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https://www.readbyqxmd.com/read/28290121/population-pharmacokinetic-analysis-of-ixazomib-an-oral-proteasome-inhibitor-including-data-from-the-phase-iii-tourmaline-mm1-study-to-inform-labelling
#1
Neeraj Gupta, Paul M Diderichsen, Michael J Hanley, Deborah Berg, Helgi van de Velde, R Donald Harvey, Karthik Venkatakrishnan
Ixazomib is an oral proteasome inhibitor, approved in USA, Canada, Australia and Europe in combination with lenalidomide and dexamethasone, for the treatment of patients with multiple myeloma who have received at least one prior therapy. We report a population pharmacokinetic model-based analysis for ixazomib that was pivotal in describing the clinical pharmacokinetics of ixazomib, to inform product labelling. Plasma concentration-time data were collected from 755 patients who received oral or intravenous ixazomib in once- or twice-weekly schedules in ten trials, including the global phase III TOURMALINE-MM1 study...
March 13, 2017: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/28240968/systematic-literature-review-and-network-meta-analysis-of-treatment-outcomes-in-relapsed-and-or-refractory-multiple-myeloma
#2
Chrissy H Y van Beurden-Tan, Margreet G Franken, Hedwig M Blommestein, Carin A Uyl-de Groot, Pieter Sonneveld
Purpose Since 2000, many new treatment options have become available for relapsed and/or refractory multiple myeloma (R/R MM) after a long period in which dexamethasone and melphalan had been the standard treatment. Direct comparisons of these novel treatments, however, are lacking. This makes it extremely difficult to evaluate the relative added value of each new treatment. Our aim was to synthesize all efficacy evidence, enabling a comparison of all current treatments for R/R MM. Methods We performed a systematic literature review to identify all publicly available phase III randomized controlled trial evidence...
February 27, 2017: Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology
https://www.readbyqxmd.com/read/28197996/upfront-lower-dose-lenalidomide-is-less-toxic-and-does-not-compromise-efficacy-for-vulnerable-patients-with-relapsed-refractory-multiple-myeloma-final-analysis-of-the-phase-ii-revlite-study
#3
Hang Quach, Liam Fernyhough, Ross Henderson, Gillian Corbett, Bart Baker, Peter Browett, Hilary Blacklock, Cecily Forsyth, Craig Underhill, Paul Cannell, Judith Trotman, Annette Neylon, Simon Harrison, Emma Link, Arlene Swern, Linda Cowan, Meletios A Dimopoulos, H Miles Prince
The combination of lenalidomide and dexamethasone is an established treatment for patients with multiple myeloma (MM). Increasingly, treatment attenuation is advocated for frail/elderly patients to minimize toxicity even though there have been no prospective studies to demonstrate whether lenalidomide dose attenuation impacts on response and survival outcome. This prospective multicentre phase II study assessed the efficacy and tolerability of lower dose lenalidomide (15 mg) and dexamethasone (20 mg) in 149 eligible patients with relapsed/refractory MM aged over 59 years and/or with renal impairment...
February 15, 2017: British Journal of Haematology
https://www.readbyqxmd.com/read/28176904/plitidepsin-design-development-and-potential-place-in-therapy
#4
REVIEW
Sara Alonso-Álvarez, Emilia Pardal, Diego Sánchez-Nieto, Miguel Navarro, Maria Dolores Caballero, Maria Victoria Mateos, Alejandro Martín
Plitidepsin is a cyclic depsipeptide that was first isolated from a Mediterranean marine tunicate (Aplidium albicans) and, at present, is manufactured by total synthesis and commercialized as Aplidin(®). Its antitumor activity, observed in preclinical in vitro and in vivo studies has prompted numerous clinical trials to be conducted over the last 17 years, alone or in combination with other anticancer agents. Single-agent plitidepsin has shown limited antitumor activity and a tolerable safety profile in several malignancies, such as noncutaneous peripheral T-cell lymphoma, melanoma, and multiple myeloma...
2017: Drug Design, Development and Therapy
https://www.readbyqxmd.com/read/28169231/palbociclib-a-new-hope-in-the-treatment-of-breast-cancer
#5
REVIEW
R Priyadharsini Palanisamy
Breast cancer being one of the common cancers has high morbidity and mortality. Despite the conventional treatment, the burden of the disease increases year after year. There is a need for newer drugs that target the different mechanisms in the pathogenesis. The interaction of cyclins with cyclin dependent kinases (CDKs) plays a major role in the abnormal cell cycle in cancer and it is considered to be an important target. Palbociclib is a CDK inhibitor currently approved for the treatment of breast cancer...
October 2016: Journal of Cancer Research and Therapeutics
https://www.readbyqxmd.com/read/28116920/safety-issues-and-management-of-toxicities-associated-with-new-treatments-for-multiple-myeloma
#6
Annamaria Brioli, Lars-Olof Mügge, Andreas Hochhaus, Marie Von Lilienfeld-Toal
In the last decade, the availability of new drugs for the treatment of Multiple Myeloma (MM) significantly improved patients' outcomes, but also raised attention towards a new spectrum of adverse events. Recently, four novel agents with different mechanisms of action (carfilzomib, elotuzumab, daratumumab and panobinostat) have been approved for the treatment of MM. This review aims at providing physicians with the tools to recognize and handle toxicity issues related with these new treatments. Areas covered: This review focuses on the management of drug related adverse events of the latest approved drug combinations...
January 27, 2017: Expert Review of Hematology
https://www.readbyqxmd.com/read/28111466/bortezomib-and-thalidomide-maintenance-after-stem-cell-transplantation-for-multiple-myeloma-a-pethema-gem-trial
#7
L Rosiñol, A Oriol, A I Teruel, A L de la Guía, MaJ Blanchard, J de la Rubia, M Granell, MaA Sampol, L Palomera, Y González, MaA Etxebeste, R Martínez-Martínez, M T Hernández, F de Arriba, A Alegre, MaT Cibeira, MaV Mateos, J Martínez-López, J J Lahuerta, J San Miguel, J Bladé
The phase III trial GEM05MENOS65 randomized 390 patients 65 years old or younger with newly diagnosed symptomatic multiple myeloma (MM) to receive induction with thalidomide/dexamethasone, bortezomib/thalidomide/dexamethasone and Vincristine, BCNU, melphalan, cyclophosphamide, prednisone/vincristine, BCNU, doxorubicin, dexamethasone bortezomib (VBMCP/VBAD/B) followed by autologous stem cell transplantation (ASCT) with MEL-200. After ASCT, a second randomization was performed to compare thalidomide/bortezomib (TV), thalidomide (T) and alfa-2b interferon (alfa2-IFN)...
February 14, 2017: Leukemia: Official Journal of the Leukemia Society of America, Leukemia Research Fund, U.K
https://www.readbyqxmd.com/read/28110581/triplet-combinations-in-relapsed-refractory-myeloma-update-on-recent-phase-3-trials
#8
Jean-Samuel Boudreault, Cyrille Touzeau, Philippe Moreau
Multiple myeloma (MM) is a rare hematologic disease of antibody-secreting plasma cells. Our understanding of the pathogenesis of this malignancy has improved greatly, and at the same time, we have access to new and more effective treatments options. Over the last 5 years, a spectrum of novel therapies with different mechanisms of action, including third-generation immunomodulatory drugs (pomalidomide), second generation proteasome inhibitors (carfilzomib and ixazomib), a histone deacetylase inhibitor (panobinostat) and monoclonal antibodies (mAbs) (elotuzumab and daratumumab) has transformed our approach to the treatment of patients with relapsed/refractory MM (RRMM)...
March 2017: Expert Review of Hematology
https://www.readbyqxmd.com/read/28061994/recommend-maintenance-therapy-with-lenalidomide-in-multiple-myeloma
#9
REVIEW
Elisabet E Manasanch
Thalidomide was the first immunomodulatory drug used as maintenance after autologous stem cell transplant (ASCT) in multiple myeloma (MM). This showed improved progression-free survival (PFS) and in some cases, overall survival (OS). Despite this, use of thalidomide was limited due to toxicity and high rates of therapy discontinuation. Lenalidomide, an analog of thalidomide, had a more favorable toxicity profile making its use in maintenance a potential approach. The use of lenalidomide as a maintenance therapy after ASCT in newly diagnosed MM patients has been investigated in four phase III randomized control studies...
December 2016: Seminars in Oncology
https://www.readbyqxmd.com/read/28042457/an-update-on-the-role-of-daratumumab-in-the-treatment-of-multiple-myeloma
#10
REVIEW
Caitlin Costello
Monoclonal antibodies (mAbs) have emerged as a promising new drug class for the treatment of multiple myeloma (MM). Daratumumab (DARA), a CD38 mAb, has demonstrated safety, tolerability and activity in a range of clinical trials, both as monotherapy and in combination strategies for MM. The favorable efficacy results in heavily pretreated patients with advanced MM have provided the rationale for the investigation of DARA in a number of ongoing and future phase II and III trials. The general tolerability of mAbs has allowed for widespread investigation and use of DARA among a variety of MM patients, however their use requires special consideration...
January 2017: Therapeutic Advances in Hematology
https://www.readbyqxmd.com/read/28017406/bortezomib-with-lenalidomide-and-dexamethasone-versus-lenalidomide-and-dexamethasone-alone-in-patients-with-newly-diagnosed-myeloma-without-intent-for-immediate-autologous-stem-cell-transplant-swog-s0777-a-randomised-open-label-phase-3-trial
#11
Brian G M Durie, Antje Hoering, Muneer H Abidi, S Vincent Rajkumar, Joshua Epstein, Stephen P Kahanic, Mohan Thakuri, Frederic Reu, Christopher M Reynolds, Rachael Sexton, Robert Z Orlowski, Bart Barlogie, Angela Dispenzieri
BACKGROUND: Lenalidomide plus dexamethasone is a reference treatment for patients with newly diagnosed myeloma. The combination of the proteasome inhibitor bortezomib with lenalidomide and dexamethasone has shown significant efficacy in the setting of newly diagnosed myeloma. We aimed to study whether the addition of bortezomib to lenalidomide and dexamethasone would improve progression-free survival and provide better response rates in patients with previously untreated multiple myeloma who were not planned for immediate autologous stem-cell transplant...
February 4, 2017: Lancet
https://www.readbyqxmd.com/read/28006855/lenalidomide-and-low-dose-dexamethasone-rd-versus-bortezomib-melphalan-prednisone-vmp-in-elderly-newly-diagnosed-multiple-myeloma-patients-a-comparison-of-two-prospective-trials
#12
Massimo Gentile, Valeria Magarotto, Massimo Offidani, Pellegrino Musto, Sara Bringhen, Maria Teresa Petrucci, Francesca Gay, Alessandra Larocca, Giuseppina Uccello, Annamaria Petrungaro, Ernesto Vigna, Rosa Greco, Anna Grazia Recchia, Giovanni Tripepi, Roberto Ria, Francesco Di Raimondo, Antonio Palumbo, Fortunato Morabito
There are currently no direct head-to-head clinical trials evaluating bortezomib-melphalan-prednisone (VMP) versus lenalidomide and low-dose dexamethasone (Rd). VMP (257 cases) and Rd (222 cases) arms of two randomized phase III trials were employed to assess the treatment influence on outcome in untreated elderly MM patients. Progression free survival (PFS) and overall survival (OS) were the primary and secondary end-points, respectively, and were investigated according to treatments administered over a 60-months follow-up period...
March 2017: American Journal of Hematology
https://www.readbyqxmd.com/read/27993621/on-the-need-for-phase-iii-studies-of-risk-adapted-therapy-in-multiple-myeloma
#13
EDITORIAL
Peter Voorhees
No abstract text is available yet for this article.
February 2017: Biology of Blood and Marrow Transplantation
https://www.readbyqxmd.com/read/27986429/practical-considerations-in-managing-relapsed-multiple-myeloma
#14
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
#15
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/27847663/extramedullary-plasmacytoma-mimicking-pancreatic-cancer-an-unusual-presentation
#16
Daniela Sciancalepore, Sergio Musci, Maria Rosaria Fracella, Grazia D'Alesio, Azzurra Sportelli, Giuseppe Ingravallo, Angelo Vacca, Roberto Ria
Multiple myeloma is a plasma cell tumor that homes to and expands in the bone marrow and that, despite the new available drugs, remains incurable. Extramedullary plasmacytoma is a not frequent manifestation during the natural history of multiple myeloma and is frequently associated with plasma cell bone marrow infiltration. The most common locations for an EMP include the gastrointestinal tract, pleura, testis, skin, peritoneum, liver, endocrine glands, and lymph nodes. Primary involvement of the gallbladder fossa is exceedingly rare...
2016: Case Reports in Oncological Medicine
https://www.readbyqxmd.com/read/27713531/translation-elongation-factor-eef1a2-is-a-novel-anticancer-target-for-the-marine-natural-product-plitidepsin
#17
Alejandro Losada, María José Muñoz-Alonso, Carolina García, Pedro A Sánchez-Murcia, Juan Fernando Martínez-Leal, Juan Manuel Domínguez, M Pilar Lillo, Federico Gago, Carlos M Galmarini
eEF1A2 is one of the isoforms of the alpha subunit of the eukaryotic Elongation Factor 1. It is overexpressed in human tumors and is endowed with oncogenic properties, favoring tumor cell proliferation while inhibiting apoptosis. We demonstrate that plitidepsin, an antitumor agent of marine origin that has successfully completed a phase-III clinical trial for multiple myeloma, exerts its antitumor activity by targeting eEF1A2. The drug interacts with eEF1A2 with a KD of 80 nM and a target residence time of circa 9 min...
October 7, 2016: Scientific Reports
https://www.readbyqxmd.com/read/27630127/a-three-drug-combo-for-multiple-myeloma
#18
(no author information available yet)
A phase III trial suggests that the combination of daratumumab, bortezomib, and dexamethasone is more powerful in patients with relapsed or relapsed and refractory melanoma than bortezomib plus dexamethasone. Patients who received all three drugs had a higher overall response rate and improved 12-month progression-free survival.
September 14, 2016: Cancer Discovery
https://www.readbyqxmd.com/read/27601551/optimizing-treatment-for-elderly-patients-with-newly-diagnosed-multiple-myeloma-a-personalized-approach
#19
Alessandra Larocca, Antonio Palumbo
The Oncology Grand Rounds series is designed to place original reports published in the Journal into clinical context. A case presentation is followed by a description of diagnostic and management challenges, a review of the relevant literature, and a summary of the authors' suggested management approaches. The goal of this series is to help readers better understand how to apply the results of key studies, including those published in Journal of Clinical Oncology, to patients seen in their own clinical practice...
September 6, 2016: Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology
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
#20
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
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