FRINK Linked Data Fragments server

Matches in SemOpenAlex for { <https://semopenalex.org/work/W2545995047> ?p ?o ?g. }

• W2545995047 endingPage "4779" @default.
• W2545995047 startingPage "4779" @default.
• W2545995047 abstract "Abstract Background High quality response [very good partial remission (VGPR), complete remission (CR)] is associated with improved long-term outcome in multiple myeloma (MM) therapy. Lenalidomide (Len)/ dexamethasone (Dex) (Rd) is considered a standard 2nd-line regimen. However, after 1st-line MM therapy containing a “novel agent” like thalidomide, only a relatively small fraction (21.3%) of patients (pts) achieved VGPR or better when RD was used in relapsed/refractory MM (RRMM)1. Bendamustine (Ben) is an alkylating agent with superior activity compared to melphalan/prednisone. The combination of Ben, Len and Dex (BRd) in pts with advanced RRMM resulted in dose-limiting hematotoxicity, which restricted its efficacy in extensively pretreated pts2. However, recent phase I experience demonstrated the feasibility of BRd as 2nd- and 3rd-line myeloma therapy3. We therefore evaluated the efficacy and toxicity of the BRd-regimen as 2nd line therapy for RRMM. Patients and methods This multicenter Phase II study was designed to enroll 50 pts with RRMM undergoing 2nd-line MM therapy [including also pts with prior autologous stem cell transplantation (ASCT)]. Pts had to have measurable disease, ECOG performance status 0-2, adequate hematological values and a creatinine clearance > 50 ml/min. Study treatment consisted of Ben 75 mg/m2 i.v. day (d) 1 & 2 and Len 25 mg p.o. d 1-21 for a total of six 28-day induction cycles. Dex (40 and 20 mg p.o. for pts <= or > 75 years of age, respectively) was given on d 1, 8, 15, and 22. Pegfilgrastim 6 mg s.c. was administered on d 3 in case of severe neutropenia, treatment delay due to neutropenia or febrile neutropenia according to predefined application rules. Induction treatment was followed by 12 cycles (28 d) of maintenance therapy with Rd at the same dose. The primary study endpoint was the CR/VGPR rate after induction therapy, based on standard IMWG criteria. A Simon's two stage design was used to differentiate between 20% (considered uninteresting) vs 40 % (considered promising, power of 80%, p=5%) of high quality responses. At least 13 pts with VGPR or better after induction therapy were required to meet the statistical threshold predefined for promising activity of the BRd regimen in this study. Results 50 pts were enrolled between 04/2012 and 07/2014 (median age 68 years [46-84y], 73% men). 49% pts had ISS stage II/III, 42.5% had undergone prior SCTs, and 13% had known high risk cytogenetic aberrations. 91% of pts had received novel agents (thalidomide, bortezomib) during 1st-line therapy. At the time of abstract submission, data from 38 pts having completed induction treatment were available. Final analysis of the primary study endpoint including all patients will be updated and presented at the meeting. Of the currently 38 evaluable pts, 20 (52.6%, Table 1) achieved a CR/VGPR after a median of 3.3 induction cycles. Only 1 patient experienced disease progression (PD) during induction phase. 77% of pts received pegfilgrastim. Dose reduction during induction therapy was required in 7.7% of pts. 42.5% received < 6 scheduled induction cycles (50% due to toxicities, 50% for other reasons). 49% had treatment-related SAEs. Grade 3/ 4 neutropenia and thrombocytopenia occurred in 51%/25.5% and 23.4%/8.5% of pts, respectively. Only 1 patient developed CTC grade 3 febrile neutropenia. Most common grade 3/4 non-hematologic toxicities were infections (14%), rash (9.5%), and diarrhea (9.5%). Anaphylactic reaction grade 4 related to Ben and pulmonary embolism grade 3 occurred in 1 patient each. A cerebral insult grade 4 occurred in a patient non-compliant with the anti-thrombotic prophylaxis required per protocol. One death due to respiratory failure (considered to be unlikely related to study treatment) was reported for an 83 year old male. Conclusion BRd is a safe and efficacious regimen for 2nd line treatment of RRMM patients whose 1st-line therapy included thalidomide or bortezomib. High quality responses (>= VGPR) can be achieved in a considerable proportion (52.6%) of these pts. Our study suggests that the fraction of patients achieving VGPR or better after BRd treatment may be substantially higher than attainable with Rd alone. References 1 Wang et al. Blood, 2008, 112: 4445-51 2 Lentzsch et al. Blood, 2012, 119: 4608-13 3 Poenisch et al., Br J Haematol, 2013, 162, 202–9 Table 1 Best response after induction CR VGPR PR MR SD total (n=38) 3 17 15 1 2 prior ASCT (n=16) 2 6 7 1 0 no prior ASCT (n=22) 1 11 8 0 2 Disclosures Mey: Mundipharma: Honoraria, Research Funding; Amgen: Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Celgene: Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding. Off Label Use: Use of Bendamustine in relapsed/refractory Multiple Myekoma. To investigate the efficacy and safety of Bendamustine in combination with the standard backbone of Lenalidomide/ Dexamethasone in patients with replaced/refractory MM.. Bargetzi:Celgene: Membership on an entity's Board of Directors or advisory committees. Taverna:Celgene: Consultancy, Membership on an entity's Board of Directors or advisory committees. Schmid:Celgene: Honoraria. Knauf:Celgene: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; Mundipharma: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees. von Moos:Amgen: Consultancy, Honoraria, Research Funding. Hiendlmeyer:Celgene: Research Funding; Mundipharma: Research Funding; Amgen: Research Funding. Hitz:Celgene: Research Funding. Driessen:Mundipharma: Membership on an entity's Board of Directors or advisory committees, Research Funding; Amgen: Membership on an entity's Board of Directors or advisory committees." @default.
• W2545995047 created "2016-11-04" @default.
• W2545995047 creator A5000841982 @default.
• W2545995047 creator A5016787940 @default.
• W2545995047 creator A5018920707 @default.
• W2545995047 creator A5018939058 @default.
• W2545995047 creator A5019048597 @default.
• W2545995047 creator A5025804381 @default.
• W2545995047 creator A5026487046 @default.
• W2545995047 creator A5033907861 @default.
• W2545995047 creator A5037009390 @default.
• W2545995047 creator A5042136522 @default.
• W2545995047 creator A5042780466 @default.
• W2545995047 creator A5043786373 @default.
• W2545995047 creator A5045139107 @default.
• W2545995047 creator A5046258011 @default.
• W2545995047 creator A5047277951 @default.
• W2545995047 creator A5049830591 @default.
• W2545995047 creator A5050931392 @default.
• W2545995047 creator A5057869933 @default.
• W2545995047 creator A5062659492 @default.
• W2545995047 creator A5068695354 @default.
• W2545995047 creator A5077719512 @default.
• W2545995047 creator A5090354292 @default.
• W2545995047 date "2014-12-06" @default.
• W2545995047 modified "2023-10-10" @default.
• W2545995047 title "Multicenter Phase II Trial of Bendamustine, Lenalidomide and Dexamethasone (BRd) As 2nd-Line Therapy for Multiple Myeloma" @default.
• W2545995047 doi "https://doi.org/10.1182/blood.v124.21.4779.4779" @default.
• W2545995047 hasPublicationYear "2014" @default.
• W2545995047 type Work @default.
• W2545995047 sameAs 2545995047 @default.
• W2545995047 citedByCount "1" @default.
• W2545995047 countsByYear W25459950472015 @default.
• W2545995047 countsByYear W25459950472017 @default.
• W2545995047 crossrefType "journal-article" @default.
• W2545995047 hasAuthorship W2545995047A5000841982 @default.
• W2545995047 hasAuthorship W2545995047A5016787940 @default.
• W2545995047 hasAuthorship W2545995047A5018920707 @default.
• W2545995047 hasAuthorship W2545995047A5018939058 @default.
• W2545995047 hasAuthorship W2545995047A5019048597 @default.
• W2545995047 hasAuthorship W2545995047A5025804381 @default.
• W2545995047 hasAuthorship W2545995047A5026487046 @default.
• W2545995047 hasAuthorship W2545995047A5033907861 @default.
• W2545995047 hasAuthorship W2545995047A5037009390 @default.
• W2545995047 hasAuthorship W2545995047A5042136522 @default.
• W2545995047 hasAuthorship W2545995047A5042780466 @default.
• W2545995047 hasAuthorship W2545995047A5043786373 @default.
• W2545995047 hasAuthorship W2545995047A5045139107 @default.
• W2545995047 hasAuthorship W2545995047A5046258011 @default.
• W2545995047 hasAuthorship W2545995047A5047277951 @default.
• W2545995047 hasAuthorship W2545995047A5049830591 @default.
• W2545995047 hasAuthorship W2545995047A5050931392 @default.
• W2545995047 hasAuthorship W2545995047A5057869933 @default.
• W2545995047 hasAuthorship W2545995047A5062659492 @default.
• W2545995047 hasAuthorship W2545995047A5068695354 @default.
• W2545995047 hasAuthorship W2545995047A5077719512 @default.
• W2545995047 hasAuthorship W2545995047A5090354292 @default.
• W2545995047 hasConcept C126322002 @default.
• W2545995047 hasConcept C143998085 @default.
• W2545995047 hasConcept C2776063141 @default.
• W2545995047 hasConcept C2776364478 @default.
• W2545995047 hasConcept C2777063308 @default.
• W2545995047 hasConcept C2777478702 @default.
• W2545995047 hasConcept C2778684742 @default.
• W2545995047 hasConcept C2779050716 @default.
• W2545995047 hasConcept C2779338263 @default.
• W2545995047 hasConcept C2779609412 @default.
• W2545995047 hasConcept C2780401358 @default.
• W2545995047 hasConcept C2780653079 @default.
• W2545995047 hasConcept C2781413609 @default.
• W2545995047 hasConcept C2781442060 @default.
• W2545995047 hasConcept C29730261 @default.
• W2545995047 hasConcept C31760486 @default.
• W2545995047 hasConcept C71924100 @default.
• W2545995047 hasConcept C90924648 @default.
• W2545995047 hasConceptScore W2545995047C126322002 @default.
• W2545995047 hasConceptScore W2545995047C143998085 @default.
• W2545995047 hasConceptScore W2545995047C2776063141 @default.
• W2545995047 hasConceptScore W2545995047C2776364478 @default.
• W2545995047 hasConceptScore W2545995047C2777063308 @default.
• W2545995047 hasConceptScore W2545995047C2777478702 @default.
• W2545995047 hasConceptScore W2545995047C2778684742 @default.
• W2545995047 hasConceptScore W2545995047C2779050716 @default.
• W2545995047 hasConceptScore W2545995047C2779338263 @default.
• W2545995047 hasConceptScore W2545995047C2779609412 @default.
• W2545995047 hasConceptScore W2545995047C2780401358 @default.
• W2545995047 hasConceptScore W2545995047C2780653079 @default.
• W2545995047 hasConceptScore W2545995047C2781413609 @default.
• W2545995047 hasConceptScore W2545995047C2781442060 @default.
• W2545995047 hasConceptScore W2545995047C29730261 @default.
• W2545995047 hasConceptScore W2545995047C31760486 @default.
• W2545995047 hasConceptScore W2545995047C71924100 @default.
• W2545995047 hasConceptScore W2545995047C90924648 @default.
• W2545995047 hasIssue "21" @default.
• W2545995047 hasLocation W25459950471 @default.
• W2545995047 hasOpenAccess W2545995047 @default.
• W2545995047 hasPrimaryLocation W25459950471 @default.
• W2545995047 hasRelatedWork W1576670771 @default.

• next