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1. Safety and efficacy of anti-BCMA CAR-T cell therapy in older adults with multiple myeloma: A systematic review and meta-analysis

Author

Akhtar, Othman Salim, Sheeba, Ba Aqeel, Azad, Farhan, Alessi, Lauren, Hansen, Doris, Alsina, Melissa, Baz, Rachid, Shain, Kenneth, Grajales Cruz, Ariel, Castaneda Puglianini, Omar, Liu, Hien, Blue, Brandon, Nishihori, Taiga, Al Jumayli, Mohammed, Extermann, Martine, Locke, Frederick L., Mhaskar, Rahul, and Freeman, Ciara Louise

Published
2024
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2. Racial and ethnic differences in clinical outcomes among patients with multiple myeloma treated with CAR T-cell therapy

Author

Peres, Lauren C., Oswald, Laura B., Dillard, Christen M., De Avila, Gabriel, Nishihori, Taiga, Blue, Brandon J., Freeman, Ciara L., Locke, Frederick L., Alsina, Melissa, Castaneda Puglianini, Omar, Shune, Leyla, Sborov, Douglas W., Wagner, Charlotte, Dima, Danai, Hashmi, Hamza, Davis, James A., Kocoglu, Mehmet H., Badros, Ashraf Z., Atrash, Shebli, Simmons, Gary, Kalariya, Nilesh, Ferreri, Christopher, Anderson, Larry D., Jr, Afrough, Aimaz, Kaur, Gurbakhash, Lin, Yi, Liu, Lawrence, Nadeem, Omar, Voorhees, Peter, Khouri, Jack, McGuirk, Joseph, Sidana, Surbhi, Hansen, Doris K., and Patel, Krina

Published
2024
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3. Safety and efficacy of standard-of-care ciltacabtagene autoleucel for relapsed/refractory multiple myeloma

Author

Sidana, Surbhi, Patel, Krina K., Peres, Lauren C., Bansal, Radhika, Kocoglu, Mehmet H., Shune, Leyla, Atrash, Shebli, Smith, Kinaya, Midha, Shonali, Ferreri, Christopher, Dhakal, Binod, Dima, Danai, Costello, Patrick, Wagner, Charlotte, Reshef, Ran, Hosoya, Hitomi, Mikkilineni, Lekha, Atanackovic, Djordje, Chhabra, Saurabh, Parrondo, Ricardo, Nadeem, Omar, Mann, Hashim, Kalariya, Nilesh, Hovanky, Vanna, De Avila, Gabriel, Freeman, Ciara L., Locke, Frederick L., Alsina, Melissa, Wong, Sandy, Herr, Megan, Htut, Myo, McGuirk, Joseph, Sborov, Douglas W., Khouri, Jack, Martin, Thomas, Janakiram, Murali, Lin, Yi, and Hansen, Doris K.

Published
2024
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4. Real-world experience of patients with multiple myeloma receiving ide-cel after a prior BCMA-targeted therapy

Author

Ferreri, Christopher J., Hildebrandt, Michelle A. T., Hashmi, Hamza, Shune, Leyla O., McGuirk, Joseph P., Sborov, Douglas W., Wagner, Charlotte B., Kocoglu, M. Hakan, Rapoport, Aaron, Atrash, Shebli, Voorhees, Peter M., Khouri, Jack, Dima, Danai, Afrough, Aimaz, Kaur, Gurbakhash, Anderson, Jr., Larry D., Simmons, Gary, Davis, James A., Kalariya, Nilesh, Peres, Lauren C., Lin, Yi, Janakiram, Murali, Nadeem, Omar, Alsina, Melissa, Locke, Frederick L., Sidana, Surbhi, Hansen, Doris K., Patel, Krina K., and Castaneda Puglianini, Omar Alexis

Published
2023
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5. The CAR-HEMATOTOX score as a prognostic model of toxicity and response in patients receiving BCMA-directed CAR-T for relapsed/refractory multiple myeloma

Author

Rejeski, Kai, Hansen, Doris K., Bansal, Radhika, Sesques, Pierre, Ailawadhi, Sikander, Logue, Jennifer M., Bräunlein, Eva, Cordas dos Santos, David M., Freeman, Ciara L., Alsina, Melissa, Theurich, Sebastian, Wang, Yucai, Krackhardt, Angela M., Locke, Frederick L., Bachy, Emmanuel, Jain, Michael D., Lin, Yi, and Subklewe, Marion

Published
2023
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6. Cardiac events after standard of care idecabtagene vicleucel for relapsed and refractory multiple myeloma

Author

Lee, Dae Hyun, Kumar, Abhishek, Mohammed, Turab, Peres, Lauren C., Alsina, Melissa, Bachmeier, Christina, Blue, Brandon J., Brayer, Jason, Chandrasekhar, Sanjay, Grajales Cruz, Ariel, De Avila, Gabe, Elmariah, Hany, Faramand, Rawan, Freeman, Ciara, Jain, Michael, Khadka, Sushmita, Khimani, Farhad, Liu, Hien, Nishihori, Taiga, Oswald, Laura B., Castaneda Puglianini, Omar A., Shain, Kenneth H., Smith, Eric, Baz, Rachid C., Locke, Frederick L., Oliveira, Guilherme H., Alomar, Mohammed, and Hansen, Doris K.

Published
2023
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7. Early cytopenias and infections after standard of care idecabtagene vicleucel in relapsed or refractory multiple myeloma

Author

Logue, Jennifer M., Peres, Lauren C., Hashmi, Hamza, Colin-Leitzinger, Christelle M., Shrewsbury, Alexandria M., Hosoya, Hitomi, Gonzalez, Rebecca M., Copponex, Christina, Kottra, Krista H., Hovanky, Vanna, Sahaf, Bita, Patil, Sunita, Lazaryan, Aleksandr, Jain, Michael D., Baluch, Aliyah, Klinkova, Olga V., Bejanyan, Nelli, Faramand, Rawan G., Elmariah, Hany, Khimani, Farhad, Davila, Marco L., Mishra, Asmita, Blue, Brandon J., Grajales-Cruz, Ariel F., Castaneda Puglianini, Omar A., Liu, Hien D., Nishihori, Taiga, Freeman, Ciara L., Brayer, Jason B., Shain, Kenneth H., Baz, Rachid C., Locke, Frederick L., Alsina, Melissa, Sidana, Surbhi, and Hansen, Doris K.

Published
2022
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8. Absolute Lymphocyte Count and Outcomes of Multiple Myeloma Patients Treated with Idecabtagene Vicleucel: The US Myeloma Immunotherapy Consortium Real- World Experience

Author

Khouri, Jack, Dima, Danai, Li, Hong, Hansen, Doris, Sidana, Surbhi, Shune, Leyla, Anwer, Faiz, Sborov, Douglas, Wagner, Charlotte, Kocoglu, Mehmet H., Atrash, Shebli, Voorhees, Peter, Peres, Lauren, Hovanky, Vanna, Simmons, Gary, Williams, Louis, Raza, Shahzad, Afrough, Aimaz, Anderson, Larry D., Jr, Ferreri, Christopher, Hashmi, Hamza, Davis, James, McGuirk, Joseph, Goldsmith, Scott, Borogovac, Azra, Lin, Yi, Midha, Shonali, Nadeem, Omar, Locke, Frederick L., Baz, Rachid, Hamilton, Betty, Alsina, Melissa, Sauter, Craig, Patel, Krina, and Kaur, Gurbakhash

Published
2024
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9. Assessment of Clonotypic Rearrangements and Minimal Residual Disease in Lymphoid Malignancies: A Large Cancer Center Experience Using clonoSEQ

Author

Hussaini, Mohammad O., Srivastava, Jaya, Lee, Lik Wee, Nishihori, Taiga, Shah, Bijal D., Alsina, Melissa, Pinilla-Ibarz, Javier, and Shain, Kenneth H.

Subjects
Nucleotide sequencing -- Usage, DNA sequencing -- Usage, Lymphoproliferative disorders -- Prognosis -- Care and treatment, Cancer -- Relapse, Biochemical assays -- Usage, Plasma cell diseases -- Prognosis -- Care and treatment, Health
Abstract

Context.--Measurable (minimal) residual disease (MRD) is an independent prognostic factor for survival outcomes in patients with lymphoid and plasma cell malignancies and has been incorporated into consensus criteria regarding treatment response, strategy, and clinical trial endpoints. clonoSEQ (a next-generation sequencing [NGS]-MRD assay) uses multiplex polymerase chain reaction and NGS to identify clonotypic rearrangements at the immunoglobulin (Ig) H, IgK, IgL, T-cell receptor (TCR)-[beta], and TCR-[gamma] loci, as well as translocated B-cell lymphoma 1/IgH and 2/IgH sequences for MRD assessment. Additionally, it can be used to confirm diagnoses of cutaneous T-cell lymphoma (CTCL). Objective.--To review the technical aspects of our experience using the clonoSEQ Assay in routine clinical practice. Design.--In this single-center experience, 390 patients with lymphoid and plasma cell malignancies were assessed with the NGS-MRD Assay at a central laboratory. Results.--Median time from arrival of the shipment to initiation of the assay (defined as captured in Adaptive's secure tracking system) was 2.1 hours. Overall, 317 patients had 1 or more samples submitted for sequence identification. Of these, 290 (91.5%) had trackable sequences identified. The median calibration rate of samples by malignancy (where n [greater than or equal to] 10 samples, excluding CTCL samples) was 88.1%, across a variety of fresh and archived sample sources (177 of 201 samples). TCR-[beta] and/ or TCR-[gamma] clonotypes were identified in 40 of 95 samples (42.1%) from 66 patients with suspected CTCL. Conclusions.--This NGS-MRD Assay is a valuable and sensitive tool for monitoring MRD in patients with plasma cell and lymphoid malignancies and assisting in the diagnosis of CTCL., In the past decade, the clinical utility of assessing measurable (minimal) residual disease (MRD) in patients with plasma cell and lymphoid malignancies has been recognized increasingly. (1) MRD has been [...]

Published
2022
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11. Racial and ethnic differences in clonal hematopoiesis, tumor markers, and outcomes of patients with multiple myeloma

Author

Peres, Lauren C., Colin-Leitzinger, Christelle M., Teng, Mingxiang, Dutil, Julie, Alugubelli, Raghunandan R., DeAvila, Gabriel, Teer, Jamie K., Du, Dongliang, Mo, Qianxing, Siegel, Erin M., Hampton, Oliver A., Alsina, Melissa, Brayer, Jason, Blue, Brandon, Baz, Rachid, Silva, Ariosto S., Nishihori, Taiga, Shain, Kenneth H., and Gillis, Nancy

Published
2022
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13. Outcomes of Haploidentical Stem Cell Transplant Recipients With HHV-6B Reactivation.

Author

Handley, Guy, Yepes, Amanda, Eliassen, Eva, Dominguez, Gabriel, Pasikhova, Yanina, Klinkova, Olga, Baluch, Aliyah, Febres-Aldana, Anthony J, Alsina, Melissa, Elmariah, Hany, Khimani, Farhad, Hansen, Doris K, Freeman, Ciara L, Jain, Michael D, Locke, Frederick, Lazaryan, Aleksandr, Liu, Hein D, Mishra, Asmita, Mirza, Abu-Sayeef, and Nishihori, Taiga

Subjects
STEM cell transplantation, HEMATOPOIETIC stem cells, CENTRAL nervous system, VIRUS reactivation, ACUTE diseases
Abstract

Background Human herpesvirus 6B (HHV-6B) frequently reactivates following allogeneic stem cell transplant (alloHCT). Consensus guidelines note that haploidentical alloHCT may represent a high-risk population for which there is little evidence; this warrants further investigation. Methods In this single-center retrospective study, we evaluated 188 consecutive adult patients receiving haploidentical alloHCT between 11/2014 and 11/2020 and compared outcomes between patients with HHV-6B reactivation receiving targeted antiviral therapy and those who were clinically observed. Results Of the 58 included patients, 21 (36.2%) received antiviral therapy for HHV-6B reactivation with foscarnet (n = 19) or ganciclovir (n = 2). There were no differences in patient or disease characteristics between treated and observed patients. Treated patients were more likely to have high-level DNAemia (85.7% vs 40.5%; P <.001) and had higher peak viral quantitative measurements (median log10, 4.65 vs 3.84; P <.001). The median time to clearance from plasma (interquartile range) was 13 (7.25–20.00) days for all patients and was not significantly different between groups. There were no differences in episodes of encephalitis, grade III/IV acute graft-vs-host disease (GVHD), or time to neutrophil or platelet engraftment among treated vs observed patients. Day 100 nonrelapse mortality was not significantly different in the multivariate analysis; however, the presence of central nervous system symptoms was strongly associated with worse survival (hazard ratio, 4.11; 95% CI, 1.27–13.34; P =.018). Conclusions We did not observe a difference in clinical outcomes between the treated and observed groups of patients with HHV-6B reactivation following haploidentical alloHCT. With the rising use of haploidentical transplant and post-transplant cyclophosphamide GVHD prevention platforms, prospective studies are needed to further characterize the risk and outcomes associated with HHV-6B reactivation and therapy. [ABSTRACT FROM AUTHOR]

Published
2024
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14. A phase 2 multicenter trial of ofatumumab and prednisone as initial therapy for chronic graft-versus-host disease

Author

Lazaryan, Aleksandr, Lee, Stephanie, Arora, Mukta, Kim, Jongphil, Betts, Brian Christopher, Khimani, Farhad, Nishihori, Taiga, Bejanyan, Nelli, Liu, Hien, Kharfan-Dabaja, Mohamed A., Locke, Frederick L., Gonzalez, Rebecca, Jain, Michael D., Davila, Marco L., Perez, Lia Elena, Mishra, Asmita, Perez Perez, Ariel, Balke, Karlie, Ayala, Ernesto, Ochoa, Leonel, Castaneda Puglianini, Omar, Faramand, Rawan, Alsina, Melissa, Elmariah, Hany, Nieder, Michael L., Fernandez, Hugo, Anasetti, Claudio, and Pidala, Joseph A.

Published
2022
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15. Simple Score of Albumin and CRP Predicts High-Grade Toxicity in Patients with Multiple Myeloma Receiving CAR-T Therapy

Author

Akhtar, Othman S., Modi, Karnav, Kim, Jongphil, Skelson, Lawrence, Smith, Eric, Al-Jumayli, Mohammed A., Extermann, Martine, De Avila, Gabriel, Parker, Nathan, Castaneda Puglianini, Omar, Grajales Cruz, Ariel, Baz, Rachid, Blue, Brandon, Shain, Kenneth, Alsina, Melissa, Liu, Hien, Nishihori, Taiga, Jain, Michael D., Locke, Frederick L., Hansen, Doris K., and Freeman, Ciara L.

Published
2024
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16. Increased Infections and Delayed CD4+ T Cell but Faster B Cell Immune Reconstitution after Post-Transplantation Cyclophosphamide Compared to Conventional GVHD Prophylaxis in Allogeneic Transplantation

Author

Khimani, Farhad, Ranspach, Peter, Elmariah, Hany, Kim, Jongphil, Whiting, Junmin, Nishihori, Taiga, Locke, Frederick L., Perez Perez, Ariel, Dean, Erin, Mishra, Asmita, Perez, Lia, Lazaryan, Aleksandr, Jain, Michael D., Nieder, Michael, Liu, Hein, Faramand, Rawan, Hansen, Doris, Alsina, Melissa, Ochoa, Leonel, Davila, Marco, Anasetti, Claudio, Pidala, Joseph, and Bejanyan, Nelli

Published
2021
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17. A phase 2 trial of GVHD prophylaxis with PTCy, sirolimus, and MMF after peripheral blood haploidentical transplantation

Author

Bejanyan, Nelli, Pidala, Joseph A., Wang, Xuefeng, Thapa, Ram, Nishihori, Taiga, Elmariah, Hany, Lazaryan, Aleksandr, Khimani, Farhad, Davila, Marco L., Mishra, Asmita, Faramand, Rawan, Jain, Michael D., Ochoa, Leonel, Perez, Lia Elena, Liu, Hien, Alsina, Melissa, Kharfan-Dabaja, Mohamed A., Fernandez, Hugo, Nieder, Michael L., Locke, Frederick L., Anasetti, Claudio, and Ayala, Ernesto

Published
2021
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18. Hypoalbuminemia at Day +90 Is Associated with Inferior Nonrelapse Mortality and Overall Survival in Allogeneic Hematopoietic Cell Transplantation Recipients: A Confirmatory Study

Author

Murthy, Hemant S., Sheets, Kyle, Kumar, Ambuj, Nishihori, Taiga, Mina, Alain, Chavez, Julio C., Ayala, Ernesto, Field, Teresa, Mathews, John, Locke, Frederick, Perez, Lia, Betts, Brian C., Khimani, Farhad, Miladinovic, Branco, Tsalatsanis, Athanasios, Ochoa-Bayona, Jose Leonel, Alsina, Melissa, Fernandez, Hugo, Pidala, Joseph, Anasetti, Claudio, and Kharfan-Dabaja, Mohamed A.

Published
2018
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20. Impact of Total Body Irradiation-Based Myeloablative Conditioning Regimens in Patients with Acute Lymphoblastic Leukemia Undergoing Allogeneic Hematopoietic Stem Cell Transplantation: Systematic Review and Meta-Analysis

Author

Khimani, Farhad, Dutta, Mudit, Faramand, Rawan, Nishihori, Taiga, Perez, Ariel Perez, Dean, Erin, Nieder, Michael, Perez, Lia, Mishra, Asmita, Elmariah, Hany, Davila, Marco, Ochoa, Leonel, Alsina, Melissa, Lazaryan, Aleksandr, Bejanyan, Nelli, Hansen, Doris, Jain, Michael, Locke, Frederick, Liu, Hien, Pidala, Joseph, Shah, Bijal, and Mhaskar, Rahul

Published
2021
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22. Patient-Reported Outcomes among Multiple Myeloma Patients Treated with Standard of Care Idecabtagene Vicleucel.

Author

Oswald, Laura B., Gudenkauf, Lisa M., Li, Xiaoyin, De Avila, Gabriel, Peres, Lauren C., Kirtane, Kedar, Gonzalez, Brian D., Hoogland, Aasha I., Nguyen, Oanh, Rodriguez, Yvelise, Baz, Rachid C., Shain, Kenneth H., Alsina, Melissa, Locke, Frederick L., Freeman, Ciara, Castaneda Puglianini, Omar, Nishihori, Taiga, Liu, Hien, Blue, Brandon, and Grajales-Cruz, Ariel

Subjects
WELL-being, HEALTH outcome assessment, CELL receptors, CANCER relapse, CANCER patients, T-test (Statistics), QUALITY of life, KAPLAN-Meier estimator, RESEARCH funding, MULTIPLE myeloma, IMMUNOTHERAPY, LONGITUDINAL method, EVALUATION
Abstract

Simple Summary: In clinical trials, patients treated with idecabtagene vicleucel (ide-cel) chimeric antigen receptor T-cell therapy (CAR T) have reported meaningful improvements in patient-reported outcomes, such as health-related quality of life. To test whether these findings are generalizable to the broader, real-world patient population, this study aimed to prospectively characterize patient-reported outcomes (i.e., health-related quality of life, symptom burden) among patients with relapsed/refractory multiple myeloma treated with ide-cel CAR T in standard of care. Patient-reported outcomes were assessed across 14 timepoints from pre-CAR T infusion through day 90 post-infusion. Patients reported significant and meaningful improvements in health-related quality of life and physical well-being by day 60 after CAR T infusion. Overall, most patients had meaningful improvement or maintenance of patient-reported outcomes collected over time. Findings have implications for treatment decision-making, patient education, and supportive interventions to improve patient outcomes post-CAR T. Idecabtagene vicleucel (ide-cel) was the first FDA-approved chimeric antigen receptor T-cell therapy for relapsed/refractory multiple myeloma (RRMM) patients. This was the first study to evaluate patient-reported outcomes (PROs) among RRMM patients receiving ide-cel in standard of care (SOC). We prospectively assessed health-related quality of life (HRQOL) and symptoms from pre-infusion (baseline) through day (D)90 post-infusion. Baseline PRO associations with patient characteristics, mean PRO changes, and time to stable change were evaluated with t-tests, linear mixed-effects models, and Kaplan–Meier analyses, respectively. Within-person change scores and minimally important difference thresholds determined clinical and meaningful significance. Participants (n = 42) were a median of 66 years old (range: 43–81). At baseline, extramedullary disease was associated with worse physical well-being (p = 0.008), global pain (p < 0.001), performance status (p = 0.002), and overall symptom burden (p < 0.001). Fatigue (p < 0.001) and functional well-being (p = 0.003) worsened by D7 before returning to baseline levels. Overall HRQOL (p = 0.008) and physical well-being (p < 0.001) improved by D60. Most participants reported PRO improvement (10–57%) or maintenance (23–69%) by D90. The median time it took to stabile deterioration in functional well-being was 14 days. The median time it took to stabile improvement in physical and emotional well-being was 60 days. Overall, RRMM patients reported improvements or maintenance of HRQOL and symptom burden after SOC ide-cel. [ABSTRACT FROM AUTHOR]

Published
2023
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25. A phase 2 trial of lenalidomide, bortezomib, and dexamethasone in patients with relapsed and relapsed/refractory myeloma

Author

Richardson, Paul G., Xie, Wanling, Jagannath, Sundar, Jakubowiak, Andrzej, Lonial, Sagar, Raje, Noopur S., Alsina, Melissa, Ghobrial, Irene M., Schlossman, Robert L., Munshi, Nikhil C., Mazumder, Amitabha, Vesole, David H., Kaufman, Jonathan L., Colson, Kathleen, McKenney, Mary, Lunde, Laura E., Feather, John, Maglio, Michelle E., Warren, Diane, Francis, Dixil, Hideshima, Teru, Knight, Robert, Esseltine, Dixie-Lee, Mitsiades, Constantine S., Weller, Edie, and Anderson, Kenneth C.

Published
2014
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32. Phase 1 study of pomalidomide MTD, safety, and efficacy in patients with refractory multiple myeloma who have received lenalidomide and bortezomib

Author

Richardson, Paul G., Siegel, David, Baz, Rachid, Kelley, Susan L., Munshi, Nikhil C., Laubach, Jacob, Sullivan, Daniel, Alsina, Melissa, Schlossman, Robert, Ghobrial, Irene M., Doss, Deborah, Loughney, Nora, McBride, Laura, Bilotti, Elizabeth, Anand, Palka, Nardelli, Lisa, Wear, Sandra, Larkins, Gail, Chen, Min, Zaki, Mohamad H., Jacques, Christian, and Anderson, Kenneth C.

Published
2013
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33. A phase 2 study of single-agent carfilzomib (PX-171-003-A1) in patients with relapsed and refractory multiple myeloma

Author

Siegel, David S., Martin, Thomas, Wang, Michael, Vij, Ravi, Jakubowiak, Andrzej J., Lonial, Sagar, Trudel, Suzanne, Kukreti, Vishal, Bahlis, Nizar, Alsina, Melissa, Chanan-Khan, Asher, Buadi, Francis, Reu, Frederic J., Somlo, George, Zonder, Jeffrey, Song, Kevin, Stewart, A. Keith, Stadtmauer, Edward, Kunkel, Lori, Wear, Sandra, Wong, Alvin F., Orlowski, Robert Z., and Jagannath, Sundar

Published
2012
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34. An open-label, single-arm, phase 2 (PX-171-004) study of single-agent carfilzomib in bortezomib-naive patients with relapsed and/or refractory multiple myeloma

Author

Vij, Ravi, Wang, Michael, Kaufman, Jonathan L., Lonial, Sagar, Jakubowiak, Andrzej J., Stewart, A. Keith, Kukreti, Vishal, Jagannath, Sundar, McDonagh, Kevin T., Alsina, Melissa, Bahlis, Nizar J., Reu, Frederic J., Gabrail, Nashat Y., Belch, Andrew, Matous, Jeffrey V., Lee, Peter, Rosen, Peter, Sebag, Michael, Vesole, David H., Kunkel, Lori A., Wear, Sandra M., Wong, Alvin F., Orlowski, Robert Z., and Siegel, David S.

Published
2012
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43. A randomized phase 2 study of lenalidomide therapy for patients with relapsed or relapsed and refractory multiple myeloma

Author

Richardson, Paul G., Blood, Emily, Mitsiades, Constantine S., Jagannath, Sundar, Zeldenrust, Steven R., Alsina, Melissa, Schlossman, Robert L., Rajkumar, S. Vincent, Desikan, K. Raman, Hideshima, Teru, Munshi, Nikhil C., Kelly-Colson, Kathleen, Doss, Deborah, McKenney, Mary L., Gorelik, Svetlana, Warren, Diane, Freeman, Andrea, Rich, Rebecca, Wu, Anfang, Olesnyckyj, Marta, Wride, Kenton, Dalton, William S., Zeldis, Jerome, Knight, Robert, Weller, Edie, and Anderson, Kenneth C.

Published
2006
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44. A phase 2 study of bortezomib in relapsed, refractory myeloma

Author

Richardson, Paul G., Barlogie, Bart, Berenson, James, Singhal, Seema, Jagannath, Sundar, Irwin, David, Rajkumar, S. Vincent, Srkalovic, Gordan, Alsina, Melissa, Alexanian, Raymond, Siegel, David, Orlowski, Robert Z., Kuter, David, Limentani, Steven A., Lee, Stephanie, Hideshima, Teru, Esseltine, Dixie-Lee, Kauffman, Michael, Adams, Julian, Schenkein, David P., and Anderson, Kenneth C.

Subjects
Millennium Pharmaceuticals Inc. -- Product information, Velcade (Medication) -- Evaluation, Biotechnology industry -- Product information, Multiple myeloma -- Drug therapy
Abstract

The drug Velcade may benefit some patients with multiple myeloma, according to a study of 193 patients who did not respond to other chemotherapy drugs. Thirty-five percent responded to the drug. The drug can suppress the immune system, and can cause fever and peripheral nerve disease.

Published
2003

45. Longitudinal Collection of Patient-Reported Outcomes and Activity Data during CAR-T Therapy: Feasibility, Acceptability, and Data Visualization.

Author

Oswald, Laura B., Li, Xiaoyin, Carvajal, Rodrigo, Hoogland, Aasha I., Gudenkauf, Lisa M., Hansen, Doris K., Alsina, Melissa, Locke, Frederick L., Rodriguez, Yvelise, Irizarry-Arroyo, Nathaly, Robinson, Edmondo J., Jim, Heather S. L., Gonzalez, Brian D., and Kirtane, Kedar

Subjects
IMMUNIZATION, HUMAN research subjects, PATIENT participation, CELLULAR therapy, PATIENT selection, HEALTH outcome assessment, WEARABLE technology, PATIENT satisfaction, TREATMENT effectiveness, CANCER patients, HEMATOLOGIC malignancies, DESCRIPTIVE statistics, EVALUATION
Abstract

Simple Summary: Patients treated with chimeric antigen receptor T-cell therapy (CAR-T) are at risk for severe toxicities post-treatment. Patient-reported outcomes and activity data from fitness trackers could be helpful for monitoring patients after CAR-T. The aim of this pilot study was to test the feasibility and acceptability of having patients complete surveys on a rigorous schedule and wear a Fitbit tracker continuously, from before their CAR-T infusion through 90-days post-infusion. In a sample of 12 patients with hematologic malignancies, we demonstrated feasibility and acceptability, with high rates of behavioral adherence to the study procedures. These findings suggest that large-scale data collection efforts using these procedures will be successful. In turn, patient-reported outcomes and activity data could be used to identify predictors of severe CAR-T-related toxicities. Background: Clinicians must closely monitor patients for toxicities after chimeric antigen receptor T-cell therapy (CAR-T). Patient-reported outcomes (PROs) (e.g., toxicities, quality of life) and activity data (e.g., steps, sleep) may complement clinicians' observations. This study tested the feasibility and acceptability of collecting PROs and activity data from patients with hematologic malignancies during CAR-T and explored preliminary data patterns. Methods: Participants wore a Fitbit tracker and completed PROs at several timepoints through 90-days post-infusion. Feasibility was assessed with a priori benchmarks for recruitment (≥50%), retention (≥70%), PRO completion (≥70%), and days wearing the Fitbit (≥50%). Acceptability was assessed with participant satisfaction (a priori benchmark > 2 on a 0–4 scale). Results: Participants (N = 12) were M = 66 years old (SD = 7). Rates of recruitment (68%), retention (83%), PRO completion (85%), and days wearing the Fitbit (85%) indicated feasibility. Satisfaction with completing the PROs (M = 3.2, SD = 0.5) and wearing the Fitbit (M = 2.9, SD = 0.5) indicated acceptability. Preliminary data patterns suggested that participants with better treatment response (vs. progressive disease) had a higher toxicity burden. Conclusions: Longitudinal PRO and activity data collection was feasible and acceptable. Data collected on a larger scale may be used to specify risk prediction models to identify predictors of severe CAR-T-related toxicities and inform early interventions. [ABSTRACT FROM AUTHOR]

Published
2022
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47. Bortezomib salvage followed by a Phase I/II study of bortezomib plus high-dose melphalan and tandem autologous transplantation for patients with primary resistant myeloma

Author

Nishihori, Taiga, Alekshun, Todd J., Shain, Kenneth, Sullivan, Daniel M., Baz, Rachid, Perez, Lia, Pidala, Joseph, Kharfan-Dabaja, Mohamed A., Ochoa-Bayona, Jose L., Fernandez, Hugo F., Yarde, Danielle N., Oliveira, Vasco, Fulp, William, Han, Gang, Kim, Jongphil, Chen, Dung-Tsa, Raychaudhuri, Jyoti, Dalton, William, Anasetti, Claudio, and Alsina, Melissa

Published
2012
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