7 results on '"Rimashevskaya, E."'
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2. PB2021: QUALITY OF LIFE AND CLINICAL OUTCOMES IN PATIENTS WITH RELAPSED/REFRACTORY MULTIPLE MYELOMA (RRMM) TREATED WITH IXAZOMIB-LENALIDOMIDE-DEXAMETHASONE (IRD): RESULTS OF A REAL-WORLD EVIDENCE STUDY
- Author
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Ionova, T., primary, Vinogradova, O., additional, Kochkareva, Y., additional, Ado, E., additional, Kaplanov, K., additional, Shirokova, M., additional, Shelekhova, T., additional, Levanov, A., additional, Kopylova, A., additional, Li, O., additional, Mitina, T., additional, Rukavitsyn, O., additional, Simashova, P., additional, Anchukova, L., additional, Babich, E., additional, Dasheeva, D., additional, Demchenkova, M., additional, Dubov, S., additional, Esenina, T., additional, Ivanova, L., additional, Kravchuk, T., additional, Rimashevskaya, E., additional, Saraeva, N., additional, Savinova, M., additional, Volkova, S., additional, Porfirieva, N., additional, and Nikitina, T., additional
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- 2022
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3. Carfilzomib and dexamethasone versus bortezomib and dexamethasone for patients with relapsed or refractory multiple myeloma (ENDEAVOR): And randomised, phase 3, open-label, multicentre study
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Dimopoulos, Ma, Moreau, P, Palumbo, A, Joshua, D, Pour, L, Hájek, R, Facon, T, Ludwig, H, Oriol, A, Goldschmidt, H, Rosiñol, L, Straub, J, Suvorov, A, Araujo, C, Rimashevskaya, E, Pika, T, Gaidano, G, Weisel, K, Goranova Marinova, V, Schwarer, A, Minuk, L, Masszi, T, Karamanesht, I, Offidani, M, Hungria, V, Spencer, A, Orlowski, Rz, Gillenwater, Hh, Mohamed, N, Feng, S, Chng, Wj, ENDEAVOR Investigators: Leahy, M, Kerridge, I, Durrant, S, Cooney, J, Horvath, N, Rowlings, P, Hahn, U, Fay, K, Renwick, W, Quach, H, Taylor, K, Ho, Sj, Johnston, A, Kasparu, H, Delforge, M, Schots, H, Vekemans, Mc, Offner, F, Wu, Kl, Doyen, C, Bittencourt, R, Duarte, G, Maiolino, A, Schaan, M, Scheliga, A, Zadra, C, Gercheva, L, Mihaylov, G, Grudeva Popova, Z, Sandhu, I, Reiman, A, Kanjeekal, S, Dueck, G, Leblanc, R, Tay, J, White, D, Maisnar, V, Scudla, V, Gregora, E, Hajek, R, Stoppa, Am, Karlin, L, Garderet, L, Fermand, Jp, Lenain, P, Rigaudeau, S, Eveillard, Jr, Escoffre Barbe, M, Knop, S, Kropff, M, Rollig, C, Munder, M, Langer, C, Mugge, Lo, Hanel, M, Niederwieser, D, Dimopoulos, M, Egyed, M, Szomor, A, Borbenyi, Z, Illes, A, Yehuda, Db, Benyamini, N, Nagler, A, Mittleman, M, Izhar, H, Cavo, M, De Fabritiis, P, Petrini, Mario, Foa, R, Gobbi, M, Rossi, G, Guglielmelli, T, Lazzaro, A, Musto, P, Gozzetti, A, Takazako, N, Izumi, T, Chou, T, Ozaki, S, Hatake, K, Suzuki, K, Uike, N, Asakura, S, Kosugi, H, Handa, H, Matsumoto, M, Tobinai, K, Iida, S, Kizaki, M, Miyamoto, T, Shibayama, H, Ando, K, Ishikawa, T, Ishida, T, Sugiura, I, Izutsu, K, Taniwaki, M, Lee, Jh, Kim, K, Kim, Js, Min, Ck, Yoon, Ss, Lee, Jo, Suh, C, Simpson, D, Ganly, P, Blacklock, H, Doocey, R, Chiruka, S, Hellmann, A, Gornik, S, Komarnicki, M, Malgorzata, Calbecka, Grosicki, S, Jurczyszyn, A, Stoia, R, Gheorghita, E, Danaila, Cd, Abdulkadyrov, K, Zaritskiy, A, Andreeva, N, Balakireva, T, Podoltseva, E, Rossiev, V, Pristupa, A, Hsieh, Ws, Gopalakrishnan, Sk, Mistrik, M, Rocafiguera, Ao, Mateos, V, Rubia, J, Dachs, Lr, Sanchez, Jm, Alegre, A, Bargay, J, de Oteyza JP, Martinez, J, Chen, Ty, Lin, Tl, Liu, Jh, Wang, Mc, Yeh, Sp, Huang, Sy, Vinnyk, Y, Kriachok, I, Pylypenko, H, Shparyk, Y, Kaplan, P, Karamanesht, L, Rekhtman, G, Romanyuk, N, Kaiser, M, Mehta, A, Williams, C, Basu, S, Rabin, N, Ramasamy, K, Hunter, H, Tholouli, E, Lebovic, D, Siegel, D, Wang, M, Niesvizky, R, Kovacsovics, T, Hurd, D, Gabrail, N, Matous, J, Pendergrass, K, Agrawal, M, Boccia, R, Chandra, S, Kassim, A, Stanisic, S, Coleman, M, Gersten, T, Braunschweig, I, Chowdhury, S, Sahovic, E., Dimopoulos, Meletios A, Moreau, Philippe, Palumbo, Antonio, Joshua, Dougla, Pour, Ludek, Hájek, Roman, Facon, Thierry, Ludwig, Heinz, Oriol, Albert, Goldschmidt, Hartmut, Rosiñol, Laura, Straub, Jan, Suvorov, Aleksandr, Araujo, Carla, Rimashevskaya, Elena, Pika, Toma, Gaidano, Gianluca, Weisel, Katja, Goranova-Marinova, Vesselina, Schwarer, Anthony, Minuk, Leonard, Masszi, Tamá, Karamanesht, Ievgenii, Offidani, Massimo, Hungria, Vania, Spencer, Andrew, Orlowski, Robert Z, Gillenwater, Heidi H, Mohamed, Nehal, Feng, Shibao, Chng, Wee-Joo, Cavo, M, Laboratory of Molecullar and Cellular Therapy, and Clinical sciences
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Oncology ,Male ,Clinical Trial, Phase III ,Dexamethasone ,Ixazomib ,Bortezomib ,chemistry.chemical_compound ,0302 clinical medicine ,immune system diseases ,hemic and lymphatic diseases ,Antineoplastic Combined Chemotherapy Protocols ,Elotuzumab ,Multiple myeloma ,education.field_of_study ,Research Support, Non-U.S. Gov't ,Medicine (all) ,Anemia ,Multicenter Study ,Survival Rate ,030220 oncology & carcinogenesis ,Randomized Controlled Trial ,Hypertension ,Retreatment ,Oligopeptide ,Female ,Multiple Myeloma ,Oligopeptides ,Human ,medicine.drug ,medicine.medical_specialty ,Aged ,Disease-Free Survival ,Follow-Up Studies ,Humans ,Pneumonia ,Thrombocytopenia ,Population ,Follow-Up Studie ,03 medical and health sciences ,Internal medicine ,medicine ,Comparative Study ,education ,Antineoplastic Combined Chemotherapy Protocol ,business.industry ,medicine.disease ,Carfilzomib ,Surgery ,chemistry ,Proteasome inhibitor ,business ,030215 immunology - Abstract
BACKGROUND: Bortezomib with dexamethasone is a standard treatment option for relapsed or refractory multiple myeloma. Carfilzomib with dexamethasone has shown promising activity in patients in this disease setting. The aim of this study was to compare the combination of carfilzomib and dexamethasone with bortezomib and dexamethasone in patients with relapsed or refractory multiple myeloma. METHODS: In this randomised, phase 3, open-label, multicentre study, patients with relapsed or refractory multiple myeloma who had one to three previous treatments were randomly assigned (1:1) using a blocked randomisation scheme (block size of four) to receive carfilzomib with dexamethasone (carfilzomib group) or bortezomib with dexamethasone (bortezomib group). Randomisation was stratified by previous proteasome inhibitor therapy, previous lines of treatment, International Staging System stage, and planned route of bortezomib administration if randomly assigned to bortezomib with dexamethasone. Patients received treatment until progression with carfilzomib (20 mg/m(2) on days 1 and 2 of cycle 1; 56 mg/m(2) thereafter; 30 min intravenous infusion) and dexamethasone (20 mg oral or intravenous infusion) or bortezomib (1·3 mg/m(2); intravenous bolus or subcutaneous injection) and dexamethasone (20 mg oral or intravenous infusion). The primary endpoint was progression-free survival in the intention-to-treat population. All participants who received at least one dose of study drug were included in the safety analyses. The study is ongoing but not enrolling participants; results for the interim analysis of the primary endpoint are presented. The trial is registered at ClinicalTrials.gov, number NCT01568866. FINDINGS: Between June 20, 2012, and June 30, 2014, 929 patients were randomly assigned (464 to the carfilzomib group; 465 to the bortezomib group). Median follow-up was 11·9 months (IQR 9·3-16·1) in the carfilzomib group and 11·1 months (8·2-14·3) in the bortezomib group. Median progression-free survival was 18·7 months (95% CI 15·6-not estimable) in the carfilzomib group versus 9·4 months (8·4-10·4) in the bortezomib group at a preplanned interim analysis (hazard ratio [HR] 0·53 [95% CI 0·44-0·65]; p
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- 2016
4. Carfilzomib and dexamethasone versus bortezomib and dexamethasone for patients with relapsed or refractory multiple myeloma (ENDEAVOR): And randomised, phase 3, open-label, multicentre study
- Author
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Dimopoulos, M.A. Moreau, P. Palumbo, A. Joshua, D. Pour, L. Hájek, R. Facon, T. Ludwig, H. Oriol, A. Goldschmidt, H. Rosiñol, L. Straub, J. Suvorov, A. Araujo, C. Rimashevskaya, E. Pika, T. Gaidano, G. Weisel, K. Goranova-Marinova, V. Schwarer, A. Minuk, L. Masszi, T. Karamanesht, I. Offidani, M. Hungria, V. Spencer, A. Orlowski, R.Z. Gillenwater, H.H. Mohamed, N. Feng, S. Chng, W.-J.
- Subjects
hemic and lymphatic diseases - Abstract
Background: Bortezomib with dexamethasone is a standard treatment option for relapsed or refractory multiple myeloma. Carfilzomib with dexamethasone has shown promising activity in patients in this disease setting. The aim of this study was to compare the combination of carfilzomib and dexamethasone with bortezomib and dexamethasone in patients with relapsed or refractory multiple myeloma. Methods: In this randomised, phase 3, open-label, multicentre study, patients with relapsed or refractory multiple myeloma who had one to three previous treatments were randomly assigned (1:1) using a blocked randomisation scheme (block size of four) to receive carfilzomib with dexamethasone (carfilzomib group) or bortezomib with dexamethasone (bortezomib group). Randomisation was stratified by previous proteasome inhibitor therapy, previous lines of treatment, International Staging System stage, and planned route of bortezomib administration if randomly assigned to bortezomib with dexamethasone. Patients received treatment until progression with carfilzomib (20 mg/m2 on days 1 and 2 of cycle 1; 56 mg/m2 thereafter; 30 min intravenous infusion) and dexamethasone (20 mg oral or intravenous infusion) or bortezomib (1·3 mg/m2; intravenous bolus or subcutaneous injection) and dexamethasone (20 mg oral or intravenous infusion). The primary endpoint was progression-free survival in the intention-to-treat population. All participants who received at least one dose of study drug were included in the safety analyses. The study is ongoing but not enrolling participants; results for the interim analysis of the primary endpoint are presented. The trial is registered at ClinicalTrials.gov, number NCT01568866. Findings: Between June 20, 2012, and June 30, 2014, 929 patients were randomly assigned (464 to the carfilzomib group; 465 to the bortezomib group). Median follow-up was 11·9 months (IQR 9·3-16·1) in the carfilzomib group and 11·1 months (8·2-14·3) in the bortezomib group. Median progression-free survival was 18·7 months (95% CI 15·6-not estimable) in the carfilzomib group versus 9·4 months (8·4-10·4) in the bortezomib group at a preplanned interim analysis (hazard ratio [HR] 0·53 [95% CI 0·44-0·65]; p
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- 2016
5. CARFILZOMIB AND DEXAMETHASONE VS SUBCUTANEOUS BORTEZOMIB AND DEXAMETHASONE IN PATIENTS WITH RELAPSED OR REFRACTORY MULTIPLE MYELOMA: SECONDARY ANALYSIS FROM THE PHASE 3 STUDY ENDEAVOR (NCT01568866)
- Author
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Goldschmidt, H., Moreau, P., Palumbo, A., Joshua, U., Pour, L., Roman Hajek, Facon, T., Ludwig, H., Niesvizky, R., Oriol, A., Rosinol, L., Straub, J., Suvorov, A., Araujo, C., Rimashevskaya, E., Pika, T., Gaidano, G., Weisel, K., Goronova-Marinova, V., Schwarer, A., Minuk, L., Masszi, T., Karamanesht, I., Offidani, M., Hungria, V., Spencer, A., Orlowski, R., Iskander, K., Feng, S., Aggarwal, S., Chng, W. J., and Dimopoulos, Ma
6. CARFILZOMIB AND DEXAMETHASONE IMPROVES PROGRESSION-FREE SURVIVAL AND RESPONSE RATES VS BORTEZOMIB AND DEXAMETHASONE IN PATIENTS (PTS) WITH RELAPSED MULTIPLE MYELOMA (RMM): THE PHASE 3 STUDY ENDEAVOR
- Author
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Dimopoulos, M., Moreau, P., Palumbo, A., Joshua, D., Pour, L., Roman Hajek, Facon, T., Ludwig, H., Oriol, A., Goldschmidt, H., Rosinol, L., Straub, J., Suvorov, A., Araujo, C., Rimashevskaya, E., Pika, T., Gaidano, G., Weisel, K., Goranova-Marinova, V., Schwarer, A., Minuk, L., Masszi, T., Karamanesht, I., Offidani, M., Hungria, V., Spencer, A., Gillenwater, H., Mohamed, N., Feng, S., and Chng, W. J.
7. Carfilzomib and dexamethasone versus bortezomib and dexamethasone for patients with relapsed or refractory multiple myeloma (ENDEAVOR): a randomised, phase 3, open-label, multicentre study.
- Author
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Dimopoulos MA, Moreau P, Palumbo A, Joshua D, Pour L, Hájek R, Facon T, Ludwig H, Oriol A, Goldschmidt H, Rosiñol L, Straub J, Suvorov A, Araujo C, Rimashevskaya E, Pika T, Gaidano G, Weisel K, Goranova-Marinova V, Schwarer A, Minuk L, Masszi T, Karamanesht I, Offidani M, Hungria V, Spencer A, Orlowski RZ, Gillenwater HH, Mohamed N, Feng S, and Chng WJ
- Subjects
- Aged, Anemia chemically induced, Antineoplastic Combined Chemotherapy Protocols adverse effects, Bortezomib administration & dosage, Bortezomib adverse effects, Dexamethasone administration & dosage, Dexamethasone adverse effects, Disease-Free Survival, Female, Follow-Up Studies, Humans, Hypertension chemically induced, Male, Oligopeptides administration & dosage, Oligopeptides adverse effects, Pneumonia chemically induced, Retreatment, Survival Rate, Thrombocytopenia chemically induced, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Multiple Myeloma drug therapy
- Abstract
Background: Bortezomib with dexamethasone is a standard treatment option for relapsed or refractory multiple myeloma. Carfilzomib with dexamethasone has shown promising activity in patients in this disease setting. The aim of this study was to compare the combination of carfilzomib and dexamethasone with bortezomib and dexamethasone in patients with relapsed or refractory multiple myeloma., Methods: In this randomised, phase 3, open-label, multicentre study, patients with relapsed or refractory multiple myeloma who had one to three previous treatments were randomly assigned (1:1) using a blocked randomisation scheme (block size of four) to receive carfilzomib with dexamethasone (carfilzomib group) or bortezomib with dexamethasone (bortezomib group). Randomisation was stratified by previous proteasome inhibitor therapy, previous lines of treatment, International Staging System stage, and planned route of bortezomib administration if randomly assigned to bortezomib with dexamethasone. Patients received treatment until progression with carfilzomib (20 mg/m(2) on days 1 and 2 of cycle 1; 56 mg/m(2) thereafter; 30 min intravenous infusion) and dexamethasone (20 mg oral or intravenous infusion) or bortezomib (1·3 mg/m(2); intravenous bolus or subcutaneous injection) and dexamethasone (20 mg oral or intravenous infusion). The primary endpoint was progression-free survival in the intention-to-treat population. All participants who received at least one dose of study drug were included in the safety analyses. The study is ongoing but not enrolling participants; results for the interim analysis of the primary endpoint are presented. The trial is registered at ClinicalTrials.gov, number NCT01568866., Findings: Between June 20, 2012, and June 30, 2014, 929 patients were randomly assigned (464 to the carfilzomib group; 465 to the bortezomib group). Median follow-up was 11·9 months (IQR 9·3-16·1) in the carfilzomib group and 11·1 months (8·2-14·3) in the bortezomib group. Median progression-free survival was 18·7 months (95% CI 15·6-not estimable) in the carfilzomib group versus 9·4 months (8·4-10·4) in the bortezomib group at a preplanned interim analysis (hazard ratio [HR] 0·53 [95% CI 0·44-0·65]; p<0·0001). On-study death due to adverse events occurred in 18 (4%) of 464 patients in the carfilzomib group and in 16 (3%) of 465 patients in the bortezomib group. Serious adverse events were reported in 224 (48%) of 463 patients in the carfilzomib group and in 162 (36%) of 456 patients in the bortezomib group. The most frequent grade 3 or higher adverse events were anaemia (67 [14%] of 463 patients in the carfilzomib group vs 45 [10%] of 456 patients in the bortezomib group), hypertension (41 [9%] vs 12 [3%]), thrombocytopenia (39 [8%] vs 43 [9%]), and pneumonia (32 [7%] vs 36 [8%])., Interpretation: For patients with relapsed or refractory multiple myeloma, carfilzomib with dexamethasone could be considered in cases in which bortezomib with dexamethasone is a potential treatment option., Funding: Onyx Pharmaceuticals, Inc., an Amgen subsidiary., (Copyright © 2016 Elsevier Ltd. All rights reserved.)
- Published
- 2016
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