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1. A Clinical and Correlative Study of Elotuzumab, Carfilzomib, Lenalidomide, and Dexamethasone (Elo-KRd) for Lenalidomide Refractory Multiple Myeloma in First Relapse

Author

Bhutani, Manisha, Foureau, David M., Robinson, Myra, Guo, Fei, Fesenkova, Kateryna, Atrash, Shebli, Paul, Barry, Varga, Cindy, Friend, Reed, Pineda-Roman, Mauricio, Rigby, Katherine, Symanowski, James T., Norek, Sarah, Tucker, Mallory R., Druhan, Lawrence J., Voorhees, Peter M., and Usmani, Saad Z.

Published
2023
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2. Efficacy of Selinexor in Relapsed/Refractory Multiple Myeloma (RRMM) Patients with del17p and Other High-Risk Abnormalities (A Retrospective Single-Center Study)

Author

Ehsan, Hamid, primary, Robinson, Myra, additional, Voorhees, Peter M., additional, Cassetta, Kristen, additional, Borden, Shanice, additional, Atrash, Shebli, additional, Bhutani, Manisha, additional, Varga, Cindy, additional, Pineda-Roman, Mauricio, additional, Friend, Reed, additional, and Paul, Barry A., additional

Published
2024
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4. Chimeric antigen receptor T-cells: a review on current status and future directions for relapsed/refractory multiple myeloma.

Author

Hamadeh, Issam S., Friend, Reed, Mailankody, Sham, and Atrash, Shebli

Subjects
T-cell exhaustion, CHIMERIC antigen receptors, INCURABLE diseases, MULTIPLE myeloma, T cells
Abstract

Although multiple myeloma is an incurable disease, the past decade has witnessed significant improvement in patient outcomes. This was brought about by the development of T-cell redirection therapies such as chimeric antigen receptor (CAR) T-cells, which can leverage the natural ability of the immune system to fight myeloma cells. The approval of the B-cell maturation antigen (BCMA)-directed CAR T, idecabtagene vicleucel (ide-cel), and ciltacabtagene autoleucel (cilta-cel) has resulted in a paradigm shift in the treatment of relapsed/refractory multiple myeloma. Overall response rates ranging from 73 to 97% are currently achievable. However, the limitations of KarMMa-1 and CARTITUDE-1 studies spurred the generation of real-world data to provide some insights into the effectiveness of ide-cel and cilta-cel among patients who were excluded from clinical trials, particularly those who received prior BCMA-targeted or other T-cell redirection therapies. Despite their unprecedented clinical efficacy in heavily pretreated patients, responses to CAR T remain non-durable. Although the underlying mechanisms of resistance to these agents haven't been fully elucidated, studies have suggested that resistance patterns could be multifaceted, implicating T-cell exhaustion and tumor intrinsic mechanisms such as BCMA target loss, upregulation of gammasecretase, and others. Herein, we provide a succinct overview of the development of CAR T-cells, manufacturing process, and associated toxicities/complications. In this review, we also recapitulate the existing literature pertaining MM CAR-T as well as emerging data from some of the ongoing clinical trials designed to mitigate the shortcomings of these agents, and improve the clinical efficacy of CAR T, especially in the relapsed/refractory setting. [ABSTRACT FROM AUTHOR]

Published
2024
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8. P-173: Prognostic utility of the evolving biomarkerbased progression model (e-model) for smoldering multiple myeloma (SMM) in a diverse population

Author

Atrash, Shebli, primary, Robinson, Myra, additional, Cassetta, Kristen, additional, Varga, Cindy, additional, Pineda-Roman, Mauricio, additional, Friend, Reed, additional, Paul, Barry, additional, Usmani, Saad, additional, Luong, Vincent, additional, Voorhees, Peter, additional, Hareth, Nahi, additional, and Bhutani, Manisha, additional

Published
2022
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9. P-242: Efficacy of selinexor in relapsed/refractory multiple myeloma (RRMM) patients with del17p and other high-risk abnormalities: a retrospective single-center study

Author

Ehsan, Hamid, primary, Robinson, Myra, additional, Voorhees, Peter, additional, Cassetta, Kristen, additional, Atrash, Shebli, additional, Bhutani, Manisha, additional, Varga, Cindy, additional, Pineda-Roman, Mauricio, additional, Friend, Reed, additional, and Paul, Barry, additional

Published
2022
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10. Outcomes for transplant-eligible, newly diagnosed Black patients (Pts) with multiple myeloma (MM): The Levine Cancer Institute (LCI) experience.

Author

Paul, Barry, primary, Atrash, Shebli, additional, Robinson, Myra M., additional, Jagosky, Megan, additional, Bhutani, Manisha, additional, Varga, Cindy, additional, Pineda-Roman, Mauricio, additional, Friend, Reed N., additional, Foureau, David, additional, Cassetta, Kristen, additional, Usmani, Saad Zafar, additional, and Voorhees, Peter M., additional

Published
2022
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11. Economic, Social, and Demographic Characteristics of Spanish-American Wage Workers on U. S. Farms.

Author

Economic Research Service (USDA), Washington, DC., Friend, Reed E., and Baum, Samuel

Abstract

This report of the current position of Spanish Americans who are farm wage workers is based on data collected for the Economic Research Service of the Department of Agriculture by the Bureau of Census in a supplement to the February, 1961 Current Population Survey (CPS). The CPS data are based on a national sample of the civilian noninstitutional population 14 years of age and over who did farm work during 1960. The report gives social and demographic characteristics as well as information on employment and earning of the Spanish American farm workers. In addition, a list of the literature cited in the report is included. (TL)

Published
1963

12. Phase II Trial of Elotuzumab in Combination with Carfilzomib, Lenalidomide and Dexamethasone for the Treatment of Relapsed/Refractory Multiple Myeloma (RRMM) after One Prior Line of Therapy

Author

Bhutani, Manisha, primary, Robinson, Myra, additional, Atrash, Shebli, additional, Foureau, David M, additional, Rigby, Katherine, additional, Friend, Reed, additional, Paul, Barry, additional, Symanowski, James T, additional, Druhan, Lawrence J, additional, Norek, Sarah, additional, Tucker, Mallory, additional, Pineda-Roman, Mauricio, additional, Voorhees, Peter M., additional, and Usmani, Saad Z., additional

Published
2021
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13. Central Memory T-Cell Differentiation Correlates with Depth of Response in Relapsed/Refractory Multiple Myeloma Patients Receiving Elotuzumab in Combination with Carfilzomib, Lenalidomide and Dexamethasone (Elo-KRd)

Author

Foureau, David M, primary, Bhutani, Manisha, additional, Guo, Fei, additional, Fesenkova, Kateryna, additional, Atrash, Shebli, additional, Friend, Reed, additional, Paul, Barry, additional, Robinson, Myra M, additional, Symanowski, James T, additional, Druhan, Lawrence J, additional, Pineda-Roman, Mauricio, additional, Voorhees, Peter M., additional, and Usmani, Saad Z., additional

Published
2021
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14. Primary Endpoint Analysis from a Response Adaptive Phase II Clinical Trial of Carfilzomib, Lenalidomide, Dexamethasone Plus Daratumumab (KRd-Dara) in Patients with Newly Diagnosed Multiple Myeloma (NDMM)

Author

Bhutani, Manisha, Robinson, Myra, Atrash, Shebli, Paul, Barry, Pineda-Roman, Mauricio, Foureau, David, Varga, Cindy, Friend, Reed, Begic, Xhevahire, Norek, Sarah, Drennan, Tiffany, Anderson, Michelle B, Symanowski, James, Voorhees, Peter M., and Usmani, Saad Z

Published
2023
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15. Daratumumab, pomalidomide, and dexamethasone in relapsed refractory multiple myeloma (RRMM): A comparison with contemporary clinical trials.

Author

Paul, Barry, primary, Robinson, Myra M., additional, Robinson, Jordan, additional, Ndiaye, Ami, additional, Bhutani, Manisha, additional, Voorhees, Peter Michael, additional, Symanowski, James Thomas, additional, Friend, Reed N., additional, Pineda-Roman, Mauricio, additional, Usmani, Saad Zafar, additional, and Atrash, Shebli, additional

Published
2021
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16. Response-Adaptive Phase II Study of Daratumumab Combined with Carfilzomib, Lenalidomide and Dexamethasone in Newly Diagnosed Multiple Myeloma

Author

Bhutani, Manisha, primary, House, Monika, additional, He, Jiaxian, additional, Atrash, Shebli, additional, Foureau, David M, additional, Paul, Barry, additional, Friend, Reed, additional, Symanowski, James T, additional, Norek, Sarah, additional, Begic, Xhevahire, additional, Acampora, Donna, additional, Farmer, Katherine K, additional, Syfert, Carrie Ann, additional, Pineda-Roman, Mauricio, additional, Voorhees, Peter, additional, and Usmani, Saad Z., additional

Published
2020
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17. Safety and Cost Benefits of the Rapid Daratumumab Infusion Protocol

Author

Hamadeh, Issam S., primary, Reese, Emily S., additional, Arnall, Justin R., additional, Kachur, Ekaterina, additional, Martin, Allison L., additional, Schneider, Meghan, additional, Friend, Reed, additional, Paul, Barry, additional, Atrash, Shebli, additional, Bhutani, Manisha, additional, Voorhees, Peter M., additional, and Usmani, Saad Z., additional

Published
2020
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18. Genetic polymorphisms associated with clostridium difficile infection in multiple myeloma patients undergoing autologous stem cell transplantation.

Author

Hamadeh, Issam, primary, Shahid, Zainab, additional, Bhutani, Manisha, additional, Patel, Jai Narendra, additional, Steuerwald, Nury, additional, Hamilton, Alicia, additional, Atrash, Shebli, additional, Friend, Reed N., additional, Paul, Barry, additional, Voorhees, Peter Michael, additional, Usmani, Saad Zafar, additional, and He, Jiaxian, additional

Published
2020
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19. Phase I/II Study of Carfilzomib, Ruxolitinib and Low-Dose Dexamethasone for Carfilzomib-Refractory Multiple Myeloma (CarJak)

Author

Atrash, Shebli, primary, Robinson, Myra, additional, Bhutani, Manisha, additional, Zonder, Jeffrey A., additional, Friend, Reed, additional, Paul, Barry, additional, Auclair, Daniel, additional, Robinsons, Jordan, additional, Ndiaye, Ami P, additional, Bumgarner, Kelly, additional, Norek, Sarah, additional, Symanowski, James T., additional, Voorhees, Peter M., additional, and Usmani, Saad Z., additional

Published
2019
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20. Patient tolerability and Estimation of Direct/Productivity costs associated with rapid infusion of daratumumab.

Author

Hamadeh, Issam, primary, Reese, Emily, additional, Schneider, Meghan, additional, Williams, Andre, additional, Arnall, Justin, additional, Kachur, Ekaterina, additional, Martin, Allison, additional, Bhutani, Manisha, additional, Atrash, Shebli, additional, Friend, Reed, additional, Paul, Barry, additional, Robinson, Jordan, additional, Ndiaye, Ami, additional, Sprouse, Chelsea, additional, Voorhees, Peter, additional, and Usmani, Saad, additional

Published
2019
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21. Peripheral Immunotype Correlates with Minimal Residual Disease Status and Is Modulated by Immunomodulatory Drugs in Multiple Myeloma

Author

Bhutani, Manisha, primary, Foureau, David, additional, Zhang, Qing, additional, Robinson, Myra, additional, Wynn, Adina S., additional, Steuerwald, Nury M., additional, Druhan, Lawrence J., additional, Guo, Fei, additional, Rigby, Katherine, additional, Turner, Mitchell, additional, Slaughter, Daniel, additional, Friend, Reed, additional, Atrash, Shebli, additional, Symanowski, James T., additional, Avalos, Belinda R., additional, Copelan, Edward A., additional, Voorhees, Peter M., additional, and Usmani, Saad Z., additional

Published
2019
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22. Daratumumab, pomalidomide and dexamethasone combination therapy in daratumumab and/or pomalidomide refractory multiple myeloma

Author

Hussain, M. Junaid, primary, Robinson, Myra M., additional, Hamadeh, Issam, additional, Arnall, Justin, additional, Bhutani, Manisha, additional, Atrash, Shebli, additional, Friend, Reed, additional, Pineda‐Roman, Mauricio, additional, Symanowski, James T., additional, Usmani, Saad Z., additional, and Voorhees, Peter M., additional

Published
2018
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23. Clinical potential of SLAMF7 antibodies – focus on elotuzumab in multiple myeloma

Author

Friend,Reed, Bhutani,Manisha, Voorhees,Peter, and Usmani,Saad

Subjects
Drug Design, Development and Therapy
Abstract

Reed Friend, Manisha Bhutani, Peter M Voorhees, Saad Z Usmani Department of Hematologic Oncology & Blood Disorders, Levine Cancer Institute, Carolinas Healthcare System, UNC School of Medicine, Charlotte, NC, USA Abstract: Elotuzumab is one of the first monoclonal antibodies to be approved for the treatment of multiple myeloma. It is a humanized immunoglobulin G kappa (IgGκ) antibody that targets signaling lymphocytic activation molecule family member 7 (SLAMF7), a surface marker that is highly expressed on normal and malignant plasma cells. This review summarizes the preclinical and clinical data that led to the approval of elotuzumab, along with a discussion on the ongoing and future clinical investigations. Keywords: multiple myeloma, relapsed, refractory, treatment, elotuzumab, SLAMF7, CS1

Published
2017

25. Increased Immune Suppression is Associated with Worse Overall Survival in Allogeneic Hematopoietic Cell Transplant Patients Receiving Reduced Intensity Continuous Infusion Busulfan

Author

Armistead, Paul M., primary, Friend, Reed, additional, Xenakis, James, additional, Ivanova, Anastasia, additional, Serody, Jonathan S., additional, Gabriel, Don, additional, Comeau, Terrance, additional, Sarantopoulos, Stefanie, additional, Coghill, James, additional, Wood, William A., additional, Walko, Christine M., additional, Rao, Kamakshi V., additional, Whitley, Julia, additional, and Shea, Thomas C., additional

Published
2017
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27. Daratumumab, pomalidomide and dexamethasone combination therapy in daratumumab and/or pomalidomide refractory multiple myeloma.

Author

Hussain, M. Junaid, Robinson, Myra M., Hamadeh, Issam, Arnall, Justin, Bhutani, Manisha, Atrash, Shebli, Friend, Reed, Pineda‐Roman, Mauricio, Symanowski, James T., Usmani, Saad Z., and Voorhees, Peter M.

Subjects
MULTIPLE myeloma, THALIDOMIDE, BORTEZOMIB, T helper cells, CYTOTOXIC T cells, KILLER cells
Abstract

The article focuses on the role of Daratumumab, pomalidomide and dexamethasone (Pd) combination therapy for the treatment of relapsed and refractory multiple myeloma. It mentions the addition of daratumumab to the Pd backbone (DaraPd) for the patients with relapsed and refractory multiple myelom and also discussions on daratumumab that depletes levels of CD38 (cluster of differentiation 38).

Published
2019
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29. Reduced Intensity Continuous Infusion Busulfan for Allogeneic Hematopoietic Cell Transplant Patients with Hematologic Disorders Who Are Ineligible or Inappropriate for Treatment with a More Intensive Therapeutic Regimen: LCCC 0306

Author

Friend, Reed, primary, Xenakis, James, additional, Serody, Jonathan S, additional, Comeau, Terrance, additional, Gabriel, Don A., additional, Sarantopoulos, Stefanie, additional, Coghill, James, additional, Wood, William A., additional, Sharf, Andrew, additional, Whitley, Julia S, additional, Rao, Kamakshi, additional, Walko, Christine M, additional, Ivanova, Anastasia, additional, Shea, Thomas C., additional, and Armistead, Paul M, additional

Published
2015
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30. Effect of Immunomodulatory Drugs (IMiDs) on Immune Effectors after Autologous Stem Cell Transplantation (ASCT) in Multiple Myeloma

Author

Foureau, David M, Bhutani, Manisha, Zhang, Qing, Robinson, Myra M, Wynn, Adina, Steuerwald, Nury M, Druhan, Lawrence J, Guo, Fei, Rigby, Katherine, Turner, Mitchell, Friend, Reed, Atrash, Shebli, Sprouse, Chelsea, Ndiaye, Ami, Symanowski, James T, Avalos, Belinda Rene, Copelan, Edward A, Voorhees, Peter M., and Usmani, Saad Z

Published
2017
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33. Western Europe's Beef Production, Consumption, and Trade: Situation and Outlook

Author

Phillips, Donald M., Lovfald, Lorin O., and Friend, Reed E.

Subjects
Productivity Analysis, Forecasts, Consumption, International Relations/Trade, Livestock Production/Industries, Demand and Price Analysis, Western Europe, Production, Crop Production/Industries, Exports, Imports, Agricultural and Food Policy, Veal, Beef, Food Consumption/Nutrition/Food Safety
Abstract

A conservative forecast of a 10- percent increase in 1974 West European beef and veal production (with continued depressed consumption) would result in more than a 650,000-metric ton fall in the net import requirements of the region. Beef production could easily go higher, equaling or even exceeding consumption. Outside suppliers--mainly Latin America, Eastern Europe, and to a lesser extent, Oceania--will likely bear the brunt of this decline in imports, as actions by the West European countries to end the meat "glut" have been characterized by import embargoes, levies, and tariffs and restrictive import licensing. As suppliers seek to divert exports, the U.S. market will receive increased pressure. However, sanitary and health regulations will prohibit the major suppliers of the West European market from shipping fresh, chilled, or frozen beef to the United States. Only cooked beef is allowed. The 1974 surge in beef production in Western Europe results from the large herd buildup over the past 2 years, which was stimulated by improved profitability in the dairy sector and a jump in beef prices. Production forecasts for 1974 will not cut significantly into herd size, so high production levels can be expected to continue into 1975 and 1976.

Published
1974
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34. Production, Consumption, and Trade of Coarse Grains: Developments and Prospects for Selected Foreign Countries and Areas

Author

Friend, Reed E. and Butell, G. Robert

Subjects
Agricultural and Food Policy, International Relations/Trade, Livestock Production/Industries, Demand and Price Analysis, Crop Production/Industries
Abstract

Excerpts from the Report: The United States is the world's major producer, consumer, and trader of coarse grains. Despite this preeminence, the grain policies of other nations have an impact on the United States. This is particularly true when the country happens to be a major importer or exporter of coarse grains. Shifts in coarse grain production, consumption, and trade of other countries influence U.S. policy decisions in several ways. These "outside" developments have a bearing on the nature of the feed grains program pursued by the United States since the level of coarse grain production targeted annually depends in part on export possibilities. This report looks briefly at trends in world production, utilization, and trade of coarse grains. The discussion centers on major coarse grain consuming or exporting countries (or regions) other than the United States and comments on trade prospects for 1970/71. An appraisal of probable developments in other countries or areas is designed to provide some insight into short-term problems (or opportunities) facing the United States in the world coarse grains market and on matters having a bearing on U.S. grain policy.

Published
1969
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39. Rural Industrialization: A Summary of Five Studies

Author

Maitland, Sheridan T. and Friend, Reed E.

Subjects
Community/Rural/Urban Development, Labor and Human Capital, Research Methods/ Statistical Methods
Abstract

Excerpts from the report Purpose: Studies summarized in this report attempted to provide some insight into the relationship of the industry and the rural community. Interest centered on the personal and family characteristics of individuals hired by rural industries and the effects of industrial development on incomes and level of living. Another question probed was how industrialization affected family participation in social and community organizations and activities. Information on the farming operations of part-time farmers was obtained. The reaction of plant employees was compared with the reaction of other residents of the rural community to measure differences in attitudes and effects of rural industrialization on two occupationally divergent groups within the community. Information was desired to serve two interested groups: (1) Federal and State agencies that have responsibilities for area development and (2) rural communities that have undergone some degree of industrialization in recent years or those planning for industrial development.

Published
1961
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40. Agriculture in the European Economic Community: An Annotated Bibliography, 1958-66

Author

Hedges, Brian D. and Friend, Reed E.

Subjects
Marketing, FOS: Economics and business, Agricultural and Food Policy, International Relations/Trade, Livestock Production/Industries, Crop Production/Industries, Research Methods/ Statistical Methods
Abstract

Excerpt from the Preface: This bibliography provides an annotated list of over 300 publications dealing with various aspects of agriculture in the European Economic Community (EEC). The major emphasis, however, is on studies dealing with factors affecting the demand, supply, and trade of agricultural commodities. Some of the listings pertain only to individual member countries. Roughly half of the entries were prepared from abstracts provided through a contract with Oxford University, Oxford, England. The rest were prepared from documents obtained by the Europe and Soviet Union Branch, Economic Research Service, U.S. Department of Agriculture, with the exception of a few entries prepared from the World Agricultural Economic and Rural Sociology Abstracts.

Published
1968
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41. Bangladesh's Agricultural Situation: A Brief Appraisal

Author

Parker, John B. and Friend, Reed E.

Subjects
Bangladesh, Imports, Consumption, Agricultural and Food Policy, International Relations/Trade, Production, International Development, Food scarcity, Food Consumption/Nutrition/Food Safety, Food Security and Poverty
Abstract

Bangladesh is facing food scarcity as a result of civil war and armed conflict in 1971. The transportation network has been severely disrupted and large numbers of people have been dislocated from rural to urban areas. It appears that the only way to avoid serious pockets of hunger in Bangladesh in the short run is through imports of foodstuffs and improved distribution. Over 1.5 million tons of wheat and 900,000 tons of rice may be imported by Bangladesh in 1972. Self-sufficiency in grains is not expected in the long run because of limited land area, population increases, and the need for nutritional improvement.

Published
1972
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44. Prognostic Significance of Ki67 Expression By Immunohistochemistry (IHC) on Bone Marrow Biopsy in Newly Diagnosed Multiple Myeloma

Author

Robinson, Myra M, Atrash, Shebli, Brown, Taylor, Block, Jared G, Lipford, Edward H, Smith, Elton T, Friend, Reed, Aneralla, Amanda, Taneja, Alankrita, Zhang, Qing, Foureau, David M, Sprouse, Chelsea, Ndiaye, Ami, Symanowski, James T, Avalos, Belinda Rene, Copelan, Edward A, Voorhees, Peter M., Usmani, Saad Z, and Bhutani, Manisha

Abstract

Background: Multiple myeloma (MM) is known to be a heterogeneous disease encompassing several molecular subtypes that can be defined either by means of genetic or molecular testing. In the multigene tests, the ‘PR’ subtype enriched with proliferation-related genes has a substantial impact on the prediction of the risk of MM recurrence. Ki-67 is a nuclear protein involved in cell cycle regulation and is considered an indicator of proliferation. It is present in dividing cells during all active phases of the cell cycle (S, G1, G2 and mitosis phases) and is distinctly absent in resting or quiescent (G0) cells. Ki67 expression has been widely used as an index to evaluate the proliferative activity of breast cancer and lymphoma but the impact of Ki-67 expression on the clinical outcomes of patients with MM has largely been unexplored. This study aimed to investigate whether Ki-67 expression by IHC is an indicator of outcome in MM patients, especially those treated with novel therapies combined with or without autologous stem cell transplantation.

Published
2017
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45. Peripheral Cellular Immunome Reveals Heterogeneity Spanning Myeloma Spectrum Diseases

Author

Bhutani, Manisha, Foureau, David M, Zhang, Qing, Robinson, Myra M, Wynn, Adina, Steuerwald, Nury M, Druhan, Lawrence J, Guo, Fei, Rigby, Katherine, Turner, Mitchell, Friend, Reed, Atrash, Shebli, Ndiaye, Ami, Sprouse, Chelsea, Symanowski, James T, Avalos, Belinda Rene, Copelan, Edward A, Voorhees, Peter M., and Usmani, Saad Z

Abstract

INTRODUCTION: Progression from precursor states, termed monoclonal gammopathy of undetermined significance (MGUS) and smoldering multiple myeloma (SMM), to multiple myeloma (MM) is facilitated by cross-talk between malignant plasma cells and cellular/soluble components of the immunosuppressive bone marrow milieu, which promotes angiogenesis, bone destruction and immune-impairment. In support of this view, the frequencies of several peripheral immune cell subsets have been shown to be affected by the disease state. We hypothesized that beyond numerical alterations, activation and differentiation state of circulating innate and adaptive immune cell subsets determines progression from pre-malignant to malignant stage.

Published
2017
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46. MRD-driven phase 2 study of daratumumab, carfilzomib, lenalidomide and dexamethasone in newly diagnosed multiple myeloma.

Author

Bhutani M, Robinson M, Foureau D, Atrash S, Paul BA, Guo F, Grayson J, Ivanina-Foureau A, Pineda-Roman M, Varga C, Friend R, Ferreri CJ, Begic X, Norek S, Drennan T, Anderson MB, Symanowski JT, Voorhees PM, and Usmani SZ

Abstract

In newly diagnosed multiple myeloma (NDMM), measurable residual disease (MRD) status is prognostically important, but its role in treatment-decisions remains unclear. In a phase II trial (NCT04113018), we assessed daratumumab, carfilzomib, lenalidomide and dexamethasone (Dara-KRd) induction followed by a next generation sequencing (NGS) based MRD-adapted strategy. The primary endpoint was rate of complete response and stringent complete response (≥CR) after induction. Flow cytometry was used to profile T cells. Among 39 patients, 21 (54%) achieved ≥CR post-induction (P=0.375) with MRD-negative rates of 59% (10-5) and 41% (10-6). MRD-negative patients (n=24, group A) received lenalidomide maintenance, showing sustained MRD-negativity in 14/18 (77.8%) for ≥12 cycles. MRD-positive transplant-eligible patients (n=8, group B) underwent ASCT, with 5 (62.5%) converting to MRD-negative (10-5) and 3 (37.5%) at 10-6. MRD-positive transplant-ineligible patients (n=4, group C) received KRd consolidation. MRD-negative rates improved to 77% (10-5) and 72% (10-6) at any time. No additional safety concerns were identified beyond those already known for Dara-KRd. With a median follow-up of 30.1 months, three, two and one patient(s) in groups A, B, and C have experienced disease progression or death. The 2-year PFS rate was 82.5%. We observed that the Dara-KRd regimen strongly activated memory T cells, which was associated with an MRD-negative state after induction. Although the primary endpoint was not met, Dara-KRd induction in NDMM achieved high rates of ≥CR and MRD-negativity without new safety concerns. The post-induction MRD-adapted strategy deepened responses in the MRD-positive group while maintaining durable MRD control in the negative group., (Copyright © 2024 American Society of Hematology.)

Published
2024
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