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    A.R.R.O.W.2: once- vs twice-weekly carfilzomib, lenalidomide, and dexamethasone in relapsed/refractory multiple myeloma
    (American Society of Hematology, 2024) Dimopoulos, Meletios A.; Coriu, Daniel; Delimpasi, Sosana; Špička, Ivan; Upchurch, Terry; Fang, Belle; Talpur, Rakhshandra; Faber, Edward; Beksaç, Meral; Leleu, Xavier
    Twice-weekly carfilzomib (27 mg/m2) plus lenalidomide and dexamethasone (KRd27) is a standard of care in relapsed/refractory multiple myeloma (RRMM). Once-weekly carfilzomib regimens have shown clinical benefits with improved patient convenience. This open-label, phase 3, multicenter, randomized study aimed to demonstrate noninferiority of the overall response rate (ORR) for once-weekly carfilzomib (56 mg/m2) plus Rd (KRd56) vs twice-weekly KRd27 in RRMM. A total of 454 patients were randomized (1:1) to receive carfilzomib as onceweekly 30-minute infusions of 56 mg/m2 (KRd56; n = 228) or twice-weekly 10-minute infusions of 27 mg/m2 (KRd27; n = 226). Baseline characteristics were balanced between groups. ORR was 82.5% (95% confidence interval [CI], 76.9-87.2) in the once-weekly group vs 86.3% (95% CI, 81.1-90.5) in the twice-weekly group (risk ratio, 0.954 [95% CI, 0.882-1.032]) and did not meet the threshold for statistical significance of noninferiority (P = .0666). Complete response (CR) or better was obtained in 46.9% of patients in the once-weekly arm and 36.3% in the twice-weekly arm. The proportions of patients who achieved CR and were also assessed negative forminimal residual disease were 21.5% and 18.1%, respectively (odds ratio, 1.235 [95% CI, 0.775-1.970]). Progression-free survival was comparable between groups (hazard ratio, 0.945 [95% CI, 0.617-1.447]). The safety profile was similar for both groups. In conclusion, although statistical significance for noninferiority of ORR was not achieved, the efficacy and safety of once-weekly KRd56 were similar to those of twice-weekly KRd27, and once-weekly KRd56 may be an effective and convenient treatment option for patients with RRMM. © 2024 by The American Society of Hematology.
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    Belantamab Mafodotin Plus Pomalidomide and Dexamethasone Vs Pomalidomide Plus Bortezomib and Dexamethasone in Patients with Relapsed/Refractory Multiple Myeloma: A Subset Analysis in Patients Who Have Received 1 Prior Line of Therapy Including Lenalidomide
    (AMER SOC HEMATOLOGY, 2024) Beksaç, Meral; Garcia, Esther Gonzalez; Delimpasi, Sosana; Robak, Pawel; Karunanithi, Kamaraj
    Belantamab Mafodotin Plus Pomalidomide and Dexamethasone Vs Pomalidomide Plus Bortezomib and Dexamethasone in Patients with Relapsed/Refractory Multiple Myeloma: A Subset Analysis in Patients Who Have Received 1 Prior Line of Therapy Including Lenalidomide
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    Belantamab Mafodotin, Pomalidomide, and Dexamethasone in Multiple Myeloma
    (Massachussetts Medical Society, 2024) Dimopoulos, Meletios Athanasios; Beksaç, Meral; Pour, Ludek
    BACKGROUND Triplet or quadruplet therapies incorporating proteasome inhibitors, immunomodulators, and anti-CD38 antibodies have led to prolonged survival among patients with newly diagnosed multiple myeloma; however, most patients have a relapse. Frontline lenalidomide therapy has increased the number of patients with lenalidomide-refractory disease at the time of the first relapse. METHODS In this phase 3, randomized, open-label trial, we evaluated belantamab mafodotin, pomalidomide, and dexamethasone (BPd), as compared with pomalidomide, bortezomib, and dexamethasone (PVd), in lenalidomide-exposed patients who had relapsed or refractory myeloma after at least one line of therapy. The primary end point was progression-free survival. Disease response and safety were also assessed. RESULTS A total of 302 patients underwent randomization; 155 were assigned to the BPd group, and 147 to the PVd group. At a median follow-up of 21.8 months (range, <0.1 to 39.2), the 12-month estimated progression-free survival with BPd was 71% (95% confidence interval [CI], 63 to 78), as compared with 51% (95% CI, 42 to 60) with PVd (hazard ratio for disease progression or death, 0.52; 95% CI, 0.37 to 0.73; P<0.001). Data on overall survival were immature. The percentage of patients with a response to treatment (partial response or better) was 77% (95% CI, 70 to 84) in the BPd group and 72% (95% CI, 64 to 79) in the PVd group; 40% (95% CI, 32 to 48) and 16% (95% CI, 11 to 23), respectively, had a complete response or better. Grade 3 or higher adverse events occurred in 94% of the patients in the BPd group and 76% of those in the PVd group. Ocular events occurred in 89% of the patients who received BPd (grade 3 or 4 in 43%) and 30% of those who received PVd (grade 3 or 4 in 2%); ocular events in the BPd group were managed with belantamab mafodotin dose modification. Ocular events led to treatment discontinuation in 9% of the patients in the BPd group and in no patients in the PVd group. CONCLUSIONS Among lenalidomide-exposed patients with relapsed or refractory myeloma, BPd conferred a significantly greater benefit than PVd with respect to progression-free survival, as well as deeper, more durable responses. Ocular events were common but were controllable by belantamab mafodotin dose modification. Copyright © 2024 Massachusetts Medical Society.
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    Haplotypes rich in activating killer-cell immnuglobulin-like receptor genes are associated with delay on age of myeloma onset
    (CIG MEDIA GROUP, 2021) Akın, Hasan Yalım; Seval, Güldane Cengiz; Atilla, Pınar Ataca; Yurdakul Mesutoğlu, Pınar; Otlu, Taner; Anlıaçık, Rıdvan; Dalva, Klara; Gürman, Günhan; Beksaç, Meral
    Natural killer (NK) cells are known for their anti-tumoral cytotoxic effects. Effector NK-cell functions are controlled by interactions between inhibitory and activating killer-cell immnuglobulin-like receptors (iKIRs and aKIRs) on NK cells in the presence of human leukocyte antigen (HLA) class I ligands on target cells. The aim of this study was to investigate the frequency of KIR genotypes with/without their cognate ligands among myeloma (MM) patients compared to a healthy population.
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    Isatuximab, Bortezomib, Lenalidomide, and Dexamethasone for Multiple Myeloma
    (Massachussetts Medical Society, 2024) Facon, Thierry; Dimopoulos, Meletios Athanasios; Leleu, Xavier P.; Beksaç, Meral; Pour, Ludek; Hájek, Roman; Liu, Zhuogang; Minarik, Jiri; Moreau, Philippe; Romejko Jarosinska, Joanna; Spicka, Ivan; Vorobyev, Vladimir I.; Besemer, Britta; Ishida, Tadao; Janowski, Wojciech; Kalayoğlu Beşisik, Sevgi; Parmar, Gurdeep; Robak, Pawel; Zamagni, Elena; Goldschmidt, Hartmut; Martin, Thomas G.; Manier, Salomon; Mohty, Mohamad; Oprea, Corina; Brégeault, Marie France; Macé, Sandrine; Berthou, Christelle; Bregman, David; Klippel, Zandra; Orlowski, Robert Z.
    Background Bortezomib, lenalidomide, and dexamethasone (VRd) is a preferred first-line treatment option for patients with newly diagnosed multiple myeloma. Whether the addition of the anti-CD38 monoclonal antibody isatuximab to the VRd regimen would reduce the risk of disease progression or death among patients ineligible to undergo transplantation is unclear. Methods In an international, open-label, phase 3 trial, we randomly assigned, in a 3:2 ratio, patients 18 to 80 years of age with newly diagnosed multiple myeloma who were ineligible to undergo transplantation to receive either isatuximab plus VRd or VRd alone. The primary efficacy end point was progression-free survival. Key secondary end points included a complete response or better and minimal residual disease (MRD)-negative status in patients with a complete response. Results A total of 446 patients underwent randomization. At a median follow-up of 59.7 months, the estimated progression-free survival at 60 months was 63.2% in the isatuximab-VRd group, as compared with 45.2% in the VRd group (hazard ratio for disease progression or death, 0.60; 98.5% confidence interval, 0.41 to 0.88; P<0.001). The percentage of patients with a complete response or better was significantly higher in the isatuximab-VRd group than in the VRd group (74.7% vs. 64.1%, P=0.01), as was the percentage of patients with MRD-negative status and a complete response (55.5% vs. 40.9%, P=0.003). No new safety signals were observed with the isatuximab-VRd regimen. The incidence of serious adverse events during treatment and the incidence of adverse events leading to discontinuation were similar in the two groups. Conclusions Isatuximab-VRd was more effective than VRd as initial therapy in patients 18 to 80 years of age with newly diagnosed multiple myeloma who were ineligible to undergo transplantation. © 2024 Massachusetts Medical Society.
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    Manual versus automated volume reduction of cord blood
    (TR- Dizin, 2022) Yurdakul Mesutoğlu, Pınar; Gençer Öncül, Emine Begüm; Akın, Hasan Yalım; Beksaç, Meral
    Objectives: All cord blood banks all over the world follow a common procedure, concentrating progenitor cells by volume reduction, with the main purpose of optimizing the use of storage space. The main objective of this study was to compare CD34 and total nucleated cell recovery rates and red blood cell depletion efficiencies following cord blood processing using automated Sepax or manual CellEffic cord blood processing systems. Methods: Nine cord blood units with high volumes were divided into 2 equal fractions and processed with CellEffic cord blood and Sepax. Total nucleated cell, mononuclear cells, CD34+, red blood cell and total nucleated cell viability, and clonogenic assays were performed, and recovery rates were calculated on pre- and post-process cord blood units and after freeze/thaw process. In the comparison group, post-thaw differential cell counting was also performed. Results: Our results showed that post-process total nucleated cell viability with CellEffic cord blood was slightly higher than Sepax, whereas Sepax post-process total nucleated cell/ mononuclear cell values were superior to CellEffic cord blood. Postthaw red blood cell depletion was better for CellEffic cord blood. Post-thaw Sepax colony-forming unit counts were higher than CellEffic cord blood. In addition, CD45+CD71+ cells were lower, whereas CD45+CD34+CD38? cells were higher for the CellEffic cord blood system. Conclusion: Despite the fact that there is a need for well-trained personnel for processing cord blood units with CellEffic cord blood, it may be an attractive alternative to Sepax system for cord blood processing, particularly for cord blood units with low volumes, at banks with low budget where the cord blood turnover rates are relatively low.