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Öğe Comparison of efficacy and safety of generic plerixafor vs original plerixafor in the mobilization of myeloma patients(American Society of Hematology, 2022) Sevindik, Ömür Gökmen; Bilgen, Hülya; Serin, İstemi; Melek, Elif; Karakuş, Volkan; Çerçi, Kübra; Mutlu, Yaşa Gül; Balık Aydın, Berrin; Sadri, Sevil; Beköz, Hüseyin Saffet; Kaynar, LeylagülIntroduction The commonest indication for an Autologous Stem Cell Transplantation (ASCT) is still Multiple Myeloma. A successful mobilization of hematopoietic stem cells (HSC) is a sine qua non of ASCT. The introduction of Plerixafor, which is a partial agonist of the alfa-chemokine receptor CXCR4 has added an important value and impact on mobilization. Plerixafor is successfully integrated into both growth factor-only and cyclophosphamide and growth factor mobilization strategies with significantly reducing the mobilization failure rate in myeloma patients. In addition, plerixafor + G-CSF has also been shown to successfully mobilize the majority of patients who previously failed to mobilize with either growth factor alone or in combination with chemotherapy. Even a Just-in-Time algorithm which induces plerixafor in patients who lacks a certain threshold of CD34 positive HSCs on the day of mobilization led to a cost-effective and successful mobilization with highly restricted rates of mobilization failure. In this study we tried to demonstrate the efficacy and safety of a novel generic Plerixafor (Pleksor - Gen Ilac) and to compare it with original one (Mozobil - Sanofi) in a retrospective manner. Method Patients who were transplanted in two centers who adopted the same mobilization standard operating procedures (SOP) were included in the study. An age and sex matched cohort of patients who received Mozobil (from 2020-2022 - Group A) were compared with the ones who received Pleksor (2021-2022 Group B) as a Just-in-Time conjunct to GCSF alone or chemo mobilization. Poor mobilization was defined as a final yield of 2 million CD34 positive HSCs per kg. Our aim was to collect enough stem cells for at least two ASCTs, thus our current SOP's indicated a minimum CD34 positive HSC threshold of at least 4 million per kg and an ideal HSC threshold of 6 million per kg. Results A total of 28 patients were included and they were equally distributed among Group A (n=14) and B (n=14). Median age of the patients at the time of mobilization were as follows, 60 (35-72) in Group A and 61 (38-70) in Group B. 14 patients who received Pleksor achieved a median yield of 8.40 million CD34 positive HSCs per kg (4.8-21) and the patients who received Mozobil have ended with a yield of 6.7 million CD34 positive HSCs per kg (4.5-13) (p=0.210). None of the patients in both groups were named to be a poor mobilizer according to the threshold of 2 million CD34 positive HSCs per kg but 3 of the patients in Group A and 2 of the patients in Group B ended with a yield of 6 million CD34 positive cells which was below to the ideal threshold for two transplants. Regarding lenalidomide exposure before mobilization, history of radiotherapy, line of the therapies received before mobilization, number of leukapheresis and the mobilization policy (chemo vs gcsf alone) there were no statistically significant difference between two groups (p=0.120, 0.702, 0.842, 0.769 and 0.420 respectively). The median neutrophil engraftment time in days were as follows for Group A and B, 11(10-14) vs 11 (10-16), p=0.541 and the median platelet engraftment time in days were 17 (10-30) in Group A and 16 (10-28) in Group B with a p value of 0.571. In none of the cases any specific side effects were noted which could be attributable to Pleksor or Mozobil. Conclusion Our study demonstrated a comparable efficacy of a generic form of Plerixafor when compared with the originator. This would lead to a decrease in the cost of total process of mobilization with a similar efficacy and toxicity profile. We are now planning to initiate a prospective trial to validate these results in a larger patient population. Up to our knowledge this is the first study comparing the efficacy of a generic Plerixafor in a sole myeloma patient cohort.Öğe Original vs. generic plerixafor for the mobilization of stem cells in multiple myeloma patients(2025) Yiğit Kaya, Süreyya; Mutlu, Yaşa Gül; Yücel, Orhan Kemal; Nizam Özen, İlknur; Ataş, Ünal; Melek, Elif; Maral, Senem; Karakuş, Volkan; Kaynar, Leylagül; Sevindik, Ömür GökmenThis study investigates the efficacy and safety of generic plerixafor (Pleksor – Gen Pharma) compared to the original plerixafor (Mozobil - Sanofi) in patients with multiple myeloma undergoing ASCT. A total of 59 patients from three centers, who underwent ASCT between 2018 and 2023, were included and divided into two groups: Mozobil (M) group (n = 32) and Pleksor (P) group (n = 27). Plerixafor was administered as a just-in-time approach with granulocyte-colony stimulating factor (G-CSF) alone or with cyclophosphamide (Cy) + G-CSF mobilization. The study aimed to assess mobilization success and engraftment kinetics. There was no statistically significant difference between the two groups in terms of age, gender, RT history, previous lines of treatment, pretransplant lenalidomide cycles (p = 0.778, 0.165, 0.520, 0.094, 0.530, respectively). However, lenalidomide exposure was significantly higher in P group (18,8% vs. 81,5%, p < 0.001). Both groups achieved a similar total yield of CD34 + cells, and no serious side effects related to plerixafor were noted. Median platelet engraftment time was longer in P group, while neutrophil engraftment time was similar in both groups. This study demonstrates the comparable efficacy of generic plerixafor in myeloma patients, suggesting that it can be a cost-effective alternative with a similar safety profile. These findings contribute to the body of evidence on the use of generic plerixafor in specific patient cohorts, emphasizing its efficacy and safety for ASCT in a sole multiple myeloma patient cohort.Öğe Plerixafor in autologous stem cell transplantation: Does it affect engraftment kinetics?(Springer Nature, 2023) Serin, İstem; Sevindik, Ömür Gökmen; Balık Aydın, Berrin; Melek, Elif; Mutlu, Yaşa Gül; Bilgen, Hülya; Bekoz, Hüseyin; Kaynar, Leylagül[Abstract Not Available]Öğe Plerixafor in autologous stem cell transplantation: Does it affect engraftment kinetics?(Elsevier Ltd, 2023) Serin, İstemi; Sevindik, Ömür Gökmen; Balık Aydın, Berrin; Melek, Elif; Mutlu, Yaşa Gül; Bilgen, Hülya; Beköz, Hüseyin; Kaynar, LeylagülPlerixafor increases stem cell mobilization by reversibly binding to the chemokine receptor CXCR4. In our study, we examined the results of mobilization with plerixafor and granulocyte colony-stimulating factor (G-CSF) and revealed their effects on autologous stem cell transplantation (ASCT) engraftment kinetics. The study included all cases of ASCT performed in the Adult Bone Marrow Transplantation Unit of xxx University between January 2014 and January 2022. It included a total of 300 patients. The total number of CD34 + cells collected was 7.44 +/- 4.19 in patients with plerixafor and 9.53 +/- 6.09 in patients without plerixafor. The mean neutrophil and platelet engraftment took longer in plerixafor-mobilized patients (neutrophil: 12 +/- 4.1 vs. 10.2 +/- 2.7 days; platelet: 21.6 +/- 13.9 vs. 14.2 +/- 5.9 days; p = 0.008 and p = 0.002). The number of febrile neutropenia attacks was significantly higher in plerixafor-mobilized patients (p = 0.04). In the chemo-mobilized patient subgroup, plerixafor-mobilized patients experienced more febrile neutropenia attacks (p = 0.04). The mean time to both neutrophil and platelet engraftment was longer in patients mobilized with plerixafor. In the subgroup of patients with MM, the mean time to platelet engraftment was longer in patients mobilized with plerixafor. Plerixafor and its effect on engraftment kinetics should be evaluated with further studies in a larger population with survival analysis.Öğe Relapsed refractory multiple myeloma with CNS involvement successfully treated with Elranatamab: First reported case(Frontiers Media SA, 2023) Mutlu, Yaşa Gül; Yiğit Kaya, Süreyya; Maral, Senem; Melek, Elif; Başlar, Zafer; Kaynar, Leylagül; Sevindik, Ömür GökmenCentral nervous system (CNS) involvement in multiple myeloma (MM) is a rare and challenging complication associated with poor prognosis and limited treatment options. Emerging T-cell directing therapies, such as bispecific antibodies (bsAbs) and chimeric antigen receptor T cells (CAR-T), have shown remarkable success in treating MM, but their efficacy in CNS involvement remains unclear. Elranatamab, a humanized bispecific antibody targeting B-cell maturation antigen (BCMA) and CD3-expressing T cells, has demonstrated promising results in relapsed refractory MM. However, its efficacy in treating CNS-MM has not been reported. We present a case of a 37-year-old male MM patient with CNS involvement who has been successfully treated with Elranatamab.Öğe Single agent vemurafenib or rituximab-vemurafenib combination for the treatment of relapsed/refractory hairy cell leukemia, a multicenter experience(2024) Yiğit Kaya, Süreyya; Mutlu, Yaşa Gül; Malkan, Ümit Yavuz; Mehtap, Özgür; Keklik Karadağ, Fatma; Korkmaz, Gülten; Elverdi, Tuğrul; Saydam, Güray; Özet, Gülsüm; Ar, Muhlis Cem; Melek, Elif; Maral, Senem; Kaynar, Leylagül; Sevindik, Ömür GökmenBackground: Hairy cell leukemia (HCL) is a rare mature B-cell malignancy that is primarily treated with purine analogues. However, relapse remains a significant challenge, prompting the search for alternative therapies. The BRAF V600E mutation prevalent in HCL patients provides a target for treatment with vemurafenib. Patients and methods: This multicenter retrospective study included nine patients with relapsed/refractory (R/R) HCL from six different centers. Patient data included demographics, prior treatments, clinical outcomes, and adverse events. Results: Patients received different treatment regimens between centers, including vemurafenib alone or in combination with rituximab. Despite the differences in protocols, all patients achieved at least a partial response, with seven patients achieving a complete response. Adverse events were generally mild with manageable side effects. The absence of myelotoxic effects and manageable side effects make BRAF inhibitors attractive, especially for patients ineligible for purine analogues or those with severe neutropenia. Conclusion: Single agent vemurafenib or in combination with rituximab appears to be a promising therapeutic option for R/R HCL. Further research is needed to establish standardized treatment protocols and to investigate long-term outcomes.
