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https://www.readbyqxmd.com/read/27925676/population-pharmacokinetics-and-exposure-response-relationship-of-carfilzomib-in-patients-with-multiple-myeloma
#1
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...
December 7, 2016: 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
#2
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...
September 29, 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
#3
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
#4
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...
August 5, 2016: 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
#5
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
#6
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
#7
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
https://www.readbyqxmd.com/read/26296679/clinical-characteristics-of-patients-with-relapsed-multiple-myeloma
#8
REVIEW
Meletios A Dimopoulos, Evangelos Terpos, Ruben Niesvizky, Antonio Palumbo
Although survival outcomes have improved over the last decade for patients with multiple myeloma (MM), few patients remain free of disease and most inevitably relapse. Selecting a treatment for patients with relapsed MM is challenging given the number and diversity of regimens patients may have previously received, which can affect subsequent therapeutic choices. Importantly, a number of patient- and disease-related factors can also have an effect on treatment choice, treatment efficacy, and tolerability; thus, an understanding of the heterogeneity of patients in the setting of relapsed MM is important for appropriate treatment selection...
December 2015: Cancer Treatment Reviews
https://www.readbyqxmd.com/read/26056177/community-based-phase-iiib-trial-of-three-upfront-bortezomib-based-myeloma-regimens
#9
RANDOMIZED CONTROLLED TRIAL
Ruben Niesvizky, Ian W Flinn, Robert Rifkin, Nashat Gabrail, Veena Charu, Billy Clowney, James Essell, Yousuf Gaffar, Thomas Warr, Rachel Neuwirth, Yanyan Zhu, Jennifer Elliott, Dixie-Lee Esseltine, Liviu Niculescu, James Reeves
PURPOSE: The US community-based, phase IIIB UPFRONT trial was designed to compare three frontline bortezomib-based regimens in transplantation-ineligible patients with myeloma. PATIENTS AND METHODS: Patients (N = 502) were randomly assigned 1:1:1 to 24 weeks (eight 21-day cycles) of induction with bortezomib-dexamethasone (VD; n = 168; intravenous bortezomib 1.3 mg/m(2), days 1, 4, 8, and 11 plus oral dexamethasone 20 mg, days 1, 2, 4, 5, 8, 9, 11, and 12 [cycles 1 to 4], or 1, 2, 4, and 5 [cycles 5 to 8]), bortezomib-thalidomide-dexamethasone (VTD; n = 167; bortezomib and dexamethasone as before plus oral thalidomide 100 mg, days 1 to 21), or bortezomib-melphalan-prednisone (VMP; n = 167; bortezomib as before plus oral melphalan 9 mg/m(2) and oral prednisone 60 mg/m(2), days 1 to 4, every other cycle), followed by 25 weeks (five 35-day cycles) of bortezomib maintenance (1...
November 20, 2015: Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology
https://www.readbyqxmd.com/read/25813205/phase-1-2-study-of-cyclin-dependent-kinase-cdk-4-6-inhibitor-palbociclib-pd-0332991-with-bortezomib-and-dexamethasone-in-relapsed-refractory-multiple-myeloma
#10
Ruben Niesvizky, Ashraf Z Badros, Luciano J Costa, Scott A Ely, Seema B Singhal, Edward A Stadtmauer, Nisreen A Haideri, Abdulraheem Yacoub, Georg Hess, Suzanne Lentzsch, Ivan Spicka, Asher A Chanan-Khan, Marc S Raab, Stefano Tarantolo, Ravi Vij, Jeffrey A Zonder, Xiangao Huang, David Jayabalan, Maurizio Di Liberto, Xin Huang, Yuqiu Jiang, Sindy T Kim, Sophia Randolph, Selina Chen-Kiang
This phase 1/2 study was the first to evaluate the safety and efficacy of the cyclin-dependent kinase (CDK) 4/6-specific inhibitor palbociclib (PD-0332991) in sequential combination with bortezomib and dexamethasone in relapsed/refractory multiple myeloma. The recommended phase 2 dose was palbociclib 100 mg orally once daily on days 1-12 of a 21-day cycle with bortezomib 1.0 mg/m2 (intravenous) and dexamethasone 20 mg (orally 30 min pre-bortezomib dosing) on days 8 and 11 (early G1 arrest) and days 15 and 18 (cell cycle resumed)...
2015: Leukemia & Lymphoma
https://www.readbyqxmd.com/read/25699653/serum-free-light-chain-reduction-correlates-with-response-and-progression-free-survival-following-carfilzomib-therapy-in-relapsed-refractory-multiple-myeloma
#11
LETTER
Ravi Vij, Michael Wang, Sundar Jagannath, Ruben Niesvizky, Andrzej J Jakubowiak, Edward Kavalerchik, Mei Huang, David S Siegel
No abstract text is available yet for this article.
2015: Leukemia & Lymphoma
https://www.readbyqxmd.com/read/25482145/carfilzomib-lenalidomide-and-dexamethasone-for-relapsed-multiple-myeloma
#12
RANDOMIZED CONTROLLED TRIAL
A Keith Stewart, S Vincent Rajkumar, Meletios A Dimopoulos, Tamás Masszi, Ivan Špička, Albert Oriol, Roman Hájek, Laura Rosiñol, David S Siegel, Georgi G Mihaylov, Vesselina Goranova-Marinova, Péter Rajnics, Aleksandr Suvorov, Ruben Niesvizky, Andrzej J Jakubowiak, Jesus F San-Miguel, Heinz Ludwig, Michael Wang, Vladimír Maisnar, Jiri Minarik, William I Bensinger, Maria-Victoria Mateos, Dina Ben-Yehuda, Vishal Kukreti, Naseem Zojwalla, Margaret E Tonda, Xinqun Yang, Biao Xing, Philippe Moreau, Antonio Palumbo
BACKGROUND: Lenalidomide plus dexamethasone is a reference treatment for relapsed multiple myeloma. The combination of the proteasome inhibitor carfilzomib with lenalidomide and dexamethasone has shown efficacy in a phase 1 and 2 study in relapsed multiple myeloma. METHODS: We randomly assigned 792 patients with relapsed multiple myeloma to carfilzomib with lenalidomide and dexamethasone (carfilzomib group) or lenalidomide and dexamethasone alone (control group)...
January 8, 2015: New England Journal of Medicine
https://www.readbyqxmd.com/read/25456369/safety-and-tolerability-of-ixazomib-an-oral-proteasome-inhibitor-in-combination-with-lenalidomide-and-dexamethasone-in-patients-with-previously-untreated-multiple-myeloma-an-open-label-phase-1-2-study
#13
Shaji K Kumar, Jesus G Berdeja, Ruben Niesvizky, Sagar Lonial, Jacob P Laubach, Mehdi Hamadani, A Keith Stewart, Parameswaran Hari, Vivek Roy, Robert Vescio, Jonathan L Kaufman, Deborah Berg, Eileen Liao, Alessandra Di Bacco, Jose Estevam, Neeraj Gupta, Ai-Min Hui, Vincent Rajkumar, Paul G Richardson
BACKGROUND: The combination of bortezomib, lenalidomide, and dexamethasone is a highly effective therapy for newly diagnosed multiple myeloma. Ixazomib is an investigational, oral, proteasome inhibitor with promising anti-myeloma effects and low rates of peripheral neuropathy. In a phase 1/2 trial we aimed to assess the safety, tolerability, and activity of ixazomib in combination with lenalidomide and dexamethasone in newly diagnosed multiple myeloma. METHODS: We enrolled patients newly diagnosed with multiple myeloma aged 18 years or older with measurable disease, Eastern Cooperative Oncology Group performance status 0-2, and no grade 2 or higher peripheral neuropathy, and treated them with oral ixazomib (days 1, 8, 15) plus lenalidomide 25 mg (days 1-21) and dexamethasone 40 mg (days 1, 8, 15, 22) for up to 12 28-day cycles, followed by maintenance therapy with ixazomib alone...
December 2014: Lancet Oncology
https://www.readbyqxmd.com/read/24904120/phase-1-study-of-weekly-dosing-with-the-investigational-oral-proteasome-inhibitor-ixazomib-in-relapsed-refractory-multiple-myeloma
#14
Shaji K Kumar, William I Bensinger, Todd M Zimmerman, Craig B Reeder, James R Berenson, Deborah Berg, Ai-Min Hui, Neeraj Gupta, Alessandra Di Bacco, Jiang Yu, Yaping Shou, Ruben Niesvizky
Proteasome inhibition is an effective treatment strategy for multiple myeloma. With improving survival, attention is increasingly focusing on ease of administration and toxicity profile. Ixazomib is an investigational, orally bioavailable 20S proteasome inhibitor. Sixty patients with relapsed and/or refractory multiple myeloma were enrolled on this phase 1 trial to evaluate safety and tolerability and determine the maximum tolerated dose (MTD) of single-agent, oral ixazomib given weekly for 3 of 4 weeks. Upon MTD determination, patients were enrolled to 4 different cohorts based on relapsed/refractory status and prior bortezomib and carfilzomib exposure...
August 14, 2014: Blood
https://www.readbyqxmd.com/read/24762720/-living-medicine-the-patient-tie-and-cock
#15
EDITORIAL
Rubén Niesvizky
No abstract text is available yet for this article.
January 2014: Revista de Investigación Clínica; Organo del Hospital de Enfermedades de la Nutrición
https://www.readbyqxmd.com/read/24690110/preclinical-and-clinical-results-with-pomalidomide-in-the-treatment-of-relapsed-refractory-multiple-myeloma
#16
REVIEW
Tomer M Mark, Morton Coleman, Ruben Niesvizky
Despite the evolution of effective frontline treatment strategies, many patients with myeloma inevitably relapse. Treatment can be complicated by the interplay of disease-, treatment-, and patient-related factors. Unfortunately, many patients eventually develop disease that is refractory to lenalidomide and bortezomib and have few treatment options. Pomalidomide is a distinct IMiD agent recently approved in the US and Europe. We review the pomalidomide mechanism of action, summarizing its direct antimyeloma, immunomodulatory, and stromal-support inhibitory activities...
May 2014: Leukemia Research
https://www.readbyqxmd.com/read/24576165/thalidomide-clarithromycin-lenalidomide-and-dexamethasone-therapy-in-newly-diagnosed-symptomatic-multiple-myeloma
#17
Tomer M Mark, Isaac A Bowman, Adriana C Rossi, Manan Shah, Melissa Rodriguez, Ryann Quinn, Roger N Pearse, Faiza Zafar, Karen Pekle, David Jayabalan, Scott Ely, Morton Coleman, Selina Chen-Kiang, Ruben Niesvizky
We studied T-BiRD (thalidomide [Thalomid(®)], clarithromycin [Biaxin(®)], lenalidomide [Revlimid(®)] and dexamethasone) in symptomatic, newly diagnosed multiple myeloma. In 28-day cycles, patients received dexamethasone 40 mg/day on days 1, 8, 15, 22, clarithromycin 500 mg twice daily on days 1-28; lenalidomide 25 mg/day on days 1-21; and thalidomide 100 mg/day (50 mg/day on days 1-7 of cycle 1 only) on days 1-28. Twenty-six patients received a median of 6 cycles (range 0-41). Overall response rate (ORR) was 80% for the group and 100% in 11 patients who underwent autologous stem cell transplantation as part of first-line therapy...
December 2014: Leukemia & Lymphoma
https://www.readbyqxmd.com/read/24518528/treatment-of-multiple-myeloma-with-carfilzomib-in-patients-with-renal-injury
#18
COMMENT
Dennis Kwon, Ruben Niesvizky
No abstract text is available yet for this article.
2013: Clinical Advances in Hematology & Oncology: H&O
https://www.readbyqxmd.com/read/24419113/international-myeloma-working-group-consensus-statement-for-the-management-treatment-and-supportive-care-of-patients-with-myeloma-not-eligible-for-standard-autologous-stem-cell-transplantation
#19
REVIEW
Antonio Palumbo, S Vincent Rajkumar, Jesus F San Miguel, Alessandra Larocca, Ruben Niesvizky, Gareth Morgan, Ola Landgren, Roman Hajek, Hermann Einsele, Kenneth C Anderson, Meletios A Dimopoulos, Paul G Richardson, Michele Cavo, Andrew Spencer, A Keith Stewart, Kazuyuki Shimizu, Sagar Lonial, Pieter Sonneveld, Brian G M Durie, Philippe Moreau, Robert Z Orlowski
PURPOSE: To provide an update on recent advances in the management of patients with multiple myeloma who are not eligible for autologous stem-cell transplantation. METHODS: A comprehensive review of the literature on diagnostic criteria is provided, and treatment options and management of adverse events are summarized. RESULTS: Patients with symptomatic disease and organ damage (ie, hypercalcemia, renal failure, anemia, or bone lesions) require immediate treatment...
February 20, 2014: Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology
https://www.readbyqxmd.com/read/24253022/new-drugs-and-novel-mechanisms-of-action-in-multiple-myeloma-in-2013-a-report-from-the-international-myeloma-working-group-imwg
#20
REVIEW
E M Ocio, P G Richardson, S V Rajkumar, A Palumbo, M V Mateos, R Orlowski, S Kumar, S Usmani, D Roodman, R Niesvizky, H Einsele, K C Anderson, M A Dimopoulos, H Avet-Loiseau, U-H Mellqvist, I Turesson, G Merlini, R Schots, P McCarthy, L Bergsagel, C S Chim, J J Lahuerta, J Shah, A Reiman, J Mikhael, S Zweegman, S Lonial, R Comenzo, W J Chng, P Moreau, P Sonneveld, H Ludwig, B G M Durie, J F S Miguel
Treatment in medical oncology is gradually shifting from the use of nonspecific chemotherapeutic agents toward an era of novel targeted therapy in which drugs and their combinations target specific aspects of the biology of tumor cells. Multiple myeloma (MM) has become one of the best examples in this regard, reflected in the identification of new pathogenic mechanisms, together with the development of novel drugs that are being explored from the preclinical setting to the early phases of clinical development...
March 2014: Leukemia: Official Journal of the Leukemia Society of America, Leukemia Research Fund, U.K
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