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2. Clonal hematopoiesis is associated with adverse outcomes in multiple myeloma patients undergoing transplant

Author

Mouhieddine, Tarek H., Sperling, Adam S., Redd, Robert, Park, Jihye, Leventhal, Matthew, Gibson, Christopher J., Manier, Salomon, Nassar, Amin H., Capelletti, Marzia, Huynh, Daisy, Bustoros, Mark, Sklavenitis-Pistofidis, Romanos, Tahri, Sabrin, Hornburg, Kalvis, Dumke, Henry, Itani, Muhieddine M., Boehner, Cody J., Liu, Chia-Jen, AlDubayan, Saud H., Reardon, Brendan, Van Allen, Eliezer M., Keats, Jonathan J., Stewart, Chip, Mehr, Shaadi, Auclair, Daniel, Schlossman, Robert L., Munshi, Nikhil C., Anderson, Kenneth C., Steensma, David P., Laubach, Jacob P., Richardson, Paul G., Ritz, Jerome, Ebert, Benjamin L., Soiffer, Robert J., Trippa, Lorenzo, Getz, Gad, Neuberg, Donna S., and Ghobrial, Irene M.

Published
2020
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3. Panobinostat plus bortezomib and dexamethasone in previously treated multiple myeloma: outcomes by prior treatment

Author

Richardson, Paul G., Hungria, Vânia T.M., Yoon, Sung-Soo, Beksac, Meral, Dimopoulos, Meletios Athanasios, Elghandour, Ashraf, Jedrzejczak, Wieslaw W., Guenther, Andreas, Nakorn, Thanyaphong Na, Siritanaratkul, Noppadol, Schlossman, Robert L., Hou, Jian, Moreau, Philippe, Lonial, Sagar, Lee, Jae Hoon, Einsele, Hermann, Sopala, Monika, Bengoudifa, Bourras-Rezki, Corrado, Claudia, Binlich, Florence, and San-Miguel, Jesús F.

Published
2016
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4. A phase 2 trial of lenalidomide, bortezomib, and dexamethasone in patients with relapsed and relapsed/refractory myeloma

Author

Richardson, Paul G., Xie, Wanling, Jagannath, Sundar, Jakubowiak, Andrzej, Lonial, Sagar, Raje, Noopur S., Alsina, Melissa, Ghobrial, Irene M., Schlossman, Robert L., Munshi, Nikhil C., Mazumder, Amitabha, Vesole, David H., Kaufman, Jonathan L., Colson, Kathleen, McKenney, Mary, Lunde, Laura E., Feather, John, Maglio, Michelle E., Warren, Diane, Francis, Dixil, Hideshima, Teru, Knight, Robert, Esseltine, Dixie-Lee, Mitsiades, Constantine S., Weller, Edie, and Anderson, Kenneth C.

Published
2014
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7. Lenalidomide, bortezomib, pegylated liposomal doxorubicin, and dexamethasone in newly diagnosed multiple myeloma: a phase 1/2 Multiple Myeloma Research Consortium trial

Author

Jakubowiak, Andrzej J., Griffith, Kent A., Reece, Donna E., Hofmeister, Craig C., Lonial, Sagar, Zimmerman, Todd M., Campagnaro, Erica L., Schlossman, Robert L., Laubach, Jacob P., Raje, Noopur S., Anderson, Tara, Mietzel, Melissa A., Harvey, Colleen K., Wear, Sandra M., Barrickman, Jennifer C., Tendler, Craig L., Esseltine, Dixie-Lee, Kelley, Susan L., Kaminski, Mark S., Anderson, Kenneth C., and Richardson, Paul G.

Published
2011
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8. Lenalidomide, bortezomib, and dexamethasone combination therapy in patients with newly diagnosed multiple myeloma

Author

Richardson, Paul G., Weller, Edie, Lonial, Sagar, Jakubowiak, Andrzej J., Jagannath, Sundar, Raje, Noopur S., Avigan, David E., Xie, Wanling, Ghobrial, Irene M., Schlossman, Robert L., Mazumder, Amitabha, Munshi, Nikhil C., Vesole, David H., Joyce, Robin, Kaufman, Jonathan L., Doss, Deborah, Warren, Diane L., Lunde, Laura E., Kaster, Sarah, DeLaney, Carol, Hideshima, Teru, Mitsiades, Constantine S., Knight, Robert, Esseltine, Dixie-Lee, and Anderson, Kenneth C.

Published
2010
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10. Targeting histone deacetylase 3 (HDAC3) in the bone marrow microenvironment inhibits multiple myeloma proliferation by modulating exosomes and IL-6 trans-signaling

Author

Ho, Matthew, Chen, Tianzeng, Liu, Jiye, Dowling, Paul, Hideshima, Teru, Zhang, Li, Morelli, Eugenio, Camci-Unal, Gulden, Wu, Xinchen, Tai, Yu-Tzu, Wen, Kenneth, Samur, Mehmet, Schlossman, Robert L., Mazitschek, Ralph, Kavanagh, Emma L., Lindsay, Sinead, Harada, Takeshi, McCann, Amanda, Anderson, Kenneth C., O'Gorman, Peter, Bianchi, Giada, Ho, Matthew, Chen, Tianzeng, Liu, Jiye, Dowling, Paul, Hideshima, Teru, Zhang, Li, Morelli, Eugenio, Camci-Unal, Gulden, Wu, Xinchen, Tai, Yu-Tzu, Wen, Kenneth, Samur, Mehmet, Schlossman, Robert L., Mazitschek, Ralph, Kavanagh, Emma L., Lindsay, Sinead, Harada, Takeshi, McCann, Amanda, Anderson, Kenneth C., O'Gorman, Peter, and Bianchi, Giada

Abstract

Multiple myeloma (MM) is an incurable cancer that derives pro-survival/proliferative signals from the bone marrow (BM) niche. Novel agents targeting not only cancer cells, but also the BM-niche have shown the greatest activity in MM. Histone deacetylases (HDACs) are therapeutic targets in MM and we previously showed that HDAC3 inhibition decreases MM proliferation both alone and in co-culture with bone marrow stromal cells (BMSC). In this study, we investigate the effects of HDAC3 targeting in BMSCs. Using both BMSC lines as well as patient-derived BMSCs, we show that HDAC3 expression in BMSCs can be induced by co-culture with MM cells. Knock-out (KO), knock-down (KD), and pharmacologic inhibition of HDAC3 in BMSCs results in decreased MM cell proliferation; including in autologous cultures of patient MM cells with BMSCs. We identified both quantitative and qualitative changes in exosomes and exosomal miRNA, as well as inhibition of IL-6 trans-signaling, as molecular mechanisms mediating anti-MM activity. Furthermore, we show that HDAC3-KD in BM endothelial cells decreases neoangiogenesis, consistent with a broad effect of HDAC3 targeting in the BM-niche. Our results therefore support the clinical development of HDAC3 inhibitors based not only on their direct anti- MM effects, but also their modulation of the BM microenvironment.

Published
2020

12. Functional Genomics Identify Distinct and Overlapping Genes Mediating Resistance to Different Classes of Heterobifunctional Degraders of Oncoproteins

Author

Shirasaki, Ryosuke, primary, Matthews, Geoffrey M., additional, Gandolfi, Sara, additional, de Matos Simoes, Ricardo, additional, Buckley, Dennis L., additional, Raja Vora, Joseline, additional, Sievers, Quinlan L., additional, Brüggenthies, Johanna B., additional, Dashevsky, Olga, additional, Poarch, Haley, additional, Tang, Huihui, additional, Bariteau, Megan A., additional, Sheffer, Michal, additional, Hu, Yiguo, additional, Downey-Kopyscinski, Sondra L., additional, Hengeveld, Paul J., additional, Glassner, Brian J., additional, Dhimolea, Eugen, additional, Ott, Christopher J., additional, Zhang, Tinghu, additional, Kwiatkowski, Nicholas P., additional, Laubach, Jacob P., additional, Schlossman, Robert L., additional, Richardson, Paul G., additional, Culhane, Aedin C., additional, Groen, Richard W.J., additional, Fischer, Eric S., additional, Vazquez, Francisca, additional, Tsherniak, Aviad, additional, Hahn, William C., additional, Levy, Joan, additional, Auclair, Daniel, additional, Licht, Jonathan D., additional, Keats, Jonathan J., additional, Boise, Lawrence H., additional, Ebert, Benjamin L., additional, Bradner, James E., additional, Gray, Nathanael S., additional, and Mitsiades, Constantine S., additional

Published
2021
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16. Targeting histone deacetylase 3 (HDAC3) in the bone marrow microenvironment inhibits multiple myeloma proliferation by modulating exosomes and IL-6 trans-signaling

Author

Ho, Matthew, Chen, Tianzeng, Liu, Jiye, Dowling, Paul, Hideshima, Teru, Zhang, Li, Morelli, Eugenio, Camci-Unal, Gulden, Wu, Xinchen, Tai, Yu-Tzu, Wen, Kenneth, Samur, Mehmet, Schlossman, Robert L., Mazitschek, Ralph, Kavanagh, Emma L., Lindsay, Sinéad, Harada, Takeshi, McCann, Amanda, Anderson, Kenneth C., O’Gorman, Peter, Bianchi, Giada, Ho, Matthew, Chen, Tianzeng, Liu, Jiye, Dowling, Paul, Hideshima, Teru, Zhang, Li, Morelli, Eugenio, Camci-Unal, Gulden, Wu, Xinchen, Tai, Yu-Tzu, Wen, Kenneth, Samur, Mehmet, Schlossman, Robert L., Mazitschek, Ralph, Kavanagh, Emma L., Lindsay, Sinéad, Harada, Takeshi, McCann, Amanda, Anderson, Kenneth C., O’Gorman, Peter, and Bianchi, Giada

Abstract

Multiple myeloma (MM) is an incurable cancer that derives pro-survival/proliferative signals from the bone marrow (BM) niche. Novel agents targeting not only cancer cells, but also the BM-niche have shown the greatest activity in MM. Histone deacetylases (HDACs) are therapeutic targets in MM and we previously showed that HDAC3 inhibition decreases MM proliferation both alone and in co-culture with bone marrow stromal cells (BMSC). In this study, we investigate the effects of HDAC3 targeting in BMSCs. Using both BMSC lines as well as patient-derived BMSCs, we show that HDAC3 expression in BMSCs can be induced by co-culture with MM cells. Knock-out (KO), knock-down (KD), and pharmacologic inhibition of HDAC3 in BMSCs results in decreased MM cell proliferation; including in autologous cultures of patient MM cells with BMSCs. We identified both quantitative and qualitative changes in exosomes and exosomal miRNA, as well as inhibition of IL-6 trans-signaling, as molecular mechanisms mediating anti-MM activity. Furthermore, we show that HDAC3-KD in BM endothelial cells decreases neoangiogenesis, consistent with a broad effect of HDAC3 targeting in the BM-niche. Our results therefore support the clinical development of HDAC3 inhibitors based not only on their direct anti-MM effects, but also their modulation of the BM microenvironment.

Published
2019

17. A Phase 1/2 Study of evofosfamide, A Hypoxia-Activated Prodrug with or without Bortezomib in Subjects with Relapsed/Refractory Multiple Myeloma

Author

Laubach, Jacob P., Liu, Chia-Jen, Raje, Noopur S., Yee, Andrew J., Armand, Philippe, Schlossman, Robert L., Rosenblatt, Jacalyn, Hedlund, Jacquelyn, Martin, Michael, Reynolds, Craig, Shain, Kenneth H., Zackon, Ira, Stampleman, Laura, Henrick, Patrick, Rivotto, Bradley, Hornburg, Kalvis T.V., Dumke, Henry J., Chuma, Stacey, Savell, Alexandra, Handisides, Damian R., Kroll, Stew, Anderson, Kenneth C., Richardson, Paul G., and Ghobrial, Irene M.

Subjects
Aged, 80 and over, Male, Kaplan-Meier Estimate, Middle Aged, Article, Bortezomib, Treatment Outcome, Drug Resistance, Neoplasm, Nitroimidazoles, Antineoplastic Combined Chemotherapy Protocols, Retreatment, Disease Progression, Humans, Female, Phosphoramide Mustards, Neoplasm Recurrence, Local, Multiple Myeloma, Aged, Neoplasm Staging
Abstract

INTRODUCTION. The presence of hypoxia in the diseased bone marrow presents a new therapeutic target for multiple myeloma (MM). Evofosfamide (formerly TH-302) is a 2-nitroimidazole prodrug of the DNA alkylator bromo-isophosphoramide mustard that is selectively activated under hypoxia. A phase 1/2 study investigating evofosfamide in combination with dexamethasone (EvoD) and in combination with bortezomib and dexamethasone (EvoBorD) in relapsed/refractory MM. EXPERIMENTAL DESIGN: 59 patients initiated therapy, 31 received EvoD and 28 received EvoBorD. Pts were heavily pre-treated with a median number of prior therapies of 7 (range: 2–15). All had previously received bortezomib and immunomodulators. The maximum tolerated dose (MTD), treatment toxicity, and efficacy were determined. RESULTS: The MTD was established at 340 mg/m(2) Evo+D with dose limiting mucositis at higher doses. For EVOBorD, no patient had a dose limiting toxicity and the recommended phase 2 dose was established at 340 mg/m(2). The most common ≥ Gr 3 adverse events were thrombocytopenia (25 patients), anemia (24 patients), neutropenia (15 patients) and leukopenia (9 patients). Skin toxicity was reported in 42 (71%). Responses included 1 VGPR, 3 PR, 2 MR, 20 SD and 4 PD for EvoD and 1 CR, 2 PR, 1 MR, 18 SD and 5 PD for EvoBorD. Disease stabilization was observed in over 80% and this was reflective of the prolonged overall survival of 11.2 months. CONCLUSIONS: Evofosfamide can be administered at 340 mg/m(2) twice a week with or without bortezomib. Clinical activity has been noted in patients with heavily pre-treated relapsed refractory MM.

Published
2018

18. Updated Results of a Phase 2 Study of Modified Lenalidomide, Bortezomib, and Dexamethasone (RVd-lite) in Transplant-Ineligible Multiple Myeloma

Author

O'Donnell, Elizabeth K., primary, Laubach, Jacob P., additional, Yee, Andrew J., additional, Redd, Robert, additional, Huff, Carol Ann, additional, Basile, Frank, additional, Wade, Philip M., additional, Paba-Prada, Claudia E., additional, Ghobrial, Irene M., additional, Schlossman, Robert L., additional, Burke, Jill N., additional, Harrington, Cynthia C., additional, Lively, Kathleen J., additional, Lyons, Hannah, additional, Munshi, Nikhil C., additional, Anderson, Kenneth C., additional, Richardson, Paul G., additional, and Raje, Noopur S., additional

Published
2019
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19. Real-World (RW) Treatment Patterns and Patient-Related Factors Including Quality of Life (QoL), Medication Adherence, and Actigraphy in Community Patients (pts) with Newly Diagnosed Multiple Myeloma (NDMM) Transitioning from Bortezomib (btz) to Ixazomib: The US MM-6 Community-Based Study

Author

Noga, Stephen J, primary, Rifkin, Robert M., additional, Manda, Sudhir, additional, Birhiray, Ruemu Ejedafeta, additional, Lyons, Roger M., additional, Whidden, Presley, additional, Schlossman, Robert L., additional, Wang, Bingxia, additional, and Boccia, Ralph V., additional

Published
2019
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20. Functional Characterization of E3 Ligases and Their Regulators: Therapeutic Implications for Development of New Proteolysis-Targeting Chimeric Degraders of Oncoproteins

Author

Shirasaki, Ryosuke, primary, Gandolfi, Sara, primary, De Matos Simoes, Ricardo, primary, Matthews, Geoffrey M, primary, Buckley, Dennis, primary, Raja, Joseline, primary, Sievers, Quinlan L, primary, Dashevsky, Olga, primary, Poarch, Haley, primary, Tang, Huihui, primary, Bariteau, Megan, primary, Sheffer, Michal, primary, Downey-Kopyscinski, Sondra L., primary, Hengeveld, Paul, primary, Glassner, Brian, primary, Dhimolea, Eugen, primary, Ott, Christopher J., primary, Zhang, Tinghu, primary, Kwiatkowski, Nicholas P, primary, Laubach, Jacob P., primary, Schlossman, Robert L., primary, Richardson, Paul G., primary, Culhane, Aedin, primary, Groen, Richard W.J., primary, Fischer, Eric, primary, Ebert, Benjamin L., primary, Vazquez, Francisca, primary, Tsherniak, Aviad, primary, Hahn, William C., primary, Levy, Joan, primary, Auclair, Daniel, primary, Licht, Jonathan D., primary, Keats, Jonathan J, primary, Boise, Lawrence H., primary, Bradner, James, primary, Gray, Nathanael, primary, and Mitsiades, Constantine S., primary

Published
2019
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21. Long-Term Proteasome Inhibitor (PI) Therapy in Community Patients (Pts) with Newly Diagnosed Multiple Myeloma (NDMM) Transitioning from Bortezomib (Btz)-Based to Ixazomib-Based Induction: Results from the US MM-6 Study in the Real World (RW) Setting

Author

Rifkin, Robert M., primary, Manda, Sudhir, additional, Noga, Stephen J, additional, Yimer, Habte A, additional, Girnius, Saulius K., additional, Birhiray, Ruemu Ejedafeta, additional, Yasenchak, Christopher A., additional, Lyons, Roger M., additional, Whidden, Presley, additional, Schlossman, Robert L., additional, Wang, Bingxia, additional, and Boccia, Ralph V., additional

Published
2019
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22. Targeting histone deacetylase 3 (HDAC3) in the bone marrow microenvironment inhibits multiple myeloma proliferation by modulating exosomes and IL-6 trans-signaling

Author

Ho, Matthew, primary, Chen, Tianzeng, additional, Liu, Jiye, additional, Dowling, Paul, additional, Hideshima, Teru, additional, Zhang, Li, additional, Morelli, Eugenio, additional, Camci-Unal, Gulden, additional, Wu, Xinchen, additional, Tai, Yu-Tzu, additional, Wen, Kenneth, additional, Samur, Mehmet, additional, Schlossman, Robert L., additional, Mazitschek, Ralph, additional, Kavanagh, Emma L., additional, Lindsay, Sinéad, additional, Harada, Takeshi, additional, McCann, Amanda, additional, Anderson, Kenneth C., additional, O’Gorman, Peter, additional, and Bianchi, Giada, additional

Published
2019
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23. A Phase I/II Study of Evofosfamide, A Hypoxia-activated Prodrug with or without Bortezomib in Subjects with Relapsed/Refractory Multiple Myeloma

Author

Laubach, Jacob P., primary, Liu, Chia-Jen, additional, Raje, Noopur S., additional, Yee, Andrew J., additional, Armand, Philippe, additional, Schlossman, Robert L., additional, Rosenblatt, Jacalyn, additional, Hedlund, Jacquelyn, additional, Martin, Michael, additional, Reynolds, Craig, additional, Shain, Kenneth H., additional, Zackon, Ira, additional, Stampleman, Laura, additional, Henrick, Patrick, additional, Rivotto, Bradley, additional, Hornburg, Kalvis T.V., additional, Dumke, Henry J., additional, Chuma, Stacey, additional, Savell, Alexandra, additional, Handisides, Damian R., additional, Kroll, Stew, additional, Anderson, Kenneth C., additional, Richardson, Paul G., additional, and Ghobrial, Irene M., additional

Published
2019
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27. Phase II Trial of the Combination of Ixazomib, Lenalidomide, and Dexamethasone in High-Risk Smoldering Multiple Myeloma

Author

Bustoros, Mark, primary, Liu, Chia-jen, additional, Reyes, Kaitlen, additional, Hornburg, Kalvis, additional, Guimond, Kathleen, additional, Styles, Rachel, additional, Savell, Alexandra, additional, Berrios, Brianna, additional, Warren, Diane, additional, Dumke, Henry, additional, Rivotto, Bradley, additional, Henrick, Patrick, additional, Scranton, Emily, additional, Leblebjian, Houry, additional, Meid, Kirsten, additional, Schlossman, Robert L., additional, Munshi, Nikhil, additional, Laubach, Jacob, additional, Anderson, Kenneth C., additional, Richardson, Paul, additional, and Ghobrial, Irene M., additional

Published
2018
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28. The Role of Clonal Hematopoiesis of Indeterminate Potential (CHIP) in Multiple Myeloma: Immunomodulator Maintenance Post Autologous Stem Cell Transplant (ASCT) Predicts Better Outcome

Author

Mouhieddine, Tarek H, primary, Park, Jihye, additional, Redd, Robert A., additional, Gibson, Christopher J., additional, Manier, Salomon, additional, Nassar, Amin H, additional, Capelletti, Marzia, additional, Huynh, Daisy, additional, Bustoros, Mark, additional, Sklavenitis-Pistofidis, Romanos, additional, Hornburg, Kalvis, additional, Dumke, Henry, additional, Itani, Muhieddine M, additional, Boehner, Cody J, additional, Liu, Chia-Jen, additional, AlDubayan, Saud H, additional, Reardon, Brendan, additional, Van Allen, Eliezer, additional, Auclair, Daniel, additional, Schlossman, Robert L., additional, Munshi, Nikhil, additional, Anderson, Kenneth, additional, Steensma, David P., additional, Laubach, Jacob, additional, Richardson, Paul, additional, Ritz, Jerome, additional, Ebert, Benjamin L., additional, Soiffer, Robert J., additional, Neuberg, Donna S, additional, and Ghobrial, Irene M., additional

Published
2018
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29. CRISPR-Based Functional Genomics Studies Reveal Distinct and Overlapping Genes Mediating Resistance to Different Classes of Heterobifunctional Degraders of Oncoproteins: Implications for Novel Therapeutics across Diverse Neoplasias

Author

Shirasaki, Ryosuke, primary, Gandolfi, Sara, additional, De Matos Simoes, Ricardo, additional, Matthews, Geoffrey, additional, Buckley, Dennis, additional, Dashevsky, Olga, additional, Downey-Kopyscinski, Sondra L., additional, Tang, Huihui, additional, Sheffer, Michal, additional, Dhimolea, Eugen, additional, Glassner, Brian, additional, Bariteau, Megan, additional, Sorrell, Jeffrey, additional, Bruggenthies, Johanna B, additional, Sievers, Quinlan, additional, Poarch, Haley, additional, Kwiatkowski, Nicholas P, additional, Zhang, Tinghu, additional, Laubach, Jacob, additional, Schlossman, Robert L., additional, Richardson, Paul, additional, Culhane, Aedin, additional, Groen, Richard WJ, additional, Fischer, Eric S., additional, Vazquez, Francisca, additional, Tsherniak, Aviad, additional, Hahn, William C., additional, Levy, Joan, additional, Auclair, Daniel, additional, Licht, Jonathan D., additional, Keats, Jonathan J, additional, Boise, Lawrence H., additional, Ebert, Benjamin L., additional, Bradner, James, additional, Gray, Nathanae, additional, and Mitsiades, Constantine S., additional

Published
2018
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30. Phase II Trial of Combination of Elotuzumab, Lenalidomide, and Dexamethasone in High-Risk Smoldering Multiple Myeloma

Author

Liu, Chia-jen, primary, Ghobrial, Irene M., additional, Bustoros, Mark, additional, Reyes, Kaitlen, additional, Hornburg, Kalvis, additional, Badros, Ashraf Z., additional, Vredenburgh, James J., additional, Boruchov, Adam, additional, Matous, Jeffrey V, additional, Caola, Aaron, additional, Rivotto, Bradley, additional, Savell, Alexandra, additional, Henrick, Patrick, additional, Paba-Prada, Claudia E., additional, Schlossman, Robert L., additional, Laubach, Jacob, additional, Rosenblatt, Jacalyn, additional, Yee, Andrew J, additional, Nadeem, Omar, additional, Maegawa, Rodrigo O., additional, Jakubowiak, Andrzej, additional, Usmani, Saad Z., additional, Bhutani, Manisha, additional, Cappuccio, Joseph, additional, Berrios, Brianna, additional, Noonan, Kimberly, additional, Zavidij, Oksana, additional, Mouhieddine, Tarek H, additional, Boehner, Cody J, additional, Neuse, Carl-Jannes, additional, Salem, Karma Ziad, additional, Reidy, Mairead, additional, Park, Jihye, additional, Agius, Michael, additional, Rahmat, Mahshid, additional, Manier, Salomon, additional, Bhutani, Divaya, additional, Zonder, Jeffrey A, additional, Munshi, Nikhil, additional, Auclair, Daniel, additional, Anderson, Kenneth, additional, and Richardson, Paul, additional

Published
2018
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31. Abstract 2954: Immunomodulator maintenance post autologous stem cell transplant predicts better outcome in multiple myeloma patients with clonal hematopoiesis of indeterminate potential

Author

Mouhieddine, Tarek H., primary, Park, Jihye, additional, Redd, Robert, additional, Gibson, Christopher J., additional, Manier, Salomon, additional, Nassar, Amin, additional, Hornburg, Kalvis, additional, Capelletti, Marzia, additional, Huynh, Daisy, additional, Pistofidis, Romanos Sklavenitits, additional, Bustoros, Mark W., additional, AlDubayan, Saud H., additional, Reardon, Brendan, additional, Boehner, Cody J., additional, Dumke, Henry, additional, Lui, Chia-Jen, additional, Schott, Darlys, additional, Allen, Eliezer M. Van, additional, Schlossman, Robert L., additional, Munshi, Nikhil C., additional, Anderson, Kenneth C., additional, Steensma, David P., additional, Laubach, Jacob P., additional, Richardson, Paul G., additional, Ritz, Jerome, additional, Ebert, Benjamin L., additional, Soiffer, Robert J., additional, Neuberg, Donna, additional, and Ghobrial, Irene M., additional

Published
2018
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32. Safety Data from a First-in-Human Phase 1 Trial of NKG2D Chimeric Antigen Receptor-T Cells in AML/MDS and Multiple Myeloma

Author

Nikiforow, Sarah, primary, Werner, Lillian, additional, Murad, Joana, additional, Jacobs, Matthew, additional, Johnston, Lauren, additional, Patches, Sarah, additional, White, Randie, additional, Daley, Heather, additional, Negre, Helene, additional, Reder, Jake, additional, Sentman, Charles, additional, Wade, Terri, additional, Schmucker, Adam, additional, Lehmann, Frédéric François, additional, Snykers, Sarah, additional, Allen, Rachel, additional, Dipietro, Heidi, additional, Cummings, Kristen, additional, Galinsky, Ilene, additional, Munshi, Nikhil C., additional, Schlossman, Robert L., additional, Stone, Richard M., additional, Neuberg, Donna S., additional, Soiffer, Robert J., additional, Dranoff, Glenn, additional, Ritz, Jerome, additional, and Baumeister, Susanne H.C., additional

Published
2016
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33. Final Results of a Phase 1/2 Open-Label Study to Assess the Safety, Tolerability and Preliminary Efficacy of Evofosfamide, a Hypoxia-Activated Prodrug, and Dexamethasone with or without Bortezomib in Subjects with Relapsed/Refractory Multiple Myeloma

Author

Laubach, Jacob P., primary, Raje, Noopur, additional, Yee, Andrew J., additional, Armand, Philippe, additional, Schlossman, Robert L., additional, Rosenblatt, Jacalyn, additional, Martin, Michael G., additional, Reynolds, Craig, additional, Shain, Kenneth H., additional, Zackon, Ira, additional, Stampleman, Laura V., additional, Lai, Emily, additional, Caola, Aaron M., additional, Cappuccio, Joseph M., additional, Rivotto, Bradley, additional, Reyes, Kaitlen, additional, Savell, Alexandra, additional, Henrick, Patrick, additional, Pearce, Tillman, additional, Handisides, Damian, additional, Kroll, Stew, additional, Anderson, Kenneth C., additional, Richardson, Paul G., additional, and Ghobrial, Irene M., additional

Published
2016
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34. Phase II Trial of Combination of Elotuzumab, Lenalidomide, and Dexamethasone in High-Risk Smoldering Multiple Myeloma

Author

Ghobrial, Irene M., primary, Badros, Ashraf Z, additional, Vredenburgh, James J., additional, Matous, Jeffrey, additional, Caola, Aaron M., additional, Savell, Alexandra, additional, Henrick, Patrick, additional, Paba-Prada, Claudia E., additional, Schlossman, Robert L., additional, Laubach, Jacob P., additional, Rosenblatt, Jacalyn, additional, Yee, Andrew, additional, Wisch, Jeffrey S., additional, Farber, Charles M., additional, Maegawa, Rodrigo O., additional, Usmani, Saad Z, additional, Cappuccio, Joseph, additional, Rivotto, Bradley, additional, Noonan, Kimberly, additional, Reyes, Kaitlen, additional, Munshi, Nikhil C., additional, Anderson, Kenneth C., additional, and Richardson, Paul, additional

Published
2016
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35. Analysis of Outcomes Based on Response in Patients with Relapsed or Relapsed and Refractory Multiple Myeloma Treated with Panobinostat or Placebo in Combination with Bortezomib and Dexamethasone in the Panorama 1 Trial: Updated Analysis Based on Prior Treatment

Author

San Miguel, Jesus F. Hungria, Vania T. M. Yoon, Sung-Soo and Beksac, Meral Dimopoulos, Meletios A. Elghandour, Ashraf and Jedrzejczak, Wieslaw W. Guenther, Andreas Nakorn, Thanyaphong Na and Siritanaratkul, Noppadol Schlossman, Robert L. Hou, Jian and Moreau, Philippe Lonial, Sagar Lee, Jae Hoon Einsele, Hermann Sopala, Monika Bengoudifa, Bourras-Rezki Corrado, Claudia Binlich, Florence Richardson, Paul G.

Published
2015

36. Final Analysis of Overall Survival from the Phase 3 Panorama 1 Trial of Panobinostat Plus Bortezomib and Dexamethasone Versus Placebo Plus Bortezomib and Dexamethasone in Patients with Relapsed or Relapsed and Refractory Multiple Myeloma

Author

San-Miguel, Jesus F. Hungria, Vania T. M. Yoon, Sung-Soo and Beksac, Meral Dimopoulos, Meletios A. Elghandour, Ashraf and Jedrzejczak, Wieslaw W. Guenther, Andreas Nakorn, Thanyaphong Na and Siritanaratkul, Noppadol Schlossman, Robert L. Hou, Jian and Moreau, Philippe Lonial, Sagar Lee, Jae Hoon Einsele, Hermann Sopala, Monika Bengoudifa, Bourras-Rezki Corrado, Claudia Richardson, Paul G.

Published
2015

37. Panobinostat plus bortezomib and dexamethasone versus placebo plus bortezomib and dexamethasone in patients with relapsed or relapsed and refractory multiple myeloma: a multicentre, randomised, double-blind phase 3 trial

Author

San-Miguel, Jesus F. Hungria, Vania T. M. Yoon, Sung-Soo and Beksac, Meral Dimopoulos, Meletios Athanasios Elghandour, Ashraf and Jedrzejczak, Wieslaw Wiktor Guenther, Andreas Nakorn, Thanyaphong Na Siritanaratkul, Noppadol Corradini, Paolo and Chuncharunee, Suporn Lee, Je-Jung Schlossman, Robert L. and Shelekhova, Tatiana Yong, Kwee Tan, Daryl Numbenjapon, Tontanai Cavenagh, Jamie D. Hou, Jian LeBlanc, Richard and Nahi, Hareth Qiu, Lugui Salwender, Hans Pulini, Stefano and Moreau, Philippe Warzocha, Krzysztof White, Darrell Blade, Joan Chen, WenMing de la Rubia, Javier Gimsing, Peter and Lonial, Sagar Kaufman, Jonathan L. Ocio, Enrique M. and Veskovski, Ljupco Sohn, Sang Kyun Wang, Ming-Chung Lee, Jae Hoon Einsele, Hermann Sopala, Monika Corrado, Claudia and Bengoudifa, Bourras-Rezki Binlich, Florence Richardson, Paul G.

Subjects
Health Sciences, Επιστήμες Υγείας
Abstract

Background Panobinostat is a potent oral pan-deacetylase inhibitor that in preclinical studies has synergistic antimyeloma activity when combined with bortezomib and dexamethasone. We aimed to compare panobinostat, bortezomib, and dexamethasone with placebo, bortezomib, and dexamethasone in patients with relapsed or relapsed and refractory multiple myeloma. Methods PANORAMA1 is a multicentre, randomised, placebo-controlled, double-blind phase 3 trial of patients with relapsed or relapsed and refractory multiple myeloma who have received between one and three previous treatment regimens. Patients were randomly assigned (1:1) via an interactive web-based and voice response system, stratified by number of previous treatment lines and by previous use of bortezomib, to receive 21 day cycles of placebo or panobinostat (20 mg; on days 1, 3, 5, 8, 10, 12, orally), both in combination with bortezomib (1.3 mg/m(2) on days 1, 4, 8, 11, intravenously) and dexamethasone (20 mg on days 1, 2, 4, 5, 8, 9, 11, 12, orally). Patients, physicians, and the investigators who did the data analysis were masked to treatment allocation; crossover was not permitted. The primary endpoint was progression-free survival (in accordance with modified European Group for Blood and Marrow Transplantation criteria and based on investigators’ assessment) and was analysed by intention to treat. The study is ongoing, but no longer recruiting, and is registered at ClinicalTrials.gov, number NCT01023308. Findings 768 patients were enrolled between Jan 21, 2010, and Feb 29, 2012, with 387 randomly assigned to panobinostat, bortezomib, and dexamethasone and 381 to placebo, bortezomib, and dexamethasone. Median follow-up was 6.47 months (IQR 1.81-13.47) in the panobinostat group and 5.59 months (2.14-11.30) in the placebo group. Median progression-free survival was significantly longer in the panobinostat group than in the placebo group (11.99 months [95% CI 10.33-12.94] vs 8.08 months [7.56-9.23]; hazard ratio [HR] 0.63, 95% CI 0.52-0.76; p

Published
2014

38. Efficacy and Safety Based on Duration of Treatment of Panobinostat Plus Bortezomib and Dexamethasone in Patients with Relapsed or Relapsed and Refractory Multiple Myeloma in the Phase 3 Panorama 1 Study

Author

San Miguel, Jesus Hungria, Vania T. M. Yoon, Sung-Soo and Beksac, Meral Dimopoulos, Meletios A. Elghandour, Ashraf and Jedrzejczak, Wieslaw Wiktor Guenther, Andreas Nakorn, Thanyaphong Na Siritanaratkul, Noppadol Schlossman, Robert L. and Hou, Jian Moreau, Philippe Lonial, Sagar Lee, Jae-Hoon and Einsele, Hermann Salwender, Hans Sopala, Monika Redhu, Suman Paul, Sofia Corrado, Claudia Binlich, Florence and Richardson, Paul G.

Published
2014

39. Mutational Profile and Prognostic Relevance of Circulating Tumor Cells in Multiple Myeloma

Author

Mishima, Yuji, primary, Paiva, Bruno, additional, Shi, Jiantao, additional, Massoud, Mira, additional, Manier, Salomon, additional, Flores, Ludmila, additional, Perilla-Glen, Adriana, additional, Aljawai, Yosra, additional, Huynh, Daisy, additional, Takagi, Satoshi, additional, Roccaro, Aldo M, additional, Sacco, Antonio, additional, Alignani, Diego, additional, Mateos, Maria Victoria, additional, Bladé, Joan, additional, Lahuerta, Juan Jose, additional, Richardson, Paul G., additional, Laubach, Jacob P., additional, Schlossman, Robert L., additional, Anderson, Kenneth C, additional, Munshi, Nikhil C., additional, Prosper, Felipe, additional, Michor, Franziska, additional, San Miguel, J.F., additional, and Ghobrial, Irene M., additional

Published
2015
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40. Analysis of Outcomes Based on Response in Patients with Relapsed or Relapsed and Refractory Multiple Myeloma Treated with Panobinostat or Placebo in Combination with Bortezomib and Dexamethasone in the Panorama 1 Trial: Updated Analysis Based on Prior Treatment

Author

San Miguel, Jesús F, primary, Hungria, Vânia TM, additional, Yoon, Sung-Soo, additional, Beksac, Meral, additional, Dimopoulos, Meletios A., additional, Elghandour, Ashraf, additional, Jedrzejczak, Wieslaw W., additional, Guenther, Andreas, additional, Nakorn, Thanyaphong Na, additional, Siritanaratkul, Noppadol, additional, Schlossman, Robert L., additional, Hou, Jian, additional, Moreau, Philippe, additional, Lonial, Sagar, additional, Lee, Jae Hoon, additional, Einsele, Hermann, additional, Sopala, Monika, additional, Bengoudifa, Bourras-Rezki, additional, Corrado, Claudia, additional, Binlich, Florence, additional, and Richardson, Paul G., additional

Published
2015
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41. A Phase II Study of Modified Lenalidomide, Bortezomib, and Dexamethasone (RVD-lite) for Transplant-Ineligible Patients with Newly Diagnosed Multiple Myeloma

Author

O'Donnell, Elizabeth K., primary, Laubach, Jacob P., additional, Yee, Andrew J., additional, Huff, Carol A., additional, Basile, Frank G., additional, Wade, Philip M., additional, Paba-Prada, Claudia E., additional, Ghobrial, Irene M., additional, Schlossman, Robert L., additional, Couture, Nicole R., additional, Doherty, Lauren, additional, Lyons, Hannah, additional, English, Caroline, additional, Munshi, Nikhil C., additional, Anderson, Kenneth C., additional, Richardson, Paul G., additional, and Raje, Noopur S., additional

Published
2015
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42. Final Analysis of Overall Survival from the Phase 3 Panorama 1 Trial of Panobinostat Plus Bortezomib and Dexamethasone Versus Placebo Plus Bortezomib and Dexamethasone in Patients with Relapsed or Relapsed and Refractory Multiple Myeloma

Author

San-Miguel, Jesús F., primary, Hungria, Vania T.M., additional, Yoon, Sung-Soo, additional, Beksac, Meral, additional, Dimopoulos, Meletios A., additional, Elghandour, Ashraf, additional, Jedrzejczak, Wieslaw W., additional, Guenther, Andreas, additional, Nakorn, Thanyaphong Na, additional, Siritanaratkul, Noppadol, additional, Schlossman, Robert L., additional, Hou, Jian, additional, Moreau, Philippe, additional, Lonial, Sagar, additional, Lee, Jae Hoon, additional, Einsele, Hermann, additional, Sopala, Monika, additional, Bengoudifa, Bourras-Rezki, additional, Corrado, Claudia, additional, and Richardson, Paul G., additional

Published
2015
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43. Final Results of the Phase I/II Study of Chemosensitization Using the CXCR4 Inhibitor Plerixafor in Combination with Bortezomib in Patients with Relapsed or Relapsed/Refractory Multiple Myeloma

Author

Ghobrial, Irene M., primary, Shain, Kenneth H., additional, Laubach, Jacob, additional, Henrick, Patrick, additional, Vredenburg, James, additional, Crilley, Pamela, additional, Constantine, Michael, additional, Block, Caroline, additional, Basile, Frank G., additional, Cappuccio, Joseph, additional, Azab, Abdel Kareem, additional, Lai, Emily, additional, Caola, Aaron, additional, Banwait, Ranjit, additional, Savell, Alexandra, additional, Munshi, Nikhil C., additional, Paba-Prada, Claudia E., additional, Schlossman, Robert L., additional, Chuma, Stacey, additional, Noonan, Kimberly, additional, Anderson, Kenneth C., additional, and Richardson, Paul G., additional

Published
2015
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44. Characterization of the Incidence and Management of Gastrointestinal Toxicity in the Phase 3 Panorama 1 Study of Panobinostat Plus Bortezomib and Dexamethasone Versus Placebo Plus Bortezomib and Dexamethasone in Patients with Relapsed or Relapsed and Refractory Multiple Myeloma

Author

Richardson, Paul G., primary, Hungria, Vania T M, additional, Yoon, Sung-Soo, additional, Beksac, Meral, additional, Dimopoulos, Meletios A., additional, Elghandour, Ashraf, additional, Jedrzejczak, Wieslaw Wiktor, additional, Guenther, Andreas, additional, Na Nakorn, Thanyaphong, additional, Siritanaratkul, Noppadol, additional, Schlossman, Robert L., additional, Hou, Jian, additional, Moreau, Philippe, additional, Lonial, Sagar, additional, Lee, Jae Hoon, additional, Einsele, Hermann, additional, Salwender, Hans, additional, Sopala, Monika, additional, Panneerselvam, Ashok, additional, Redhu, Suman, additional, Corrado, Claudia, additional, Binlich, Florence, additional, and San Miguel, Jesus F., additional

Published
2014
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45. A Phase II Study of Modified Lenalidomide, Bortezomib, and Dexamethasone (RVD lite) for Transplant-Ineligible Patients with Newly Diagnosed Multiple Myeloma

Author

O'Donnell, Elizabeth, primary, Laubach, Jacob P., additional, Yee, Andrew J, additional, Huff, Carol Ann, additional, Basile, Frank, additional, Wade, Philip M., additional, Paba-Prada, Claudia E., additional, Ghobrial, Irene M., additional, Schlossman, Robert L, additional, Couture, Nicole, additional, Doherty, Lauren, additional, Lyons, Hannah, additional, English, Caroline, additional, Munshi, Nikhil, additional, Anderson, Kenneth C., additional, Richardson, Paul G., additional, and Raje, Noopur, additional

Published
2014
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46. An Open-Label, Dose Escalation, Multi-Center Phase 1 Study of PRLX 93936, an Agent Synthetically Active Against the Activated Ras Pathway, in the Treatment of Relapsed or Relapsed and Refractory Multiple Myeloma

Author

Voorhees, Peter M, primary, Schlossman, Robert L., additional, Gasparetto, Cristina J, additional, Berdeja, Jesus G., additional, Morris, John, additional, Jacobstein, Douglas A, additional, Anderson, Kenneth C., additional, Mitsiades, Constantine S, additional, Laubach, Jacob P., additional, and Richardson, Paul G., additional

Published
2014
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47. A Phase 1/2 Trial of TH-302 and Dexamethasone without or with Bortezomib (TBorD) in Patients with Relapsed/Refractory Multiple Myeloma

Author

Laubach, Jacob P., primary, Raje, Noopur S., additional, Yee, Andrew J., additional, Armand, Philippe, additional, Schlossman, Robert L., additional, Rosenblatt, Jacalyn, additional, Matous, Jeffrey, additional, Hedlund, Jacquelyn, additional, Martin, Michael G, additional, Reynolds, Craig, additional, Shain, Kenneth H., additional, Zackon, Ira, additional, Stampleman, Laura V., additional, Boswell, Erica N, additional, Chuma, Stacey, additional, Liguori, Rebecca, additional, Mar, Stephanie, additional, Handisides, Damian, additional, Kroll, Stew, additional, Anderson, Kenneth C., additional, Richardson, Paul G., additional, and Ghobrial, Irene M., additional

Published
2014
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48. Time to Development of Treatment-Emergent Extramedullary and Osseous Plasmacytomas in the Era of Novel Agents: An Analysis of Upfront Regimens in Newly Diagnosed MM Incorporating Lenalidomide and Bortezomib

Author

Varga, Cindy, primary, Laubach, Jacob P., additional, Ghobrial, Irene M., additional, Weinstock, Matthew, additional, Paba-Prada, Claudia E., additional, Schlossman, Robert L., additional, Munshi, Nikhil, additional, Xie, Wanling, additional, Weller, Edie A., additional, Anderson, Kenneth C., additional, Mitsiades, Constantine S., additional, and Richardson, Paul G., additional

Published
2014
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49. Efficacy and Safety Based on Duration of Treatment of Panobinostat Plus Bortezomib and Dexamethasone in Patients with Relapsed or Relapsed and Refractory Multiple Myeloma in the Phase 3 Panorama 1 Study

Author

San Miguel, Jesus, primary, Hungria, Vania TM, additional, Yoon, Sung-Soo, additional, Beksac, Meral, additional, Dimopoulos, Meletios A., additional, Elghandour, Ashraf, additional, Jedrzejczak, Wieslaw Wiktor, additional, Guenther, Andreas, additional, Na Nakorn, Thanyaphong, additional, Siritanaratkul, Noppadol, additional, Schlossman, Robert L, additional, Hou, Jian, additional, Moreau, Philippe, additional, Lonial, Sagar, additional, Lee, Jae-Hoon, additional, Einsele, Hermann, additional, Salwender, Hans, additional, Sopala, Monika, additional, Redhu, Suman, additional, Paul, Sofia, additional, Corrado, Claudia, additional, Binlich, Florence, additional, and Richardson, Paul G., additional

Published
2014
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50. Phase I/II Trial of Plerixafor and Bortezomib As a Chemosensitization Strategy in Relapsed or Relapsed/Refractory Multiple Myeloma

Author

Ghobrial, Irene M., primary, Laubach, Jacob P., additional, Shain, Kenneth H., additional, Baz, Rachid, additional, Boswell, Erica N, additional, Henrick, Patrick M, additional, Azab, Abdel Kareem, additional, Hanlon, Courtney, additional, Chuma, Stacey, additional, Leblebjian, Houry, additional, Noonan, Kimberly, additional, MacNabb, Megan H., additional, Warren, Diane, additional, Armand, Philippe, additional, Paba-Prada, Claudia E., additional, Munshi, Nikhil C., additional, Schlossman, Robert L, additional, Anderson, Kenneth C., additional, and Richardson, Paul G., additional

Published
2014
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