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Carfilzomib, Lenalidomide, and Dexamethasone for Relapsed Multiple Myeloma

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https://www.readbyqxmd.com/read/28243125/carfilzomib-boosted-combination-therapy-for-relapsed-multiple-myeloma
#1
REVIEW
Raphael E Steiner, Elisabet E Manasanch
Carfilzomib is a proteasome inhibitor that binds selectively and irreversibly to the 20S proteasome, the proteolytic core particle within the 26S proteasome, resulting in the accumulation of proteasome substrates and ultimately growth arrest and apoptosis of tumor cells. The development and ultimate approval of this medication by regulatory agencies has been an important step toward improving clinical outcomes in multiple myeloma. Although initially approved as a single agent for the treatment of multiply relapsed and/or refractory myeloma, in the USA, it is now widely used in the early relapse setting in combination with lenalidomide and dexamethasone...
2017: OncoTargets and Therapy
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
#2
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...
February 17, 2017: British Journal of Haematology
https://www.readbyqxmd.com/read/28151709/progress-and-paradigms-in-multiple-myeloma
#3
EDITORIAL
Kenneth C Anderson
Remarkable progress has been achieved in multiple myeloma, and patient median survival has been extended 3- to 4-fold. Specifically, there have been 18 newly approved treatments for multiple myeloma in the past 12 years, including seven in 2015, and the treatment paradigm and patient outcome have been transformed. The definition of patients benefitting from these therapies has been broadened. Response criteria now include minimal residual disease (MRD), assessed in bone marrow by multicolor flow cytometry or sequencing, and by imaging for extramedullary disease...
November 15, 2016: Clinical Cancer Research: An Official Journal of the American Association for Cancer Research
https://www.readbyqxmd.com/read/28092421/carfilzomib-lenalidomide-and-dexamethasone-in-patients-with-heavily-pretreated-multiple-myeloma-a-phase-1-study-in-japan
#4
Kenshi Suzuki, Masaki Ri, Takaaki Chou, Isamu Sugiura, Naoki Takezako, Kazutaka Sunami, Tadao Ishida, Tohru Izumi, Shuji Ozaki, Yoshihisa Shumiya, Kenji Ota, Shinsuke Iida
This is the first study in which the carfilzomib, lenalidomide, and dexamethasone (KRd) regimen was evaluated in heavily pretreated multiple myeloma. This study is a multicenter, open-label phase 1 study of KRd in Japanese patients with relapsed or refractory multiple myeloma (RRMM). The objectives were to evaluate the safety, tolerability, efficacy and pharmacokinetics. Carfilzomib was administrated intravenously over 10 min on days 1, 2, 8, 9, 15, and 16 of a 28-day cycle. In cycle 1, the dosage for days 1 and 2 was 20 mg/m(2) , followed by 27 mg/m(2) ...
January 16, 2017: Cancer Science
https://www.readbyqxmd.com/read/27986429/practical-considerations-in-managing-relapsed-multiple-myeloma
#5
REVIEW
Amit Agarwal, Eric Chow, Manisha Bhutani, Peter M Voorhees, Reed Friend, Saad Z Usmani
Considerable advances have been made in the treatment of relapsed and relapsed/refractory multiple myeloma, with numerous novel agents and combination strategies receiving regulatory approval worldwide during the past several years. An increasing body of phase III data has clearly demonstrated increased overall response rates, improved depths of response, and more durable responses when a third novel agent is incorporated into lenalidomide-dexamethasone and bortezomib-dexamethasone platforms, in most cases with acceptable toxicity...
February 2017: Clinical Lymphoma, Myeloma & Leukemia
https://www.readbyqxmd.com/read/27904737/a-clinical-update-on-the-role-of-carfilzomib-in-the-treatment-of-relapsed-or-refractory-multiple-myeloma
#6
REVIEW
B Franken, N W C J van de Donk, J C Cloos, S Zweegman, H M Lokhorst
Even though the prognosis of patients with multiple myeloma is continuing to improve, all patients eventually develop relapsed refractory disease. Several novel therapeutics have been developed in the last few years including the second-generation proteasome inhibitor carfilzomib which has been approved for patients with relapsed and refractory multiple myeloma in the United States since 2012. Recently data from several phase III studies have become available showing the promising efficacy of carfilzomib in combination with lenalidomide, which led to the renewed approval of carfilzomib in combination with lenalidomide and dexamethasone for relapsed myeloma in 2015...
December 2016: Therapeutic Advances in Hematology
https://www.readbyqxmd.com/read/27650125/treatment-options-for-relapse-after-autograft-in-multiple-myeloma-report-from-an-ebmt-educational-meeting
#7
Laurent Garderet, Gordon Cook, Holger W Auner, Benedetto Bruno, Henk Lokhorst, Jose Antonio Perez-Simon, Firoozeh Sahebi, Christof Scheid, Curly Morris, Anja van Biezen, Mohamad Sobh, Mauricette Michallet, Gösta Gahrton, Stefan Schönland, Nicolaus Kröger
Major improvements have been made in the treatment of myeloma. However, all patients, perhaps with some exceptions, eventually relapse, even after autologous stem cell transplantation (ASCT). In that setting, the combinations of new drugs, namely the IMiDs and the proteasome inhibitors along with steroids, give encouraging results in relapsed patients. The median progression-free survival (PFS) is 20 months with lenalidomide plus dexamethasone plus ixazomib and 26 months with lenalidomide plus dexamethasone plus carfilzomib...
September 21, 2016: Leukemia & Lymphoma
https://www.readbyqxmd.com/read/27646819/current-treatments-for-renal-failure-due-to-multiple-myeloma
#8
REVIEW
Maria Gavriatopoulou, Evangelos Terpos, Efstathios Kastritis, Meletios A Dimopoulos
Renal impairment (RI) is one of the most common complication of multiple myeloma (MM). RI is present in almost 20% of MM patients at diagnosis and in 40%-50% of patients during the course of their disease. Areas covered: Biology along with tools for diagnosis and management of RI are reported in this paper. Papers published in PubMed and reported abstracts up to May 2016 were used. Expert opinion: Moderate and severe RI increases the risk of early death; thus rapid intervention and initiation of anti-myeloma treatment is essential and improves renal outcomes in RI patients...
November 2016: Expert Opinion on Pharmacotherapy
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
#9
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
#10
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/27459662/estimating-the-economic-impact-of-adding-panobinostat-to-a-u-s-formulary-for-relapsed-and-or-refractory-multiple-myeloma-a-budget-impact-and-cost-benefit-model
#11
Lisa Bloudek, Anuja Roy, Jonathan K Kish, David S Siegel, Sundar Jagannath, Denise Globe, Laurie Orloski, Emil T Kuriakose
BACKGROUND: Multiple myeloma is an incurable B-cell malignancy with a natural history that involves alternating periods of remission and subsequent relapse. For relapsed and/or refractory multiple myeloma (RRMM), the typical patient currently receives more lines of therapy than has been feasible in the past, translating into longer progression-free survival (PFS). Consequently, cost issues have become more prominent because patients may be offered newer and more expensive therapies during a more prolonged overall treatment course...
August 2016: Journal of Managed Care & Specialty Pharmacy
https://www.readbyqxmd.com/read/27458170/carfilzomib-pomalidomide-single-agent-or-in-combination-with-other-agents-for-the-management-of-relapsed-refractory-multiple-myeloma-a-meta-analysis-of-37-trials
#12
Yandun Zou, Xiaoyan Ma, Haiying Yu, Chunling Hu, Limei Fan, Xuehong Ran
PURPOSE: The use of carfilzomib/pomalidomide single-agent or in combination with other agents in patients with refractory/relapsed multiple myeloma (RRMM) was not clearly clarified in clinical practice. We sought to compile the available clinical reports to better understand the efficacy and safety of carfilzomib (CFZ) and pomalidomide (POM). RESULTS: Based on our research criteria, we identified 37 prospective studies that evaluated 1160 patients. Analysis of subgroup differences between carfilzomib single-agent and CFZ/DEX dual combination showed significantly(P < 0...
July 21, 2016: Oncotarget
https://www.readbyqxmd.com/read/27439911/carfilzomib-significantly-improves-the-progression-free-survival-of-high-risk-patients-in-multiple-myeloma
#13
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/27291302/multiple-myeloma-2016-update-on-diagnosis-risk-stratification-and-management
#14
S Vincent Rajkumar
Multiple myeloma accounts for approximately 10% of hematologic malignancies.The diagnosis requires ≥10% clonal bone marrow plasma cells or a biopsy proven plasmacytoma plus evidence of one or more multiple myeloma defining events (MDE): CRAB (hypercalcemia, renal failure, anemia, or lytic bone lesions) features felt related to the plasma cell disorder, bone marrow clonal plasmacytosis ≥60%, serum involved/uninvolved free light chain (FLC) ratio ≥100 (provided involved FLC is ≥100 mg/L), or >1 focal lesion on magnetic resonance imaging...
July 2016: American Journal of Hematology
https://www.readbyqxmd.com/read/27224006/cost-effectiveness-of-adding-carfilzomib-to-lenalidomide-and-dexamethasone-in-relapsed-multiple-myeloma-from-a-us-perspective
#15
Andrzej J Jakubowiak, Marco Campioni, Ágnes Benedict, Ivan Houisse, Eszter Tichy, Andromachi Giannopoulou, Sanjay K Aggarwal, Beth L Barber, Sumeet Panjabi
OBJECTIVE: To assess the economic value of carfilzomib (Kyprolis), this study developed the Kyprolis Global Economic Model (K-GEM), which examined from a United States (US) payer perspective the cost-effectiveness of carfilzomib-lenalidomide-dexamethasone (KRd) versus lenalidomide-dexamethasone (Rd) in relapsed multiple myeloma (RMM; 1-3 prior therapies) based on results from the phase III ASPIRE trial that directly compared these regimens. METHODS: A partitioned survival model that included three health states of progression-free (on or off treatment), post-progression, and death was developed...
November 2016: Journal of Medical Economics
https://www.readbyqxmd.com/read/27207788/champion-1-a-phase-1-2-study-of-once-weekly-carfilzomib-and-dexamethasone-for-relapsed-or-refractory-multiple-myeloma
#16
James R Berenson, Alan Cartmell, Alberto Bessudo, Roger M Lyons, Wael Harb, Dimitrios Tzachanis, Richy Agajanian, Ralph Boccia, Morton Coleman, Robert A Moss, Robert M Rifkin, Priti Patel, Sandra Dixon, Ying Ou, Janet Anderl, Sanjay Aggarwal, Jesus G Berdeja
Carfilzomib, a proteasome inhibitor, is approved in the United States as a single agent, and in combination with dexamethasone or lenalidomide/dexamethasone (KRd) for relapsed or refractory multiple myeloma (MM). Under the single-agent and KRd approvals, carfilzomib is administered as a 10-minute IV infusion on days 1, 2, 8, 9, 15, and 16 of 28-day cycles (20 mg/m(2) [cycle 1, days 1-2]; 27 mg/m(2) thereafter). This multicenter, single-arm, phase 1/2 study, Community Harmonized Assessment of Myeloma Patients via an Integrated Oncology Network-1 (CHAMPION-1), evaluated once-weekly carfilzomib with dexamethasone in relapsed, or relapsed and refractory MM (1-3 prior therapies)...
June 30, 2016: Blood
https://www.readbyqxmd.com/read/27018162/safety-and-tolerability-of-pomalidomide-based-regimens-pomalidomide-carfilzomib-dexamethasone-with-or-without-cyclophosphamide-in-relapsed-refractory-multiple-myeloma-and-severe-renal-dysfunction-a-case-series
#17
Joshua Richter, Noa Biran, Narjust Duma, David H Vesole, David Siegel
Renal dysfunction negatively impacts outcomes in patients with multiple myeloma (MM). Few treatment options are currently available for patients with MM and comorbid renal dysfunction, and as they are generally excluded from clinical trials, data on the use of immunomodulatory drugs in this population are scarce. In this paper, we describe a case series of five women with MM and severe renal dysfunction or dialysis dependency who were refractory to both bortezomib and either lenalidomide or thalidomide and were treated with full-dose (4 mg) pomalidomide...
March 27, 2016: Hematological Oncology
https://www.readbyqxmd.com/read/26972294/carfilzomib-triple-combination-therapy-a-review-in-relapsed-multiple-myeloma
#18
REVIEW
Sheridan M Hoy
Carfilzomib (Kyprolis®) is a proteasome inhibitor that binds selectively and irreversibly to the 20S proteasome (the proteolytic core particle within the 26S proteasome), inducing growth arrest and apoptosis. This intravenous drug is approved in the EU and the USA as combination therapy with oral lenalidomide and intravenous or oral dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy. In the multinational, phase III ASPIRE study in this patient population, carfilzomib triple combination therapy significantly prolonged progression-free survival (PFS), reflecting a clinically relevant gain in PFS of 8...
April 2016: Targeted Oncology
https://www.readbyqxmd.com/read/26907720/management-of-carfilzomib-associated-cardiac-adverse-events
#19
Joseph Mikhael
Carfilzomib is a proteasome inhibitor that is approved for use as a single agent in patients with relapsed and refractory multiple myeloma and when used in combination with lenalidomide and dexamethasone in patients with relapsed multiple myeloma (1-3 prior lines of therapy). Cardiac and cardiopulmonary adverse events have been reported to be associated with carfilzomib-based treatment regimens. This article discusses the cardiac-related adverse events that have been reported in clinical studies of carfilzomib and presents a single institution perspective on the prevention and management of cardiac adverse events following treatment with this agent...
May 2016: Clinical Lymphoma, Myeloma & Leukemia
https://www.readbyqxmd.com/read/26458446/-novel-agents-in-multiple-myeloma-treatment
#20
Shigeki Ito
The introduction of bortezomib and IMiDs has improved outcomes of patients with multiple myeloma (MM). Moreover, second-generation IMiDs (pomalidomide) have recently been approved in Japan. Due to the incurability of this disease, newer drugs with different mechanisms of action designed to prolong survival and achieve cure are urgently needed. There are novel agents which appear to be promising, such as monoclonal antibodies (elotuzumab, daratumumab), second-generation proteasome inhibitors (carfilzomib), deacethylase inhibitors (panobinostat), and the kinesin protein inhibitor (Arry-520)...
October 2015: [Rinshō Ketsueki] the Japanese Journal of Clinical Hematology
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