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4. Treatment with low‐dose, single‐agent belantamab mafodotin is safe and provides long‐term responses in heavily pretreated multiple myeloma patients.

Author

Avivi, Irit, Shragai, Tamir, Luttwak, Efrat, Trestman, Svetlana, and Cohen, Yael C.

Subjects
*MULTIPLE myeloma, *OCULAR toxicology, *PROGRESSION-free survival, *OVERALL survival, *TREATMENT delay (Medicine)
Abstract

Objectives: To evaluate whether low‐dose belantamab mafodotin (B‐MAF) dosing results in lower toxicity and better overall outcome. Methods: We retrospectively evaluated nine consecutive patients treated with low‐dose (1.9 mg/kg) B‐MAF. Results: The median age was 70 years. Most patients were penta‐refractory. Ocular toxicity was observed in 77.7%. Adverse events resulting in treatment delays were recorded in 9 out of 124 cycles being given. Overall response rate was 66% (6/9), and all responding patients achieved very good partial response or better. Within a median follow‐up of 12 (range 0.5–13.8) months, median progression‐free survival and overall survival were 14 (CI95% 6–22) and 20 (95%CI 0–41) months, respectively. Conclusion: Low‐dose B‐MAF regimen showed high‐efficacy and low‐toxicity profile. [ABSTRACT FROM AUTHOR]

Published
2024
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5. POSTER: MM-362 Multiple Myeloma Oligosecretory Relapse: A Cross-Sectional Historical Cohort Study

Author

Cohen, Inbar, primary, Vaxman, Iuliana, additional, Zamir, Itai, additional, Fridberg, Gil, additional, Shragai, Tamir, additional, Trestman, Svetlana, additional, Baran, Tomer Ziv, additional, Luttwak, Efrat, additional, Shmuel, Ronit, additional, Melamed, Natan, additional, Avivi, Irit, additional, Raanani, Pia, additional, Dispenzieri, Angela, additional, Gertz, Morie A., additional, and Cohen, Yael C., additional

Published
2023
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6. MM-362 Multiple Myeloma Oligosecretory Relapse: A Cross-Sectional Historical Cohort Study

Author

Cohen, Inbar, primary, Vaxman, Iuliana, additional, Zamir, Itai, additional, Fridberg, Gil, additional, Shragai, Tamir, additional, Trestman, Svetlana, additional, Baran, Tomer Ziv, additional, Luttwak, Efrat, additional, Shmuel, Ronit, additional, Melamed, Natan, additional, Avivi, Irit, additional, Raanani, Pia, additional, Dispenzieri, Angela, additional, Gertz, Morie A., additional, and Cohen, Yael C., additional

Published
2023
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7. P942: MULTIPLE MYELOMA OLIGOSECRETORY RELAPSE- A CROSS SECTIONAL HISTORICAL COHORT STUDY

Author

Vaxman, Iuliana, primary, Zamir, Itai, additional, Cohen, Inbar, additional, Fridberg, Gil, additional, Shragai, Tamir, additional, Trestman, Svetlana, additional, Ziv, Tomer, additional, Luttwak, Efrat, additional, Shmuel, Ronit, additional, Melamed, Natan, additional, Levi, Shai, additional, Avivi, Irit, additional, Raanani, Pia, additional, Dispenzieri, Angela, additional, Gertz, Morie, additional, and Cohen, Yael, additional

Published
2023
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9. P571: OUTPATIENT INITIATION OF VENETOCLAX-AZACITIDINE FOR SELECTED ACUTE MYELOID LEUKEMIA PATIENTS IS FEASIBLE AND SAFE: A REAL WORLD SINGLE CENTER ANALYSIS

Author

Gat, Roi, primary, Neeman, Miri, additional, Levi, Shai, additional, Levi, Mor, additional, Eilati, Nili, additional, Bronstein, Yotam, additional, Shragai, Tamir, additional, Neuman, Tsipora, additional, Segman, Yafit, additional, Vitkon, Roy, additional, Mittelman, Moshe, additional, Avivi, Irit, additional, and Moshe, Yakir, additional

Published
2023
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10. P560: IMPROVEMENT IN OVERALL AND RELAPSE FREE SURVIVAL OF AML PATIENTS OVER THE AGE OF 75 SINCE THE APPROVAL OF VENETOCLAX IN A REAL-WORLD SINGLE CENTER STUDY.

Author

Moshe, Yakir, primary, Levi, Shai, additional, Neeman, Miri, additional, Gat, Roi, additional, Levi, Mor, additional, Eilati, Nili, additional, Shragai, Tamir, additional, Basood, May, additional, Segman, Yafit, additional, Baron, Yaeli, additional, Luttwak, Efrat, additional, Neuman, Tsipora, additional, Vitkon, Roy, additional, Mittelman, Moshe, additional, and Avivi, Irit, additional

Published
2023
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12. A Phase II Multicenter Clinical Trial Assessing the Safety and Efficacy of Ixazomib Pomalidomide Dexamethasone Combination As Second or Third-Line Treatment for Patients with Triple Exposed Relapsed and Refractory Multiple Myeloma: Prespecified Interim Analysis (IPoD-790 trial)

Author

Cohen, Yael C, primary, Shragai, Tamir, additional, Lavi, Noa, additional, Vaxman, Iuliana, additional, Chubar, Evgeni, additional, Gatt, Moshe E, additional, Ganzel, Chezi, additional, Magen, Hila, additional, Luttwak, Efrat, additional, Lowenton-Spier, Noa, additional, Gez-Aaronson, Liron, additional, Melamed, Natan, additional, and Avivi, Irit, additional

Published
2022
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13. P-114: Real-world experience with belantamab mafodotin therapy for relapsed/refractory multiple myeloma: a multi-center retrospective study

Author

Shragai, Tamir, primary, Magen, Hila, additional, Lavi, Noa, additional, Gatt, Moshe, additional, Trestman, Svetlana, additional, Zektser, Miri, additional, Ganzel, Chezi, additional, Jarchowsky, Osant, additional, Berger, Tamar, additional, Tadmor, Tamar, additional, Leiba, Merav, additional, Hertzog-Zarfaty, Katrin, additional, Horowitz, Netanel, additional, Shapira, Michael, additional, Varssano, David, additional, Berger, Yoav, additional, Frenkel, Shahar, additional, Krauthammer, Mark, additional, Avivi, Irit, additional, Luttwak, Efrat, additional, and Cohen, Yael, additional

Published
2022
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14. COVID-19 in patients with lymphoproliferative diseases during the Omicron variant surge

Author

Bronstein, Yotam, primary, Gat, Roi, additional, Levi, Shai, additional, Cohen, Yael C., additional, Luttwak, Efrat, additional, Benyamini, Noam, additional, Shragai, Tamir, additional, Vitkon, Roy, additional, Neaman, Miriam, additional, Eilaty, Nili, additional, Levi, Mor, additional, Trestman, Svetlana, additional, Perry, Chava, additional, Herishanu, Yair, additional, and Avivi, Irit, additional

Published
2022
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15. Real‐world experience with belantamab mafodotin therapy for relapsed/refractory multiple myeloma: A multicentre retrospective study.

Author

Shragai, Tamir, Magen, Hila, Lavi, Noa, Gatt, Moshe, Trestman, Svetlana, Zektser, Miri, Ganzel, Chezi, Jarchowsky, Osnat, Berger, Tamar, Tadmor, Tamar, Leiba, Merav, Hertzog‐Tzarfaty, Katrin, Horowitz, Netanel, Shapira, Michael, Varssano, David, Berger, Yoav, Frenkel, Shahar, Krauthammer, Mark, Avivi, Irit, and Luttwak, Efrat

Subjects
*MULTIPLE myeloma, *OCULAR toxicology, *PROGRESSION-free survival, *RETROSPECTIVE studies, *OVERALL survival
Abstract

Summary: Belantamab mafodotin, an immuno‐conjugate targeting B‐cell maturation antigen, showed single‐agent activity in phase 1 and 2 studies, and was recently approved for heavily pretreated relapsed/refractory multiple myeloma (RRMM) patients. Real‐world data and long‐term follow‐up are scarce. We conducted a multisite retrospective study aimed to assess safety and efficacy of belantamab mafodotin monotherapy administered via the GSK expanded access compassionate care programme. One‐hundred and six RRMM patients were treated with belantamab mafodotin between July 2019 and March 2021. The median age was 69.4 years. Patients were heavily pretreated with a median of six (range 2–11) prior therapy lines. Major adverse effects included ocular toxicity (keratopathy 68.4%, grade ≥3: 40.5%; blurred vision 36.8%, grade ≥3: 6.3%), thrombocytopenia (27.4%, grade ≥3: 17.9%) and infections (11.3%, grade ≥3: 7.5%). Median follow‐up time was 11.9 [95% confidence interval (CI) 10.0–13.8] months. Overall response rate was 45.5%. Median progression‐free survival was 4.7 (95% CI 3.5–5.9) months in the entire cohort and 8.8 (95% CI 6.6–10.9) months among responders. Median overall survival was 14.5 (95% CI 9.5–19.6) months, and not reached for responders. To conclude, in a real‐world setting, belantamab mafodotin monotherapy showed efficacy comparable with the prospective clinical trials, with a tolerable toxicity profile. [ABSTRACT FROM AUTHOR]

Published
2023
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16. Single Cell RNA Sequencing in Patients Enrolled in a Selinexor Clinical Trial Reveals Overexpression of Alternative Nuclear Export Pathways Associated with Resistance to Selinexor in Refractory Multiple Myeloma

Author

Cohen, Yael C, primary, Zada, Mor, additional, Wang, Shuang-Yin, additional, Bentur, Ohad S., additional, Chubar, Evgeni, additional, Cohen, Amos, additional, Lavi, Noa, additional, Magen, Hila, additional, Gatt, Moshe, additional, Zektser, Miri, additional, Leiba, Merav, additional, Stemer, Galia, additional, Shragai, Tamir, additional, Avivi, Irit, additional, Weiner, Assaf, additional, and Amit, Ido, additional

Published
2021
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19. Humoral response rate and predictors of response to BNT162b2 mRNA COVID19 vaccine in patients with multiple myeloma

Author

Avivi, Irit, primary, Balaban, Roi, additional, Shragai, Tamir, additional, Sheffer, Gabi, additional, Morales, Miguel, additional, Aharon, Anat, additional, Lowenton‐Spier, Noa, additional, Trestman, Svetlana, additional, Perry, Chava, additional, Benyamini, Noam, additional, Mittelman, Moshe, additional, Tabib, Yaara, additional, Bar Lev, Tali, additional, Zavaro, Mor, additional, Herishanu, Yair, additional, Luttwak, Efrat, additional, and Cohen, Yael C., additional

Published
2021
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20. Daratumumab for relapsed AL amyloidosis—When cumulative real‐world data precedes clinical trials: A multisite study and systematic literature review

Author

Shragai, Tamir, primary, Gatt, Moshe, additional, Lavie, Noa, additional, Vaxman, Iuliana, additional, Tadmor, Tamar, additional, Rouvio, Ory, additional, Zektser, Miri, additional, Horowitz, Nethanel, additional, Magen, Hila, additional, Ballan, Mouna, additional, Suru, Celia, additional, Luttwak, Efrat, additional, Levi, Shai, additional, Ziv‐Baran, Tomer, additional, Avivi, Irit, additional, and Cohen, Yael C., additional

Published
2020
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22. Hematogenous extramedullary relapse in multiple myeloma ‐ a multicenter retrospective study in 127 patients

Author

Avivi, Irit, primary, Cohen, Yael C., additional, Suska, Anna, additional, Shragai, Tamir, additional, Mikala, Gabor, additional, Garderet, Laurent, additional, Seny, Gueye M., additional, Glickman, Sophia, additional, Jayabalan, David S., additional, Niesvizky, Ruben, additional, Gozzetti, Alessandro, additional, Wiśniewska‐Piąty, Katarzyna, additional, Waszczuk‐Gajda, Anna, additional, Usnarska‐Zubkiewicz, Lidia, additional, Hus, Iwona, additional, Guzicka, Renata, additional, Radocha, Jakub, additional, Milunovic, Vibor, additional, Davila, Julio, additional, Gentile, Massimo, additional, Castillo, Jorge J., additional, and Jurczyszyn, Artur, additional

Published
2019
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23. Characteristics and Outcome of Multiple Myeloma Patients Presenting with Anemia Only: a Retrospective Multi-Center Study

Author

Shragai, Tamir, primary, Gatt, Moshe E., additional, Shaulov, Adir, additional, Katodritou, Eirini, additional, Triantafyllou, Theodora, additional, Lavi, Noa, additional, Pouli, Anastasia, additional, Sioni, Anastasia, additional, Vaxman, Iuliana, additional, Zektser, Miri, additional, Ganzel, Chezi, additional, Benyamini, Noam, additional, Trestman, Svetlana, additional, ziv Baran, Tomer, additional, Cohen, Yael C, additional, and Avivi, Irit, additional

Published
2018
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24. Daratumumab for relapsed AL amyloidosis—When cumulative real‐world data precedes clinical trials: A multisite study and systematic literature review.

Author

Shragai, Tamir, Gatt, Moshe, Lavie, Noa, Vaxman, Iuliana, Tadmor, Tamar, Rouvio, Ory, Zektser, Miri, Horowitz, Nethanel, Magen, Hila, Ballan, Mouna, Suru, Celia, Luttwak, Efrat, Levi, Shai, Ziv‐Baran, Tomer, Avivi, Irit, and Cohen, Yael C.

Subjects
*AMYLOIDOSIS, *CLINICAL trials, *MULTIVARIATE analysis, *PROGRESSION-free survival, *DARATUMUMAB
Abstract

Objectives: Patients with relapsed/refractory AL amyloidosis (RRAL) have poor prognosis, but emerging data shows promising results with the use daratumumab. We evaluated daratumumab treatment in RRAL in real‐world setting. Methods: A retrospective multisite study of RRAL patients treated with daratumumab alone and in combinations. Results: Forty‐nine patients, diagnosed between 1.1.2008 and 1.2.2018 were included; 27% also had multiple myeloma (MM). Revised Mayo score was ≥ 3 in 67%. Hematologic overall response rate was 81%, 64% achieved very good partial response (VGPR) or better. Concurrent active MM was associated with lower rates of VGPR (OR 0.19, 95% CI 0.04‐0.81; P =.03) in a multi‐variate analysis. Cardiac and renal responses were 74% and 73%, respectively. Median progression‐free survival (PFS) was 28.4 months and median overall survival (OS) was not reached; 2‐year PFS and OS were 68.6 ± 7.5% and 90.4 ± 4.6%, respectively. Hematologic response correlated with prolonged PFS and OS. Daratumumab was safe and well tolerated, no patients discontinued therapy due to toxicity. Our data was aligned with outcomes from a systematic literature review, which identified 10 case series (n = 517) and 2 clinical trials (n = 62) meeting prespecified criteria. Conclusions: Our data support favorable safety tolerability and efficacy of daratumumab among non‐selective RRAL patients in a real‐world setting. [ABSTRACT FROM AUTHOR]

Published
2021
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25. Belantamab Mafodotin in Relapse/Refractory AL Amyloidosis- Real-Life Multi-Center Experience

Author

Lebel, Eyal, Vainstein, Vladimir, Milani, Paolo, Palladini, Giovanni, Shragai, Tamir, Lavi, Noa, Magen, Hila, Miri, Assayag, Avivi Mazza, Irit, and Gatt, Moshe E

Abstract

Introduction:Bortezomib and daratumumab revolutionized the therapy for AL amyloidosis (AL). However, relapsed/refractory AL resistant to both drugs is an unmet clinical need, with limited options due to the frailty of these patients and paucity of prospective data. The safety profile and efficacy of belantamab mafodotin (BLM) in multiple myeloma (MM) are well known. In contrast, published data for AL are currently limited to case series of 6 (Zhang, Ann Hematol. 2022) and 12 patients only (Khwaga, Blood Cancer J. 2022). Here, we report a multicenter real-world data on 12 AL patients treated with BLM and compare these to the prior reports.

Published
2023
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26. A Phase II Multicenter Clinical Trial Assessing the Safety and Efficacy of Ixazomib, Pomalidomide and Dexamethasone Combination As Second or Third-Line Treatment for Triple-Class Exposed Patients with Relapsed and Refractory Multiple Myeloma (iPod-790 Trial)

Author

Cohen, Yael C., Shragai, Tamir, Lavi, Noa, Vaxman, Iuliana, Chubar, Evgeni, Gatt, Moshe E, Ganzel, Chezi, Magen, Hila, Luttwak, Efrat, Mittelman, Moshe, Tzoran, Inna, Vainstein, Vladimir, Lowenton-Spier, Noa, Melamed, Natan, Krayzler, Ella, Pereg, Ilana, and Avivi Mazza, Irit

Abstract

Introduction:

Published
2023
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