Gang Wu, Maria V Revuelta, Jian Sun, Jinghui Zhang, Michael F Walsh, Kim E Nichols, Vijai Joseph, Carrie Snyder, Celine M Vachon, James D McKay, Shu-Ping Wang, David S Jayabalan, Lauren M Jacobs, Dina Becirovic, Rosalie G Waller, Mykyta Artomov, Agnes Viale, Jayeshkumar Patel, Jude M Phillip, Selina Chen-Kiang, Karen Curtin, Mohamed Salama, Djordje Atanackovic, Ruben Niesvizky, Ola Landgren, Susan L Slager, Lucy A Godley, Jane Churpek, Judy E Garber, Kenneth C Anderson, Mark J Daly, Robert G Roeder, Charles Dumontet, Henry T Lynch, Charles G Mullighan, Nicola J Camp, Kenneth Offit, Robert J Klein, Haiyuan Yu, Leandro Cerchietti, Steven M Lipkin
Given the frequent and largely incurable occurrence of multiple myeloma (MM), identification of germline genetic mutations that predispose cells to MM may provide insight into disease etiology and the developmental mechanisms of its cell of origin, the plasma cell. Here we identified familial and early-onset MM kindreds with truncating mutations in lysine-specific demethylase 1 (LSD1/KDM1A), an epigenetic transcriptional repressor that primarily demethylates histone H3 on lysine 4 and regulates hematopoietic stem cell self-renewal...
March 20, 2018: Cancer Research
Kenar D Jhaveri, Ruben Niesvizky
No abstract text is available yet for this article.
December 5, 2017: JAMA: the Journal of the American Medical Association
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, data regarding the optimal timing of G-CSFs post-transplantation are limited and conflicting. This retrospective study was performed at NewYork-Presbyterian/Weill Cornell Medical Center between November 5, 2013, and August 9, 2016, of adult inpatient autologous PBSCT recipients who received G-CSF empirically starting on day +5 (early) versus on those who received G-CSF on day +12 only if absolute neutrophil count (ANC) was <0...
February 2018: Biology of Blood and Marrow Transplantation
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...
December 2017: Clinical Lymphoma, Myeloma & Leukemia
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
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
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
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
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
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
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
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
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
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
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
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
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
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...
November 10, 2016: Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology
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
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
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