FRINK Linked Data Fragments server

Matches in SemOpenAlex for { <https://semopenalex.org/work/W3215393386> ?p ?o ?g. }

• W3215393386 endingPage "4774" @default.
• W3215393386 startingPage "4774" @default.
• W3215393386 abstract "Abstract Backrground: Several randomized controlled clinical trials have demonstrated improved outcomes for newly diagnosed multiple myeloma (NDMM) patients who were treated with lenalidomide as maintenance therapy after autologous stem cell transplant (ASCT). Proteasome inhibitors have demonstrated clinical benefit in myeloma patients when used as part of induction and maintenance regimens, and the combination of proteasome inhibitors and lenalidomide in induction regimens has produced strong clinical responses. In this study, the addition of ixazomib to lenalidomide maintenance post-ASCT in NDMM patients was evaluated. Methods: Patients (n=64) were started on maintenance therapy with lenalidomide and ixazomib within 60-180 days of stem cell infusion. Each cycle was defined as 28 days with lenalidomide starting at 10 mg/day orally for 28 days with the option to increase the dose to 15 mg after 3 cycles. Ixazomib was provided at 3 mg (n=48 patients) or 4 mg (n=16 patients) orally on days 1, 8, and 15 of each 28-day cycle. However, ixazomib dose was reduced to 3 mg in all patients based on toxicity observed in other clinical trials of ixazomib at that time. The primary endpoint measured was progression-free survival (PFS), which was defined as the time between ASCT and disease progression or death, whichever occurred first. Results: A total of 64 patients were enrolled on this study between December 4, 2012, and May 13, 2015. Of these patients, 41 (64.06%) were 60 years of age or older and 42 (65.63%) were male. Fourteen patients had high-risk cytogenetic features (+1q21, Del17p, t(14:16), t(4:14)), 50 patients had standard cytogenetic risk features (t(11:14), t(6:14), hyperdiploidy, normal) and 9 patients had International Staging System stage 3 disease. Median PFS (mPFS) for all patients was 73.3 months and has not been reached for those with ISS stage 1 disease. mPFS for ISS Stage 3 disease and high-risk cytogenetic subgroups was 33.8 and 25.4 months, respectively. Twenty-two patients had progressive disease, while 21 patients continue to receive dual maintenance. Response rates deepened over time from baseline post-ASCT for 39 patients. The complete response (CR)/stringent CR rate was 42.9% and median overall survival was not reached with a median follow-up of 62 months (range 25.4 - 82.1 months). Thirty-one patients (48%) had improvement from their baseline response after maintenance therapy: 6 patients improved from PR to VGPR; 7 from PR to stringent CR (sCR)/CR; 16 from VGPR to sCR/CR; 1 from SD to CR; and 1 patient improved from SD to VGPR. The median time to response in the 31 patients with improved response to maintenance therapy was 10.9 months (range, 0.9 to 51.3 months). Minimal residual disease (MRD) was evaluated by multicolor flow cytometry (10^-5) in 21 patients by bone marrow biopsy; 8 patients were MRD-positive. The most common grade 3/4 adverse events (AEs) included neutropenia (46.9%), leukopenia (20.3%), thrombocytopenia (15.6%), lung infections (26.6%), diarrhea and maculopapular rash (12.5% each). Secondary primary malignancies occurred in 9 patients; these included squamous cell carcinoma of the skin (n=4), basal cell carcinoma of the skin (n=1), squamous cell carcinoma and basal cell carcinoma of the skin (n=1), hepatocellular carcinoma (n=1), melanoma (n=1) and leukemia (n=1). AEs led to dose reductions in ixazomib and lenalidomide in 20 and 31 patients, respectively. Discontinuation of ixazomib due to AEs occurred in 4 patients. Grade 1/2 neuropathy occurred in 22 patients and led to reduction or discontinuation of ixazomib in 2 patients. Conclusion: Addition of ixazomib to lenalidomide maintenance in myeloma patients demonstrated a better than expected PFS compared with what has been reported in studies of lenalidomide alone, and was both safe and tolerable. These results indicate a significant clinical benefit, especially for standard risk patients. Figure 1 Figure 1. Disclosures Patel: Oncopeptides: Consultancy; Pfizer: Consultancy; Janssen: Consultancy, Research Funding; BMS Celgene: Consultancy, Research Funding. Shah: Karyopharm Therapeutics Inc.: Current Employment, Current equity holder in publicly-traded company. Lee: GlaxoSmithKline: Consultancy, Research Funding; Bristol Myers Squibb: Consultancy; Celgene: Consultancy; Regeneron: Research Funding; Takeda Pharmaceuticals: Consultancy, Research Funding; Oncopetides: Consultancy; Amgen: Consultancy, Research Funding; Karyopharm: Consultancy; Legend Biotech: Consultancy; Sanofi: Consultancy; Janssen: Consultancy, Research Funding; Genentech: Consultancy. Thomas: BeiGene: Membership on an entity's Board of Directors or advisory committees; BMS: Research Funding; Ascentage Pharma: Research Funding; X4 Pharma: Research Funding; Genentech: Research Funding; Acerta Pharma: Research Funding; Pharmacyclics: Membership on an entity's Board of Directors or advisory committees. Qazilbash: NexImmune: Research Funding; Angiocrine: Research Funding; Amgen: Research Funding; Bristol-Myers Squibb: Other: Advisory Board; Oncopeptides: Other: Advisory Board; Janssen: Research Funding; Biolline: Research Funding. Orlowski: Amgen, Inc., BioTheryX, Inc., Bristol-Myers Squibb, Celgene, EcoR1 Capital LLC, Genzyme, GSK Biologicals, Janssen Biotech, Karyopharm Therapeutics, Inc., Neoleukin Corporation, Oncopeptides AB, Regeneron Pharmaceuticals, Inc., Sanofi-Aventis, and Takeda P: Consultancy, Honoraria; Asylia Therapeutics, Inc., BioTheryX, Inc., and Heidelberg Pharma, AG.: Other: Laboratory research funding; CARsgen Therapeutics, Celgene, Exelixis, Janssen Biotech, Sanofi-Aventis, Takeda Pharmaceuticals North America, Inc.: Other: Clinical research funding; Asylia Therapeutics, Inc.: Current holder of individual stocks in a privately-held company, Patents & Royalties; Amgen, Inc., BioTheryX, Inc., Bristol-Myers Squibb, Celgene, Forma Therapeutics, Genzyme, GSK Biologicals, Janssen Biotech, Juno Therapeutics, Karyopharm Therapeutics, Inc., Kite Pharma, Neoleukin Corporation, Oncopeptides AB, Regeneron Pharmaceuticals, I: Membership on an entity's Board of Directors or advisory committees." @default.
• W3215393386 created "2021-12-06" @default.
• W3215393386 creator A5008785159 @default.
• W3215393386 creator A5015342719 @default.
• W3215393386 creator A5017057018 @default.
• W3215393386 creator A5017555479 @default.
• W3215393386 creator A5023910969 @default.
• W3215393386 creator A5038235561 @default.
• W3215393386 creator A5048362577 @default.
• W3215393386 creator A5055929208 @default.
• W3215393386 creator A5057254430 @default.
• W3215393386 creator A5060313982 @default.
• W3215393386 creator A5068834306 @default.
• W3215393386 creator A5076833560 @default.
• W3215393386 creator A5080598017 @default.
• W3215393386 date "2021-11-05" @default.
• W3215393386 modified "2023-09-26" @default.
• W3215393386 title "Safety and Efficacy of Combination Maintenance Therapy with Ixazomib and Lenalidomide in Post-Transplant Myeloma Patients" @default.
• W3215393386 doi "https://doi.org/10.1182/blood-2021-151950" @default.
• W3215393386 hasPublicationYear "2021" @default.
• W3215393386 type Work @default.
• W3215393386 sameAs 3215393386 @default.
• W3215393386 citedByCount "0" @default.
• W3215393386 crossrefType "journal-article" @default.
• W3215393386 hasAuthorship W3215393386A5008785159 @default.
• W3215393386 hasAuthorship W3215393386A5015342719 @default.
• W3215393386 hasAuthorship W3215393386A5017057018 @default.
• W3215393386 hasAuthorship W3215393386A5017555479 @default.
• W3215393386 hasAuthorship W3215393386A5023910969 @default.
• W3215393386 hasAuthorship W3215393386A5038235561 @default.
• W3215393386 hasAuthorship W3215393386A5048362577 @default.
• W3215393386 hasAuthorship W3215393386A5055929208 @default.
• W3215393386 hasAuthorship W3215393386A5057254430 @default.
• W3215393386 hasAuthorship W3215393386A5060313982 @default.
• W3215393386 hasAuthorship W3215393386A5068834306 @default.
• W3215393386 hasAuthorship W3215393386A5076833560 @default.
• W3215393386 hasAuthorship W3215393386A5080598017 @default.
• W3215393386 hasConcept C126322002 @default.
• W3215393386 hasConcept C141071460 @default.
• W3215393386 hasConcept C143998085 @default.
• W3215393386 hasConcept C203092338 @default.
• W3215393386 hasConcept C2776063141 @default.
• W3215393386 hasConcept C2776364478 @default.
• W3215393386 hasConcept C2776694085 @default.
• W3215393386 hasConcept C2778283404 @default.
• W3215393386 hasConcept C2779050716 @default.
• W3215393386 hasConcept C2779609412 @default.
• W3215393386 hasConcept C2780108899 @default.
• W3215393386 hasConcept C2781098529 @default.
• W3215393386 hasConcept C535046627 @default.
• W3215393386 hasConcept C71924100 @default.
• W3215393386 hasConceptScore W3215393386C126322002 @default.
• W3215393386 hasConceptScore W3215393386C141071460 @default.
• W3215393386 hasConceptScore W3215393386C143998085 @default.
• W3215393386 hasConceptScore W3215393386C203092338 @default.
• W3215393386 hasConceptScore W3215393386C2776063141 @default.
• W3215393386 hasConceptScore W3215393386C2776364478 @default.
• W3215393386 hasConceptScore W3215393386C2776694085 @default.
• W3215393386 hasConceptScore W3215393386C2778283404 @default.
• W3215393386 hasConceptScore W3215393386C2779050716 @default.
• W3215393386 hasConceptScore W3215393386C2779609412 @default.
• W3215393386 hasConceptScore W3215393386C2780108899 @default.
• W3215393386 hasConceptScore W3215393386C2781098529 @default.
• W3215393386 hasConceptScore W3215393386C535046627 @default.
• W3215393386 hasConceptScore W3215393386C71924100 @default.
• W3215393386 hasIssue "Supplement 1" @default.
• W3215393386 hasLocation W32153933861 @default.
• W3215393386 hasOpenAccess W3215393386 @default.
• W3215393386 hasPrimaryLocation W32153933861 @default.
• W3215393386 hasRelatedWork W1968775433 @default.
• W3215393386 hasRelatedWork W2033089666 @default.
• W3215393386 hasRelatedWork W2056322049 @default.
• W3215393386 hasRelatedWork W2109013784 @default.
• W3215393386 hasRelatedWork W2172613078 @default.
• W3215393386 hasRelatedWork W2344741804 @default.
• W3215393386 hasRelatedWork W2914458920 @default.
• W3215393386 hasRelatedWork W3005849948 @default.
• W3215393386 hasRelatedWork W3089210822 @default.
• W3215393386 hasRelatedWork W3215393386 @default.
• W3215393386 hasVolume "138" @default.
• W3215393386 isParatext "false" @default.
• W3215393386 isRetracted "false" @default.
• W3215393386 magId "3215393386" @default.
• W3215393386 workType "article" @default.