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151. Geriatric Assessment Identifies Impairments in Younger Candidates for Allogeneic Hematopoietic Stem Cell Transplantation

Author

Lew, Meagan V., primary, Ren, Yi, additional, Lowder, Yen P., additional, Romero, Kristi M., additional, Thompson, Jillian C., additional, Bohannon, Lauren M., additional, Cohen, Harvey, additional, Bartlett, David A., additional, Pastva, Amy M., additional, Morey, Miriam, additional, Hall, Katherine, additional, Smith, Patrick, additional, Peters, Katherine B., additional, Somers, Tamara, additional, Kelleher, Sarah, additional, Smith, Sophia, additional, Wischmeyer, Paul, additional, Lin, Pao-Hwa, additional, Thorpe, Glynnis, additional, Minor, Kerry, additional, Adler, Allison, additional, Wiggins, Kristi, additional, Hennig, Therese, additional, Helms, Tanya, additional, Welch, Renee, additional, Hicks, Whitney, additional, Eren, Margaret, additional, Porter, Rebecca, additional, Matthews, Brittany, additional, Liu, JoAnn, additional, Burleson, Jill, additional, Andrew, Whitney, additional, Aberant, Thomas, additional, Engemann, Ashley K., additional, Henshall, Bethany, additional, Darby, Maurisa, additional, Valea, Renea, additional, Proch, Christina, additional, Dellascio, Michelle, additional, Pittman, Alyssa, additional, Choi, Taewoong, additional, Gasparetto, Cristina, additional, Long, Gwynn D., additional, Lopez, Richard D., additional, Rizzieri, David A., additional, Sarantopoulos, Stefanie, additional, Horwitz, Mitchell E., additional, Chao, Nelson J., additional, and Sung, Anthony D., additional

Published
2019
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152. T(11;14) and High BCL2 Expression Are Predictive Biomarkers of Response to Venetoclax in Combination with Bortezomib and Dexamethasone in Patients with Relapsed/Refractory Multiple Myeloma: Biomarker Analyses from the Phase 3 Bellini Study

Author

Harrison, Simon, primary, Cavo, Michele, primary, De La Rubia, Javier, primary, Popat, Rakesh, primary, Gasparetto, Cristina, primary, Hungria, Vania T.M., primary, Salwender, Hans, primary, Suzuki, Kenshi, primary, Kim, Inho, primary, Moreau, Philippe, primary, Spencer, Andrew, primary, O'Dwyer, Michael E, primary, Garg, Mamta, primary, Punnoose, Elizabeth A, primary, Jalaluddin, Muhammad, primary, Jia, Jia, primary, Yang, Xiaoqing, primary, Sun, Yan, primary, Ward, James E., primary, Maciag, Paulo C., primary, Ross, Jeremy A., primary, and Kumar, Shaji K., primary

Published
2019
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153. Decreased Mortality after the First Year of Allogeneic Hematopoietic Stem Cell Transplant in Recipients of Umbilical Cord Blood Vs. Matched Related or Matched Unrelated Donors

Author

Bohannon, Lauren M., primary, Page, Kristin M., additional, Ren, Yi, additional, Jung, Sin-Ho, additional, Giri, Vinay K., additional, Lew, Meagan V., additional, Kelly, Matthew, additional, Choi, Taewoong, additional, Gasparetto, Cristina, additional, Long, Gwynn D., additional, Lopez, Richard D., additional, Rizzieri, David A., additional, Sarantopoulos, Stefanie, additional, Chao, Nelson J., additional, Horwitz, Mitchell E., additional, and Sung, Anthony D., additional

Published
2019
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154. Treatment Patterns and Outcomes in Elderly Patients with Newly Diagnosed Multiple Myeloma: Results from the Connect® MM Registry

Author

Lee, Hans C., primary, Ailawadhi, Sikander, additional, Gasparetto, Cristina, additional, Jagannath, Sundar, additional, Rifkin, Robert M., additional, Durie, Brian G.M., additional, Narang, Mohit, additional, Terebelo, Howard R., additional, Toomey, Kathleen, additional, Hardin, James W., additional, Wagner, Lynne I., additional, Omel, James L., additional, Srinivasan, Shankar, additional, Liu, Liang, additional, Dhalla, Mazaher, additional, Agarwal, Amit, additional, and Abonour, Rafat, additional

Published
2019
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155. Phase I/II Study Evaluating the Safety and Efficacy of Venetoclax in Combination with Dexamethasone As Targeted Therapy for Patients with t(11;14) Relapsed/Refractory Multiple Myeloma

Author

Kaufman, Jonathan L., primary, Gasparetto, Cristina, primary, Schjesvold, Fredrik H., primary, Moreau, Philippe, primary, Touzeau, Cyrille, primary, Facon, Thierry, primary, Boise, Lawrence H., primary, Alzate, Stefanie, primary, Macartney, Tammy, primary, Pesko, John, primary, Salem, Ahmed Hamed, primary, Ross, Jeremy A., primary, Hong, Wan-Jen, primary, Maciag, Paulo C., primary, Pauff, James M., primary, and Kumar, Shaji K., primary

Published
2019
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156. Updated Analysis of Bellini, a Phase 3 Study of Venetoclax or Placebo in Combination with Bortezomib and Dexamethasone in Patients with Relapsed/Refractory Multiple Myeloma

Author

Moreau, Philippe, primary, Harrison, Simon, additional, Cavo, Michele, additional, De La Rubia, Javier, additional, Popat, Rakesh, additional, Gasparetto, Cristina, additional, Hungria, Vania T.M., additional, Salwender, Hans, additional, Suzuki, Kenshi, additional, Kim, Inho, additional, Gay, Francesca, additional, Mikala, Gábor, additional, Punnoose, Elizabeth A, additional, Hong, Wan-Jen, additional, Sood, Anjla, additional, Jalaluddin, Muhammad, additional, Ross, Jeremy A., additional, Ward, James E., additional, Maciag, Paulo C., additional, and Kumar, Shaji K., additional

Published
2019
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157. Clinical Outcomes and Health-Related Quality of Life (HRQoL) Among Randomized Clinical Trial (RCT)-Eligible and RCT-Ineligible Patients: Results from the Connect® MM Registry

Author

Wagner, Lynne I., primary, Toomey, Kathleen, additional, Ailawadhi, Sikander, additional, Jagannath, Sundar, additional, Gasparetto, Cristina, additional, Durie, Brian G.M., additional, Narang, Mohit, additional, Rifkin, Robert M., additional, Terebelo, Howard R., additional, Omel, James L., additional, Hardin, James W., additional, Lee, Hans C., additional, Srinivasan, Shankar, additional, Liu, Liang, additional, Dhalla, Mazaher, additional, Catamero, Donna, additional, and Abonour, Rafat, additional

Published
2019
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158. Evaluation of the Oral SYK Inhibitor Fostamatinib in Patients after Allogeneic Transplantation for Chronic Graft-Versus-Host Disease

Author

McManigle, William C., primary, DiCioccio, Rachel A., additional, Anand, Sarah, additional, Li, Zhiguo, additional, Poe, Jonathan C, additional, Nichols, Krista R., additional, Suthers, Amy N., additional, Jia, Wei, additional, Corbet, Kelly, additional, Covington, Megan, additional, Lloyd-Cowden, Julia, additional, Lopez, Richard D., additional, Long, Gwynn D., additional, Horwitz, Mitchell E., additional, Gasparetto, Cristina, additional, Sung, Anthony D., additional, Chao, Nelson J., additional, Rizzieri, David A., additional, and Sarantopoulos, Stefanie, additional

Published
2019
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159. Results from Phase 1/2 Trial of Tagraxofusp in Combination with Pomalidomide and Dexamethasone in Relapsed or Refractory Multiple Myeloma

Author

Richardson, Paul G., primary, Htut, Myo, additional, Gasparetto, Cristina, additional, Zonder, Jeffrey A., additional, Martin, Thomas G., additional, Chen, Janice, additional, Brooks, Christopher, additional, McDonald, Peter, additional, Rupprecht, Nicole, additional, Wysowskyj, Halyna, additional, Chauhan, Dharminder, additional, Ray, Arghya, additional, Anderson, Kenneth C., additional, and Paba-Prada, Claudia E., additional

Published
2019
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160. Selinexor, Pomalidomide, and Dexamethasone (SPd) in Patients with Relapsed or Refractory Multiple Myeloma

Author

Chen, Christine I, primary, Bahlis, Nizar, primary, Gasparetto, Cristina, primary, Tuchman, Sascha A, primary, Lipe, Brea C., primary, Baljevic, Muhamed, primary, Kotb, Rami, primary, Sutherland, Heather J., primary, Bensinger, William I., primary, Sebag, Michael, primary, Leblanc, Richard, primary, Venner, Christopher P, primary, Schiller, Gary J., primary, Lentzsch, Suzanne, primary, Callander, Natalie Scott, primary, Sheehan, Heidi, primary, Chai, Yi, primary, Kai, Kazuharu, primary, Shah, Jatin, primary, Shacham, Sharon, primary, Kauffman, Michael G., primary, and White, Darrell J, primary

Published
2019
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161. Physical Function, Pain Severity, and Fatigue in Patients with Relapsed/Refractory Multiple Myeloma: Health-Related Quality of Life Results in Patients Receiving Venetoclax or Placebo in Combination with Bortezomib and Dexamethasone

Author

Gasparetto, Cristina, primary, Popat, Rakesh, additional, Kumar, Shaji K., additional, Cavo, Michele, additional, de la Rubia, Javier, additional, Hungria, Vania T.M., additional, Salwender, Hans, additional, Suzuki, Kenshi, additional, Kim, Inho, additional, Maciel, James, additional, Hsiao, Liang-Tsai, additional, Moreau, Philippe, additional, Harrison, Simon, additional, Jia, Jia, additional, Karve, Sudeep, additional, Ma, Esprit, additional, Devine, Jacob, additional, and Benjamin, Katy, additional

Published
2019
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162. Pre-Transplant Hepatic Steatosis (fatty liver) Predicts Chronic Graft-Vs-Host Disease but Does Not Affect Mortality

Author

Maung, Ko Ko Ko, primary, Chaudhry, Mohammad, additional, Ren, Yi, additional, Jung, Sin-Ho, additional, Romero, Kristi M., additional, Corbet, Kelly, additional, Chao, Nelson J., additional, Choi, Taewoong, additional, Diehl, Anna Mae, additional, Diehl, Louis F., additional, Gasparetto, Cristina, additional, Horwitz, Mitchell E., additional, Long, Gwynn D., additional, Lopez, Richard D., additional, Rizzieri, David A., additional, Sarantopoulos, Stefanie, additional, Sullivan, Keith, additional, Bashir, Mustafa R., additional, and Sung, Anthony D., additional

Published
2019
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163. A Phase 3 Study of Venetoclax or Placebo in Combination with Bortezomib and Dexamethasone in Patients with Relapsed/Refractory Multiple Myeloma

Author

Kumar, Shaji, primary, Harrison, Simon J., additional, Cavo, Michele, additional, Rubia, Javier DE.LA., additional, Popat, Rakesh, additional, Gasparetto, Cristina J., additional, Hungria, Vania, additional, Salwender, Hans J., additional, Suzuki, Kenshi, additional, Kim, Inho, additional, Punnoose, Elizabeth, additional, Hong, Wan-Jen, additional, Freise, Kevin J., additional, Sood, Anjla, additional, Jalaluddin, Muhammad, additional, Ross, Jeremy, additional, Ward, James E., additional, Maciag, Paulo, additional, and Moreau, Philippe, additional

Published
2019
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164. Safety and Efficacy of the Combination of Selinexor, Lenalidomide and Dexamethasone (SRd) in Patients with Relapsed/Refractory Multiple Myeloma (RRMM)

Author

White, Darrell, primary, LeBlanc, Richard, additional, Venner, Chritopher, additional, Bahlis, Nizar J., additional, Lentzsch, Suzanne, additional, Gasparetto, Cristina J., additional, Chen, Christine, additional, Lipe, Brea, additional, Sutherland, Heather, additional, Tuchman, Sascha, additional, Baljevic, Muhamed, additional, Kotb, Rami, additional, Sebag, Michael, additional, Callander, Nancy, additional, Bensinger, William, additional, Kai, Kazuharu, additional, Liu, Jianjun, additional, Sheehan, Heidi, additional, Estepan, Daniel Nova, additional, Shah, Jatin, additional, and Schiller, Gary J., additional

Published
2019
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165. Frequency of and Associations Amongst Baseline Cytogenetics in Patients With Newly Diagnosed Multiple Myeloma in the Connect® MM Registry

Author

Ailawadhi, Sikander, primary, Gasparetto, Cristina J., additional, Jagannath, Sundar, additional, Rifkin, Robert, additional, Durie, Brian, additional, Narang, Mohit, additional, Terebelo, Howard, additional, Toomey, Kathleen, additional, Hardin, James, additional, Wagner, Lynne, additional, Omel, Jim, additional, Lee, Hans, additional, Srinivasan, Shankar, additional, He, Mia, additional, Dhalla, Mazaher, additional, Catamero, Donna, additional, Bharadwaj, Anjali, additional, Agarwal, Amit, additional, and Abonour, Rafat, additional

Published
2019
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166. Effect of t(11;14) on Outcomes of Patients With Newly Diagnosed Multiple Myeloma in the Connect® MM Registry

Author

Gasparetto, Cristina J., primary, Jagannath, Sundar, additional, Rifkin, Robert, additional, Durie, Brian, additional, Narang, Mohit, additional, Terebelo, Howard, additional, Toomey, Kathleen, additional, Hardin, James, additional, Wagner, Lynne, additional, Ailawadhi, Sikander, additional, Omel, Jim, additional, Lee, Hans, additional, Srinivasan, Shankar, additional, Dhalla, Mazaher, additional, Catamero, Donna, additional, Agarwal, Amit, additional, and Abonour, Rafat, additional

Published
2019
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167. Pembrolizumab plus pomalidomide and dexamethasone for patients with relapsed or refractory multiple myeloma (KEYNOTE-183): a randomised, open-label, phase 3 trial

Author

Mateos, Maria-Victoria, primary, Blacklock, Hilary, additional, Schjesvold, Fredrik, additional, Oriol, Albert, additional, Simpson, David, additional, George, Anupkumar, additional, Goldschmidt, Hartmut, additional, Larocca, Alessandra, additional, Chanan-Khan, Asher, additional, Sherbenou, Daniel, additional, Avivi, Irit, additional, Benyamini, Noam, additional, Iida, Shinsuke, additional, Matsumoto, Morio, additional, Suzuki, Kenshi, additional, Ribrag, Vincent, additional, Usmani, Saad Z, additional, Jagannath, Sundar, additional, Ocio, Enrique M, additional, Rodriguez-Otero, Paula, additional, San Miguel, Jesus, additional, Kher, Uma, additional, Farooqui, Mohammed, additional, Liao, Jason, additional, Marinello, Patricia, additional, Lonial, Sagar, additional, Nicol, Andrew, additional, Grigoriadis, George, additional, Catalano, John, additional, LeBlanc, Richard, additional, Elemary, Mohamed, additional, Bahlis, Nizar, additional, Facon, Thierry, additional, Karlin, Lionel, additional, Attal, Michel, additional, Engelhardt, Monika, additional, Weisel, Katja, additional, Mackensen, Andreas, additional, Nagler, Arnon, additional, Ben Yehuda, Dina, additional, Magen-Nativ, Hila, additional, Palumbo, Antonio, additional, Cavo, Michele, additional, Tobinai, Kensei, additional, Chou, Takaai, additional, Kosugi, Hiroshi, additional, Taniwaki, Masafumi, additional, Sunami, Kazutaka, additional, Ando, Kiyoshi, additional, Ganly, Peter, additional, Gjertsen, Bjorn, additional, Lahuerta, Juan, additional, Blade, Joan, additional, Oriol Rocafiguera, Albert, additional, Mateos, Maria, additional, Larson, Sarah, additional, Atanackovic, Djordje, additional, Devarakonda, Srinivas, additional, Bitran, Jacob, additional, Zonder, Jeffrey, additional, Morganstein, Neil, additional, Hay, Mohammad, additional, Saylors, Gene, additional, Kio, Ebenezer, additional, Oliff, Ira, additional, Kirkel, Dean, additional, Shtivelband, Mikhail, additional, Yuen, Carrie, additional, Yee, Andrew, additional, Shah, Jatin, additional, Htut, Myo, additional, Raza, Shahzad, additional, Chhabra, Saurabh, additional, Stiff, Patrick, additional, Hari, Parameswaran, additional, Bank, Bruce, additional, Malek, Ehsan, additional, Gasparetto, Cristina, additional, Faroun, Ycaoub, additional, Kreisle, William, additional, Singhal, Seema, additional, Rosenblatt, Jacalyn, additional, Usmani, Saad, additional, Lee, Wes, additional, Safah, Hana, additional, Lutzky, Jose, additional, Suh, Jason, additional, Pan, Dorothy, additional, Baron, Ari, additional, Manges, Robert, additional, Steis, Ronald, additional, Oliveira, Moacyr, additional, Moreb, Jan, additional, Callander, Natalie, additional, Anz, Bertrand, additional, Raptis, Anastasios, additional, Stampleman, Laura, additional, Melear, Jason, additional, Boyd, Thomas, additional, Garbo, Lawrence, additional, Klein, Leonard, additional, Shao, Spencer, additional, Lyons, Roger, additional, McIntyre, Kristi, additional, Tarantolo, Stefano, additional, Yasenchak, Christopher, additional, and Yimer, Habte, additional

Published
2019
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168. Effect of t(11;14) on outcomes of patients (pts) with newly diagnosed multiple myeloma (NDMM) in the connect MM registry.

Author

Gasparetto, Cristina, primary, Jagannath, Sundar, additional, Rifkin, Robert M., additional, Durie, Brian G., additional, Narang, Mohit, additional, Terebelo, Howard R., additional, Toomey, Kathleen, additional, Hardin, James W., additional, Wagner, Lynne I., additional, Ailawadhi, Sikander, additional, Omel, James, additional, Lee, Hans Chulhee, additional, Srinivasan, Shankar, additional, Dhalla, Mazaher, additional, Catamero, Donna, additional, Agarwal, Amit, additional, and Abonour, Rafat, additional

Published
2019
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169. Revised International Staging System Is Predictive and Prognostic for Early Relapse (<24 months) after Autologous Transplantation for Newly Diagnosed Multiple Myeloma

Author

Gopalakrishnan, Sathish, primary, D'Souza, Anita, additional, Scott, Emma, additional, Fraser, Raphael, additional, Davila, Omar, additional, Shah, Nina, additional, Gale, Robert Peter, additional, Kamble, Rammurti, additional, Diaz, Miguel Angel, additional, Lazarus, Hillard M., additional, Savani, Bipin N., additional, Hildebrandt, Gerhard C., additional, Solh, Melhem, additional, Freytes, Cesar O., additional, Lee, Cindy, additional, Kyle, Robert A, additional, Usmani, Saad Z., additional, Ganguly, Siddhartha, additional, Assal, Amer, additional, Berdeja, Jesus, additional, Kanate, Abraham S., additional, Dhakal, Binod, additional, Meehan, Kenneth, additional, Kindwall-Keller, Tamila, additional, Saad, Ayman, additional, Locke, Frederick, additional, Seo, Sachiko, additional, Nishihori, Taiga, additional, Gergis, Usama, additional, Gasparetto, Cristina, additional, Mark, Tomer, additional, Nieto, Yago, additional, Kumar, Shaji, additional, and Hari, Parameswaran, additional

Published
2019
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170. Phase I, Dose Escalation Study of Naïve T-Cell Depleted Donor Lymphocyte Infusion Following Allogeneic Stem Cell Transplantation

Author

Maung, Ko Ko, primary, Chen, Benny J, additional, Rizzieri, David A, additional, Gasparetto, Cristina, additional, Sullivan, Keith, additional, Long, Gwynn D, additional, Engemann, Ashley Morris, additional, Waters-Pick, Barbara, additional, Nichols, Krista Rowe, additional, Lopez, Richard, additional, Kang, Yubin, additional, Sarantopoulos, Stefanie, additional, Sung, Anthony D., additional, Chao, Nelson J., additional, and Horwitz, Mitchell E., additional

Published
2019
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174. Effect of initial treatment on health‐related quality of life in patients with newly diagnosed multiple myeloma without immediate stem cell transplant intent: results from the Connect® MM Registry.

Author

Abonour, Rafat, Rifkin, Robert M., Gasparetto, Cristina, Toomey, Kathleen, Durie, Brian G. M., Hardin, James W., Terebelo, Howard R., Jagannath, Sundar, Narang, Mohit, Ailawadhi, Sikander, Omel, James L., Lee, Hans C., Srinivasan, Shankar, Kitali, Amani, Agarwal, Amit, and Wagner, Lynne

Subjects
QUALITY of life, MULTIPLE myeloma, STEM cell transplantation, TREATMENT effectiveness, FUNCTIONAL assessment
Abstract

Summary: Although new multiple myeloma (MM) therapies are effective in alleviating some disease‐associated symptoms (e.g. bone pain, fatigue, functional decline), they can result in additional toxicities, further impacting health‐related quality of life (HRQoL). Here, we compared HRQoL and safety of lenalidomide‐bortezomib‐dexamethasone [RVd (n = 445)], bortezomib‐melphalan‐prednisone [VMP (n = 77)] and Vd or VMP (n = 588) in patients with newly diagnosed MM (NDMM) from the Connect® MM Registry, a large, USA, multicentre, prospective observational cohort study. Functional Assessment of Cancer Therapy‐Multiple Myeloma subscale, EuroQol‐5D overall score and Bone Pain Inventory HRQoL scores were significantly improved with RVd versus Vd/VMP. Serious adverse event rates were similar in all groups. Treatment with RVd maintained HRQoL in this real‐world, largely community‐based population of patients with NDMM. [ABSTRACT FROM AUTHOR]

Published
2021
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175. Selinexor, daratumumab, and dexamethasone in patients with relapsed or refractory multiple myeloma.

Author

Gasparetto, Cristina, Lentzsch, Suzanne, Schiller, Gary, Callander, Natalie, Tuchman, Sascha, Chen, Christine, White, Darrell, Kotb, Rami, Sutherland, Heather, Sebag, Michael, Baljevic, Muhamed, Bensinger, William, LeBlanc, Richard, Venner, Chris, Bahlis, Nizar, Rossi, Adriana, Biran, Noa, Sheehan, Heidi, Saint‐Martin, Jean‐Richard, and Van Domelen, Dane

Published
2021
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177. 539 - A Phase 1 Study of the Safety and Feasibility of Improving Cardiorespiratory Fitness through a Remotely Monitored, Mobile Health Supported High Intensity Interval Training Program (REMM-HIIT)

Author

Sung, Anthony D., Miller, Hilary M., Romero, Kristi, MacDonald, Grace, Bohannon, Lauren, Molinger, Jeroen, Ren, Yi, Bush, Amy, Lew, Meagan, Cohen, Harvey J, Pastva, Amy, Jung, Sin-Ho, Shah, Nirmish R, Smith, Patrick J, Wischmeyer, Paul E, Wood, William A, Alyea, Edwin, Choi, Taewoong, Gasparetto, Cristina, Horwitz, Mitchell E., Long, Gwynn D, Lopez, Richard D, Rizzieri, David A, Sarantopoulos, Stefanie, Sullivan, Keith M, Chao, Nelson J., and Bartlett, David B

Published
2021
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178. 106 - Assessing the Feasibility of a Novel mHealth App in Hematopoietic Stem Cell Transplant Patients

Author

Racioppi, Alessandro, Dalton, Tara, Ramalingam, Sendhilnathan, Romero, Kristi, Ren, Yi, Bohannon, Lauren, Arellano, Consuelo, Jonassaint, Jude, Miller, Hilary M., Barak, Ian, Fish, Laura J., Choi, Taewoong, Gasparetto, Cristina, Long, Gwynn D, Lopez, Richard D, Rizzieri, David A, Sarantopoulos, Stefanie, Horwitz, Mitchell E., Chao, Nelson J., Shah, Nirmish R, and Sung, Anthony

Published
2021
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179. Association between race and treatment patterns and survival outcomes in multiple myeloma: A Connect MM Registry analysis.

Author

Ailawadhi, Sikander, Jagannath, Sundar, Lee, Hans C., Narang, Mohit, Rifkin, Robert M., Terebelo, Howard R., Durie, Brian G. M., Toomey, Kathleen, Hardin, James W., Gasparetto, Cristina J., Wagner, Lynne, Omel, James L., He, Mia, Yue, Lihua, Flick, Elizabeth Dawn, Agarwal, Amit, Abonour, Rafat, and Connect MM Registry Investigators

Subjects
MULTIPLE myeloma, STEM cell transplantation, HEALTH services accessibility, CELL transplantation, PROGRESSION-free survival, POPULATION, RESEARCH, RESEARCH methodology, ACQUISITION of data, MEDICAL cooperation, EVALUATION research, COMPARATIVE studies, SURVIVAL analysis (Biometry), LONGITUDINAL method
Abstract

Background: Studies have reported racial disparities in access to and use of multiple myeloma (MM) treatments between African American (AA) and White patients. Although AA patients demonstrate longer disease-specific survival, this has not uniformly translated into improved survival over time. The association between race and treatment patterns and survival outcomes was analyzed using data from the Connect MM Registry.Methods: The Connect MM Registry is a large US, multicenter, prospective observational cohort study of patients with newly diagnosed MM. Patients who received first-line (1L) stem cell transplantation (SCT) or who did not receive SCT (non-SCT or non-stem cell transplantation [NSCT]) were grouped by raceEffects of race and transplantation status on the use of triplet treatment were estimated using logistic regression.Results: Treatment patterns in 1L (types and duration of induction, posttransplantation maintenance) were similar between AA and White patients. SCT rates in 1L (32% vs 36%) and triplet treatment use (AA: 44% for NSCT patients and 72% for SCT patients; and White: 48% for NSCT patients and 72% for SCT patients) during first induction were similar. No significant effect of race or transplantation status on 1L triplet treatment use was observed. Race was not found to be associated with survival outcomes among patients who underwent NSCT; however, AA patients who received SCT had significantly longer overall survival compared with White patients who underwent SCT (not reached vs 88.2 months; hazard ratio, 0.56; 95% CI, 0.35-0.89 [P = .0141]).Conclusions: AA and White patients were found to have similar treatment patterns in the Connect MM Registry, suggesting that both groups had equal access to health care. In this real-world setting, AA patients received standard-of-care treatment, which might have contributed to better MM-specific survival compared with White patients. [ABSTRACT FROM AUTHOR]

Published
2020
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180. Connect MM Registry as a national reference for United States multiple myeloma patients.

Author

Ailawadhi, Sikander, Jagannath, Sundar, Narang, Mohit, Rifkin, Robert M., Terebelo, Howard R., Toomey, Kathleen, Durie, Brian G. M., Hardin, James W., Gasparetto, Cristina J., Wagner, Lynne, Omel, James L., Kumar, Vivek, Yue, Lihua, Kitali, Amani, Agarwal, Amit, and Abonour, Rafat

Subjects
MULTIPLE myeloma, PROPORTIONAL hazards models, PROGNOSIS, MONOCLONAL gammopathies, PLASMACYTOMA
Abstract

Background: The Surveillance, Epidemiology, and End Results (SEER) database and National Cancer Database (NCDB) show improved overall survival (OS) in patients with multiple myeloma (MM) over the last 15 years. This analysis evaluated the validity of the largely community‐based Connect MM Registry as a national reference for MM. Methods: Baseline disease characteristics and survival in US newly diagnosed MM patients were examined using the Connect MM Registry as well as SEER and NCDB databases. Baseline characteristics predictive of longer survival in Connect MM were also identified. Results: As of February 2017, 3011 patients were enrolled in the Connect MM Registry; 2912 were treated. Median age at time of MM diagnosis and age range were numerically similar from 2010 to 2015 across all 3 registries; SEER had a higher representation of nonwhite racial groups than that in the other 2 registries. OS rates suggest proportionate improvement with year of diagnosis among the 3 registries. A Cox proportional hazards model suggests that younger age (<65 years) is associated with longer survival (vs ≥75; HR, 0.39; 95% confidence interval, 0.34‐0.46) in the Connect MM Registry. However, sex (HR, 0.91; P =.15) and race (black vs white; HR, 0.88; P =.21) were not associated with longer OS. Conclusions: Data from the Connect MM Registry appear to be largely representative of national trends, comprehensive, and reliable representations of the national MM population. Baseline characteristics were comparable, and survival similarly improved over time among the 3 registries. ClinicalTrials.gov, identifier: NCT01081028. [ABSTRACT FROM AUTHOR]

Published
2020
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181. Development of a prognostic model for overall survival in multiple myeloma using the Connect® MM Patient Registry.

Author

Terebelo, Howard R., Abonour, Rafat, Gasparetto, Cristina J., Toomey, Kathleen, Durie, Brian G. M., Hardin, James W., Jagannath, Sundar, Wagner, Lynne, Narang, Mohit, Flick, E. Dawn, Srinivasan, Shankar, Yue, Lihua, Kitali, Amani, Agarwal, Amit, and Rifkin, Robert M.

Subjects
MULTIPLE myeloma, MEDICAL registries, PLATELET count, PLASMACYTOMA
Abstract

Summary: Median overall survival (OS) has improved for patients with newly diagnosed multiple myeloma (NDMM), but prognosis varies depending on baseline patient characteristics. Current models use data from selected clinical trial populations, which prevent application to patients in an unselected community setting that reflects routine clinical practice. Using data from the Connect® MM Registry, a large, US, multicentre, prospective observational cohort study (Cohort 1: 2009–2011; Cohort 2: 2012–2016) of 3011 patients with NDMM, we identified prognostic variables for OS via the multivariable analysis of baseline patient characteristics in Cohort 1 (n = 1493) and developed a tool to examine individual outcomes. Factors associated with OS (n = 1450 treated patients; P < 0·05) were age, del(17p), triplet therapy use, EQ‐5D mobility, International Staging System stage, solitary plasmacytoma, history of diabetes, platelet count, Eastern Cooperative Oncology Group performance status and serum creatinine, which were used to create survival matrices for 3‐ and 5‐year OS. The model was internally and externally validated using Connect MM Cohort 2 (Harrell's concordance index, 0·698), MM‐015 (0·649), and the phase 3 FIRST (0·647) clinical trials. This novel prognostic tool may help inform outcomes for NDMM in the era of triplet therapy use with novel agents. [ABSTRACT FROM AUTHOR]

Published
2019
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182. Selinexor Plus Pomalidomide and Low Dose Dexamethasone (SPd) in Patients with Relapsed or Refractory Multiple Myeloma

Author

Chen, Christine I, primary, Sutherland, Heather J., additional, Kotb, Rami, additional, Sebag, Michael, additional, White, Darrell J., additional, Bensinger, William, additional, Gasparetto, Cristina J, additional, Leblanc, Richard, additional, Venner, Christopher P., additional, Lentzsch, Suzanne, additional, Schiller, Gary J., additional, Lipe, Brea, additional, Del Col, Aldo, additional, Shah, Jatin J., additional, Jeha, Jacqueline, additional, Saint-Martin, Jean-Richard, additional, Kauffman, Michael G., additional, Shacham, Sharon, additional, and Bahlis, Nizar, additional

Published
2018
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183. A Phase I, Open-Label Study to Evaluate the Safety, Pharmacokinetic, Pharmacodynamic, and Clinical Activity of PF-06863135, a B-Cell Maturation Antigen/CD3 Bispecific Antibody, in Patients with Relapsed/Refractory Advanced Multiple Myeloma

Author

Lesokhin, Alexander M., primary, Raje, Noopur, additional, Gasparetto, Cristina J, additional, Walker, Justine, additional, Krupka, Heike I., additional, Joh, Tenshang, additional, Taylor, Carrie T., additional, and Jakubowiak, Andrzej, additional

Published
2018
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184. Deep and Durable Responses with Selinexor, Daratumumab, and Dexamethasome (SDd) in Patients with Multiple Myeloma (MM) Previously Exposed to Proteasome Inhibitors and Immunomodulatory Drugs: Results of Phase 1b Study of SDd

Author

Gasparetto, Cristina J, primary, Lentzsch, Suzanne, additional, Schiller, Gary J., additional, Bensinger, William, additional, Bahlis, Nizar, additional, Sutherland, Heather J., additional, White, Darrell J., additional, Sebag, Michael, additional, Kotb, Rami, additional, Venner, Christopher P., additional, Leblanc, Richard, additional, Chen, Christine I, additional, Del Col, Aldo, additional, Shah, Jatin J., additional, Jeha, Jacqueline, additional, Saint-Martin, Jean-Richard, additional, Kauffman, Michael G., additional, Shacham, Sharon, additional, Turner, Joel G., additional, Sullivan, Daniel M, additional, and Lipe, Brea, additional

Published
2018
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185. Results from a Phase II Study of Isatuximab As a Single Agent and in Combination with Dexamethasone in Patients with Relapsed/Refractory Multiple Myeloma

Author

Dimopoulos, Meletios A, primary, Bringhen, Sara, additional, Anttila, Pekka, additional, Capra, Marcelo, additional, Cavo, Michele, additional, Cole, Craig E., additional, Gasparetto, Cristina J, additional, Hungria, Vania T. M., additional, Jenner, Matthew, additional, Vorobyev, Vladimir, additional, Yanez Ruiz, Eduardo, additional, Yin, Jianyun, additional, Hamlett, Anthony, additional, and Vij, Ravi, additional

Published
2018
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186. Treatment Choices and Outcomes for Patients with Multiple Myeloma after Relapse on Lenalidomide Maintenance Therapy: Results from the Connect® MM Registry

Author

Jagannath, Sundar, primary, Narang, Mohit, additional, Ailawadhi, Sikander, additional, Rifkin, Robert M, additional, Terebelo, Howard R, additional, Toomey, Kathleen, additional, Durie, Brian GM, additional, Hardin, James W, additional, Gasparetto, Cristina J, additional, Wagner, Lynne, additional, Omel, James, additional, Srinivasan, Shankar, additional, Kitali, Amani, additional, Agarwal, Amit, additional, and Abonour, Rafat, additional

Published
2018
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187. Impact of post-ASCT maintenance therapy on outcomes in patients with newly diagnosed multiple myeloma in Connect MM

Author

Jagannath, Sundar, primary, Abonour, Rafat, additional, Durie, Brian G. M., additional, Narang, Mohit, additional, Terebelo, Howard R., additional, Gasparetto, Cristina J., additional, Toomey, Kathleen, additional, Hardin, James W., additional, Wagner, Lynne, additional, Agarwal, Amit, additional, Srinivasan, Shankar, additional, Kitali, Amani, additional, Flick, E. Dawn, additional, Sturniolo, Michael, additional, and Rifkin, Robert M., additional

Published
2018
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188. Treatment (tx) journeys in newly diagnosed multiple myeloma (NDMM) patients (pts): Results from the Connect MM Registry.

Author

Jagannath, Sundar, primary, Rifkin, Robert M., additional, Gasparetto, Cristina, additional, Toomey, Kathleen, additional, Durie, Brian G., additional, Hardin, James W., additional, Terebelo, Howard R., additional, Wagner, Lynne I., additional, Narang, Mohit, additional, Ailawadhi, Sikander, additional, Srinivasan, Shankar, additional, YoussefAgha, Ahmed, additional, Ung, Brian, additional, Kitali, Amani, additional, Flick, E. Dawn, additional, Agarwal, Amit, additional, and Abonour, Rafat, additional

Published
2018
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189. Predictors of long-term survival in newly diagnosed multiple myeloma (NDMM) patients (pts) enrolled in the Connect MM registry.

Author

Gasparetto, Cristina, primary, Rifkin, Robert M., additional, Terebelo, Howard R., additional, Toomey, Kathleen, additional, Durie, Brian G., additional, Hardin, James W., additional, Jagannath, Sundar, additional, Wagner, Lynne I., additional, Narang, Mohit, additional, Ailawadhi, Sikander, additional, Flick, E. Dawn, additional, Kotey, Stanley, additional, Srinivasan, Shankar, additional, Kitali, Amani, additional, Agarwal, Amit, additional, and Abonour, Rafat, additional

Published
2018
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191. Phase 1 trial of ibrutinib and carfilzomib combination therapy for relapsed or relapsed and refractory multiple myeloma

Author

Chari, Ajai, primary, Larson, Sarah, additional, Holkova, Beata, additional, Cornell, Robert F., additional, Gasparetto, Cristina, additional, Karanes, Chatchada, additional, Matous, Jeffrey V., additional, Niesvizky, Ruben, additional, Valent, Jason, additional, Lunning, Matthew, additional, Usmani, Saad Z., additional, Anderson, Larry D., additional, Chang, Lipo, additional, Lee, Yihua, additional, Pak, Yvonne, additional, Salman, Zeena, additional, Graef, Thorsten, additional, Bilotti, Elizabeth, additional, and Chhabra, Saurabh, additional

Published
2018
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193. Hematopoietic Stem Cell Transplantation at Home

Author

Sung, Anthony D., primary, Nichols, Krista R., additional, Messina, Julia A., additional, Romero, Kristi, additional, Dalton, Tara, additional, Bush, Amy, additional, Covington, Megan, additional, Shelby, Rebecca, additional, Frith, Jennifer, additional, Gasparetto, Cristina J., additional, Horwitz, Mitchell E., additional, Long, Gwynn D., additional, Lopez, Richard, additional, Rizzieri, David A., additional, Sarantopoulos, Stefanie, additional, Sullivan, Keith M., additional, and Chao, Nelson J., additional

Published
2017
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194. Isatuximab as monotherapy and combined with dexamethasone in patients with relapsed/refractory multiple myeloma

Author

Dimopoulos, Meletios, Bringhen, Sara, Anttila, Pekka, Capra, Marcelo, Cavo, Michele, Cole, Craig, Gasparetto, Cristina, Hungria, Vania, Jenner, Matthew, Vorobyev, Vladimir, Ruiz, Eduardo Yanez, Yin, Jian Y., Saleem, Rao, Hellet, Maeva, Macé, Sandrine, Paiva, Bruno, and Vij, Ravi

Abstract

This phase 2 study evaluated isatuximab as monotherapy or combined with dexamethasone in relapsed/refractory multiple myeloma (RRMM). Patients had RRMM refractory to an immunomodulatory drug (IMiD) and a proteasome inhibitor (PI) or had received ≥3 prior lines of therapy incorporating an IMiD and PI. Patients received isatuximab either as monotherapy (20 mg/kg on days 1, 8, 15, and 22 [once weekly] of cycle 1 followed by 20 mg/kg on days 1 and 15 of subsequent cycles; Isa group) or in combination with dexamethasone (40 mg/d [20 mg/d in patients aged ≥75 years] once weekly; Isa-dex group). Treated patients (N = 164) had received a median of 4 (range, 2-10) prior treatment lines. Patients received a median of 5 (1-24) and 7 (1-22) treatment cycles; at data cutoff, 13 (11.9%) of 109 and 15 (27.3%) of 55 patients remained on treatment in the Isa and Isa-dex arms, respectively. Overall response rate (primary efficacy end point) was 23.9% in the Isa arm and 43.6% in the Isa-dex arm (odds ratio, 0.405; 95% confidence interval, 0.192-0.859; P = .008). Median progression-free survival and overall survival were 4.9 and 18.9 months for Isa, and 10.2 and 17.3 months for Isa-dex. Infusion reactions (mostly grade 1/2) and hematologic abnormalities were the most common adverse events. There was a similar incidence of grade 3 or higher infections in both groups (22.0% and 21.8%). In conclusion, addition of dexamethasone to isatuximab increased response rates and survival outcomes with no detrimental effect on safety. This trial was registered at www.clinicaltrials.gov as #NCT01084252.

Published
2021
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195. A phase 1b dose-escalation/expansion study of BET inhibitor RO6870810 in patients with advanced multiple myeloma.

Author

Ramasamy, Karthik, Nooka, Ajay, Quach, Hang, Htut, Myo, Popat, Rakesh, Liedtke, Michaela, Tuchman, Sascha A., Laubach, Jacob, Gasparetto, Cristina, Chanan-Khan, Asher, Hertzberg, Mark, deMario, Mark, Nueesch, Eveline, Chesne, Evelyne, Franjkovic, Izolda, Lechner, Katharina, Kornacker, Martin, and Cho, Hearn Jay

Subjects
MULTIPLE myeloma, CANCER cell growth, DIFFUSE large B-cell lymphomas, MONONUCLEAR leukocytes
Abstract

A majority of patients experienced at least one grade >=3 AE (21 patients [87-5%]) and/or serious adverse event (SAE) (13 patients [54-2%]). The SAEs experienced by >=5% of patients were thrombocytopenia (three patients [12-5%]), injection site reaction, acute kidney injury, and malaise (two patients [8-3%] in each PT). The most common treatment-emergent AEs, experienced by >=30% patients, were injection site reaction (19 patients [79-2%]), fatigue (15 patients [62-5%]), anemia (12 patients [50-0%]), thrombocytopenia (11 patients [45-8%]), nausea (ten patients [41-7%]), diarrhea (nine patients [37-5%]), and decreased appetite (eight patients [33-3%]). Patients had a median of 6 (range 3-9) prior lines of therapy and were refractory to immunomodulatory drugs (IMiDs, 46% of patients), proteasome inhibitors (54%), IMiDs and proteasome inhibitors (38%), and daratumumab (33%) (Supplementary Table 1). [Extracted from the article]

Published
2021
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196. NCCN Guidelines® Insights Multiple Myeloma, Version 3.2016: Featured Updates to the NCCN Guidelines

Author

Anderson, Kenneth C., Alsina, Melissa, Atanackovic, Djordje, Biermann, J. Sybil, Chandler, Jason C., Costello, Caitlin, Djulbegovic, Benjamin, Fung, Henry C., Gasparetto, Cristina, Godby, Kelly, Hofmeister, Craig, Holmberg, Leona, Holstein, Sarah, Huff, Carol Ann, Kassim, Adetola, Krishnan, Amrita Y., Kumar, Shaji K., Liedtke, Michaela, Lunning, Matthew, Raje, Noopur, Reu, Frederic J., Singhal, Seema, Somlo, George, Stockerl-Goldstein, Keith, Treon, Steven P., Weber, Donna, Yahalom, Joachim, Shead, Dorothy A., and Kumar, Rashmi

Subjects
hemic and lymphatic diseases, Humans, sense organs, skin and connective tissue diseases, Multiple Myeloma, Article
Abstract

These NCCN Guidelines Insights highlight the important updates/changes specific to the 2016 version of the NCCN Clinical Practice Guidelines in Oncology for Multiple Myeloma. These changes include updated recommendations to the overall management of multiple myeloma from diagnosis and staging to new treatment options.

Published
2016

197. Updated data from a phase II dose finding trial of single agent isatuximab (SAR650984, anti-CD38 mAb) in relapsed/refractory multiple myeloma (RRMM)

Author

Richter, Joshua Ryan Martin, Thomas G. Vij, Ravi Cole, Craig and Atanackovic, Djordje Zonder, Jeffrey A. Kaufman, Jonathan L. and Mikhael, Joseph Bensinger, William Dimopoulos, Meletios A. and Zimmerman, Todd M. Lendvai, Nikoletta Hari, Parameswaran and Ocio, Enrique M. Gasparetto, Cristina Kumar, Shaji Oprea, Corina Charpentier, Eric Strickland, Stephen Anthony Miguel, Jesus San

Published
2016

198. Assessing the Feasibility of a Novel mHealth App in Hematopoietic Stem Cell Transplant Patients

Author

Racioppi, Alessandro, Dalton, Tara, Ramalingam, Sendhilnathan, Romero, Kristi, Ren, Yi, Bohannon, Lauren, Arellano, Consuelo, Jonassaint, Jude, Miller, Hilary, Barak, Ian, Fish, Laura J., Choi, Taewoong, Gasparetto, Cristina, Long, Gwynn D., Lopez, Richard D., Rizzieri, David A., Sarantopoulos, Stefanie, Horwitz, Mitchell E., Chao, Nelson J., Shah, Nirmish R., and Sung, Anthony D.

Abstract

Hematopoietic stem cell transplantation (HCT) is a curative treatment option for patients with hematologic conditions but presents many complications that must be managed as a complex, chronic condition. Mobile health applications (mHealth apps) may permit tracking of symptoms in HCT. In seeking strategies to manage the complexities of HCT, our team collaborated with Sicklesoft, Inc., to develop an mHealth app specifically for HCT patients to allow for daily evaluation of patient health, Technology Recordings to better Understand Bone Marrow Transplantation (TRU-BMT). The primary value of this application is that of potentially enhancing the monitoring of symptoms and general health of patients undergoing HCT, with the ultimate goal of allowing earlier detection of adverse events, earlier intervention, and improving outcomes. To first evaluate patient interest in mHealth apps, we designed and administered an interest survey to patients at the 2017 BMT-InfoNet reunion. As a follow-up to the positive feedback received, we began testing the TRU-BMT app in a Phase 1 pilot study. Thirty patients were enrolled in this single-arm study and were given the TRU-BMT mHealth app on a smartphone device in addition to a wearable activity tracker. Patients were followed for up to 180 days, all the while receiving daily app monitoring. Adherence to TRU-BMT was approximately 30% daily and 44% weekly, and greater adherence was associated with increased meal completion, decreased heart rate, and shorter hospital stay. TRU-BMT assessments of symptom severity were significantly associated with duration of hospital stay and development of chronic graft-versus-host disease. Our findings suggest that using TRU-BMT throughout HCT is feasible for patients and established a proof-of-concept for a future randomized control trial of the TRU-BMT application in HCT.

Published
2021
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199. Phase I dose escalation study of naive T-cell depleted donor lymphocyte infusion following allogeneic stem cell transplantation

Author

Maung, Ko K., Chen, Benny J., Barak, Ian, Li, Zhiguo, Rizzieri, David A., Gasparetto, Cristina, Sullivan, Keith M., Long, Gwynn D., Engemann, Ashley M., Waters-Pick, Barbara, Nichols, Krista Rowe, Lopez, Richard, Kang, Yubin, Sarantopoulos, Stefanie, Sung, Anthony D., Chao, Nelson J., and Horwitz, Mitchell E.

Abstract

Prophylactic donor lymphocyte infusions (DLI) are used to augment post-transplant immune recovery to reduce both infectious complications and disease recurrence. Preclinical studies implicate the naive T-cell subset as the primary driver of graft-versus-host disease (GvHD). In this phase I dose escalation study, we assessed the safety of a DLI that was depleted of CD45RA+ naive T cells. Sixteen adult patients received a prophylactic DLI at a median of 113 days (range 76–280 days) following an HLA-identical, non-myeloablative allogeneic hematopoietic stem cell transplantation. Three patients each received the naive T-cell depleted DLI with a CD3+ dose of 1?×?105/kg, 1?×?106/kg, and 5?×?106/kg. The maximum dose of 1?×?107/kg was expanded to 7 patients. No dose-limiting grade III/IV acute GvHD or adverse events attributable to the DLI were observed at any dose level. One patient developed grade 2 acute GvHD of skin and upper intestines, and another developed moderate chronic GvHD of the lungs following the DLI. With a median follow-up of 2.8 years, 2-year progression-free and overall survival is 50.0% and 68.8%, respectively. In conclusion, these data suggest that a DLI that has been depleted of CD45RA+ naive T cells is feasible and carries a low risk of acute or chronic GvHD.

Published
2021
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200. A dose-finding Phase 2 study of single agent isatuximab (anti-CD38 mAb) in relapsed/refractory multiple myeloma

Author

Mikhael, Joseph, Richter, Joshua, Vij, Ravi, Cole, Craig, Zonder, Jeffrey, Kaufman, Jonathan L., Bensinger, William, Dimopoulos, Meletios, Lendvai, Nikoletta, Hari, Parameswaran, Ocio, Enrique M., Gasparetto, Cristina, Kumar, Shaji, Oprea, Corina, Chiron, Marielle, Brillac, Claire, Charpentier, Eric, San-Miguel, Jesús, and Martin, Thomas

Abstract

A Phase 2 dose-finding study evaluated isatuximab, an anti-CD38 monoclonal antibody, in relapsed/refractory multiple myeloma (RRMM; NCT01084252). Patients with =3 prior lines or refractory to both immunomodulatory drugs and proteasome inhibitors (dual refractory) were randomized to isatuximab 3?mg/kg every 2 weeks (Q2W), 10?mg/kg Q2W(2 cycles)/Q4W, or 10?mg/kg Q2W. A fourth arm evaluated 20?mg/kg QW(1 cycle)/Q2W. Patients (N?=?97) had a median (range) age of 62 years (38–85), 5 (2–14) prior therapy lines, and 85% were double refractory. The overall response rate (ORR) was 4.3, 20.0, 29.2, and 24.0% with isatuximab 3?mg/kg Q2W, 10?mg/kg Q2W/Q4W, 10?mg/kg Q2W, and 20?mg/kg QW/Q2W, respectively. At doses =10?mg/kg, median progression-free survival and overall survival were 4.6 and 18.7 months, respectively, and the ORR was 40.9% (9/22) in patients with high-risk cytogenetics. CD38 receptor density was similar in responders and non-responders. The most common non-hematologic adverse events (typically grade =2) were nausea (34.0%), fatigue (32.0%), and upper respiratory tract infections (28.9%). Infusion reactions (typically with first infusion and grade =2) occurred in 51.5% of patients. In conclusion, isatuximab is active and generally well tolerated in heavily pretreated RRMM, with greatest efficacy at doses =10?mg/kg.

Published
2020
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