34 results on '"SCHECTER, J"'
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2. P23 EMAGINE/CARTITUDE-6: A RANDOMIZED PHASE 3 STUDY OF DVRD FOLLOWED BY CILTACABTAGENE AUTOLEUCEL VERSUS DVRD FOLLOWED BY AUTOLOGOUS STEM CELL TRANSPLANT IN TRANSPLANT-ELIGIBLE PATIENTS WITH NEWLY DIAGNOSED MULTIPLE MYELOMA
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Broijl, A., primary, San-Miguel, J., additional, Suzuki, K., additional, Krishnan, A., additional, van de Donk, N., additional, Cook, G., additional, Jakubowiak, A., additional, Madduri, D., additional, Afifi, S., additional, Stevens, A., additional, Schecter, J., additional, Deraedt, W., additional, Kuppens, S., additional, Mistry, P., additional, Pacaud, L., additional, Boccadoro, M., additional, Gay, F., additional, Mina, R., additional, Rasche, L., additional, Moreau, P., additional, Mateos, M., additional, Einsele, H., additional, and Sonneveld, P., additional
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- 2023
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3. P46 SEER-MEDICARE DATABASE: REAL-WORLD TREATMENTS AND OUTCOMES IN PATIENTS WITH LENALIDOMIDE-REFRACTORY RELAPSED MULTIPLE MYELOMA TREATED WITH 1–3 PRIOR LINES OF THERAPY, INCLUDING A PI AND IMID
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Einsele, H., primary, Dhakal, B., additional, Potluri, R., additional, Schecter, J., additional, Deraedt, W., additional, Lendvai, N., additional, Slaughter, A., additional, Lonardi, C., additional, Nair, S., additional, He, J., additional, Voelker, J., additional, Cost, P., additional, Valluri, S., additional, Yalniz, F., additional, Pacaud, L., additional, and Yong, K., additional
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- 2023
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4. P904: CILTACABTAGENE AUTOLEUCEL VS TREATMENTS FROM REAL-WORLD CLINICAL PRACTICE FOR TRIPLE CLASS EXPOSED PATIENTS WITH MULTIPLE MYELOMA: ADJUSTED COMPARISONS BASED ON CARTITUDE-1 AND THE EMMY FRENCH COHORT
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Decaux, O., primary, Hulin, C., additional, Perrot, A., additional, Macro, M., additional, Frenzel, L., additional, Diels, J., additional, Perualila, N. J., additional, Ghilotti, F., additional, Haefliger, B., additional, Goldsztajn, E., additional, Vernet, S., additional, Thevenon, J., additional, Willaime, M., additional, Texier, N., additional, Schecter, J. M., additional, Madduri, D., additional, Jackson, C., additional, Valluri, S., additional, and Moreau, P., additional
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- 2022
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5. S185: CARTITUDE-2 COHORT B: UPDATED CLINICAL DATA AND BIOLOGICAL CORRELATIVE ANALYSES OF CILTACABTAGENE AUTOLEUCEL IN PATIENTS WITH MULTIPLE MYELOMA AND EARLY RELAPSE AFTER INITIAL THERAPY
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Agha, M. E., primary, van de Donk, N. W., additional, Cohen, A. D., additional, Cohen, Y. C., additional, Anguille, S., additional, Kerre, T., additional, Roeloffzen, W., additional, Schecter, J. M., additional, De Braganca, K. C., additional, Varsos, H., additional, Mistry, P., additional, Roccia, T., additional, Zudaire, E., additional, Corsale, C., additional, Akram, M., additional, Geng, D., additional, Nesheiwat, T, additional, Pacaud, L., additional, Sonneveld, P., additional, and Zweegman, S., additional
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- 2022
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6. P958: REAL-LIFE CURRENT STANDARD OF CARE IN PATIENTS WITH RELAPSED/REFRACTORY MULTIPLE MYELOMA: SUBGROUP ANALYSES FROM THE LOCOMMOTION STUDY
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Einsele, H., primary, Moreau, P., additional, De Stefano, V., additional, Dytfeld, D., additional, Angelucci, E., additional, Benjamin, R., additional, Goldschmidt, H., additional, van de Donk, N. W., additional, Besemer, B., additional, Scheid, C., additional, Vij, R., additional, ’. Groen-Damen, E. I., additional, Semerjian, M., additional, Strulev, V., additional, Schecter, J. M., additional, Roccia, T., additional, Nesheiwat, T., additional, Wapenaar, R., additional, Weisel, K., additional, and Mateos, M.-V., additional
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- 2022
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7. P959: CILTACABTAGENE AUTOLEUCEL IN LENALIDOMIDE-REFRACTORY PATIENTS WITH PROGRESSIVE MULTIPLE MYELOMA AFTER 1-3 PRIOR LINES OF THERAPY: CARTITUDE-2 BIOLOGICAL CORRELATIVE ANALYSES AND UPDATED CLINICAL DATA
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Hillengass, J., primary, Cohen, A. D., additional, Delforge, M., additional, Einsele, H., additional, Goldschmidt, H., additional, Weisel, K., additional, Raab, M.-S., additional, Scheid, C., additional, Schecter, J. M., additional, De Braganca, K. C., additional, Varsos, H., additional, Yeh, T.-M., additional, Mistry, P., additional, Roccia, T., additional, Corsale, C., additional, Akram, M., additional, Pacaud, L., additional, Nesheiwat, T., additional, Agha, M., additional, and Cohen, Y. C., additional
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- 2022
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8. P960: HEALTH-RELATED QUALITY OF LIFE IN THE LOCOMMOTION STUDY OF REAL-LIFE CURRENT STANDARD OF CARE IN PATIENTS WITH RELAPSED/REFRACTORY MULTIPLE MYELOMA
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Delforge, M., primary, Moreau, P., additional, Einsele, H., additional, De Stefano, V., additional, Lindsey-Hill, J., additional, Vincent, L., additional, Mangiacavalli, S., additional, Perrot, A., additional, Ocio, E., additional, ten Seldam, S., additional, ’. Groen-Damen, E. I., additional, Semerjian, M., additional, Strulev, V., additional, Schecter, J. M., additional, Roccia, T., additional, Gries, K. S., additional, Nesheiwat, T., additional, Wapenaar, R., additional, Mateos, M.-V., additional, and Weisel, K., additional
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- 2022
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9. P899: REAL-WORLD ASSESSMENT OF TREATMENT PATTERNS AND OUTCOMES IN PATIENTS WITH LENALIDOMIDE-REFRACTORY RELAPSED/REFRACTORY MULTIPLE MYELOMA FROM THE OPTUM DATABASE
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Dhakal, B., primary, Einsele, H., additional, Potluri, R., additional, Schecter, J., additional, Deraedt, W., additional, Lendvai, N., additional, Slaughter, A., additional, Lonardi, C., additional, Nair, S., additional, He, J., additional, Joseph, N., additional, Cost, P., additional, Valluri, S., additional, Yalniz, F., additional, Pacaud, L., additional, and Yong, K., additional
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- 2022
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10. P971: ADJUSTED COMPARISON OF PATIENT REPORTED OUTCOMES FROM CARTITUDE-1 AND LOCOMMOTION COMPARING CILTACABTAGENE AUTOLEUCEL VERSUS REAL WORLD CLINICAL PRACTICE IN TRIPLE-CLASS EXPOSED MULTIPLE MYELOMA
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Weisel, K., primary, Mateos, M.-V., additional, Vincent, L., additional, Martin, T., additional, Berdeja, J. G., additional, Jakubowiak, A., additional, Jagannath, S., additional, Lin, Y., additional, Thilakarathne, P., additional, Ghilotti, F., additional, Diels, J., additional, Haefliger, B., additional, Hague, C., additional, Gonzalez, A., additional, Schecter, J. M., additional, Gries, K. S., additional, Strulev, V., additional, Nesheiwat, T., additional, Pacaud, L., additional, Einsele, H., additional, and Moreau, P., additional
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- 2022
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11. Daratumumab-Based Treatment for Immunoglobulin Light-Chain Amyloidosis
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Kastritis E., Palladini G., Minnema M. C., Wechalekar A. D., Jaccard A., Lee H. C., Sanchorawala V., Gibbs S., Mollee P., Venner C. P., Lu J., Schonland S., Gatt M. E., Suzuki K., Kim K., Cibeira M. T., Beksac M., Libby E., Valent J., Hungria V., Wong S. W., Rosenzweig M., Bumma N., Huart A., Dimopoulos M. A., Bhutani D., Waxman A. J., Goodman S. A., Zonder J. A., Lam S., Song K., Hansen T., Manier S., Roeloffzen W., Jamroziak K., Kwok F., Shimazaki C., Kim J. -S., Crusoe E., Ahmadi T., Tran N., Qin X., Vasey S. Y., Tromp B., Schecter J. M., Weiss B. M., Zhuang S. H., Vermeulen J., Merlini G., Comenzo R. L., Bradley Augustson, Fiona Kwok, Peter Mollee, Simon Gibbs, Chantal Doyen, Greet Bries, Isabelle Vande Broek, Ka Lung Wu, Koen Theunissen, Koen Van Eygen, Michel Delforge, Nathalie Meuleman, Philip Vlummens, Angelo Maiolino, Breno Moreno de Gusmão, Carlos Eduardo Miguel, Edvan Crusoe, Fernanda Moura, Fernanda Seguro, Jandey Bigonha, Juliane Musacchio, Karla Zanella, Laura Garcia, Marcelo Eduardo Zanella Capra, Reijane Alves de Assis, Rosane Bittencourt, Vania Hungria, Walter Braga, Wolney Barreto, Christopher Venner, Donna Reece, Emilie Lemieux-Blanchard, Kevin Song, Michael Sebag, Selay Lam, Victor Zepeda, Haitao Zhang, Jianda Hu, Jin Lu, Juan Li, Songfu Jiang, Ting Niu, Wenming Chen, Xiaonong Chen, Zhen Cai, Zhou Fude, Maja Oelholm Vase, Morten Salomo, Niels Abildgaard, Alain Fuzibet, Anne-Marie Stoppa, Arnaud Jaccard, Bertrand Arnulf, Bruno Moulin, Bruno Royer, David Ghez, Denis Caillot, Dominique Chauveau, Franck Bridoux, Lauriane Clement-Filliatre, Lionel Karlin, Lotfi Benboubker, Mamoun Dib, Margaret Macro, Mohamad Mohty, Olivier Decaux, Olivier Hermine, Olivier Tournilhac, Philippe Moreau, Salomon Manier, Sylvain Choquet, Véronique Dorvaux, Alexander Carpinteiro, Axel Nogai, Britta Besemer, Christoph Roellig, Roland Fenk, Stefan Knop, Stefan Schönland, Timon Hansen, Argiris Symeonidis, Efstathios Kastritis, Gabor Mikala, Tamás Masszi, Zsolt Nagy, Celia Suriu, Hila Magen, Iuliana Vaxman, Lev Shvidel, Meir Preis, Moshe Gatt, Noa Lavi, Osnat Jarchowsky, Tamar Tadmor, Yael Cohen, Angelo Vacca, Giovanni Palladini, Mario Boccadoro, Maurizio Martelli, Maurizio Musso, Michele Cavo, Chihiro Shimazaki, Hiroyuki Takamatsu, Kazutaka Sunami, Kenshi Suzuki, Nagaaki Katoh, Shinsuke Iida, Takayuki Ikezoe, Tomoaki Fujisaki, Yuta Katayama, Chang Ki Min, Ho-Jin Shin, Jin Seok Kim, Jung Yong Hong, Ki Hyun Kim, Sung-Soo Yoon, Aline Ramirez, Alvaro Cabrera, Christian Ramos, David Gomez Almaguer, Deborah Martinez, Guillermo Ruiz, Helen Dayani Caballero, Juan Antonio Flores Jimenez, Annemiek Broijl, Laurens Nieuwenhuizen, Monique Minnema, Paula Ypma, Wilfried Roeloffzen, Dominik Dytfeld, Grzegorz Charlinski, Grzegorz Helbig, Krzysztof Jamroziak, Sebastian Grosicki, Wieslaw Jedrzejczak, Albert Oriol Rocafiguera, Elham Askari, Fernando Escalante Barrigon, Isabel Krsnik Castello, Javier De la Rubia Comos, Jesus Martin Sanchez, Joaquin Martinez Lopez, Jose Angel Hernandez Rivas, Luis Felipe Casado Montero, Maria Jesus Blanchard Rodriguez, Maria Teresa Cibeira Lopez, Maria Victoria Mateos Manteca, Marta Sonia Gonzalez Perez, Mercedes Gironella Mesa, Rafael Rios Tamayo, Ramon Lecumberri Villamediana, Ricarda Garcia Sanchez, Sunil Lakhwani, Yolanda Gonzalez, Hareth Nahi, Kristina Carlsson, Markus Hansson, Ulf-Henrik Mellqvist, Ali Unal, Burhan Ferhanoglu, Hayri Ozsan, Levent Undar, Mehmet Turgut, Mehmet Yilmaz, Meral Beksac, Muhlis Cem Ar, Muzaffer Demir, Sevgi Besisik, Ashutosh Wechalekar, Jamie Cavenagh, Jim Cavet, Mark Cook, Rachel Hall, Adam Waxman, Anuj Mahindra, Cesar Rodriguez Valdes, Christine Ye, Craig Reeder, Daphne Friedman, David Siegel, Divaya Bhutani, Edward Libby, Eva Medvedova, Frank Passero, Giada Bianchi, Giampaolo Talamo, Guido Tricot, Hans Lee, Heather Landau, Jan Moreb, Jason Valent, Jeffrey Matous, Jeffrey A Zonder, Jesus Berdeja, Jonathan Kaufman, Keith Stockerl-Goldstein, Keren Osman, Ketan Doshi, Kevin Barton, Larry Anderson, Manisha Bhutani, Mehmet Kocoglu, Michael Rosenzweig, Michael Schuster, Michaela Liedtke, Morie Gertz, Naresh Bumma, Natalie Callander, Raymond Comenzo, Robert Vescio, Roger Pearse, Sandy W Wong, Stacey A Goodman, Stefano Tarantolo, Taimur Sher, Tibor Kovacsovics, Tomer Mark, Vaishali Sanchorawala, William Bensinger, Role of intra-Clonal Heterogeneity and Leukemic environment in ThErapy Resistance of chronic leukemias (CHELTER), Université Clermont Auvergne (UCA), Kastritis E., Palladini G., Minnema M.C., Wechalekar A.D., Jaccard A., Lee H.C., Sanchorawala V., Gibbs S., Mollee P., Venner C.P., Lu J., Schonland S., Gatt M.E., Suzuki K., Kim K., Cibeira M.T., Beksac M., Libby E., Valent J., Hungria V., Wong S.W., Rosenzweig M., Bumma N., Huart A., Dimopoulos M.A., Bhutani D., Waxman A.J., Goodman S.A., Zonder J.A., Lam S., Song K., Hansen T., Manier S., Roeloffzen W., Jamroziak K., Kwok F., Shimazaki C., Kim J.-S., Crusoe E., Ahmadi T., Tran N., Qin X., Vasey S.Y., Tromp B., Schecter J.M., Weiss B.M., Zhuang S.H., Vermeulen J., Merlini G., and Comenzo R.L., Bradley Augustson, Fiona Kwok, Peter Mollee, Simon Gibbs, Chantal Doyen, Greet Bries, Isabelle Vande Broek, Ka Lung Wu, Koen Theunissen, Koen Van Eygen, Michel Delforge, Nathalie Meuleman, Philip Vlummens, Angelo Maiolino, Breno Moreno de Gusmão, Carlos Eduardo Miguel, Edvan Crusoe, Fernanda Moura, Fernanda Seguro, Jandey Bigonha, Juliane Musacchio, Karla Zanella, Laura Garcia, Marcelo Eduardo Zanella Capra, Reijane Alves de Assis, Rosane Bittencourt, Vania Hungria, Walter Braga, Wolney Barreto, Christopher Venner, Donna Reece, Emilie Lemieux-Blanchard, Kevin Song, Michael Sebag, Selay Lam, Victor Zepeda, Haitao Zhang, Jianda Hu, Jin Lu, Juan Li, Songfu Jiang, Ting Niu, Wenming Chen, Xiaonong Chen, Zhen Cai, Zhou Fude, Maja Oelholm Vase, Morten Salomo, Niels Abildgaard, Alain Fuzibet, Anne-Marie Stoppa, Arnaud Jaccard, Bertrand Arnulf, Bruno Moulin, Bruno Royer, David Ghez, Denis Caillot, Dominique Chauveau, Franck Bridoux, Lauriane Clement-Filliatre, Lionel Karlin, Lotfi Benboubker, Mamoun Dib, Margaret Macro, Mohamad Mohty, Olivier Decaux, Olivier Hermine, Olivier Tournilhac, Philippe Moreau, Salomon Manier, Sylvain Choquet, Véronique Dorvaux, Alexander Carpinteiro, Axel Nogai, Britta Besemer, Christoph Roellig, Roland Fenk, Stefan Knop, Stefan Schönland, Timon Hansen, Argiris Symeonidis, Efstathios Kastritis, Gabor Mikala, Tamás Masszi, Zsolt Nagy, Celia Suriu, Hila Magen, Iuliana Vaxman, Lev Shvidel, Meir Preis, Moshe Gatt, Noa Lavi, Osnat Jarchowsky, Tamar Tadmor, Yael Cohen, Angelo Vacca, Giovanni Palladini, Mario Boccadoro, Maurizio Martelli, Maurizio Musso, Michele Cavo, Chihiro Shimazaki, Hiroyuki Takamatsu, Kazutaka Sunami, Kenshi Suzuki, Nagaaki Katoh, Shinsuke Iida, Takayuki Ikezoe, Tomoaki Fujisaki, Yuta Katayama, Chang Ki Min, Ho-Jin Shin, Jin Seok Kim, Jung Yong Hong, Ki Hyun Kim, Sung-Soo Yoon, Aline Ramirez, Alvaro Cabrera, Christian Ramos, David Gomez Almaguer, Deborah Martinez, Guillermo Ruiz, Helen Dayani Caballero, Juan Antonio Flores Jimenez, Annemiek Broijl, Laurens Nieuwenhuizen, Monique Minnema, Paula Ypma, Wilfried Roeloffzen, Dominik Dytfeld, Grzegorz Charlinski, Grzegorz Helbig, Krzysztof Jamroziak, Sebastian Grosicki, Wieslaw Jedrzejczak, Albert Oriol Rocafiguera, Elham Askari, Fernando Escalante Barrigon, Isabel Krsnik Castello, Javier De la Rubia Comos, Jesus Martin Sanchez, Joaquin Martinez Lopez, Jose Angel Hernandez Rivas, Luis Felipe Casado Montero, Maria Jesus Blanchard Rodriguez, Maria Teresa Cibeira Lopez, Maria Victoria Mateos Manteca, Marta Sonia Gonzalez Perez, Mercedes Gironella Mesa, Rafael Rios Tamayo, Ramon Lecumberri Villamediana, Ricarda Garcia Sanchez, Sunil Lakhwani, Yolanda Gonzalez, Hareth Nahi, Kristina Carlsson, Markus Hansson, Ulf-Henrik Mellqvist, Ali Unal, Burhan Ferhanoglu, Hayri Ozsan, Levent Undar, Mehmet Turgut, Mehmet Yilmaz, Meral Beksac, Muhlis Cem Ar, Muzaffer Demir, Sevgi Besisik, Ashutosh Wechalekar, Jamie Cavenagh, Jim Cavet, Mark Cook, Rachel Hall, Adam Waxman, Anuj Mahindra, Cesar Rodriguez Valdes, Christine Ye, Craig Reeder, Daphne Friedman, David Siegel, Divaya Bhutani, Edward Libby, Eva Medvedova, Frank Passero, Giada Bianchi, Giampaolo Talamo, Guido Tricot, Hans Lee, Heather Landau, Jan Moreb, Jason Valent, Jeffrey Matous, Jeffrey A Zonder, Jesus Berdeja, Jonathan Kaufman, Keith Stockerl-Goldstein, Keren Osman, Ketan Doshi, Kevin Barton, Larry Anderson, Manisha Bhutani, Mehmet Kocoglu, Michael Rosenzweig, Michael Schuster, Michaela Liedtke, Morie Gertz, Naresh Bumma, Natalie Callander, Raymond Comenzo, Robert Vescio, Roger Pearse, Sandy W Wong, Stacey A Goodman, Stefano Tarantolo, Taimur Sher, Tibor Kovacsovics, Tomer Mark, Vaishali Sanchorawala, William Bensinger
- Subjects
Male ,Treatment outcome ,Immunoglobulin Light-chain Amyloidosis/drug therapy ,CD38 ,Dexamethasone ,Cyclophosphamide/administration & dosage ,Bortezomib ,0302 clinical medicine ,Antineoplastic Combined Chemotherapy Protocols ,Medicine ,CRITERIA ,Immunoglobulin Light-chain Amyloidosis ,ComputingMilieux_MISCELLANEOUS ,Aged, 80 and over ,biology ,Amyloidosis ,Antibodies, Monoclonal ,[SDV.MHEP.HEM]Life Sciences [q-bio]/Human health and pathology/Hematology ,General Medicine ,Middle Aged ,3. Good health ,Treatment Outcome ,030220 oncology & carcinogenesis ,Female ,Antibody ,Human ,Adult ,Dexamethasone/administration & dosage ,ANTIBODY DARATUMUMAB ,Immunoglobulin light chain ,DIAGNOSIS ,Antibodies, Monoclonal/administration & dosage ,Disease-Free Survival ,03 medical and health sciences ,Humans ,Cyclophosphamide ,Aged ,Antineoplastic Combined Chemotherapy Protocol ,business.industry ,Antineoplastic Combined Chemotherapy Protocols/adverse effects ,AL AMYLOIDOSIS ,Daratumumab ,Amyloid fibril ,medicine.disease ,Molecular biology ,Immunoglobulin Light-chain Amyloidosi ,biology.protein ,Bortezomib/administration & dosage ,business ,030215 immunology - Abstract
Systemic immunoglobulin light-chain (AL) amyloidosis is characterized by deposition of amyloid fibrils of light chains produced by clonal CD38+ plasma cells. Daratumumab, a human CD38-targeting antibody, may improve outcomes for this disease.We randomly assigned patients with newly diagnosed AL amyloidosis to receive six cycles of bortezomib, cyclophosphamide, and dexamethasone either alone (control group) or with subcutaneous daratumumab followed by single-agent daratumumab every 4 weeks for up to 24 cycles (daratumumab group). The primary end point was a hematologic complete response.A total of 388 patients underwent randomization. The median follow-up was 11.4 months. The percentage of patients who had a hematologic complete response was significantly higher in the daratumumab group than in the control group (53.3% vs. 18.1%) (relative risk ratio, 2.9; 95% confidence interval [CI], 2.1 to 4.1; P0.001). Survival free from major organ deterioration or hematologic progression favored the daratumumab group (hazard ratio for major organ deterioration, hematologic progression, or death, 0.58; 95% CI, 0.36 to 0.93; P = 0.02). At 6 months, more cardiac and renal responses occurred in the daratumumab group than in the control group (41.5% vs. 22.2% and 53.0% vs. 23.9%, respectively). The four most common grade 3 or 4 adverse events were lymphopenia (13.0% in the daratumumab group and 10.1% in the control group), pneumonia (7.8% and 4.3%, respectively), cardiac failure (6.2% and 4.8%), and diarrhea (5.7% and 3.7%). Systemic administration-related reactions to daratumumab occurred in 7.3% of the patients. A total of 56 patients died (27 in the daratumumab group and 29 in the control group), most due to amyloidosis-related cardiomyopathy.Among patients with newly diagnosed AL amyloidosis, the addition of daratumumab to bortezomib, cyclophosphamide, and dexamethasone was associated with higher frequencies of hematologic complete response and survival free from major organ deterioration or hematologic progression. (Funded by Janssen Research and Development; ANDROMEDA ClinicalTrials.gov number, NCT03201965.).
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- 2021
12. APOLLO: Phase 3 randomized study of subcutaneous Daratumumab plus Pomalidomide and Dexamethasone (D-Pd) versus Pomalidomide and Dexamethasone (Pd) alone in patients with Relapsed/Refractory Multiple Myeloma (RRMM)
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Einsele, H, Dimopoulos, M, Terpos, E, Boccadoro, M, Delimpasi, S, Beksac, M, Katodritou, E, Moreau, P, Baldini, L, Symeonidis, A, Bila, J, Oriol, A, Mateos, MV, Orfanidis, I, Ahmadi, T, Ukropec, J, Kampfenkel, T, Schecter, J, Qiu, Y, Amin, H, Vermeulen, J, Carson, R, and Sonneveld, P
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- 2021
13. Daratumumab-Based Treatment for Immunoglobulin Light-Chain Amyloidosis
- Author
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Kastritis, E. Palladini, G. Minnema, M. C. Wechalekar, A. D. and Jaccard, A. Lee, H. C. Sanchorawala, V Gibbs, S. and Mollee, P. Venner, C. P. Lu, J. Schonland, S. Gatt, M. E. Suzuki, K. Kim, K. Cibeira, M. T. Beksac, M. and Libby, E. Valent, J. Hungria, V Wong, S. W. Rosenzweig, M. Bumma, N. Huart, A. Dimopoulos, M. A. Bhutani, D. and Waxman, A. J. Goodman, S. A. Zonder, J. A. Lam, S. Song, K. Hansen, T. Manier, S. Roeloffzen, W. Jamroziak, K. and Kwok, F. Shimazaki, C. Kim, J-S Crusoe, E. Ahmadi, T. Tran, N. P. Qin, X. Vasey, S. Y. Tromp, B. and Schecter, J. M. Weiss, B. M. Zhuang, S. H. Vermeulen, J. and Merlini, G. Comenzo, R. L. ANDROMEDA Trial Investigators
- Abstract
Background Systemic immunoglobulin light-chain (AL) amyloidosis is characterized by deposition of amyloid fibrils of light chains produced by clonal CD38+ plasma cells. Daratumumab, a human CD38-targeting antibody, may improve outcomes for this disease. Methods We randomly assigned patients with newly diagnosed AL amyloidosis to receive six cycles of bortezomib, cyclophosphamide, and dexamethasone either alone (control group) or with subcutaneous daratumumab followed by single-agent daratumumab every 4 weeks for up to 24 cycles (daratumumab group). The primary end point was a hematologic complete response. Results A total of 388 patients underwent randomization. The median follow-up was 11.4 months. The percentage of patients who had a hematologic complete response was significantly higher in the daratumumab group than in the control group (53.3% vs. 18.1%) (relative risk ratio, 2.9; 95% confidence interval [CI], 2.1 to 4.1; P
- Published
- 2021
14. UPDATE OF CARTITUDE-1: A PHASE 1B/2 STUDY OF JNJ-68284528 (JNJ-4528), A B-CELL MATURATION ANTIGEN (BCMA)-DIRECTED CHIMERIC ANTIGEN RECEPTOR T (CAR-T) CELL THERAPY, IN RELAPSED/REFRACTORY MULTIPLE MYELOMA (MM)
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Berdeja, J.G., primary, Madduri, D., additional, Usmani, S.Z., additional, Singh, I., additional, Zudaire, E., additional, Yeh, T.M., additional, Allred, A.J., additional, Olyslager, Y., additional, Banerjee, A., additional, Goldberg, J.D., additional, Schecter, J., additional, Geng, D., additional, Wu, X., additional, Carrasco-Alfonso, M.J., additional, Rizvi, S., additional, Fan, F., additional, Jakubowiak, A., additional, and Jagannath, S., additional
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- 2020
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15. Daratumumab, Bortezomib, and Dexamethasone Versus Bortezomib and Dexamethasone in Patients With Previously Treated Multiple Myeloma: Three-year Follow-up of CASTOR
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Mateos, M.V., Sonneveld, P. (Pieter), Hungria, V., Nooka, A.K. (Ajay), Estell, J.A. (Jane A.), Barreto, W. (Wolney), Corradini, P. (P.), Min, C.-K. (Chang-Ki), Medvedova, E. (Eva), Weisel, K. (Katja), Chiu, C. (Christopher), Schecter, J. (Jordan), Amin, H. (Himal), Qin, X. (Xiang), Ukropec, J. (Jon), Kobos, R. (Rachel), Spencer, A. (Andrew), Mateos, M.V., Sonneveld, P. (Pieter), Hungria, V., Nooka, A.K. (Ajay), Estell, J.A. (Jane A.), Barreto, W. (Wolney), Corradini, P. (P.), Min, C.-K. (Chang-Ki), Medvedova, E. (Eva), Weisel, K. (Katja), Chiu, C. (Christopher), Schecter, J. (Jordan), Amin, H. (Himal), Qin, X. (Xiang), Ukropec, J. (Jon), Kobos, R. (Rachel), and Spencer, A. (Andrew)
- Abstract
Background: In the phase III CASTOR study in relapsed or refractory multiple myeloma, daratumumab, bortezomib, and dexamethasone (D-Vd) demonstrated significant clinical benefit versus Vd alone. Outcomes after 40.0 months of median follow-up are discussed. Patients and Methods: Eligible patients had received ≥ 1 line of treatment and were administered bortezomib (1.3 mg/m2) and dexamethasone (20 mg) for 8 cycles with or without daratumumab (16 mg/kg) until disease progression. Results: Of 498 patients in the intent-to-treat (ITT) population (D-Vd, n = 251; Vd, n = 247), 47% had 1 prior line of treatment (1PL; D-Vd, n = 122; Vd, n = 113). Median progression-free survival (PFS) was significantly prolonged with D-Vd versus Vd in the ITT population (16.7 vs. 7.1 months; hazard ratio [HR], 0.31; 95% confidence interval [CI], 0.25-0.40; P < .0001) and the 1PL subgroup (27.0 vs. 7.9 months; HR, 0.22; 95% CI, 0.15-0.32; P < .0001). In lenalidomide-refractory patients, the median PFS was 7.8 versus 4.9 months (HR, 0.44; 95% CI, 0.28-0.68; P = .0002) for D-Vd (n = 60) versus Vd (n = 81). Minimal residual disease (MRD)–negativity rates (10−5) were greater with D-Vd versus Vd (ITT: 14% vs. 2%; 1PL: 20% vs. 3%; both P < .0001). PFS2 was significantly prolonged with D-Vd versus Vd (ITT: HR, 0.48; 95% CI, 0.38-0.61; 1PL: HR, 0.35; 95% CI, 0.24-0.51; P < .0001). No new safety concerns were observed. Conclusion: After 3 years, D-Vd maintained significant benefits in patients with relapsed or refractory multiple myeloma with a consistent safety profile. D-Vd provided the greatest benefit at first relapse and increased MRD-negativity rates.CASTOR showed the significant clinical benefit of daratumumab plus bortezomib and dexamethasone for patients with previously treated multiple myeloma. With ∼3 years median follow-up, this regimen continues to demonstrate significantly improved progression-free survival with higher minimal residual dise
- Published
- 2019
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16. Pharmacokinetics and Exposure–Response Analyses of Daratumumab in Combination Therapy Regimens for Patients with Multiple Myeloma
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Xu, X.S. Dimopoulos, M.A. Sonneveld, P. Ho, P.J. Belch, A. Leiba, M. Capra, M. Gomez, D. Medvedova, E. Iida, S. Min, C.-K. Schecter, J. Jansson, R. Zhang, L. Sun, Y.-N. Clemens, P.L.
- Abstract
Introduction: Daratumumab, a human IgG monoclonal antibody targeting CD38, has demonstrated activity as monotherapy and in combination with standard-of-care regimens in multiple myeloma. Population pharmacokinetic analyses were conducted to determine the pharmacokinetics of intravenous daratumumab in combination therapy versus monotherapy, evaluate the effect of patient- and disease-related covariates on drug disposition, and examine the relationships between daratumumab exposure and efficacy/safety outcomes. Methods: Four clinical studies of daratumumab in combination with lenalidomide/dexamethasone (POLLUX and GEN503); bortezomib/dexamethasone (CASTOR); pomalidomide/dexamethasone, bortezomib/thalidomide/dexamethasone, and bortezomib/melphalan/prednisone (EQUULEUS) were included in the analysis. Using various dosing schedules, the majority of patients (684/694) received daratumumab at a dose of 16 mg/kg. In GEN503, daratumumab was administered at a dose of 2 mg/kg (n = 3), 4 mg/kg (n = 3), 8 mg/kg (n = 4), and 16 mg/kg (n = 34). A total of 650 patients in EQUULEUS (n = 128), POLLUX (n = 282), and CASTOR (n = 240) received daratumumab 16 mg/kg. The exposure–efficacy and exposure–safety relationships examined progression-free survival (PFS) and selected adverse events (infusion-related reactions; thrombocytopenia, anemia, neutropenia, lymphopenia, and infections), respectively. Results: Pharmacokinetic profiles of daratumumab were similar between monotherapy and combination therapy. Covariate analysis identified no clinically important effects on daratumumab exposure, and no dose adjustments were recommended on the basis of these factors. Maximal clinical benefit on PFS was achieved for the majority of patients (approximately 75%) at the 16 mg/kg dose. No apparent relationship was observed between daratumumab exposure and selected adverse events. Conclusion: These data support the recommended 16 mg/kg dose of daratumumab and the respective dosing schedules in the POLLUX and CASTOR pivotal studies. Funding: Janssen Research & Development. © 2018, The Author(s).
- Published
- 2018
17. S145 PHASE 3 RANDOMIZED STUDY OF DARATUMUMAB + BORTEZOMIB/THALIDOMIDE/DEXAMETHASONE (D-VTD) VERSUS VTD IN TRANSPLANT-ELIGIBLE NEWLY DIAGNOSED MULTIPLE MYELOMA: PART 1 CASSIOPEIA RESULTS
- Author
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Moreau, P., primary, Attal, M., additional, Hulin, C., additional, Arnulf, B., additional, Belhadj, K., additional, Benboubker, L., additional, Béné, M. C., additional, Broijl, A., additional, Caillon, H., additional, Caillot, D., additional, Corre, J., additional, Delforge, M., additional, Dejoie, T., additional, Doyen, C., additional, Facon, T., additional, Sonntag, C., additional, Garderet, L., additional, Jie, K.-S., additional, Karlin, L., additional, Kuhnowski, F., additional, Lambert, J., additional, Leleu, X., additional, Lenain, P., additional, Macro, M., additional, Orsini-Piocelle, F., additional, Perrot, A., additional, Stoppa, A.-M., additional, van de Donk, N. W., additional, Wuilleme, S., additional, Zweegman, S., additional, Kolb, B., additional, Touzeau, C., additional, Roussel, M., additional, Tiab, M., additional, Marolleau, J.-P., additional, Meuleman, N., additional, Vekemans, M.-C., additional, Westerman, M., additional, Klein, S. K., additional, Levin, M.-D., additional, Escoffre-Barbe, M., additional, Eveillard, J.-R., additional, Garidi, R., additional, Ahmadi, T., additional, Zhuang, S., additional, Chiu, C., additional, Pei, L., additional, Vanquickelberghe, V., additional, de Boer, C., additional, Smith, E., additional, Deraedt, W., additional, Kampfenkel, T., additional, Schecter, J., additional, Vermeulen, J., additional, Avet-Loiseau, H., additional, and Sonneveld, P., additional
- Published
- 2019
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18. Pharmacokinetics and Exposure–Response Analyses of Daratumumab in Combination Therapy Regimens for Patients with Multiple Myeloma
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Xu, X.S. (Xu Steven), Dimopoulos, M.A. (Meletios), Sonneveld, P. (Pieter), Ho, P.J. (P. Joy), Belch, A., Leiba, M. (Merav), Capra, M. (Marcelo), Gomez, D. (David), Medvedova, E. (Eva), Iida, S. (Shinsuke), Min, C.-K. (Chang-Ki), Schecter, J. (Jordan), Jansson, R. (Richard), Zhang, L. (Liping), Sun, Y.-N. (Yu-Nien), Clemens, P.L. (Pamela L.), Xu, X.S. (Xu Steven), Dimopoulos, M.A. (Meletios), Sonneveld, P. (Pieter), Ho, P.J. (P. Joy), Belch, A., Leiba, M. (Merav), Capra, M. (Marcelo), Gomez, D. (David), Medvedova, E. (Eva), Iida, S. (Shinsuke), Min, C.-K. (Chang-Ki), Schecter, J. (Jordan), Jansson, R. (Richard), Zhang, L. (Liping), Sun, Y.-N. (Yu-Nien), and Clemens, P.L. (Pamela L.)
- Abstract
Introduction: Daratumumab, a human IgG monoclonal antibody targeting CD38, has demonstrated activity as monotherapy and in combination with standard-of-care regimens in multiple myeloma. Population pharmacokinetic analyses were conducted to determine the pharmacokinetics of intravenous daratumumab in combination therapy versus monotherapy, evaluate the effect of patient- and disease-related covariates on drug disposition, and examine the relationships between daratumumab exposure and efficacy/safety outcomes. Methods: Four clinical studies of daratumumab in combination with lenalidomide/dexamethasone (POLLUX and GEN503); bortezomib/dexamethasone (CASTOR); pomalidomide/dexamethasone, bortezomib/thalidomide/dexamethasone, and bortezomib/melphalan/prednisone (EQUULEUS) were included in the analysis. Using various dosing schedules, the majority of patients (684/694) received daratumumab at a dose of 16 mg/kg. In GEN503, daratumumab was administered at a dose of 2 mg/kg (n = 3), 4 mg/kg (n = 3), 8 mg/kg (n = 4), and 16 mg/kg (n = 34). A total of 650 patients in EQUULEUS (n = 128), POLLUX (n = 282), and CASTOR (n = 240) received daratumumab 16 mg/kg. The exposure–efficacy and exposure–safety relationships examined progression-free survival (PFS) and selected adverse events (infusion-related reactions; thrombocytopenia, anemia, neutropenia, lymphopenia, and infections), respectively. Results: Pharmacokinetic profiles of daratumumab were similar between monotherapy and combination therapy. Covariate analysis identified no clinically important effects on daratumumab exposure, and no dose adjustments were recommended on the basis of these factors. Maximal clinical benefit on PFS was achieved for the majority of patients (approximately 75%) at the 16 mg/kg dose. No apparent relationship was observed between daratumumab exposure and selected adverse events. Conclusion: These data support the recommended 16 mg/kg dose of daratumumab and the respective dosing schedules in the POL
- Published
- 2018
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- View/download PDF
19. Pharmacokinetics and Exposure-Response Analyses of Daratumumab in Combination Therapy Regimens for Patients with Multiple Myeloma
- Author
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Xu, XS, Dimopoulos, MA, Sonneveld, Pieter, Ho, PJ, Belch, A, Leiba, M, Capra, M, Gomez, D, Medvedova, E, Iida, S, Min, CK, Schecter, J, Jansson, R, Zhang, LP, Sun, YN, Clemens, P L, Xu, XS, Dimopoulos, MA, Sonneveld, Pieter, Ho, PJ, Belch, A, Leiba, M, Capra, M, Gomez, D, Medvedova, E, Iida, S, Min, CK, Schecter, J, Jansson, R, Zhang, LP, Sun, YN, and Clemens, P L
- Published
- 2018
20. NEXT GENERATION SEQUENCING METHODOLOGY FOR DETERMINING CYTOGENETIC RISK STATUS IN THE DARATUMUMAB PHASE 3 CASTOR AND POLLUX STUDIES IN RELAPSED OR REFRACTORY MULTIPLE MYELOMA
- Author
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Chiu, C Soong, D Spicka, I Beksac, M Schaffer, M Schecter, J Bahlis, NJ Dimopoulos, MA
- Subjects
Health Sciences ,Επιστήμες Υγείας - Published
- 2017
21. P23 EM AGINE/CARTITUDE-6: A RANDOMIZED PHASE 3 STUDY OF DVRD FOLLOWED BY CILTACABTAGENE AUTOLEUCEL VERSUS DVRD FOLLOWED BY AUTOLOGOUS STEM CELL TRANSPLANT IN TRANSPLANT-ELIGIBLE PATIENTS WITH NEWLY DIAGNOSED MULTIPLE MYELOMA.
- Author
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Broijl, A., San-Miguel, J., Suzuki, K., Krishnan, A., van de Donk, N., Cook, G., Jakubowiak, A., Madduri, D., Afifi, S., Stevens, A., Schecter, J., Deraedt, W., Kuppens, S., Mistry, P., Pacaud, L., Boccadoro, M., Gay, F., Mina, R., Rasche, L., and Moreau, P.
- Published
- 2023
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22. Interference of daratumumab on the serum protein electrophoresis
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McCudden, C., Axel, A., Slaets, D., Dejoie, T., Clemens, P., Frans, S., Bald, J., Plesner, T., Jacobs, J.F.M., Donk, N. van de, Moreau, P., Schecter, J., Sasser, A.K., McCudden, C., Axel, A., Slaets, D., Dejoie, T., Clemens, P., Frans, S., Bald, J., Plesner, T., Jacobs, J.F.M., Donk, N. van de, Moreau, P., Schecter, J., and Sasser, A.K.
- Abstract
Item does not contain fulltext
- Published
- 2017
23. DARATUMUMAB, BORTEZOMIB AND DEXAMETHASONE (DVD) VS BORTEZOMIB AND DEXAMETHASONE (VD) IN RELAPSED OR REFRACTORY MULTIPLE MYELOMA (RRMM): EFFICACY AND SAFETY UPDATE (CASTOR)
- Author
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Lentzsch, S., primary, Weisel, K., additional, Mateos, M.V., additional, Hungria, V., additional, Munder, M., additional, Nooka, A., additional, Mark, T., additional, Quach, H., additional, Scott, E., additional, Lee, J., additional, Sonneveld, P., additional, Casneuf, T., additional, Chiu, C., additional, Qin, X., additional, Amin, H., additional, Thiyagarajah, P., additional, Schecter, J., additional, Qi, M., additional, and Spencer, A., additional
- Published
- 2017
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24. Phase 3 randomised study of daratumumab, bortezomib and dexamethasone (DVd) vs bortezomib and dexamethasone (Vd) in patients (pts) with relapsed or refractory multiple myeloma (RRMM): CASTOR
- Author
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Weisel, K. (Katja), Palumbo, A. (Antonio), Chanan-Khan, A. (Asher Alban), Nooka, A.K. (Ajay), Spicka, I. (Ivan), Masszi, T. (Tamás), Beksaç, M. (Meral), Hungria, V., Munder, M. (Markus), Mateos, M.V., Mark, T.M. (Tomer M.), Spencer, A. (Andrew), Qi, M. (Ming), Schecter, J. (Jordan), Amin, H. (Himal), Qin, X. (X.), Deraedt, W. (William), Ahmadi, T. (Tahamtan), Sonneveld, P. (Pieter), Weisel, K. (Katja), Palumbo, A. (Antonio), Chanan-Khan, A. (Asher Alban), Nooka, A.K. (Ajay), Spicka, I. (Ivan), Masszi, T. (Tamás), Beksaç, M. (Meral), Hungria, V., Munder, M. (Markus), Mateos, M.V., Mark, T.M. (Tomer M.), Spencer, A. (Andrew), Qi, M. (Ming), Schecter, J. (Jordan), Amin, H. (Himal), Qin, X. (X.), Deraedt, W. (William), Ahmadi, T. (Tahamtan), and Sonneveld, P. (Pieter)
- Published
- 2016
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25. Phase 3 randomised study of daratumumab, bortezomib and dexamethasone (DVd) vs bortezomib and dexamethasone (Vd) in patients (pts) with relapsed or refractory multiple myeloma (RRMM): CASTOR
- Author
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Weisel, K., primary, Palumbo, A., additional, Chanan-Khan, A., additional, Nooka, A.K., additional, Spicka, I., additional, Masszi, T., additional, Beksac, M., additional, Hungria, V., additional, Munder, M., additional, Mateos, M.-V., additional, Mark, T.M., additional, Spencer, A., additional, Qi, M., additional, Schecter, J., additional, Amin, H., additional, Qin, X., additional, Deraedt, W., additional, Ahmadi, T., additional, and Sonneveld, P., additional
- Published
- 2016
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26. Assessment of biochemical response for multiple myeloma (MM) patients treated with Daratumumab: proposal in Cassiopeia study, IFM 2015/01
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Caillon, H., primary, Sasser, K., additional, Schecter, J., additional, Axel, A., additional, Scullion, M., additional, Moreau, P., additional, and Dejoie, T., additional
- Published
- 2015
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27. 906O - Phase 3 randomised study of daratumumab, bortezomib and dexamethasone (DVd) vs bortezomib and dexamethasone (Vd) in patients (pts) with relapsed or refractory multiple myeloma (RRMM): CASTOR
- Author
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Weisel, K., Palumbo, A., Chanan-Khan, A., Nooka, A.K., Spicka, I., Masszi, T., Beksac, M., Hungria, V., Munder, M., Mateos, M.-V., Mark, T.M., Spencer, A., Qi, M., Schecter, J., Amin, H., Qin, X., Deraedt, W., Ahmadi, T., and Sonneveld, P.
- Published
- 2016
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28. Enhancing Organizational Review and Promoting Sustainability of DNP Student Projects: Implications for Nurse Leaders.
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Chipps E, Buck J, Burt M, Chignolli H, Francis D, Knupp A, Labardee R, Masciola R, and Spaulding-Schecter J
- Subjects
- Humans, Students, Nursing, Program Evaluation, Academic Medical Centers organization & administration, Education, Nursing, Graduate organization & administration, Nurse Administrators education, Leadership
- Abstract
This project aimed to evaluate the DNP projects at an academic medical center, assess the sustainability of DNP final projects, and explore potential opportunities to enhance the organizational review processes. The organization's graduate student review committee reviewed DNP projects implemented at the organization over the last 8 years. The sustainability of projects was less than anticipated. Recommendations are provided to enhance the DNP project approval process and improve strategies for sustainability., Competing Interests: The authors declare no conflicts of interest., (Copyright © 2024 Wolters Kluwer Health, Inc. All rights reserved.)
- Published
- 2024
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29. Daratumumab With Cetrelimab, an Anti-PD-1 Monoclonal Antibody, in Relapsed/Refractory Multiple Myeloma.
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Cohen YC, Oriol A, Wu KL, Lavi N, Vlummens P, Jackson C, Garvin W, Carson R, Crist W, Fu J, Feng H, Xie H, Schecter J, San-Miguel J, and Lonial S
- Subjects
- Adult, Aged, Antibodies, Monoclonal pharmacology, Antineoplastic Combined Chemotherapy Protocols pharmacology, Female, Humans, Male, Middle Aged, Multiple Myeloma mortality, Survival Analysis, Antibodies, Monoclonal therapeutic use, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Multiple Myeloma drug therapy, Neoplasm Recurrence, Local drug therapy
- Abstract
Background: Daratumumab is approved for relapsed or refractory multiple myeloma (RRMM) as monotherapy or in combination regimens. We evaluated daratumumab plus cetrelimab, a programmed death receptor-1 inhibitor, in RRMM., Patients and Methods: This open-label, multiphase study enrolled adults with RRMM with ≥ 3 prior lines of therapy. Part 1 was a safety run-in phase examining dose-limiting toxicities of daratumumab (16 mg/kg intravenously weekly for cycles 1-2, biweekly for cycles 3-6, and monthly thereafter) plus cetrelimab (240 mg intravenously biweekly, all cycles). In Parts 2 and 3, patients were to be randomized to daratumumab with or without cetrelimab (same schedule as Part 1). Endpoints included safety, overall response rate, pharmacokinetics, and biomarker analyses., Results: Nine patients received daratumumab plus cetrelimab in the safety run-in, and 1 received daratumumab in Part 2 before administrative study termination following a data monitoring committee's global recommendation to stop any trial including daratumumab combined with inhibitors of programmed death receptor-1 or its ligand (programmed death-ligand 1). The median follow-up times were 6.7 months (safety run-in) and 0.3 months (Part 2). No dose-limiting toxicities occurred. All 10 patients had ≥ 1 treatment-emergent adverse event; 7 patients had grade 3 to 4 treatment-emergent adverse events, and none led to treatment discontinuation or death. In the safety run-in, 7 (77.7%) patients had ≥ 1 infusion-related reaction (most grade 1-2), and 1 had a grade 2 immune-mediated reaction. Among safety run-in patients, the overall response rate was 44.4%., Conclusions: No new safety concerns were identified for daratumumab plus cetrelimab in RRMM. The short study duration and small population limit complete analysis of this combination., (Copyright © 2020 The Author(s). Published by Elsevier Inc. All rights reserved.)
- Published
- 2021
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30. Daratumumab plus carfilzomib and dexamethasone in patients with relapsed or refractory multiple myeloma.
- Author
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Chari A, Martinez-Lopez J, Mateos MV, Bladé J, Benboubker L, Oriol A, Arnulf B, Rodriguez-Otero P, Pineiro L, Jakubowiak A, de Boer C, Wang J, Clemens PL, Ukropec J, Schecter J, Lonial S, and Moreau P
- Subjects
- Adult, Aged, Aged, 80 and over, Antibodies, Monoclonal administration & dosage, Antineoplastic Combined Chemotherapy Protocols adverse effects, Dexamethasone administration & dosage, Drug Resistance, Neoplasm, Female, Humans, Male, Middle Aged, Multiple Myeloma diagnosis, Multiple Myeloma mortality, Oligopeptides administration & dosage, Prognosis, Recurrence, Retreatment, Survival Analysis, Treatment Outcome, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Multiple Myeloma drug therapy
- Abstract
Patients with relapsed or refractory multiple myeloma (RRMM) have limited treatment options and poor survival outcomes. The increasing adoption of lenalidomide-based therapy for frontline treatment of multiple myeloma has resulted in a need for effective regimens for lenalidomide-refractory patients. This phase 1b study evaluated daratumumab plus carfilzomib and dexamethasone (D-Kd) in patients with RRMM after 1 to 3 prior lines of therapy, including bortezomib and an immunomodulatory drug; lenalidomide-refractory patients were eligible. Carfilzomib- and daratumumab-naïve patients (n = 85) received carfilzomib weekly on days 1, 8, and 15 of each 28-day cycle (20 mg/m
2 initial dose, escalated to 70 mg/m2 thereafter) and dexamethasone (40 mg/wk). Of these, 10 patients received the first daratumumab dose as a single infusion (16 mg/kg, day 1 cycle 1), and 75 patients received a split first dose (8 mg/kg, days 1-2 cycle 1). Subsequent dosing was per the approved schedule for daratumumab. Patients received a median of 2 (range, 1-4) prior lines of therapy; 60% were lenalidomide refractory. The most common grade 3/4 treatment-emergent adverse events were thrombocytopenia (31%), lymphopenia (24%), anemia (21%), and neutropenia (21%). Infusion-related reactions were observed in 60% and 43% of single and split first-dose patients, respectively. Overall response rate was 84% (79% in lenalidomide-refractory patients). Median progression-free survival (PFS) was not reached; 12-month PFS rates were 74% for all treated patients and 65% for lenalidomide-refractory patients. D-Kd was well tolerated with low neutropenia rates, and it demonstrated deep responses and encouraging PFS, including in patients refractory to lenalidomide. The trial was registered at www.clinicaltrials.gov as #NCT01998971., (© 2019 by The American Society of Hematology.)- Published
- 2019
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31. Bortezomib, thalidomide, and dexamethasone with or without daratumumab before and after autologous stem-cell transplantation for newly diagnosed multiple myeloma (CASSIOPEIA): a randomised, open-label, phase 3 study.
- Author
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Moreau P, Attal M, Hulin C, Arnulf B, Belhadj K, Benboubker L, Béné MC, Broijl A, Caillon H, Caillot D, Corre J, Delforge M, Dejoie T, Doyen C, Facon T, Sonntag C, Fontan J, Garderet L, Jie KS, Karlin L, Kuhnowski F, Lambert J, Leleu X, Lenain P, Macro M, Mathiot C, Orsini-Piocelle F, Perrot A, Stoppa AM, van de Donk NW, Wuilleme S, Zweegman S, Kolb B, Touzeau C, Roussel M, Tiab M, Marolleau JP, Meuleman N, Vekemans MC, Westerman M, Klein SK, Levin MD, Fermand JP, Escoffre-Barbe M, Eveillard JR, Garidi R, Ahmadi T, Zhuang S, Chiu C, Pei L, de Boer C, Smith E, Deraedt W, Kampfenkel T, Schecter J, Vermeulen J, Avet-Loiseau H, and Sonneveld P
- Subjects
- Adult, Antibodies, Monoclonal administration & dosage, Antibodies, Monoclonal therapeutic use, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Bortezomib administration & dosage, Bortezomib therapeutic use, Chemotherapy, Adjuvant, Combined Modality Therapy, Dexamethasone administration & dosage, Dexamethasone therapeutic use, Drug Administration Schedule, Female, Humans, Male, Middle Aged, Survival Analysis, Thalidomide administration & dosage, Thalidomide therapeutic use, Transplantation, Autologous, Treatment Outcome, Young Adult, Antineoplastic Combined Chemotherapy Protocols administration & dosage, Hematopoietic Stem Cell Transplantation methods, Multiple Myeloma therapy
- Abstract
Background: Bortezomib, thalidomide, and dexamethasone (VTd) plus autologous stem-cell transplantation is standard treatment in Europe for transplant-eligible patients with newly diagnosed multiple myeloma. We evaluated whether the addition of daratumumab to VTd before and after autologous stem-cell transplantation would improve stringent complete response rate in patients with newly diagnosed multiple myeloma., Methods: In this two-part, randomised, open-label, phase 3 CASSIOPEIA trial, we recruited transplant-eligible patients with newly diagnosed multiple myeloma at 111 European sites. Patients were randomly assigned (1:1) to receive four pre-transplant induction and two post-transplant consolidation cycles of VTd alone (VTd group) or in combination with daratumumab (D-VTd group). The primary endpoint of part 1 was stringent complete response assessed 100 days after transplantation. Part 2 (maintenance) is ongoing. The trial is registered with ClinicalTrials.gov, number NCT02541383., Findings: Between Sept 22, 2015, and Aug 1, 2017, 1085 patients were enrolled at 111 European sites and were randomly assigned to the D-VTd group (n=543) or the VTd group (n=542). At day 100 after transplantation, 157 (29%) of 543 patients in the D-VTd group and 110 (20%) of 542 patients in the VTd group in the intention-to-treat population had achieved a stringent complete response (odds ratio 1·60, 95% CI 1·21-2·12, p=0·0010). 211 (39%) patients in the D-VTd group versus 141 (26%) in the VTd group achieved a complete response or better, and 346 (64%) of 543 versus 236 (44%) of 542 achieved minimal residual disease-negativity (10
-5 sensitivity threshold, assessed by multiparametric flow cytometry; both p<0·0001). Median progression-free survival from first randomisation was not reached in either group (hazard ratio 0·47, 95% CI 0·33-0·67, p<0·0001). 46 deaths on study were observed (14 vs 32, 0·43, 95% CI 0·23-0·80). The most common grade 3 or 4 adverse events were neutropenia (28% vs 15%), lymphopenia (17% vs 10%), and stomatitis (13% vs 16%)., Interpretation: D-VTd before and after autologous stem-cell transplantation improved depth of response and progression-free survival with acceptable safety. CASSIOPEIA is the first study showing the clinical benefit of daratumumab plus standard of care in transplant-eligible patients with newly diagnosed multiple myeloma., Funding: The Intergroupe Francophone du Myélome and Dutch-Belgian Cooperative Trial Group for Hematology Oncology., (Copyright © 2019 Elsevier Ltd. All rights reserved.)- Published
- 2019
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32. Pharmacokinetics and Exposure-Response Analyses of Daratumumab in Combination Therapy Regimens for Patients with Multiple Myeloma.
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Xu XS, Dimopoulos MA, Sonneveld P, Ho PJ, Belch A, Leiba M, Capra M, Gomez D, Medvedova E, Iida S, Min CK, Schecter J, Jansson R, Zhang L, Sun YN, and Clemens PL
- Subjects
- Age Factors, Aged, Aged, 80 and over, Bortezomib therapeutic use, Dexamethasone therapeutic use, Female, Finland, Humans, Lenalidomide therapeutic use, Male, Melphalan therapeutic use, Middle Aged, Neutropenia chemically induced, Progression-Free Survival, Thalidomide therapeutic use, Treatment Outcome, Antibodies, Monoclonal pharmacokinetics, Antibodies, Monoclonal therapeutic use, Antineoplastic Combined Chemotherapy Protocols pharmacokinetics, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Dose-Response Relationship, Drug, Multiple Myeloma drug therapy
- Abstract
Introduction: Daratumumab, a human IgG monoclonal antibody targeting CD38, has demonstrated activity as monotherapy and in combination with standard-of-care regimens in multiple myeloma. Population pharmacokinetic analyses were conducted to determine the pharmacokinetics of intravenous daratumumab in combination therapy versus monotherapy, evaluate the effect of patient- and disease-related covariates on drug disposition, and examine the relationships between daratumumab exposure and efficacy/safety outcomes., Methods: Four clinical studies of daratumumab in combination with lenalidomide/dexamethasone (POLLUX and GEN503); bortezomib/dexamethasone (CASTOR); pomalidomide/dexamethasone, bortezomib/thalidomide/dexamethasone, and bortezomib/melphalan/prednisone (EQUULEUS) were included in the analysis. Using various dosing schedules, the majority of patients (684/694) received daratumumab at a dose of 16 mg/kg. In GEN503, daratumumab was administered at a dose of 2 mg/kg (n = 3), 4 mg/kg (n = 3), 8 mg/kg (n = 4), and 16 mg/kg (n = 34). A total of 650 patients in EQUULEUS (n = 128), POLLUX (n = 282), and CASTOR (n = 240) received daratumumab 16 mg/kg. The exposure-efficacy and exposure-safety relationships examined progression-free survival (PFS) and selected adverse events (infusion-related reactions; thrombocytopenia, anemia, neutropenia, lymphopenia, and infections), respectively., Results: Pharmacokinetic profiles of daratumumab were similar between monotherapy and combination therapy. Covariate analysis identified no clinically important effects on daratumumab exposure, and no dose adjustments were recommended on the basis of these factors. Maximal clinical benefit on PFS was achieved for the majority of patients (approximately 75%) at the 16 mg/kg dose. No apparent relationship was observed between daratumumab exposure and selected adverse events., Conclusion: These data support the recommended 16 mg/kg dose of daratumumab and the respective dosing schedules in the POLLUX and CASTOR pivotal studies., Funding: Janssen Research & Development.
- Published
- 2018
- Full Text
- View/download PDF
33. Contextual variability and exemplar strength in phonotactic learning.
- Author
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Denby T, Schecter J, Arn S, Dimov S, and Goldrick M
- Subjects
- Adult, Humans, Probability Learning, Psychomotor Performance physiology, Young Adult, Generalization, Psychological physiology, Learning physiology, Phonetics, Psycholinguistics, Recognition, Psychology physiology, Speech Perception physiology
- Abstract
Phonotactics-constraints on the position and combination of speech sounds within syllables-are subject to statistical differences that gradiently affect speaker and listener behavior (e.g., Vitevitch & Luce, 1999). What statistical properties drive the acquisition of such constraints? Because they are naturally highly correlated, previous work has been unable to dissociate the contribution of 2 properties: contextual variability (the number of unique phonological contexts in which a phonotactic pattern appears) and exemplar strength (the overall number of times the pattern appears). Using an artificial language learning paradigm, 3 experiments disentangled the effects of variability and strength, indexed by type and token frequency, respectively, on the learning of gradient phonotactics. When the 2 factors were decorrelated (Experiment 2), participants showed greater generalization of patterns advantaged for contextual variability, but not those advantaged for exemplar strength. When the 2 factors were anticorrelated (Experiment 3), participants preferred patterns advantaged in contextual variability, even though they were disadvantaged for exemplar strength. These results suggest that contextual variability is the key force driving phonotactic learning, as it allows learners to home in on the invariant features of the input. (PsycINFO Database Record, ((c) 2018 APA, all rights reserved).)
- Published
- 2018
- Full Text
- View/download PDF
34. Daratumumab, Bortezomib, and Dexamethasone for Multiple Myeloma.
- Author
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Palumbo A, Chanan-Khan A, Weisel K, Nooka AK, Masszi T, Beksac M, Spicka I, Hungria V, Munder M, Mateos MV, Mark TM, Qi M, Schecter J, Amin H, Qin X, Deraedt W, Ahmadi T, Spencer A, and Sonneveld P
- Subjects
- Adult, Aged, Antibodies, Monoclonal adverse effects, Bortezomib adverse effects, Dexamethasone adverse effects, Disease-Free Survival, Drug Resistance, Neoplasm, Female, Humans, Infusions, Intravenous, Male, Middle Aged, Recurrence, ADP-ribosyl Cyclase 1 antagonists & inhibitors, Antibodies, Monoclonal administration & dosage, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Bortezomib administration & dosage, Dexamethasone administration & dosage, Multiple Myeloma drug therapy
- Abstract
Background: Daratumumab, a human IgGκ monoclonal antibody that targets CD38, induces direct and indirect antimyeloma activity and has shown substantial efficacy as monotherapy in heavily pretreated patients with multiple myeloma, as well as in combination with bortezomib in patients with newly diagnosed multiple myeloma., Methods: In this phase 3 trial, we randomly assigned 498 patients with relapsed or relapsed and refractory multiple myeloma to receive bortezomib (1.3 mg per square meter of body-surface area) and dexamethasone (20 mg) alone (control group) or in combination with daratumumab (16 mg per kilogram of body weight) (daratumumab group). The primary end point was progression-free survival., Results: A prespecified interim analysis showed that the rate of progression-free survival was significantly higher in the daratumumab group than in the control group; the 12-month rate of progression-free survival was 60.7% in the daratumumab group versus 26.9% in the control group. After a median follow-up period of 7.4 months, the median progression-free survival was not reached in the daratumumab group and was 7.2 months in the control group (hazard ratio for progression or death with daratumumab vs. control, 0.39; 95% confidence interval, 0.28 to 0.53; P<0.001). The rate of overall response was higher in the daratumumab group than in the control group (82.9% vs. 63.2%, P<0.001), as were the rates of very good partial response or better (59.2% vs. 29.1%, P<0.001) and complete response or better (19.2% vs. 9.0%, P=0.001). Three of the most common grade 3 or 4 adverse events reported in the daratumumab group and the control group were thrombocytopenia (45.3% and 32.9%, respectively), anemia (14.4% and 16.0%, respectively), and neutropenia (12.8% and 4.2%, respectively). Infusion-related reactions that were associated with daratumumab treatment were reported in 45.3% of the patients in the daratumumab group; these reactions were mostly grade 1 or 2 (grade 3 in 8.6% of the patients), and in 98.2% of these patients, they occurred during the first infusion., Conclusions: Among patients with relapsed or relapsed and refractory multiple myeloma, daratumumab in combination with bortezomib and dexamethasone resulted in significantly longer progression-free survival than bortezomib and dexamethasone alone and was associated with infusion-related reactions and higher rates of thrombocytopenia and neutropenia than bortezomib and dexamethasone alone. (Funded by Janssen Research and Development; ClinicalTrials.gov number, NCT02136134.).
- Published
- 2016
- Full Text
- View/download PDF
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