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2. A multicenter study of posttransplantation low-dose inotuzumab ozogamicin to prevent relapse of acute lymphoblastic leukemia

Author

Metheny, Leland L., Sobecks, Ronald, Cho, Christina, Fu, Pingfu, Margevicius, Seunghee, Wang, Jiasheng, Ciarrone, Lisa, Kopp, Shelby, Convents, Robin D., Majhail, Navneet, Caimi, Paolo F., Otegbeye, Folashade, Cooper, Brenda W., Gallogly, Molly, Malek, Ehsan, Tomlinson, Benjamin, Gerds, Aaron T., Hamilton, Betty, Giralt, Sergio, Perales, Miguel-Angel, and de Lima, Marcos

Published
2024
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3. Pomalidomide plus low‐dose dexamethasone in relapsed refractory multiple myeloma after lenalidomide treatment failure

Author

Siegel, David S, Schiller, Gary J, Song, Kevin W, Agajanian, Richy, Stockerl‐Goldstein, Keith, Kaya, Hakan, Sebag, Michael, Samaras, Christy, Malek, Ehsan, Talamo, Giampaolo, Seet, Christopher S, Mouro, Jorge, Pierceall, William E, Zafar, Faiza, Chung, Weiyuan, Srinivasan, Shankar, Agarwal, Amit, and Bahlis, Nizar J

Subjects
Biomedical and Clinical Sciences, Cardiovascular Medicine and Haematology, Oncology and Carcinogenesis, Clinical Trials and Supportive Activities, Cancer, Hematology, Rare Diseases, Clinical Research, Evaluation of treatments and therapeutic interventions, 6.1 Pharmaceuticals, Adult, Aged, Aged, 80 and over, Antineoplastic Combined Chemotherapy Protocols, Dexamethasone, Disease-Free Survival, Female, Humans, Lenalidomide, Male, Middle Aged, Multiple Myeloma, Survival Rate, Thalidomide, pomalidomide, dexamethasone, lenalidomide, multiple myeloma, refractory, Cardiorespiratory Medicine and Haematology, Immunology, Cardiovascular medicine and haematology
Abstract

Patients with relapsed/refractory multiple myeloma (RRMM) for whom the benefits of lenalidomide have been exhausted in early treatment lines need effective therapies. In cohort A of the phase 2 MM-014 trial, we examined the safety and efficacy of pomalidomide plus low-dose dexamethasone immediately after lenalidomide-based treatment failure in patients with RRMM and two prior lines of therapy. Pomalidomide 4 mg was given on days 1 to 21 of 28-day cycles. Dexamethasone 40 mg (20 mg for patients aged >75 years) was given on days 1, 8, 15 and 22 of 28-day cycles. The primary endpoint was overall response rate (ORR), and secondary endpoints included progression-free survival (PFS), overall survival (OS) and safety. The intention-to-treat population comprised 56 patients; all received prior lenalidomide (87·5% lenalidomide refractory) and 39 (69·6%) received prior bortezomib. ORR was 32·1% (28·2% in the prior-bortezomib subgroup). Median PFS was 12·2 months (7·9 months in the prior-bortezomib subgroup). Median OS was 41·7 months (38·6 months in the prior-bortezomib subgroup). The most common grade 3/4 treatment-emergent adverse events were anaemia (25·0%), pneumonia (14·3%) and fatigue (14·3%). These findings support earlier sequencing of pomalidomide-based therapy in lenalidomide-pretreated patients with RRMM, including those who have become refractory to lenalidomide. Trial registration: www.ClinicalTrials.gov identifier NCT01946477.

Published
2020

5. Staging Systems for Newly Diagnosed Myeloma Patients Undergoing Autologous Hematopoietic Cell Transplantation: The Revised International Staging System Shows the Most Differentiation between Groups

Author

Scott, Emma C, Hari, Parameswaran, Kumar, Sathish, Fraser, Raphael, Davila, Omar, Shah, Nina, Gale, Robert Peter, Diaz, Miguel Angel, Agrawal, Vaibhav, Cornell, Robert F, Ganguly, Siddhartha, Akpek, Gorgun, Freytes, Cesar, Hashmi, Shahrukh, Malek, Ehsan, Kamble, Rammurti T, Lazarus, Hillard, Solh, Melhem, Usmani, Saad Z, Kanate, Abraham S, Saad, Ayman, Chhabra, Saurabh, Gergis, Usama, Cerny, Jan, Kyle, Robert A, Lee, Cindy, Kindwall-Keller, Tamila, Assal, Amer, Hildebrandt, Gerhard C, Holmberg, Leona, Maziarz, Richard T, Nishihori, Taiga, Seo, Sachiko, Kumar, Shaji, Mark, Tomer, and D'Souza, Anita

Subjects
Biomedical and Clinical Sciences, Cardiovascular Medicine and Haematology, Transplantation, Rare Diseases, Hematology, Cancer, Clinical Research, Adult, Aged, Cell Differentiation, Female, Hematopoietic Stem Cell Transplantation, Humans, Male, Middle Aged, Multiple Myeloma, Neoplasm Staging, Prospective Studies, Transplantation, Autologous, International staging system, Revised international staging system, Staging system comparison, Clinical Sciences, Immunology, Cardiovascular medicine and haematology
Abstract

The Revised International Staging System (R-ISS) and the International Myeloma Working Group 2014 (IMWG 2014) are newer staging systems used to prognosticate multiple myeloma (MM) outcomes. We hypothesized that these would provide better prognostic differentiation for newly diagnosed multiple myeloma (MM) compared with ISS. We analyzed the Center for International Blood and Marrow Transplant Research database from 2008 to 2014 to compare the 3 systems (N = 628) among newly diagnosed MM patients undergoing upfront autologous hematopoietic cell transplantation (AHCT). The median follow-up of survivors was 48 (range, 3 to 99) months. The R-ISS provided the greatest differentiation between survival curves for each stage (for overall survival [OS], the differentiation was 1.74 using the R-ISS, 1.58 using ISS, and 1.60 using the IMWG 2014) . Univariate analyses at 3 years for OS showed R-ISS I at 88% (95% confidence interval [CI], 83% to 93%), II at 75% (95% CI, 70% to 80%), and III at 56% (95% CI, 3% to 69%; P < .001). An integrated Brier score function demonstrated the R-ISS had the best prediction for PFS, though all systems had similar prediction for OS. Among available systems, the R-ISS is the most optimal among available prognostic tools for newly diagnosed MM undergoing AHCT. We recommend that serum lactate dehydrogenase and cytogenetic data be performed on every MM patient at diagnosis to allow accurate prognostication.

Published
2018

6. Comparison of Cilta-cel, an Anti-BCMA CAR-T Cell Therapy, Versus Conventional Treatment in Patients With Relapsed/Refractory Multiple Myeloma

Author

Costa, Luciano J., Lin, Yi, Cornell, R. Frank, Martin, Thomas, Chhabra, Saurabh, Usmani, Saad Z., Jagannath, Sundar, Callander, Natalie S., Berdeja, Jesus G., Kang, Yubin, Vij, Ravi, Godby, Kelly N., Malek, Ehsan, Neppalli, Amarendra, Liedtke, Michaela, Fiala, Mark, Tian, Hong, Valluri, Satish, Marino, Jennifer, Jackson, Carolyn C., Banerjee, Arnob, Kansagra, Ankit, Schecter, Jordan M., Kumar, Shaji, and Hari, Parameswaran

Published
2022
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11. Impact of Visceral Obesity on Clinical Outcome and Quality of Life for Patients with Multiple Myeloma: A Secondary Data Analysis of STaMINA (BMT CTN 0702) Trial

Author

Malek, Ehsan, primary, Kort, Jeries, additional, Metheny, Leland, additional, Fu, Pingfu, additional, Li, Gen, additional, Hari, Parameswaran, additional, Efebera, Yvonne, additional, Callander, Natalie S., additional, Qazilbash, Muzaffar H., additional, Giralt, Sergio, additional, Krishnan, Amrita, additional, Stadtmauer, Edward A., additional, and Lazarus, Hillard M, additional

Published
2024
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13. Data from Randomized Phase II Trial of Dendritic Cell/Myeloma Fusion Vaccine with Lenalidomide Maintenance after Upfront Autologous Hematopoietic Cell Transplantation for Multiple Myeloma: BMT CTN 1401

Author

Chung, David J., primary, Shah, Nina, primary, Wu, Juan, primary, Logan, Brent, primary, Bisharat, Lina, primary, Callander, Natalie, primary, Cheloni, Giulia, primary, Anderson, Kenneth, primary, Chodon, Thinle, primary, Dhakal, Binod, primary, Devine, Steve, primary, Somaiya Dutt, Poorvi, primary, Efebera, Yvonne, primary, Geller, Nancy, primary, Ghiasuddin, Haider, primary, Hematti, Peiman, primary, Holmberg, Leona, primary, Howard, Alan, primary, Johnson, Bryon, primary, Karagkouni, Dimitra, primary, Lazarus, Hillard M., primary, Malek, Ehsan, primary, McCarthy, Philip, primary, McKenna, David, primary, Mendizabal, Adam, primary, Nooka, Ajay, primary, Munshi, Nikhil, primary, O'Donnell, Lynn, primary, Rapoport, Aaron P., primary, Reese, Jane, primary, Rosenblatt, Jacalyn, primary, Soiffer, Robert, primary, Stroopinsky, Dina, primary, Uhl, Lynne, primary, Vlachos, Ioannis S., primary, Waller, Edmund K., primary, Young, James W., primary, Pasquini, Marcelo C., primary, and Avigan, David, primary

Published
2023
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17. Pembrolizumab plus pomalidomide and dexamethasone for patients with relapsed or refractory multiple myeloma (KEYNOTE-183): a randomised, open-label, phase 3 trial

Author

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

Published
2019
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20. Comparison of Peripheral Blast Clearance and Day 14 Bone Marrow Biopsy in Predicting Remission Status and Survival After 7+3 Induction in Acute Myeloid Leukemia

Author

Covut, Fahrettin, Gupta, Divya, Pinto, Raisa, Dambrosio, Nina, El Jurdi, Najla, Meyerson, Howard, Ueda, Masumi, Kolk, Merle, Creger, Richard, Metheny, Leland, Cooper, Brenda W., Caimi, Paolo F., Malek, Ehsan, Otegbeye, Folashade, Lazarus, Hillard M., De Lima, Marcos, and Tomlinson, Benjamin K.

Published
2019
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21. Impact of Visceral Obesity on Clinical Outcome and Quality of Life for Patients with Multiple Myeloma: A Secondary Data Analysis of STaMINA (BMT CTN 0702) Trial

Author

Malek, Ehsan, primary, Kort, Jeries, additional, Metheny, Leland, additional, Fu, Pingfu, additional, Hari, Parameswaran, additional, Li, Gen, additional, Efebera, Yvonne, additional, Callander, Natalie, additional, Qazilbash, Muzaffar, additional, Giralt, Sergio, additional, Krishnan, Amrita, additional, Stadtmauer, Edward, additional, and Lazarus, Hillard, additional

Published
2023
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23. P-020 Dendritic cell/myeloma fusion vaccine with lenalidomide maintenance following autologous hematopoietic cell transplant (HCT) results in long-term sustained T cell activation and clonotypic expansion

Author

Karagkouni, Dimitra, primary, Cheloni, Giulia, additional, Torres, Daniela, additional, Chung, David, additional, Shah, Nina, additional, Callander, Natalie, additional, Chodon, Thinle, additional, Efebera, Yvonne, additional, Geller, Nancy, additional, Hematti, Peiman, additional, Lazarus, Hillard, additional, Malek, Ehsan, additional, McCarthy, Philip, additional, Nooka, Ajay, additional, Rosenblatt, Jacalyn, additional, Rapoport, Aaron, additional, Soiffer, Robert, additional, Bisharat, Lina, additional, Stroopinsky, Dina, additional, Waller, Edmund, additional, Pasquini, Marcelo, additional, Vlachos, Ioannis, additional, and Avigan, David, additional

Published
2023
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29. P-050 GEN3014 (HexaBody-CD38) versus daratumumab in patients with relapsed/ refractory multiple myeloma: design of randomized head-to-head expansion cohort of phase 1/2 trial

Author

Grosicki, Sebastian, primary, Dhakal, Binod, additional, Malek, Ehsan, additional, Creignou, Maria, additional, Jurczak, Wojciech, additional, Broijl, Annemiek, additional, Iversen, Katrine Fladeland, additional, Gregersen, Henrik, additional, Radocha, Jakub, additional, Chen, Jenny, additional, Ogunkanmi, Adeleye, additional, and Spencer, Andrew, additional

Published
2023
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34. Study Representativeness Table 1 from Randomized Phase II Trial of Dendritic Cell/Myeloma Fusion Vaccine with Lenalidomide Maintenance after Upfront Autologous Hematopoietic Cell Transplantation for Multiple Myeloma: BMT CTN 1401

Author

Chung, David J., primary, Shah, Nina, primary, Wu, Juan, primary, Logan, Brent, primary, Bisharat, Lina, primary, Callander, Natalie, primary, Cheloni, Giulia, primary, Anderson, Kenneth, primary, Chodon, Thinle, primary, Dhakal, Binod, primary, Devine, Steve, primary, Somaiya Dutt, Poorvi, primary, Efebera, Yvonne, primary, Geller, Nancy, primary, Ghiasuddin, Haider, primary, Hematti, Peiman, primary, Holmberg, Leona, primary, Howard, Alan, primary, Johnson, Bryon, primary, Karagkouni, Dimitra, primary, Lazarus, Hillard M., primary, Malek, Ehsan, primary, McCarthy, Philip, primary, McKenna, David, primary, Mendizabal, Adam, primary, Nooka, Ajay, primary, Munshi, Nikhil, primary, O'Donnell, Lynn, primary, Rapoport, Aaron P., primary, Reese, Jane, primary, Rosenblatt, Jacalyn, primary, Soiffer, Robert, primary, Stroopinsky, Dina, primary, Uhl, Lynne, primary, Vlachos, Ioannis S., primary, Waller, Edmund K., primary, Young, James W., primary, Pasquini, Marcelo C., primary, and Avigan, David, primary

Published
2023
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35. Figure S1 from Randomized Phase II Trial of Dendritic Cell/Myeloma Fusion Vaccine with Lenalidomide Maintenance after Upfront Autologous Hematopoietic Cell Transplantation for Multiple Myeloma: BMT CTN 1401

Author

Chung, David J., primary, Shah, Nina, primary, Wu, Juan, primary, Logan, Brent, primary, Bisharat, Lina, primary, Callander, Natalie, primary, Cheloni, Giulia, primary, Anderson, Kenneth, primary, Chodon, Thinle, primary, Dhakal, Binod, primary, Devine, Steve, primary, Somaiya Dutt, Poorvi, primary, Efebera, Yvonne, primary, Geller, Nancy, primary, Ghiasuddin, Haider, primary, Hematti, Peiman, primary, Holmberg, Leona, primary, Howard, Alan, primary, Johnson, Bryon, primary, Karagkouni, Dimitra, primary, Lazarus, Hillard M., primary, Malek, Ehsan, primary, McCarthy, Philip, primary, McKenna, David, primary, Mendizabal, Adam, primary, Nooka, Ajay, primary, Munshi, Nikhil, primary, O'Donnell, Lynn, primary, Rapoport, Aaron P., primary, Reese, Jane, primary, Rosenblatt, Jacalyn, primary, Soiffer, Robert, primary, Stroopinsky, Dina, primary, Uhl, Lynne, primary, Vlachos, Ioannis S., primary, Waller, Edmund K., primary, Young, James W., primary, Pasquini, Marcelo C., primary, and Avigan, David, primary

Published
2023
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37. Targeted Marrow Irradiation Intensification of Reduced-Intensity Fludarabine/Busulfan Conditioning for Allogeneic Hematopoietic Stem Cell Transplantation

Author

Ali, Naveed, Sharma, Ashish Arunkumar, de Rezende, Ana Carolina Pires, Otegbeye, Folashade, Latif, Bilal Muhammad, Kerbauy, Mariana Nassif, Cooper, Brenda W., Sanchez, Gabriela, Metheny, Leland, Bal, Saswat K., Sakuraba, Roberto, Tomlinson, Benjamin K., Boughan, Kirsten M., Kerbauy, Lucila, Malek, Ehsan, Ribeiro, Andreza Feitosa, Gallogly, Molly, Mansur, David, Pereira, Gisele, Weltman, Eduardo, Sekaly, Rafick-Pierre, de Lima, Marcos, Caimi, Paolo F., and Hamerschlak, Nelson

Published
2022
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38. Outcomes of patients with multiple myeloma refractory to CD38-targeted monoclonal antibody therapy

Author

Gandhi, Ujjawal H., Cornell, Robert F., Lakshman, Arjun, Gahvari, Zhubin J., McGehee, Elizabeth, Jagosky, Megan H., Gupta, Ridhi, Varnado, William, Fiala, Mark A., Chhabra, Saurabh, Malek, Ehsan, Mansour, Joshua, Paul, Barry, Barnstead, Alyssa, Kodali, Saranya, Neppalli, Amarendra, Liedtke, Michaela, Narayana, Swapna, Godby, Kelly N., Kang, Yubin, Kansagra, Ankit, Umyarova, Elvira, Scott, Emma C., Hari, Parameswaran, Vij, Ravi, Usmani, Saad Z., Callander, Natalie S., Kumar, Shaji K., and Costa, Luciano J.

Published
2019
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39. Randomized Trial of a Personalized Dendritic Cell Vaccine after Autologous Stem Cell Transplant for Multiple Myeloma

Author

Chung, David J., primary, Shah, Nina, additional, Wu, Juan, additional, Logan, Brent, additional, Bisharat, Lina, additional, Callander, Natalie, additional, Cheloni, Giulia, additional, Anderson, Kenneth, additional, Chodon, Thinle, additional, Dhakal, Binod, additional, Devine, Steven, additional, Somaiya Dutt, Poorvi, additional, Efebera, Yvonne, additional, Geller, Nancy, additional, Ghiasuddin, Haider, additional, Hematti, Peiman, additional, Holmberg, Leona, additional, Howard, Alan, additional, Johnson, Bryon, additional, Karagkouni, Dimitra, additional, Lazarus, Hillard M., additional, Malek, Ehsan, additional, McCarthy, Philip, additional, McKenna, David, additional, Mendizabal, Adam, additional, Nooka, Ajay, additional, Munshi, Nikhil, additional, O'Donnell, Lynn, additional, Rapoport, Aaron P., additional, Reese, Jane, additional, Rosenblatt, Jacalyn, additional, Soiffer, Robert, additional, Stroopinsky, Dina, additional, Uhl, Lynne, additional, Vlachos, Ioannis S., additional, Waller, Edmund K., additional, Young, James W., additional, Pasquini, Marcelo C., additional, and Avigan, David, additional

Published
2023
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42. Abstract 6785: Dendritic cell/myeloma fusion vaccine with lenalidomide maintenance following autologous hematopoietic cell transplant induced T cell activation and expansion

Author

Cheloni, Giulia, primary, Karagkouni, Dimitra, additional, Torres, Daniela, additional, Chung, David J., additional, Shah, Nina, additional, Callander, Natalie S., additional, Chodon, Thinle, additional, Efebera, Yvonne, additional, Geller, Nancy, additional, Hematti, Peiman, additional, Lazarus, Hillard, additional, Malek, Ehsan, additional, McCarthy, Philip L., additional, Nooka, Ajay K., additional, Rosenblatt, Jacalyn, additional, Rapoport, Aaron P., additional, Soiffer, Robert J., additional, Stroopinsky, Dina, additional, Waller, Edmund K., additional, Pasquini, Marcelo C., additional, Vlachos, Ioannis, additional, and Avigan, David, additional

Published
2023
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44. Impact of Visceral Obesity on Clinical Outcome and Quality of Life for Patients with Multiple Myeloma: A Secondary Data Analysis of Stamina Trial

Author

Malek, Ehsan, primary, Kort, Jeries, additional, Metheny, Leland, additional, Fu, Pingfu, additional, Li, Gen, additional, Hari, Parameswaran, additional, Efebera, Yvonne, additional, Qazilbash, Muzaffar H., additional, Giralt, Sergio, additional, Krishnan, Amrita, additional, Stadtmauer, Edward A., additional, and Lazarus, Hillard, additional

Published
2023
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46. A Multicenter Study of Post-Transplant Low-Dose Inotuzumab Ozogamicin to Prevent Relapse of Acute Lymphoblastic Leukemia

Author

Metheny, Leland, primary, Sobecks, Ronald, additional, Cho, Christina, additional, Fu, Pingfu, additional, Margevicius, Seunghee, additional, Wang, Jiasheng, additional, Ciarrone, Lisa, additional, Kopp, Shelby, additional, Convents, Robin D., additional, Majhail, Navneet, additional, Caimi, Paolo F., additional, Otegbeye, Folashade, additional, Cooper, Brenda W., additional, Gallogly, Molly, additional, Malek, Ehsan, additional, Tomlinson, Benjamin, additional, Gerds, Aaron T., additional, Hamilton, Betty, additional, Giralt, Sergio A., additional, Perales, Miguel-Angel, additional, and de Lima, Marcos, additional

Published
2023
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50. Multicenter Phase I Study of Post-Transplant Low-Dose Inotuzumab Ozogamicin to Prevent Relapse of Acute Lymphoblastic Leukemia

Author

Metheny, Leland, primary, Sobecks, Ronald M., additional, Cho, Christina, additional, Wang, Jiasheng, additional, Ciarrone, Lisa, additional, Caimi, Paolo F., additional, Otegbeye, Folashade, additional, Cooper, Brenda W., additional, Gallogly, Molly, additional, Malek, Ehsan, additional, Gerds, Aaron T., additional, Hamilton, Betty K., additional, Giralt, Sergio A, additional, Perales, Miguel-Angel, additional, and de Lima, Marcos J.G., additional

Published
2022
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