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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

4. 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

7. 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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10. 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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11. 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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12. 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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14. 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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16. 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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19. 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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27. Efficacy of Treatments for Patients with Triple-Class Refractory (TCR) Multiple Myeloma (MM): Benchmark for New Agents Utilizing Real-World Data (RWD)

Author

Costa, Luciano J., primary, Cornell, Robert Frank, additional, Callander, Natalie S., additional, Chhabra, Saurabh, additional, Liedtke, Michaela, additional, Kansagra, Ankit, additional, Godby, Kelly N., additional, Bal, Susan, additional, Giri, Smith, additional, Malek, Ehsan, additional, Kang, Yubin, additional, Vij, Ravi, additional, Usmani, Saad Z., additional, Hari, Parameswaran, additional, and Kumar, Shaji, additional

Published
2021
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30. Impact of Autologous Hematopoietic Cell Transplant (HCT) Followed By Dendritic Cell/Myeloma Fusion Vaccine with Lenalidomide Maintenance in Increasing Multiple Myeloma (MM) Immunity (BMT CTN 1401)

Author

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

Published
2021
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32. Post-Transplant Inotuzumab Ozogamicin for Acute Lymphoblastic Leukemia

Author

Metheny, Leland, primary, Sobecks, Ronald M., additional, Cho, Christina, additional, Caimi, Paolo F., additional, Majhail, Navneet S., additional, Otegbeye, Folashade, additional, Boughan, Kirsten M, additional, Cooper, Brenda W., additional, Galloway, Erin, additional, Gallogly, Molly, additional, Malek, Ehsan, additional, Tomlinson, Benjamin, additional, Gerds, Aaron T., additional, Hamilton, Betty K., additional, Kalaycio, Matt, additional, Giralt, Sergio A, additional, and de Lima, Marcos J.G., additional

Published
2021
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42. Immune Profiling and Responses of Smoldering Multiple Myeloma Patients Treated in a Phase Ib Study of Pvx-410 Vaccine Targeting XBP1/CD138/CS1 Antigens, and Citarinostat, a Histone Deacetylase Inhibitor (HDACi) with and without Lenalidomide

Author

Cirstea, Diana, Shome, Rajib, Connolly, Joseph James, Duvallet, Emilie, Joyce, Amanda N. R., Moyo, Victor, Lively, Kathleen, Basinsky, Gina, Yee, Andrew J., Costa Chase, Cristiana, Malek, Ehsan, Niesvizky, Ruben, Richardson, Paul G., and Raje, Noopur S.

Published
2023
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45. Age no bar : A CIBMTR analysis of elderly patients undergoing autologous hematopoietic cell transplantation for multiple myeloma

Author

Munshi, Pashna N., Vesole, David, Jurczyszyn, Artur, Zaucha, Jan Maciej, St Martin, Andrew, Davila, Omar, Agrawal, Vaibhav, Badawy, Sherif M., Battiwalla, Minoo, Chhabra, Saurabh, Copelan, Edward, Kharfan-Dabaja, Mohamed A., Farhadfar, Nosha, Ganguly, Siddhartha, Hashmi, Shahrukh, Krem, Maxwell M., Lazarus, Hillard M., Malek, Ehsan, Meehan, Kenneth, Murthy, Hemant S., Nishihori, Taiga, Olin, Rebecca L., Olsson, Richard F., Schriber, Jeffrey, Seo, Sachiko, Shah, Gunjan, Solh, Melhem, Tay, Jason, Kumar, Shaji, Qazilbash, Muzaffar H., Shah, Nina, Hari, Parameswaran N., D'Souza, Anita, Munshi, Pashna N., Vesole, David, Jurczyszyn, Artur, Zaucha, Jan Maciej, St Martin, Andrew, Davila, Omar, Agrawal, Vaibhav, Badawy, Sherif M., Battiwalla, Minoo, Chhabra, Saurabh, Copelan, Edward, Kharfan-Dabaja, Mohamed A., Farhadfar, Nosha, Ganguly, Siddhartha, Hashmi, Shahrukh, Krem, Maxwell M., Lazarus, Hillard M., Malek, Ehsan, Meehan, Kenneth, Murthy, Hemant S., Nishihori, Taiga, Olin, Rebecca L., Olsson, Richard F., Schriber, Jeffrey, Seo, Sachiko, Shah, Gunjan, Solh, Melhem, Tay, Jason, Kumar, Shaji, Qazilbash, Muzaffar H., Shah, Nina, Hari, Parameswaran N., and D'Souza, Anita

Abstract

Background Upfront autologous hematopoietic stem cell transplantation (AHCT) remains an important therapy in the management of patients with multiple myeloma (MM), a disease of older adults. Methods The authors investigated the outcomes of AHCT in patients with MM who were aged >= 70 years. The Center for International Blood and Marrow Transplant Research (CIBMTR) database registered 15,999 patients with MM in the United States within 12 months of diagnosis during 2013 through 2017; a total of 2092 patients were aged >= 70 years. Nonrecurrence mortality (NRM), disease recurrence and/or progression (relapse; REL), progression-free survival (PFS), and overall survival (OS) were modeled using Cox proportional hazards models with age at transplantation as the main effect. Because of the large sample size, aPvalue <.01 was considered to be statistically significant a priori. Results An increase in AHCT was noted in 2017 (28%) compared with 2013 (15%) among patients aged >= 70 years. Although approximately 82% of patients received melphalan (Mel) at a dose of 200 mg/m(2)overall, 58% of the patients aged >= 70 years received Mel at a dose of 140 mg/m(2). On multivariate analysis, patients aged >= 70 years demonstrated no difference with regard to NRM (hazard ratio [HR] 1.3; 99% confidence interval [99% CI], 1-1.7 [P = .06]), REL (HR, 1.03; 99% CI, 0.9-1.1 [P = 0.6]), PFS (HR, 1.06; 99% CI, 1-1.2 [P = 0.2]), and OS (HR, 1.2; 99% CI, 1-1.4 [P = .02]) compared with the reference group (those aged 60-69 years). In patients aged >= 70 years, Mel administered at a dose of 140 mg/m(2)was found to be associated with worse outcomes compared with Mel administered at a dose of 200 mg/m(2), including day 100 NRM (1% [95% CI, 1%-2%] vs 0% [95% CI, 0%-1%];P = .003]), 2-year PFS (64% [95% CI, 60%-67%] vs 69% [95% CI, 66%-73%];P = .003), and 2-year OS (85% [95% CI, 82%-87%] vs 89% [95% CI, 86%-91%];P = .01]), likely representing frailty. Conclusions The results of the

Published
2020
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46. Socioeconomic Factors and Survival of Multiple Myeloma Patients

Author

Chamoun, Kamal, primary, Firoozmand, Amin, additional, Caimi, Paolo, additional, Fu, Pingfu, additional, Cao, Shufen, additional, Otegbeye, Folashade, additional, Metheny, Leland, additional, Patel, Seema, additional, Gerson, Stanton L., additional, Boughan, Kirsten, additional, De Lima, Marcos, additional, and Malek, Ehsan, additional

Published
2021
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49. Impact of Daratumumab on Stem Cell Collection, Graft Composition and Engraftment Among Multiple Myeloma Patients Undergoing Autologous Stem Cell Transplant

Author

Manjappa, Shivaprasad, primary, Fox, Robert, additional, Reese, Jane, additional, Firoozamand, Amin, additional, Schmikla, Hannah, additional, Nall, Savannah, additional, Kolk, Merle, additional, Caimi, Paolo F, additional, Driscoll, James J., additional, de Lima, Marcos, additional, and Malek, Ehsan, additional

Published
2020
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50. Low Dose Daily Corticosteroid Tapering Regimen Allows Highly Effective and Practical Desensitization for Multiple Myeloma Patients with Skin Rash after Immunomodulatory Drugs

Author

Firoozmand, Amin, primary, Ali, Naveed, additional, Ahmed, Nausheen, additional, Fu, Pingfu, additional, Cao, Shufen, additional, Brown, George, additional, Schmikla, Hannah, additional, Driscoll, James J., additional, O'Brien, Timothy, additional, Caimi, Paolo, additional, de Lima, Marcos, additional, and Malek, Ehsan, additional

Published
2020
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