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2. Harmonizing definitions for hematopoietic recovery, graft rejection, graft failure, poor graft function, and donor chimerism in allogeneic hematopoietic cell transplantation: a report on behalf of the EBMT, ASTCT, CIBMTR, and APBMT

Author

Sureda, Anna, Carpenter, Paul A., Bacigalupo, Andrea, Bhatt, Vijaya Raj, de la Fuente, Josu, Ho, Aloysius, Kean, Leslie, Lee, Jong Wook, Sánchez-Ortega, Isabel, Savani, Bipin N., Schetelig, Johannes, Stadtmauer, Edward A., Takahashi, Yoshiyuki, Atsuta, Yoshiko, Koreth, John, Kröger, Nicolaus, Ljungman, Per, Okamoto, Shinichiro, Popat, Uday, Soiffer, Robert, Stefanski, Heather E., and Kharfan-Dabaja, Mohamed A.

Published
2024
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3. Mitigation of chromosome loss in clinical CRISPR-Cas9-engineered T cells

Author

Tsuchida, Connor A, Brandes, Nadav, Bueno, Raymund, Trinidad, Marena, Mazumder, Thomas, Yu, Bingfei, Hwang, Byungjin, Chang, Christopher, Liu, Jamin, Sun, Yang, Hopkins, Caitlin R, Parker, Kevin R, Qi, Yanyan, Hofman, Laura, Satpathy, Ansuman T, Stadtmauer, Edward A, Cate, Jamie HD, Eyquem, Justin, Fraietta, Joseph A, June, Carl H, Chang, Howard Y, Ye, Chun Jimmie, and Doudna, Jennifer A

Subjects
Biomedical and Clinical Sciences, Immunology, Genetics, Clinical Research, Gene Therapy, Biotechnology, Bioengineering, 5.2 Cellular and gene therapies, 5.1 Pharmaceuticals, Generic health relevance, Cancer, Humans, Chromosomes, CRISPR-Cas Systems, DNA Damage, Gene Editing, T-Lymphocytes, Clinical Trials as Topic, Chromosome Aberrations, CAR T cells, CRISPR screen, CRISPR-Cas9, DNA repair, T cells, aneuploidy, chromosome loss, clinical trial, genome editing, immunoengineering, genome editing&#x3a, CAR T cells, Biological Sciences, Medical and Health Sciences, Developmental Biology, Biological sciences, Biomedical and clinical sciences
Abstract

CRISPR-Cas9 genome editing has enabled advanced T cell therapies, but occasional loss of the targeted chromosome remains a safety concern. To investigate whether Cas9-induced chromosome loss is a universal phenomenon and evaluate its clinical significance, we conducted a systematic analysis in primary human T cells. Arrayed and pooled CRISPR screens revealed that chromosome loss was generalizable across the genome and resulted in partial and entire loss of the targeted chromosome, including in preclinical chimeric antigen receptor T cells. T cells with chromosome loss persisted for weeks in culture, implying the potential to interfere with clinical use. A modified cell manufacturing process, employed in our first-in-human clinical trial of Cas9-engineered T cells (NCT03399448), reduced chromosome loss while largely preserving genome editing efficacy. Expression of p53 correlated with protection from chromosome loss observed in this protocol, suggesting both a mechanism and strategy for T cell engineering that mitigates this genotoxicity in the clinic.

Published
2023

4. T cell lymphoma and secondary primary malignancy risk after commercial CAR T cell therapy

Author

Ghilardi, Guido, Fraietta, Joseph A., Gerson, James N., Van Deerlin, Vivianna M., Morrissette, Jennifer J. D., Caponetti, Gabriel C., Paruzzo, Luca, Harris, Jaryse C., Chong, Elise A., Susanibar Adaniya, Sandra P., Svoboda, Jakub, Nasta, Sunita D., Ugwuanyi, Ositadimma H., Landsburg, Daniel J., Fardella, Eugenio, Waxman, Adam J., Chong, Emeline R., Patel, Vrutti, Pajarillo, Raymone, Kulikovskaya, Irina, Lieberman, David B., Cohen, Adam D., Levine, Bruce L., Stadtmauer, Edward A., Frey, Noelle V., Vogl, Dan T., Hexner, Elizabeth O., Barta, Stefan K., Porter, David L., Garfall, Alfred L., Schuster, Stephen J., June, Carl H., and Ruella, Marco

Published
2024
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5. Correction: Harmonizing definitions for hematopoietic recovery, graft rejection, graft failure, poor graft function, and donor chimerism in allogeneic hematopoietic cell transplantation: a report on behalf of the EBMT, ASTCT, CIBMTR, and APBMT

Author

Sureda, Anna, Carpenter, Paul A., Bacigalupo, Andrea, Bhatt, Vijaya Raj, de la Fuente, Josu, Ho, Aloysius, Kean, Leslie, Lee, Jong Wook, Sánchez-Ortega, Isabel, Savani, Bipin N., Schetelig, Johannes, Stadtmauer, Edward A., Takahashi, Yoshiyuki, Atsuta, Yoshiko, Koreth, John, Kröger, Nicolaus, Ljungman, Per, Okamoto, Shinichiro, Popat, Uday, Soiffer, Robert, Stefanski, Heather E., and Kharfan-Dabaja, Mohamed A.

Published
2024
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8. Mass-Fix better predicts for PFS and OS than standard methods among multiple myeloma patients participating on the STAMINA trial (BMT CTN 0702 /07LT)

Author

Dispenzieri, Angela, Krishnan, Amrita, Arendt, Bonnie, Blackwell, Beth, Wallace, Paul K, Dasari, Surendra, Vogl, Dan T, Efebera, Yvonne, Fei, Mingwei, Geller, Nancy, Giralt, Sergio, Hahn, Theresa, Howard, Alan, Kohlhagen, Mindy, Landau, Heather, Hari, Parameswaran, Pasquini, Marcelo C, Qazilbash, Muzaffar H, McCarthy, Philip, Shah, Nina, Vesole, David H, Stadtmauer, Edward, and Murray, David

Subjects
Biomedical and Clinical Sciences, Cardiovascular Medicine and Haematology, Clinical Research, Hematology, Cancer, Humans, Diterpenes, Flow Cytometry, Multiple Myeloma, Neoplasm, Residual, Prognosis, Progression-Free Survival, Treatment Outcome, Cardiorespiratory Medicine and Haematology, Oncology and Carcinogenesis, Cardiovascular medicine and haematology, Oncology and carcinogenesis
Abstract

Measuring response among patients with multiple myeloma is essential for the care of patients. Deeper responses are associated with better progression free survival (PFS) and overall survival (OS). To test the hypothesis that Mass-Fix, a mass spectrometry-based means to detect monoclonal proteins, is superior to existing methodologies to predict for survival outcomes, samples from the STAMINA trial (NCT01109004), a trial comparing three transplant approaches, were employed. Samples from 575 patients from as many as three time points (post-induction [post-I; pre-maintenance [pre-M]; 1 year post enrollment [1YR]) were tested when available. Four response parameters were assessed: Mass-Fix, serum immunofixation, complete response, and measurable residual disease (MRD) by next generation flow cytometry. Of the four response measures, only MRD and Mass-Fix predicted for PFS and OS at multiple testing points on multivariate analyses. Although MRD drove Mass-Fix from the model for PFS at post-I and pre-M, 1YR Mass-Fix was independent of 1YR MRD. For OS, the only prognostic pre-I measure was Mass-Fix, and the only 1YR measures that were prognostic on multivariate analysis were 1YR MRD and 1YR Mass-Fix. SIFE and CR were not. Mass-Fix is a powerful means to track response.

Published
2022

9. Adjuvanted recombinant zoster vaccine in adult autologous stem cell transplant recipients: polyfunctional immune responses and lessons for clinical practice

Author

Stadtmauer, Edward A, Sullivan, Keith M, Idrissi, Mohamed El, Salaun, Bruno, Alonso, Aránzazu Alonso, Andreadis, Charalambos, Anttila, Veli-Jukka, Bloor, Adrian JC, Broady, Raewyn, Cellini, Claudia, Cuneo, Antonio, Dagnew, Alemnew F, Di Paolo, Emmanuel, Eom, HyeonSeok, González-Rodríguez, Ana Pilar, Grigg, Andrew, Guenther, Andreas, Heineman, Thomas C, Jarque, Isidro, Kwak, Jae-Yong, Lucchesi, Alessandro, Oostvogels, Lidia, Zarzuela, Marta Polo, Schuind, Anne E, Shea, Thomas C, Sinisalo, Ulla Marjatta, Vural, Filiz, San Segundo, Lucrecia Yáñez, Zachée, Pierre, and Bastidas, Adriana

Subjects
Clinical Research, Rare Diseases, Cancer, Immunization, Prevention, Clinical Trials and Supportive Activities, Hematology, Lymphoma, Vaccine Related, Stem Cell Research, Transplantation, 6.2 Cellular and gene therapies, Evaluation of treatments and therapeutic interventions, Good Health and Well Being, Hematopoietic Stem Cell Transplantation, Herpes Zoster, Herpes Zoster Vaccine, Herpesvirus 3, Human, Humans, Immunity, Cellular, Vaccine Efficacy, Autologous hematopoietic stem cell transplant, cell-mediated immunity, polyfunctionality, humoral immune response, adjuvanted recombinant zoster vaccine, vaccine efficacy, Immunology, Medical Microbiology, Pharmacology and Pharmaceutical Sciences, Virology
Abstract

Immunocompromised individuals, particularly autologous hematopoietic stem cell transplant (auHSCT) recipients, are at high risk for herpes zoster (HZ). We provide an in-depth description of humoral and cell-mediated immune (CMI) responses by age (protocol-defined) or underlying disease (post-hoc) as well as efficacy by underlying disease (post-hoc) of the adjuvanted recombinant zoster vaccine (RZV) in a randomized observer-blind phase III trial (ZOE-HSCT, NCT01610414). 1846 adult auHSCT recipients were randomized to receive a first dose of either RZV or placebo 50-70 days post-auHSCT, followed by the second dose at 1-2 months (M) later. In cohorts of 114-1721 participants, at 1 M post-second vaccine dose: Anti-gE antibody geometric mean concentrations (GMCs) and median gE-specific CD4[2+] T-cell frequencies (CD4 T cells expressing ≥2 of four assessed activation markers) were similar between 18-49 and ≥50-year-olds. Despite lower anti-gE antibody GMCs in non-Hodgkin B-cell lymphoma (NHBCL) patients, CD4[2+] T-cell frequencies were similar between NHBCL and other underlying diseases. The proportion of polyfunctional CD4 T cells increased over time, accounting for 79.6% of gE-specific CD4 T cells at 24 M post-dose two. Vaccine efficacy against HZ ranged between 42.5% and 82.5% across underlying diseases and was statistically significant in NHBCL and multiple myeloma patients. In conclusion, two RZV doses administered early post-auHSCT induced robust, persistent, and polyfunctional gE-specific immune responses. Efficacy against HZ was also high in NHBCL patients despite the lower humoral response.

Published
2021

10. Blood and Marrow Transplant Clinical Trials Network State of the Science Symposium 2021: Looking Forward as the Network Celebrates its 20th Year

Author

Heslop, Helen E, Stadtmauer, Edward A, Levine, John E, Ballen, Karen K, Chen, Yi-Bin, DeZern, Amy E, Eapen, Mary, Hamadani, Mehdi, Hamilton, Betty K, Hari, Parameswaran, Jones, Richard J, Logan, Brent R, Kean, Leslie S, Leifer, Eric S, Locke, Frederick L, Maziarz, Richard T, Nemecek, Eneida R, Pasquini, Marcelo, Phelan, Rachel, Riches, Marcie L, Shaw, Bronwen E, Walters, Mark C, Foley, Amy, Devine, Steven M, and Horowitz, Mary M

Subjects
Stem Cell Research, Clinical Trials and Supportive Activities, Transplantation, Clinical Research, Bone Marrow Transplantation, Clinical Trials as Topic, Hematopoietic Stem Cell Transplantation, Humans, Transplants, BMT, Cell Therapy, Clinical Trial
Abstract

In 2021 the BMT CTN held the 4th State of the Science Symposium where the deliberations of 11 committees concerning major topics pertinent to a particular disease, modality, or complication of transplant, as well as two committees to consider clinical trial design and inclusion, diversity, and access as cross-cutting themes were reviewed. This article summarizes the individual committee reports and their recommendations on the highest priority questions in hematopoietic stem cell transplant and cell therapy to address in multicenter trials.

Published
2021

13. Survival Outcomes for Patients with Relapsed/ Refractory Aggressive B Cell Lymphomas Following Receipt of High-Dose Chemotherapy/Autologous Stem Transplantation and/or Chimeric Antigen Receptor-Modified T Cells

Author

Landsburg, Daniel J., Nasta, Sunita D., Svoboda, Jakub, Gerson, James N., Schuster, Stephen J., Barta, Stefan K., Chong, Elise A., Difilippo, Heather, Weber, Elizabeth, Cunningham, Kathleen, Catania, Christopher, Garfall, Alfred L., Stadtmauer, Edward A., Frey, Noelle V., and Porter, David L.

Published
2023
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15. List of contributors

Author

Benson, Merrill D., primary, Connaughton, Dervla M., additional, Friedman, David J., additional, Ginsburg, David, additional, Hildebrandt, Friedhelm, additional, Jalanko, Hannu, additional, Kääriäinen, Helena, additional, Luger, Selina M., additional, Morrissette, Jennifer J.D., additional, Mrug, Michal, additional, Peslak, Scott, additional, Pollak, Martin R., additional, Pyeritz, Reed E., additional, Rahbari Oskoui, Frederic, additional, Rizk, Dana V., additional, Roth, Jacquelyn J., additional, Saigusa, Takamitsu, additional, Sayani, Farzana, additional, Shavit, Jordan A., additional, Stadtmauer, Edward A., additional, Sullivan, Kathleen E., additional, and Weyand, Angela C., additional

Published
2023
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16. Clofarabine and Busulfan Myeloablative Conditioning in Allogeneic Hematopoietic Cell Transplantation for Patients With Active Myeloid Malignancies

Author

Connor, Matthew P., Loren, Alison W., Hexner, Elizabeth O., Martin, Mary Ellen, Gill, Saar I., Luger, Selina M., Mangan, James K., Perl, Alexander E., McCurdy, Shannon R., Pratz, Keith W., Timlin, Colleen, Freyer, Craig W., Carulli, Alison, Catania, Christopher, Smith, Jacqueline, Hollander, Lauren, Zebrowski, Alexis M., Stadtmauer, Edward A., Porter, David L., and Frey, Noelle V.

Published
2023
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18. Prospective Study of Cardiac Events During Proteasome Inhibitor Therapy for Relapsed Multiple Myeloma.

Author

Cornell, Robert, Ky, Bonnie, Weiss, Brendan, Dahm, Cherie, Gupta, Deepak, Du, Liping, Carver, Joseph, Cohen, Adam, Engelhardt, Brian, Garfall, Alfred, Goodman, Stacey, Harrell, Shelton, Kassim, Adetola, Jadhav, Trafina, Jagasia, Madan, Moslehi, Javid, OQuinn, Rupal, Savona, Michael, Slosky, David, Smith, Amanda, Stadtmauer, Edward, Vogl, Dan, Waxman, Adam, and Lenihan, Daniel

Subjects
Adult, Aged, Aged, 80 and over, Bortezomib, Cardiovascular Diseases, Disease-Free Survival, Electrocardiography, Female, Heart Diseases, Humans, Kaplan-Meier Estimate, Male, Middle Aged, Molecular Targeted Therapy, Multiple Myeloma, Natriuretic Peptide, Brain, Neoplasm Recurrence, Local, Oligopeptides, Prospective Studies, Proteasome Inhibitors, Risk Factors, Time-to-Treatment, Treatment Outcome, Troponin I, Troponin T
Abstract

PURPOSE: Cardiovascular adverse events (CVAEs) can occur during proteasome inhibitor (PI) therapy. We conducted a prospective, observational, multi-institutional study to define risk factors and outcomes in patients with multiple myeloma (MM) receiving PIs. PATIENTS AND METHODS: Patients with relapsed MM initiating carfilzomib- or bortezomib-based therapy underwent baseline assessments and repeated assessments at regular intervals over 6 months, including cardiac biomarkers (troponin I or T, brain natriuretic peptide [BNP], and N-terminal proBNP), ECG, and echocardiography. Monitoring occurred over 18 months for development of CVAEs. RESULTS: Of 95 patients enrolled, 65 received carfilzomib and 30 received bortezomib, with median 25 months of follow-up. Sixty-four CVAEs occurred, with 55% grade 3 or greater in severity. CVAEs occurred in 51% of patients treated with carfilzomib and 17% of those treated with bortezomib (P = .002). Median time to first CVAE from treatment start was 31 days, and 86% occurred within the first 3 months. Patients receiving carfilzomib-based therapy with a baseline elevated BNP level higher than 100 pg/mL or N-terminal proBNP level higher than 125 pg/mL had increased risk for CVAE (odds ratio, 10.8; P < .001). Elevated natriuretic peptides occurring mid-first cycle of treatment with carfilzomib were associated with a substantially higher risk of CVAEs (odds ratio, 36.0; P < .001). Patients who experienced a CVAE had inferior progression-free survival (log-rank P = .01) and overall survival (log-rank P < .001). PI therapy was safely resumed in 89% of patients, although 41% required chemotherapy modifications. CONCLUSION: CVAEs are common during PI therapy for relapsed MM, especially with carfilzomib, particularly within the first 3 months of therapy. CVAEs were associated with worse overall outcomes, but usually, discontinuation of therapy was not required. Natriuretic peptides were highly predictive of CVAEs; however, validation of this finding is necessary before uniform incorporation into the routine management of patients receiving carfilzomib.

Published
2019

19. Autologous Transplantation, Consolidation, and Maintenance Therapy in Multiple Myeloma: Results of the BMT CTN 0702 Trial

Author

Stadtmauer, Edward A, Pasquini, Marcelo C, Blackwell, Beth, Hari, Parameswaran, Bashey, Asad, Devine, Steven, Efebera, Yvonne, Ganguly, Siddharta, Gasparetto, Cristina, Geller, Nancy, Horowitz, Mary M, Koreth, John, Knust, Kristin, Landau, Heather, Brunstein, Claudio, McCarthy, Philip, Nelson, Courtney, Qazilbash, Muzaffar H, Shah, Nina, Vesole, David H, Vij, Ravi, Vogl, Dan T, Giralt, Sergio, Somlo, George, and Krishnan, Amrita

Subjects
Cancer, Clinical Trials and Supportive Activities, Hematology, Clinical Research, Rare Diseases, Transplantation, 6.1 Pharmaceuticals, Evaluation of treatments and therapeutic interventions, Good Health and Well Being, Adult, Aged, Antineoplastic Combined Chemotherapy Protocols, Bortezomib, Consolidation Chemotherapy, Dexamethasone, Disease Progression, Female, Hematopoietic Stem Cell Transplantation, Humans, Lenalidomide, Maintenance Chemotherapy, Male, Melphalan, Middle Aged, Multiple Myeloma, Myeloablative Agonists, Progression-Free Survival, Prospective Studies, Remission Induction, Reoperation, Time Factors, Transplantation, Autologous, United States, Young Adult, Clinical Sciences, Oncology and Carcinogenesis, Oncology & Carcinogenesis
Abstract

PurposeSingle-cycle melphalan 200 mg/m2 and autologous hematopoietic cell transplantation (AHCT) followed by lenalidomide (len) maintenance have improved progression-free survival (PFS) and overall survival (OS) for transplantation-eligible patients with multiple myeloma (MM). We designed a prospective, randomized, phase III study to test additional interventions to improve PFS by comparing AHCT, tandem AHCT (AHCT/AHCT), and AHCT and four subsequent cycles of len, bortezomib, and dexamethasone (RVD; AHCT + RVD), all followed by len until disease progression.Patients and methodsPatients with symptomatic MM within 12 months from starting therapy and without progression who were age 70 years or younger were randomly assigned to AHCT/AHCT + len (n = 247), AHCT + RVD + len (n = 254), or AHCT + len (n = 257). The primary end point was 38-month PFS.ResultsThe study population had a median age of 56 years (range, 20 to 70 years); 24% of patients had high-risk MM, 73% had a triple-drug regimen as initial therapy, and 18% were in complete response at enrollment. The 38-month PFS rate was 58.5% (95% CI, 51.7% to 64.6%) for AHCT/AHCT + len, 57.8% (95% CI, 51.4% to 63.7%) for AHCT + RVD + len, and 53.9% (95% CI, 47.4% to 60%) for AHCT + len. For AHCT/AHCT + len, AHCT + RVD + len, and AHCT + len, the OS rates were 81.8% (95% CI, 76.2% to 86.2%), 85.4% (95% CI, 80.4% to 89.3%), and 83.7% (95% CI, 78.4% to 87.8%), respectively, and the complete response rates at 1 year were 50.5% (n = 192), 58.4% (n = 209), and 47.1% (n = 208), respectively. Toxicity profiles and development of second primary malignancies were similar across treatment arms.ConclusionSecond AHCT or RVD consolidation as post-AHCT interventions for the up-front treatment of transplantation-eligible patients with MM did not improve PFS or OS. Single AHCT and len should remain as the standard approach for this population.

Published
2019

20. Iberdomide plus dexamethasone in heavily pretreated late-line relapsed or refractory multiple myeloma (CC-220-MM-001): a multicentre, multicohort, open-label, phase 1/2 trial

Author

Lonial, Sagar, Popat, Rakesh, Hulin, Cyrille, Jagannath, Sundar, Oriol, Albert, Richardson, Paul G, Facon, Thierry, Weisel, Katja, Larsen, Jeremy T, Minnema, Monique C, Abdallah, Al-Ola, Badros, Ashraf Z, Knop, Stefan, Stadtmauer, Edward A, Cheng, Yiming, Amatangelo, Michael, Chen, Min, Nguyen, Tuong Vi, Amin, Alpesh, Peluso, Teresa, and van de Donk, Niels W C J

Published
2022
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21. Real-world effectiveness of CPX-351 vs venetoclax and azacitidine in acute myeloid leukemia

Author

Matthews, Andrew H., Perl, Alexander E., Luger, Selina M., Loren, Alison W., Gill, Saar I., Porter, David L., Babushok, Daria V., Maillard, Ivan P., Carroll, Martin P., Frey, Noelle V., Hexner, Elizabeth O., Martin, Mary Ellen, McCurdy, Shannon R., Stadtmauer, Edward A., Paralkar, Vikram R., Bruno, Ximena Jordan, Hwang, Wei-Ting, Margolis, David, and Pratz, Keith W.

Published
2022
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22. Noninfectious Pulmonary Toxicity after Allogeneic Hematopoietic Cell Transplantation

Author

Patel, Sagar S., Ahn, Kwang Woo, Khanal, Manoj, Bupp, Caitrin, Allbee-Johnson, Mariam, Majhail, Navneet S., Hamilton, Betty K., Rotz, Seth J., Hashem, Hasan, Beitinjaneh, Amer, Lazarus, Hillard M., Krem, Maxwell M., Prestidge, Tim, Bhatt, Neel S., Sharma, Akshay, Gadalla, Shahinaz M., Murthy, Hemant S., Broglie, Larisa, Nishihori, Taiga, Freytes, César O., Hildebrandt, Gerhard C., Gergis, Usama, Seo, Sachiko, Wirk, Baldeep, Pasquini, Marcelo C., Savani, Bipin N., Sorror, Mohamed L., Stadtmauer, Edward A., and Chhabra, Saurabh

Published
2022
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23. A randomized phase 2 trial of idiotype vaccination and adoptive autologous T-cell transfer in patients with multiple myeloma

Author

Qazilbash, Muzaffar H., Saini, Neeraj Y., Cha, Soung-chul, Wang, Zhe, Stadtmauer, Edward A., Baladandayuthapani, Veerabhadran, Lin, Heather, Tross, Beryl, Honhar, Medhavi, Rao, Sheetal S., Kim, Kunhwa, Popescu, Michael, Szymura, Szymon, Zhang, Tiantian, Anderson, Aaron, Bashir, Qaiser, Shpall, Elizabeth J., Orlowski, Robert Z., Levine, Bruce L., Kerr, Naseem, Garfall, Alfred, Cohen, Adam, Vogl, Dan T., Dengel, Karen, June, Carl H., Champlin, Richard, and Kwak, Larry W.

Published
2022
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24. Consensus guidelines and recommendations for infection prevention in multiple myeloma: a report from the International Myeloma Working Group

Author

Raje, Noopur S, Anaissie, Elias, Kumar, Shaji K, Lonial, Sagar, Martin, Thomas, Gertz, Morie A, Krishnan, Amrita, Hari, Parameswaran, Ludwig, Heinz, O'Donnell, Elizabeth, Yee, Andrew, Kaufman, Jonathan L, Cohen, Adam D, Garderet, Laurent, Wechalekar, Ashutosh F, Terpos, Evangelos, Khatry, Navin, Niesvizky, Ruben, Yi, Qing, Joshua, Douglas E, Saikia, Tapan, Leung, Nelson, Engelhardt, Monika, Mothy, Mohamad, Branagan, Andrew, Chari, Ajai, Reiman, Anthony J, Lipe, Brea, Richter, Joshua, Rajkumar, S Vincent, Miguel, Jesús San, Anderson, Kenneth C, Stadtmauer, Edward A, Prabhala, Rao H, McCarthy, Phillip L, and Munshi, Nikhil C

Published
2022
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25. Preconditioning Frailty Phenotype Influences Survival and Relapse for Older Allogeneic Transplantation Recipients

Author

Sung, Anthony D., Koll, Thuy, Gier, Shannon H., Racioppi, Alessandro, White, Griffin, Lew, Meagan, Free, Marcia, Agarwal, Priyal, Bohannon, Lauren M., Johnson, Ernaya J., Selvan, Bharathi, Babushok, Daria V., Frey, Noelle V., Gill, Saar I., Hexner, Elizabeth O., Martin, MaryEllen, Perl, Alexander E., Pratz, Keith W., Luger, Selina M., Chao, Nelson J., Fisher, Alfred L., Stadtmauer, Edward A., Porter, David L., Loren, Alison W., Bhatt, Vijaya R., Gimotty, Phyllis A., and McCurdy, Shannon R.

Published
2024
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26. Human IL-6 fosters long-term engraftment of patient derived disease-driving myeloma cells in immunodeficient mice

Author

Hasanali, Zainul S., primary, Garfall, Alfred L., additional, Burzenski, Lisa, additional, Shultz, Leonard D., additional, Tang, Yan, additional, Kadu, Siddhant, additional, Sheppard, Neil C., additional, Liu, Wei, additional, Dopkin, Derek, additional, Vogl, Dan T., additional, Cohen, Adam D., additional, Waxman, Adam J., additional, Susanibar-Adaniya, Sandra P., additional, Carroll, Martin, additional, Stadtmauer, Edward A., additional, and Allman, David, additional

Published
2024
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28. Impact of Pretransplantation Renal Dysfunction on Outcomes after Allogeneic Hematopoietic Cell Transplantation

Author

Farhadfar, Nosha, Dias, Ajoy, Wang, Tao, Fretham, Caitrin, Chhabra, Saurabh, Murthy, Hemant S., Broglie, Larisa, D'Souza, Anita, Gadalla, Shahinaz M., Gale, Robert Peter, Hashmi, Shahrukh, Al-Homsi, A. Samer, Hildebrandt, Gerhard C., Hematti, Peiman, Rizzieri, David, Chee, Lynette, Lazarus, Hillard M., Bredeson, Christopher, Jaimes, Edgar A., Beitinjaneh, Amer, Bashey, Asad, Prestidge, Tim, Krem, Maxwell M., Marks, David I., Benoit, Stefanie, Yared, Jean A., Nishihori, Taiga, Olsson, Richard F., Freytes, Cesar O., Stadtmauer, Edward, Savani, Bipin N., Sorror, Mohamed L., Ganguly, Siddhartha, Wingard, John R., and Pasquini, Marcelo

Published
2021
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29. Clinical features associated with COVID-19 outcome in multiple myeloma: first results from the International Myeloma Society data set

Author

Chari, Ajai, Samur, Mehmet Kemal, Martinez-Lopez, Joaquin, Cook, Gordon, Biran, Noa, Yong, Kwee, Hungria, Vania, Engelhardt, Monika, Gay, Francesca, García Feria, Ana, Oliva, Stefania, Oostvogels, Rimke, Gozzetti, Alessandro, Rosenbaum, Cara, Kumar, Shaji, Stadtmauer, Edward A., Einsele, Hermann, Beksac, Meral, Weisel, Katja, Anderson, Kenneth C., Mateos, María-Victoria, Moreau, Philippe, San-Miguel, Jesus, Munshi, Nikhil C., and Avet-Loiseau, Hervé

Published
2020
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30. Minimal Residual Disease Status in Multiple Myeloma 1 Year After Autologous Hematopoietic Cell Transplantation and Lenalidomide Maintenance Are Associated With Long-Term Overall Survival.

Author

Pasquini, Marcelo C., Wallace, Paul K., Logan, Brent, Kaur, Manmeet, Tario, Joseph D., Howard, Alan, Zhang, Yali, Brunstein, Claudio, Efebera, Yvonne, Geller, Nancy, Giralt, Sergio, Hari, Parameswaran, Horowitz, Mary M., Koreth, John, Krishnan, Amrita, Landau, Heather, Somlo, George, Shah, Nina, Stadtmauer, Edward, and Vogl, Dan T.

Published
2024
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31. One versus two sets of busulfan therapeutic drug monitoring in myeloablative allogeneic hematopoietic cell transplant.

Author

Chippendale, Lindsey, Freyer, Craig W, Carulli, Alison, Babushok, Daria V, Frey, Noelle V, Gill, Saar I, Hexner, Elizabeth O, Luger, Selina M, Martin, Mary Ellen, Porter, David L, Stadtmauer, Edward A, and Loren, Alison W

Subjects
HEMATOPOIETIC stem cell transplantation, GRAFT versus host disease, STOMATITIS, BUSULFAN, TREATMENT effectiveness, DRUG monitoring, DISEASE relapse, HEPATIC veno-occlusive disease, PROGRESSION-free survival, OVERALL survival
Abstract

Introduction: Busulfan is a common component of allogeneic hematopoietic cell transplant (alloHCT) conditioning, however interpatient pharmacokinetic variability can result in enhanced toxicity or increased relapse risk. Therapeutic drug monitoring (TDM) can minimize variability, yet the optimal frequency of TDM is unknown. We compared outcomes for patients with one versus two sets of busulfan TDM during myeloablative conditioning (MAC) prior to alloHCT. Methods: We analyzed the impact of busulfan TDM frequency and dose adjustments, with the primary outcome being relapse-free survival (RFS). Other outcomes included the incidence of acute and chronic graft versus host disease (GVHD), oral mucositis, pulmonary toxicity, sinusoidal obstruction syndrome (SOS), the cumulative incidence of relapse (CIR), and overall survival (OS). Results: Twenty-two patients underwent one set of sampling while 53 patients underwent two sets. Similar baseline characteristics were observed between the groups. There were no significant differences observed in RFS by day +180 (77.3% vs. 79.2%, p = 1.0), CIR by day +180 (18.2% vs. 17.8%, p = 0.74), or OS (p = 0.73). The incidences of acute GVHD, chronic GVHD, SOS, and severe mucositis were also similar. In each group, 63% received busulfan dose adjustments after one set, with 52.8% receiving further dose adjustments following the second set. Conclusion: We observed no significant difference in alloHCT outcomes between patients who underwent one versus two sets of busulfan TDM sampling, suggesting that a single-time TDM and dose adjustment may be adequate to maximize outcomes after MAC alloHCT. [ABSTRACT FROM AUTHOR]

Published
2024
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32. Tandem Autologous-Autologous versus Autologous-Allogeneic Hematopoietic Stem Cell Transplant for Patients with Multiple Myeloma: Long-Term Follow-Up Results from the Blood and Marrow Transplant Clinical Trials Network 0102 Trial

Author

Giralt, Sergio, Costa, Luciano J., Maloney, David, Krishnan, Amrita, Fei, Mingwei, Antin, Joseph H., Brunstein, Claudio, Geller, Nancy, Goodman, Stacey, Hari, Parameswaran, Logan, Brent, Lowsky, Robert, Qazilbash, Muzaffar H., Sahebi, Firoozeh, Somlo, George, Rowley, Scott, Vogl, Dan T., Vesole, David H., Pasquini, Marcelo, and Stadtmauer, Edward

Published
2020
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35. Discovery of an Inherited Variant Associated with Susceptibility to Secondary Acute Lymphoblastic Leukemia (ALL) after Lenalidomide Maintenance and Autologous HCT for Multiple Myeloma (MM)

Author

Zhu, Qianqian, primary, Herr, Megan, additional, Liang, Shuyi, additional, Hu, Qiang, additional, Singh, Prashant K, additional, Gao, Xinyu, additional, Pasquini, Marcelo C., additional, Leonard, Jessica T., additional, Rosko, Ashley, additional, Bayer, Ruthee-Lu, additional, Krishnan, Amrita, additional, Stadtmauer, Edward A., additional, Maziarz, Richard T., additional, McCarthy, Phillip L, additional, and Hahn, Theresa E., additional

Published
2024
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37. 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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39. International harmonization in performing and reporting minimal residual disease assessment in multiple myeloma trials

Author

Costa, Luciano J., Derman, Benjamin A., Bal, Susan, Sidana, Surbhi, Chhabra, Saurabh, Silbermann, Rebecca, Ye, Jing C., Cook, Gordon, Cornell, Robert F., Holstein, Sarah A., Shi, Qian, Omel, James, Callander, Natalie S., Chng, Wee Joo, Hungria, Vania, Maiolino, Angelo, Stadtmauer, Edward, Giralt, Sergio, Pasquini, Marcelo, Jakubowiak, Andrzej J., Morgan, Gareth J., Krishnan, Amrita, Jackson, Graham H., Mohty, Mohamad, Mateos, Maria Victoria, Dimopoulos, Meletious A., Facon, Thierry, Spencer, Andrew, Miguel, Jesus San, Hari, Parameswaran, Usmani, Saad Z., Manier, Salomon, McCarthy, Phillip, Kumar, Shaji, Gay, Francesca, and Paiva, Bruno

Published
2021
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40. A Multicenter Phase II, Double-Blind, Placebo-Controlled Trial of Maintenance Ixazomib After Allogeneic Transplantation for High-Risk Multiple Myeloma: Results of the Blood and Marrow Transplant Clinical Trials Network 1302 Trial

Author

Bashir, Qaiser, Nishihori, Taiga, Pasquini, Marcelo C., Martens, Michael J., Wu, Juan, Alsina, Melissa, Anasetti, Claudio, Brunstein, Claudio, Dawson, Peter, Efebera, Yvonne, Gasparetto, Cristina, Geller, Nancy, Giralt, Sergio, Hall, Aric C., Koreth, John, McCarthy, Philip, Scott, Emma, Stadtmauer, Edward A., Vesole, David H., and Hari, Parameswaran

Published
2023
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41. Comparison of High Doses of Total Body Irradiation in Myeloablative Conditioning before Hematopoietic Cell Transplantation

Author

Sabloff, Mitchell, Chhabra, Saurabh, Wang, Tao, Fretham, Caitrin, Kekre, Natasha, Abraham, Allistair, Adekola, Kehinde, Auletta, Jeffery J., Barker, Christopher, Beitinjaneh, Amer M., Bredeson, Christopher, Cahn, Jean-Yves, Diaz, Miguel Angel, Freytes, Cesar, Gale, Robert Peter, Ganguly, Siddhartha, Gergis, Usama, Guinan, Eva, Hamilton, Betty K., Hashmi, Shahrukh, Hematti, Peiman, Hildebrandt, Gerhard, Holmberg, Leona, Hong, Sanghee, Lazarus, Hillard M., Martino, Rodrigo, Muffly, Lori, Nishihori, Taiga, Perales, Miguel-Angel, Yared, Jean, Mineishi, Shin, Stadtmauer, Edward A., Pasquini, Marcelo C., and Loren, Alison W.

Published
2019
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42. Long-term survival of 1338 MM patients treated with tandem autologous vs. autologous-allogeneic transplantation

Author

Costa, Luciano J., Iacobelli, Simona, Pasquini, Marcelo C., Modi, Riddhi, Giaccone, Luisa, Blade, Joan, Schonland, Stefan, Evangelista, Andrea, Perez-Simon, Jose A., Hari, Parameswaran, Brown, Elizabeth E., Giralt, Sergio A., Patriarca, Francesca, Stadtmauer, Edward A., Rosinol, Laura, Krishnan, Amrita Y., Gahrton, Gösta, and Bruno, Benedetto

Published
2020
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43. Expanded HCT-CI Definitions Capture Comorbidity Better for Younger Patients of Allogeneic HCT for Nonmalignant Diseases

Author

Broglie, Larisa, Friend, Brian D., Chhabra, Saurabh, Logan, Brent R., Bupp, Caitrin, Schiller, Gary, Savani, Bipin N., Stadtmauer, Edward, Abraham, Allistair A., Aljurf, Mahmoud, Badawy, Sherif M., Perez, Miguel Angel Diaz, Guinan, Eva C., Hashem, Hasan, Krem, Maxwell M., Lazarus, Hillard M., Rotz, Seth J., Wirk, Baldeep, Yared, Jean A., Pasquini, Marcelo, Thakar, Monica S., and Sorror, Mohamed L.

Published
2023
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44. Adapting the HCT-CI Definitions for Children, Adolescents, and Young Adults with Hematologic Malignancies Undergoing Allogeneic Hematopoietic Cell Transplantation

Author

Friend, Brian D., Broglie, Larisa, Logan, Brent R., Chhabra, Saurabh, Bupp, Caitrin, Schiller, Gary, Beitinjaneh, Amer, Perez, Miguel Angel Diaz, Guilcher, Gregory M.T., Hashem, Hasan, Hildebrandt, Gerhard C., Krem, Maxwell M., Lazarus, Hillard M., Nishihori, Taiga, Nusrat, Roomi, Rotz, Seth J., Wirk, Baldeep, Wieduwilt, Matthew, Pasquini, Marcelo, Savani, Bipin N., Stadtmauer, Edward A., Sorror, Mohamed L., and Thakar, Monica S.

Published
2023
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