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Browsing by Author "Mailankody, Sham"
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Item ASTCT Clinical Practice Recommendations for Transplantation and Cellular Therapies in Multiple Myeloma(Elsevier, 2022) Dhakal, Binod; Shah, Nina; Kansagra, Ankit; Kumar, Ambuj; Lonial, Sagar; Garfall, Alfred; Cowan, Andrew; Poudyal, Bishesh Sharma; Costello, Caitlin; Gay, Francesca; Cook, Gordon; Quach, Hang; Einsele, Herman; Schriber, Jeff; Hou, Jian; Costa, Luciano; Aljurf, Mahmoud; Chaudhry, Maria; Beksac, Meral; Prince, Miles; Mohty, Mohamad; Janakiram, Murali; Callander, Natalie; Biran, Noa; Malhotra, Pankaj; Rodriguez Otero, Paula; Moreau, Philippe; Abonour, Rafat; Iftikhar, Raheel; Silberman, Rebecca; Mailankody, Sham; Gregory, Tara; Lin, Yi; Carpenter, Paul; Hamadani, Mehdi; Usmani, Saad; Kumar, Shaji; Medicine, School of MedicineOver the past decade, therapeutic options in multiple myeloma (MM) have changed dramatically. Given the unprecedented efficacy of novel agents, the role of hematopoietic cell transplantation (HCT) in MM remains under scrutiny. Rapid advances in myeloma immunotherapy including the recent approval of chimeric antigen receptor (CAR) T-cell therapy will impact the MM therapeutic landscape. The American Society for Transplantation and Cellular Therapy convened an expert panel to formulate clinical practice recommendations for role, timing, and sequencing of autologous (auto-HCT), allogeneic (allo-HCT) and CAR T-cell therapy for patients with newly diagnosed (NDMM) and relapsed/refractory MM (RRMM). The RAND-modified Delphi method was used to generate consensus statements. Twenty consensus statements were generated. The panel endorsed continued use of auto-HCT consolidation for patients with NDMM as a standard-of-care option, whereas in the front line allo-HCT and CAR-T were not recommended outside the setting of clinical trial. For patients not undergoing auto-HCT upfront, the panel recommended its use in first relapse. Lenalidomide as a single agent was recommended for maintenance especially for standard risk patients. In the RRMM setting, the panel recommended the use of CAR-T in patients with 4 or more prior lines of therapy. The panel encouraged allo-HCT in RRMM setting only in the context of clinical trial. The panel found RAND-modified Delphi methodology effective in providing a formal framework for developing consensus recommendations for the timing and sequence of cellular therapies for MM.Item Replication competent retrovirus testing (RCR) in the National Gene Vector Biorepository: No evidence of RCR in 1,595 post-treatment peripheral blood samples obtained from 60 clinical trials(Elsevier, 2023) Cornetta, Kenneth; Yao, Jing; House, Kimberley; Duffy, Lisa; Adusumilli, Prasad S.; Beyer, Rachel; Booth, Claire; Brenner, Malcolm; Curran, Kevin; Grilley, Bambi; Heslop, Helen; Hinrichs, Christian S.; Kaplan, Rosandra N.; Kiem, Hans-Peter; Kochenderfer, James; Kohn, Donald B.; Mailankody, Sham; Norberg, Scott M.; O’Cearbhaill, Roisin E.; Pappas, Jennifer; Park, Jae; Ramos, Carlos; Ribas, Antonio; Rivière, Isabelle; Rosenberg, Steven A.; Sauter, Craig; Shah, Nirali N.; Slovin, Susan F.; Thrasher, Adrian; Williams, David A.; Lin, Tsai-Yu; Medical and Molecular Genetics, School of MedicineThe clinical impact of any therapy requires the product be safe and effective. Gammaretroviral vectors pose several unique risks, including inadvertent exposure to replication competent retrovirus (RCR) that can arise during vector manufacture. The US FDA has required patient monitoring for RCR, and the National Gene Vector Biorepository is an NIH resource that has assisted eligible investigators in meeting this requirement. To date, we have found no evidence of RCR in 338 pre-treatment and 1,595 post-treatment blood samples from 737 patients associated with 60 clinical trials. Most samples (75%) were obtained within 1 year of treatment, and samples as far out as 9 years after treatment were analyzed. The majority of trials (93%) were cancer immunotherapy, and 90% of the trials used vector products produced with the PG13 packaging cell line. The data presented here provide further evidence that current manufacturing methods generate RCR-free products and support the overall safety profile of retroviral gene therapy.Item Summary of the 2019 Blood and Marrow Transplant Clinical Trials Network Myeloma Intergroup Workshop on Minimal Residual Disease and Immune Profiling(Elsevier, 2020-10) Holstein, Sarah A.; Howard, Alan; Avigan, David; Bhutani, Manisha; Cohen, Adam D.; Costa, Luciano J.; Dhodapkar, Madhav V.; Gay, Francesca; Gormley, Nicole; Green, Damian J.; Hillengass, Jens; Korde, Neha; Li, Zihai; Mailankody, Sham; Neri, Paola; Parekh, Samir; Pasquini, Marcelo C.; Puig, Noemi; Roodman, G. David; Samur, Mehmet Kemal; Shah, Nina; Shah, Urvi A.; Shi, Qian; Spencer, Andrew; Suman, Vera J.; Usmani, Saad Z.; McCarthy, Philip L.; Medicine, School of MedicineThe Blood and Marrow Transplant Clinical Trials Network (BMT CTN) Myeloma Intergroup has organized an annual workshop focused on minimal residual disease (MRD) testing and immune profiling (IP) in multiple myeloma since 2016. In 2019, the workshop took place as an American Society of Hematology (ASH) Friday Scientific Workshop entitled “Immune Profiling and Minimal Residual Disease Testing in Multiple Myeloma”. This workshop focused on four main topics: the molecular and immunological evolution of plasma cell disorders, the development of new laboratory- and imaging-based MRD assessment approaches, chimeric antigen receptor T-cell therapy research, and the statistical and regulatory issues associated with novel clinical endpoints. In this report, we provide a summary of the workshop and discuss future directions.