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1. Daratumumab in transplant-eligible patients with newly diagnosed multiple myeloma: final analysis of clinically relevant subgroups in GRIFFIN

Author

Chari, Ajai, Kaufman, Jonathan L., Laubach, Jacob, Sborov, Douglas W., Reeves, Brandi, Rodriguez, Cesar, Silbermann, Rebecca, Costa, Luciano J., Anderson, Jr, Larry D., Nathwani, Nitya, Shah, Nina, Bumma, Naresh, Holstein, Sarah A., Costello, Caitlin, Jakubowiak, Andrzej, Wildes, Tanya M., Orlowski, Robert Z., Shain, Kenneth H., Cowan, Andrew J., Pei, Huiling, Cortoos, Annelore, Patel, Sharmila, Lin, Thomas S., Voorhees, Peter M., Usmani, Saad Z., and Richardson, Paul G.

Published
2024
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2. Comparison of infectious complications with BCMA-directed therapies in multiple myeloma

Author

Nath, Karthik, Shekarkhand, Tala, Nemirovsky, David, Derkach, Andriy, Costa, Bruno Almeida, Nishimura, Noriko, Farzana, Tasmin, Rueda, Colin, Chung, David J., Landau, Heather J., Lahoud, Oscar B., Scordo, Michael, Shah, Gunjan L., Hassoun, Hani, Maclachlan, Kylee, Korde, Neha, Shah, Urvi A., Tan, Carlyn Rose, Hultcrantz, Malin, Giralt, Sergio A., Usmani, Saad Z., Shahid, Zainab, Mailankody, Sham, and Lesokhin, Alexander M.

Published
2024
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3. Prognostic impact of corticosteroid and tocilizumab use following chimeric antigen receptor T-cell therapy for multiple myeloma

Author

Costa, Bruno Almeida, Flynn, Jessica, Nishimura, Noriko, Devlin, Sean M., Farzana, Tasmin, Rajeeve, Sridevi, Chung, David J., Landau, Heather J., Lahoud, Oscar B., Scordo, Michael, Shah, Gunjan L., Hassoun, Hani, Maclachlan, Kylee, Hultcrantz, Malin, Korde, Neha, Lesokhin, Alexander M., Shah, Urvi A., Tan, Carlyn R., Giralt, Sergio A., Usmani, Saad Z., Nath, Karthik, and Mailankody, Sham

Published
2024
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4. Daratumumab-based quadruplet therapy for transplant-eligible newly diagnosed multiple myeloma with high cytogenetic risk

Author

Callander, Natalie S., Silbermann, Rebecca, Kaufman, Jonathan L., Godby, Kelly N., Laubach, Jacob, Schmidt, Timothy M., Sborov, Douglas W., Medvedova, Eva, Reeves, Brandi, Dhakal, Binod, Rodriguez, Cesar, Chhabra, Saurabh, Chari, Ajai, Bal, Susan, Anderson, Jr, Larry D., Dholaria, Bhagirathbhai R., Nathwani, Nitya, Hari, Parameswaran, Shah, Nina, Bumma, Naresh, Holstein, Sarah A., Costello, Caitlin, Jakubowiak, Andrzej, Wildes, Tanya M., Orlowski, Robert Z., Shain, Kenneth H., Cowan, Andrew J., Pei, Huiling, Cortoos, Annelore, Patel, Sharmila, Lin, Thomas S., Giri, Smith, Costa, Luciano J., Usmani, Saad Z., Richardson, Paul G., and Voorhees, Peter M.

Published
2024
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5. Sustained Minimal Residual Disease Negativity in Multiple Myeloma is Associated with Stool Butyrate and Healthier Plant-Based Diets.

Author

Shah, Urvi A, Maclachlan, Kylee H, Derkach, Andriy, Salcedo, Meghan, Barnett, Kelly, Caple, Julia, Blaslov, Jenna, Tran, Linh, Ciardiello, Amanda, Burge, Miranda, Shekarkhand, Tala, Adintori, Peter, Cross, Justin, Pianko, Matthew J, Hosszu, Kinga, McAvoy, Devin, Mailankody, Sham, Korde, Neha, Hultcrantz, Malin, Hassoun, Hani, Tan, Carlyn R, Lu, Sydney X, Patel, Dhwani, Diamond, Benjamin, Shah, Gunjan, Scordo, Michael, Lahoud, Oscar, Chung, David J, Landau, Heather, Usmani, Saad Z, Giralt, Sergio, Taur, Ying, Landgren, C Ola, Block, Gladys, Block, Torin, Peled, Jonathan U, van den Brink, Marcel RM, and Lesokhin, Alexander M

Subjects
Nutrition, Rare Diseases, Complementary and Integrative Health, Clinical Research, Cancer, Hematology, Oral and gastrointestinal, Good Health and Well Being, Humans, Multiple Myeloma, Butyrates, Neoplasm, Residual, Diet, Healthy, Diet, Vegetarian, Oncology and Carcinogenesis, Oncology & Carcinogenesis
Abstract

PurposeSustained minimal residual disease (MRD) negativity is associated with long-term survival in multiple myeloma. The gut microbiome is affected by diet, and in turn can modulate host immunity, for example through production of short-chain fatty acids including butyrate. We hypothesized that dietary factors affect the microbiome (abundance of butyrate-producing bacteria or stool butyrate concentration) and may be associated with multiple myeloma outcomes.Experimental designWe examined the relationship of dietary factors (via a food frequency questionnaire), stool metabolites (via gas chromatography-mass spectrometry), and the stool microbiome (via 16S sequencing - α-diversity and relative abundance of butyrate-producing bacteria) with sustained MRD negativity (via flow cytometry at two timepoints 1 year apart) in myeloma patients on lenalidomide maintenance. The Healthy Eating Index 2015 score and flavonoid nutrient values were calculated from the food frequency questionnaire. The Wilcoxon rank sum test was used to evaluate associations with two-sided P < 0.05 considered significant.ResultsAt 3 months, higher stool butyrate concentration (P = 0.037), butyrate producers (P = 0.025), and α-diversity (P = 0.0035) were associated with sustained MRD negativity. Healthier dietary proteins, (from seafood and plants), correlated with butyrate at 3 months (P = 0.009) and sustained MRD negativity (P = 0.05). Consumption of dietary flavonoids, plant nutrients with antioxidant effects, correlated with stool butyrate concentration (anthocyanidins P = 0.01, flavones P = 0.01, and flavanols P = 0.02).ConclusionsThis is the first study to demonstrate an association between a plant-based dietary pattern, stool butyrate production, and sustained MRD negativity in multiple myeloma, providing rationale to evaluate a prospective dietary intervention.

Published
2022

6. Teclistamab in Relapsed or Refractory Multiple Myeloma

Author

Moreau, Philippe, Garfall, Alfred L, van de Donk, Niels WCJ, Nahi, Hareth, San-Miguel, Jesús F, Oriol, Albert, Nooka, Ajay K, Martin, Thomas, Rosinol, Laura, Chari, Ajai, Karlin, Lionel, Benboubker, Lotfi, Mateos, Maria-Victoria, Bahlis, Nizar, Popat, Rakesh, Besemer, Britta, Martínez-López, Joaquín, Sidana, Surbhi, Delforge, Michel, Pei, Lixia, Trancucci, Danielle, Verona, Raluca, Girgis, Suzette, Lin, Shun XW, Olyslager, Yunsi, Jaffe, Mindy, Uhlar, Clarissa, Stephenson, Tara, Van Rampelbergh, Rian, Banerjee, Arnob, Goldberg, Jenna D, Kobos, Rachel, Krishnan, Amrita, and Usmani, Saad Z

Subjects
Biomedical and Clinical Sciences, Cardiovascular Medicine and Haematology, Oncology and Carcinogenesis, Cancer, Clinical Research, Vaccine Related, Clinical Trials and Supportive Activities, Biotechnology, Rare Diseases, Hematology, 6.2 Cellular and gene therapies, Evaluation of treatments and therapeutic interventions, Antibodies, Bispecific, Antibodies, Monoclonal, Humanized, Antineoplastic Agents, Antineoplastic Agents, Immunological, Antineoplastic Combined Chemotherapy Protocols, B-Cell Maturation Antigen, CD3 Complex, Humans, Injections, Subcutaneous, Multiple Myeloma, Neoplasm Recurrence, Local, Recurrence, T-Lymphocytes, Medical and Health Sciences, General & Internal Medicine, Biomedical and clinical sciences, Health sciences
Abstract

BackgroundTeclistamab is a T-cell-redirecting bispecific antibody that targets both CD3 expressed on the surface of T cells and B-cell maturation antigen expressed on the surface of myeloma cells. In the phase 1 dose-defining portion of the study, teclistamab showed promising efficacy in patients with relapsed or refractory multiple myeloma.MethodsIn this phase 1-2 study, we enrolled patients who had relapsed or refractory myeloma after at least three therapy lines, including triple-class exposure to an immunomodulatory drug, a proteasome inhibitor, and an anti-CD38 antibody. Patients received a weekly subcutaneous injection of teclistamab (at a dose of 1.5 mg per kilogram of body weight) after receiving step-up doses of 0.06 mg and 0.3 mg per kilogram. The primary end point was the overall response (partial response or better).ResultsAmong 165 patients who received teclistamab, 77.6% had triple-class refractory disease (median, five previous therapy lines). With a median follow-up of 14.1 months, the overall response rate was 63.0%, with 65 patients (39.4%) having a complete response or better. A total of 44 patients (26.7%) were found to have no minimal residual disease (MRD); the MRD-negativity rate among the patients with a complete response or better was 46%. The median duration of response was 18.4 months (95% confidence interval [CI], 14.9 to not estimable). The median duration of progression-free survival was 11.3 months (95% CI, 8.8 to 17.1). Common adverse events included cytokine release syndrome (in 72.1% of the patients; grade 3, 0.6%; no grade 4), neutropenia (in 70.9%; grade 3 or 4, 64.2%), anemia (in 52.1%; grade 3 or 4, 37.0%), and thrombocytopenia (in 40.0%; grade 3 or 4, 21.2%). Infections were frequent (in 76.4%; grade 3 or 4, 44.8%). Neurotoxic events occurred in 24 patients (14.5%), including immune effector cell-associated neurotoxicity syndrome in 5 patients (3.0%; all grade 1 or 2).ConclusionsTeclistamab resulted in a high rate of deep and durable response in patients with triple-class-exposed relapsed or refractory multiple myeloma. Cytopenias and infections were common; toxic effects that were consistent with T-cell redirection were mostly grade 1 or 2. (Funded by Janssen Research and Development; MajesTEC-1 ClinicalTrials.gov numbers, NCT03145181 and NCT04557098.).

Published
2022

8. Patterns of CRS with teclistamab in relapsed/refractory multiple myeloma with or without prior T-cell redirection therapy

Author

Hamadeh, Issam S., Shekarkhand, Tala, Rueda, Colin, Firestone, Ross S., Wang, Alice X., Korde, Neha, Hultcrantz, Malin L., Lesokhin, Alexander M., Mailankody, Sham, Hassoun, Hani, Shah, Urvi A., Maclachlan, Kylee, Rajeeve, Sridevi, Patel, Dhwani, Shah, Gunjan L., Scordo, Michael, Lahoud, Oscar B., Chung, David J., Landau, Heather J., Giralt, Sergio, Usmani, Saad Z., and Tan, Carlyn R.

Published
2024
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9. Unscheduled health care interactions in patients with multiple myeloma receiving T-cell redirection therapies

Author

Howard, Anna J., Concepcion, Isabel, Wang, Alice X., Hamadeh, Issam S., Hultcrantz, Malin, Mailankody, Sham, Tan, Carlyn, Korde, Neha, Lesokhin, Alexander M., Hassoun, Hani, Shah, Urvi A., Maclachlan, Kylee H., Rajeeve, Sridevi, Landau, Heather J., Scordo, Michael, Shah, Gunjan L., Lahoud, Oscar B., Chung, David J., Giralt, Sergio, Usmani, Saad Z., and Firestone, Ross S.

Published
2024
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10. CD8 effector T cells enhance teclistamab response in BCMA-exposed and -naïve multiple myeloma

Author

Firestone, Ross S., McAvoy, Devin, Shekarkhand, Tala, Serrano, Edith, Hamadeh, Issam, Wang, Alice, Zhu, Menglei, Qin, Wei Ge, Patel, Dhwani, Tan, Carlyn R., Hultcrantz, Malin, Mailankody, Sham, Hassoun, Hani, Shah, Urvi S., Korde, Neha, Maclachlan, Kylee H., Landau, Heather J., Scordo, Michael, Shah, Gunjan L., Lahoud, Oscar B., Giralt, Sergio, Murata, Kazunori, Hosszu, Kinga K., Chung, David J., Lesokhin, Alexander M., and Usmani, Saad Z.

Published
2024
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13. Bortezomib, lenalidomide and dexamethasone (VRd) vs carfilzomib, lenalidomide and dexamethasone (KRd) as induction therapy in newly diagnosed multiple myeloma

Author

Tan, Carlyn Rose, Derkach, Andriy, Nemirovsky, David, Ciardiello, Amanda, Diamond, Benjamin, Hultcrantz, Malin, Hassoun, Hani, Mailankody, Sham, Shah, Urvi, Maclachlan, Kylee, Patel, Dhwani, Lahoud, Oscar B., Landau, Heather J., Chung, David J., Shah, Gunjan L., Scordo, Michael, Giralt, Sergio A., Lesokhin, Alexander, Usmani, Saad Z., Landgren, Ola, and Korde, Neha

Published
2023
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17. Daratumumab for patients with myeloma with early or late relapse after initial therapy: subgroup analysis of CASTOR and POLLUX

Author

Spencer, Andrew, Moreau, Philippe, Mateos, Maria-Victoria, Goldschmidt, Hartmut, Suzuki, Kenshi, Levin, Mark-David, Sonneveld, Pieter, Orlowski, Robert Z., Yoon, Sung-Soo, Usmani, Saad Z., Weisel, Katja, Reece, Donna, Ahmadi, Tahamtan, Pei, Huiling, Mayo, Wendy Garvin, Gai, Xue, Carey, Jodi, Bartlett, J. Blake, Carson, Robin, and Dimopoulos, Meletios A.

Published
2024
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18. Prevalence and impact of diabetes on survival of patients with multiple myeloma in different racial groups

Author

Shah, Urvi A., Moshier, Erin, Derkach, Andriy, Huang, Yuanhui, Mailankody, Sham, Tan, Carlyn R., Maclachlan, Kylee, Hultcrantz, Malin, Korde, Neha, Hassoun, Hani, Thibaud, Santiago, Sanchez, Larysa, Rodriguez, Cesar, Richard, Shambavi, Richter, Joshua, Rossi, Adriana, Cho, Hearn Jay, Lesokhin, Alexander, Chari, Ajai, Usmani, Saad Z., Jagannath, Sundar, Parekh, Samir, and Gallagher, Emily J.

Published
2024
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19. The 2020 BMT CTN Myeloma Intergroup Workshop on Immune Profiling and Minimal Residual Disease Testing in Multiple Myeloma

Author

Holstein, Sarah A, Bahlis, Nizar, Bergsagel, P Leif, Bhutani, Manisha, Bolli, Niccolo, Brownstein, Carrie, Demolis, Pierre, Foureau, David, Gay, Francesca, Ghobrial, Irene M, Gormley, Nicole, Hillengass, Jens, Kaiser, Martin, Maus, Marcela V, Melenhorst, J Joseph, Merz, Maximilian, Dwyer, Michael O, Paiva, Bruno, Pasquini, Marcelo C, Shah, Nina, Wong, Sandy W, Usmani, Saad Z, and McCarthy, Philip L

Subjects
Transplantation, Rare Diseases, Cancer, Hematology, Good Health and Well Being, Humans, Bone Marrow, Diterpenes, High-Throughput Nucleotide Sequencing, Multiple Myeloma, Neoplasm, Residual, Minimal residual disease, Immune profiling, Multiple myeloma, Endpoint, CAR T-cell, Cellular therapy
Abstract

The fifth annual Blood and Marrow Transplant Clinical Trials Network Myeloma Intergroup Workshop on Immune Profiling and Minimal Residual Disease Testing in Multiple Myeloma was conducted as one of the American Society of Hematology Annual Meeting Scientific Workshops on Thursday December 3, 2020. This workshop focused on four main topics: (1) integrating minimal residual disease into clinical trial design and practice; (2) the molecular and immunobiology of disease evolution and progression in myeloma; (3) adaptation of next-generation sequencing, next-generation flow cytometry, and cytometry by time of flight techniques; and (4) chimeric antigen receptor T-cell and other cellular therapies for myeloma. In this report, we provide a summary of the workshop presentations and discuss future directions in the field.

Published
2021

20. Management of patients with multiple myeloma beyond the clinical-trial setting: understanding the balance between efficacy, safety and tolerability, and quality of life

Author

Terpos, Evangelos, Mikhael, Joseph, Hajek, Roman, Chari, Ajai, Zweegman, Sonja, Lee, Hans C, Mateos, María-Victoria, Larocca, Alessandra, Ramasamy, Karthik, Kaiser, Martin, Cook, Gordon, Weisel, Katja C, Costello, Caitlin L, Elliott, Jennifer, Palumbo, Antonio, and Usmani, Saad Z

Subjects
Comparative Effectiveness Research, Health Services, Rare Diseases, Clinical Research, Patient Safety, Clinical Trials and Supportive Activities, Hematology, Orphan Drug, Cancer, Evaluation of treatments and therapeutic interventions, 6.1 Pharmaceuticals, Good Health and Well Being, Antineoplastic Agents, Clinical Trials, Phase III as Topic, Disease Management, Humans, Multiple Myeloma, Quality of Life, Treatment Outcome, Cardiorespiratory Medicine and Haematology, Oncology and Carcinogenesis
Abstract

Treatment options in multiple myeloma (MM) are increasing with the introduction of complex multi-novel-agent-based regimens investigated in randomized clinical trials. However, application in the real-world setting, including feasibility of and adherence to these regimens, may be limited due to varying patient-, treatment-, and disease-related factors. Furthermore, approximately 40% of real-world MM patients do not meet the criteria for phase 3 studies on which approvals are based, resulting in a lack of representative phase 3 data for these patients. Therefore, treatment decisions must be tailored based on additional considerations beyond clinical trial efficacy and safety, such as treatment feasibility (including frequency of clinic/hospital attendance), tolerability, effects on quality of life (QoL), and impact of comorbidities. There are multiple factors of importance to real-world MM patients, including disease symptoms, treatment burden and toxicities, ability to participate in daily activities, financial burden, access to treatment and treatment centers, and convenience of treatment. All of these factors are drivers of QoL and treatment satisfaction/compliance. Importantly, given the heterogeneity of MM, individual patients may have different perspectives regarding the most relevant considerations and goals of their treatment. Patient perspectives/goals may also change as they move through their treatment course. Thus, the 'efficacy' of treatment means different things to different patients, and treatment decision-making in the context of personalized medicine must be guided by an individual's composite definition of what constitutes the best treatment choice. This review summarizes the various factors of importance and practical issues that must be considered when determining real-world treatment choices. It assesses the current instruments, methodologies, and recent initiatives for analyzing the MM patient experience. Finally, it suggests options for enhancing data collection on patients and treatments to provide a more holistic definition of the effectiveness of a regimen in the real-world setting.

Published
2021

22. B-cell maturation antigen (BCMA) in multiple myeloma: rationale for targeting and current therapeutic approaches

Author

Shah, Nina, Chari, Ajai, Scott, Emma, Mezzi, Khalid, and Usmani, Saad Z

Subjects
Rare Diseases, Clinical Research, Orphan Drug, Biotechnology, Cancer, Hematology, Development of treatments and therapeutic interventions, 5.1 Pharmaceuticals, Antibodies, Bispecific, Antibodies, Monoclonal, Humanized, Antineoplastic Agents, Immunological, Antineoplastic Combined Chemotherapy Protocols, B-Cell Maturation Antigen, B-Lymphocytes, Biomarkers, Tumor, Clinical Trials as Topic, Drug Resistance, Neoplasm, Gene Expression, Humans, Immunoconjugates, Immunotherapy, Adoptive, Molecular Targeted Therapy, Multiple Myeloma, Recurrence, Treatment Outcome, Clinical Sciences, Oncology and Carcinogenesis, Immunology
Abstract

Despite considerable advances in the treatment of multiple myeloma (MM) in the last decade, a substantial proportion of patients do not respond to current therapies or have a short duration of response. Furthermore, these treatments can have notable morbidity and are not uniformly tolerated in all patients. As there is no cure for MM, patients eventually become resistant to therapies, leading to development of relapsed/refractory MM. Therefore, an unmet need exists for MM treatments with novel mechanisms of action that can provide durable responses, evade resistance to prior therapies, and/or are better tolerated. B-cell maturation antigen (BCMA) is preferentially expressed by mature B lymphocytes, and its overexpression and activation are associated with MM in preclinical models and humans, supporting its potential utility as a therapeutic target for MM. Moreover, the use of BCMA as a biomarker for MM is supported by its prognostic value, correlation with clinical status, and its ability to be used in traditionally difficult-to-monitor patient populations. Here, we review three common treatment modalities used to target BCMA in the treatment of MM: bispecific antibody constructs, antibody-drug conjugates, and chimeric antigen receptor (CAR)-modified T-cell therapy. We provide an overview of preliminary clinical data from trials using these therapies, including the BiTE® (bispecific T-cell engager) immuno-oncology therapy AMG 420, the antibody-drug conjugate GSK2857916, and several CAR T-cell therapeutic agents including bb2121, NIH CAR-BCMA, and LCAR-B38M. Notable antimyeloma activity and high minimal residual disease negativity rates have been observed with several of these treatments. These clinical data outline the potential for BCMA-targeted therapies to improve the treatment landscape for MM. Importantly, clinical results to date suggest that these therapies may hold promise for deep and durable responses and support further investigation in earlier lines of treatment, including newly diagnosed MM.

Published
2020

23. Waldenström macroglobulinemia whole genome reveals prolonged germinal center activity and late copy number aberrations

Author

Maclachlan, Kylee H., Bagratuni, Tina, Kastritis, Efstathios, Ziccheddu, Bachisio, Lu, Sydney, Yellapantula, Venkata, Famulare, Chris, Argyropoulos, Kimon, Derkach, Andriy, Papaemmanuil, Elli, Dogan, Ahmet, Lesokhin, Alexander, Usmani, Saad Z., Landgren, C. Ola, Palomba, Lia M., Maura, Francesco, and Dimopoulos, Meletios A.

Published
2023
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24. Association of patient activity bio-profiles with health-related quality of life in patients with newly diagnosed multiple myeloma: a prospective observational cohort study

Author

Korde, Neha, Tavitian, Elizabet, Mastey, Donna, Lengfellner, Joseph, Hevroni, Gil, Zarski, Andrew, Salcedo, Meghan, Mailankody, Sham, Hassoun, Hani, Smith, Eric L., Hultcrantz, Malin, Shah, Urvi, Tan, Carlyn, Diamond, Benjamin, Shah, Gunjan, Scordo, Michael, Lahoud, Oscar, Chung, David J., Landau, Heather, Giralt, Sergio, Derkach, Andriy, Atkinson, Thomas M., Sabbatini, Paul, König, Francesca, Usmani, Saad Z., Landgren, Ola, and Lesokhin, Alexander M.

Published
2023
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25. Impact of second primary malignancy postautologous transplantation on outcomes of multiple myeloma: a CIBMTR analysis

Author

Ragon, Brittany Knick, Shah, Mithun Vinod, D’Souza, Anita, Estrada-Merly, Noel, Gowda, Lohith, George, Gemlyn, de Lima, Marcos, Hashmi, Shahrukh, Kharfan-Dabaja, Mohamed A., Majhail, Navneet S., Banerjee, Rahul, Saad, Ayman, Hildebrandt, Gerhard C., Mian, Hira, Abid, Muhammad Bilal, Battiwalla, Minoo, Lekakis, Lazaros J., Patel, Sagar S., Murthy, Hemant S., Nieto, Yago, Strouse, Christopher, Badawy, Sherif M., Al Hadidi, Samer, Dholaria, Bhagirathbhai, Aljurf, Mahmoud, Vesole, David H., Lee, Cindy H., Pawarode, Attaphol, Gergis, Usama, Miller, Kevin C., Holmberg, Leona A., Afrough, Aimaz, Solh, Melhem, Munshi, Pashna N., Nishihori, Taiga, Anderson, Larry D., Jr., Wirk, Baldeep, Kaur, Gurbakhash, Qazilbash, Muzaffar H., Shah, Nina, Kumar, Shaji K., and Usmani, Saad Z.

Published
2023
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26. Health‐related quality of life in transplant‐eligible patients with newly diagnosed multiple myeloma treated with daratumumab, lenalidomide, bortezomib, and dexamethasone: Patient‐reported outcomes from GRIFFIN

Author

Silbermann, Rebecca, primary, Laubach, Jacob, additional, Kaufman, Jonathan L., additional, Sborov, Douglas W., additional, Reeves, Brandi, additional, Rodriguez, Cesar, additional, Chari, Ajai, additional, Costa, Luciano J., additional, Anderson, Larry D., additional, Nathwani, Nitya, additional, Shah, Nina, additional, Bumma, Naresh, additional, Holstein, Sarah A., additional, Costello, Caitlin, additional, Jakubowiak, Andrzej, additional, Orlowski, Robert Z., additional, Shain, Kenneth H., additional, Cowan, Andrew J., additional, Gries, Katharine S., additional, Pei, Huiling, additional, Cortoos, Annelore, additional, Patel, Sharmila, additional, Lin, Thomas S., additional, Voorhees, Peter M., additional, Usmani, Saad Z., additional, and Richardson, Paul G., additional

Published
2024
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27. Unscheduled healthcare interactions in multiple myeloma patients receiving T cell redirection therapies

Author

Howard, Anna J, primary, Concepcion, Isabel, additional, Wang, Alice X., additional, Hamadeh, Issam S., additional, Hultcrantz, Malin L., additional, Mailankody, Sham, additional, Tan, Carlyn Rose, additional, Korde, Neha, additional, Lesokhin, Alexander M., additional, Hassoun, Hani, additional, Shah, Urvi A., additional, Maclachlan, Kylee H., additional, Rajeeve, Sridevi, additional, Landau, Heather J., additional, Scordo, Michael, additional, Shah, Gunjan L, additional, Lahoud, Oscar B, additional, Chung, David J., additional, Giralt, Sergio A, additional, Usmani, Saad Z, additional, and Firestone, Ross S., additional

Published
2024
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28. Patterns of CRS with Teclistamab in Relapsed/Refractory Multiple Myeloma patients with Prior T-Cell Redirection Therapy

Author

Hamadeh, Issam S., primary, Shekarkhand, Tala, additional, Rueda, Colin Joseph, additional, Firestone, Ross S., additional, Wang, Alice X., additional, Korde, Neha, additional, Hultcrantz, Malin L., additional, Lesokhin, Alexander M., additional, Mailankody, Sham, additional, Hassoun, Hani, additional, Shah, Urvi A., additional, Maclachlan, Kylee H., additional, Rajeeve, Sridevi, additional, Patel, Dhwani, additional, Shah, Gunjan L, additional, Scordo, Michael, additional, Lahoud, Oscar B, additional, Chung, David J., additional, Landau, Heather J., additional, Giralt, Sergio A, additional, Usmani, Saad Z, additional, and Tan, Carlyn Rose, additional

Published
2024
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29. INSIGHT MM: a large, global, prospective, non-interventional, real-world study of patients with multiple myeloma

Author

Costello, Caitlin, Davies, Faith E, Cook, Gordon, Vela-Ojeda, Jorge, Omel, Jim, Rifkin, Robert M, Berdeja, Jesus, Puig, Noemi, Usmani, Saad Z, Weisel, Katja, Zonder, Jeffrey A, Terpos, Evangelos, Spencer, Andrew, Leleu, Xavier, Boccadoro, Mario, Thompson, Michael A, Romanus, Dorothy, Stull, Dawn M, and Hungria, Vania

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Oncology and Carcinogenesis, Clinical Research, Clinical Trials and Supportive Activities, Cancer, Comparative Effectiveness Research, Hematology, Orphan Drug, Rare Diseases, 6.1 Pharmaceuticals, Evaluation of treatments and therapeutic interventions, Adolescent, Adult, Aged, Aged, 80 and over, Antineoplastic Combined Chemotherapy Protocols, Disease Progression, Follow-Up Studies, Humans, International Agencies, Middle Aged, Multiple Myeloma, Neoplasm Recurrence, Local, Prospective Studies, Quality of Life, Treatment Outcome, Young Adult, multiple myeloma, observational study, treatment, Oncology & Carcinogenesis, Oncology and carcinogenesis
Abstract

With the introduction of new drugs with different mechanisms of action, multiple myeloma (MM) patients' outcomes have improved. However, the efficacy seen in clinical trials is often not seen in real-world settings and data on the effectiveness of MM therapies are needed. INSIGHT MM is a prospective, global, non-interventional, observational study that is enrolling approximately 4200 patients with newly diagnosed or relapsed/refractory MM, making it the largest study of its kind to date. The study aims to describe contemporary, real-world patterns of patient characteristics, clinical disease presentation, therapies chosen, clinical outcomes (response, treatment duration, time-to-next-therapy, progression-free and overall survival), safety, healthcare resource utilization and quality of life. One interim analysis has been conducted to date; current accrual is approximately 3094 patients. Trial registration number: NCT02761187.

Published
2019

30. Revised International Staging System Is Predictive and Prognostic for Early Relapse (<24 months) after Autologous Transplantation for Newly Diagnosed Multiple Myeloma

Author

Gopalakrishnan, Sathish, D'Souza, Anita, Scott, Emma, Fraser, Raphael, Davila, Omar, Shah, Nina, Gale, Robert Peter, Kamble, Rammurti, Diaz, Miguel Angel, Lazarus, Hillard M, Savani, Bipin N, Hildebrandt, Gerhard C, Solh, Melhem, Freytes, Cesar O, Lee, Cindy, Kyle, Robert A, Usmani, Saad Z, Ganguly, Siddhartha, Assal, Amer, Berdeja, Jesus, Kanate, Abraham S, Dhakal, Binod, Meehan, Kenneth, Kindwall-Keller, Tamila, Saad, Ayman, Locke, Frederick, Seo, Sachiko, Nishihori, Taiga, Gergis, Usama, Gasparetto, Cristina, Mark, Tomer, Nieto, Yago, Kumar, Shaji, and Hari, Parameswaran

Subjects
Biomedical and Clinical Sciences, Cardiovascular Medicine and Haematology, Oncology and Carcinogenesis, Rare Diseases, Hematology, Cancer, Transplantation, Adult, Aged, Female, Hematopoietic Stem Cell Transplantation, Humans, Male, Middle Aged, Multiple Myeloma, Neoplasm Staging, Prognosis, Recurrence, Transplantation Conditioning, Transplantation, Autologous, Myeloma stage, Postrelapse survival, Transplant, Clinical Sciences, Immunology, Cardiovascular medicine and haematology
Abstract

The revised International Staging System (R-ISS) combines ISS with genetic markers and lactate dehydrogenase and can prognosticate newly diagnosed multiple myeloma (MM). Early relapse (

Published
2019

31. Staging Systems for Newly Diagnosed Myeloma Patients Undergoing Autologous Hematopoietic Cell Transplantation: The Revised International Staging System Shows the Most Differentiation between Groups

Author

Scott, Emma C, Hari, Parameswaran, Kumar, Sathish, Fraser, Raphael, Davila, Omar, Shah, Nina, Gale, Robert Peter, Diaz, Miguel Angel, Agrawal, Vaibhav, Cornell, Robert F, Ganguly, Siddhartha, Akpek, Gorgun, Freytes, Cesar, Hashmi, Shahrukh, Malek, Ehsan, Kamble, Rammurti T, Lazarus, Hillard, Solh, Melhem, Usmani, Saad Z, Kanate, Abraham S, Saad, Ayman, Chhabra, Saurabh, Gergis, Usama, Cerny, Jan, Kyle, Robert A, Lee, Cindy, Kindwall-Keller, Tamila, Assal, Amer, Hildebrandt, Gerhard C, Holmberg, Leona, Maziarz, Richard T, Nishihori, Taiga, Seo, Sachiko, Kumar, Shaji, Mark, Tomer, and D'Souza, Anita

Subjects
Biomedical and Clinical Sciences, Cardiovascular Medicine and Haematology, Transplantation, Rare Diseases, Hematology, Cancer, Clinical Research, Adult, Aged, Cell Differentiation, Female, Hematopoietic Stem Cell Transplantation, Humans, Male, Middle Aged, Multiple Myeloma, Neoplasm Staging, Prospective Studies, Transplantation, Autologous, International staging system, Revised international staging system, Staging system comparison, Clinical Sciences, Immunology, Cardiovascular medicine and haematology
Abstract

The Revised International Staging System (R-ISS) and the International Myeloma Working Group 2014 (IMWG 2014) are newer staging systems used to prognosticate multiple myeloma (MM) outcomes. We hypothesized that these would provide better prognostic differentiation for newly diagnosed multiple myeloma (MM) compared with ISS. We analyzed the Center for International Blood and Marrow Transplant Research database from 2008 to 2014 to compare the 3 systems (N = 628) among newly diagnosed MM patients undergoing upfront autologous hematopoietic cell transplantation (AHCT). The median follow-up of survivors was 48 (range, 3 to 99) months. The R-ISS provided the greatest differentiation between survival curves for each stage (for overall survival [OS], the differentiation was 1.74 using the R-ISS, 1.58 using ISS, and 1.60 using the IMWG 2014) . Univariate analyses at 3 years for OS showed R-ISS I at 88% (95% confidence interval [CI], 83% to 93%), II at 75% (95% CI, 70% to 80%), and III at 56% (95% CI, 3% to 69%; P < .001). An integrated Brier score function demonstrated the R-ISS had the best prediction for PFS, though all systems had similar prediction for OS. Among available systems, the R-ISS is the most optimal among available prognostic tools for newly diagnosed MM undergoing AHCT. We recommend that serum lactate dehydrogenase and cytogenetic data be performed on every MM patient at diagnosis to allow accurate prognostication.

Published
2018

32. Proceedings from the Blood and Marrow Transplant Clinical Trials Network Myeloma Intergroup Workshop on Immune and Cellular Therapy in Multiple Myeloma

Author

Holstein, Sarah A., Asimakopoulos, Fotis, Azab, Abdel Kareem, Bianchi, Giada, Bhutani, Manisha, Crews, Leslie A., Cupedo, Tom, Giles, Hannah, Gooding, Sarah, Hillengass, Jens, John, Lukas, Kaiser, Shari, Lee, Lydia, Maclachlan, Kylee, Pasquini, Marcelo C., Pichiorri, Flavia, Shah, Nina, Shokeen, Monica, Shy, Brian R., Smith, Eric L., Verona, Raluca, Usmani, Saad Z., and McCarthy, Philip L.

Published
2022
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33. Prognostic value of minimal residual disease negativity in myeloma: combined analysis of POLLUX, CASTOR, ALCYONE, and MAIA

Author

Cavo, Michele, San-Miguel, Jesus, Usmani, Saad Z., Weisel, Katja, Dimopoulos, Meletios A., Avet-Loiseau, Hervé, Paiva, Bruno, Bahlis, Nizar J., Plesner, Torben, Hungria, Vania, Moreau, Philippe, Mateos, Maria-Victoria, Perrot, Aurore, Iida, Shinsuke, Facon, Thierry, Kumar, Shaji, van de Donk, Niels W.C.J., Sonneveld, Pieter, Spencer, Andrew, Krevvata, Maria, Heuck, Christoph, Wang, Jianping, Ukropec, Jon, Kobos, Rachel, Sun, Steven, Qi, Mia, and Munshi, Nikhil

Published
2022
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35. Sustained Minimal Residual Disease Negativity With Daratumumab in Newly Diagnosed Multiple Myeloma: MAIA and ALCYONE

Author

San-Miguel, Jesus, Avet-Loiseau, Hervé, Paiva, Bruno, Kumar, Shaji, Dimopoulos, Meletios A., Facon, Thierry, Mateos, María-Victoria, Touzeau, Cyrille, Jakubowiak, Andrzej, Usmani, Saad Z., Cook, Gordon, Cavo, Michele, Quach, Hang, Ukropec, Jon, Ramaswami, Priya, Pei, Huiling, Qi, Mia, Sun, Steven, Wang, Jianping, Krevvata, Maria, DeAngelis, Nikki, Heuck, Christoph, Rampelbergh, Rian Van, Kudva, Anupa, Kobos, Rachel, Qi, Ming, and Bahlis, Nizar J.

Published
2021
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36. Summary of the 2019 Blood and Marrow Transplant Clinical Trials Network Myeloma Intergroup Workshop on Minimal Residual Disease and Immune Profiling

Author

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., and McCarthy, Philip L.

Published
2020
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39. CD8 effector T cells enhance response in BCMA-exposed and -naïve multiple myeloma.

Author

Firestone, Ross S, primary, McAvoy, Devin, additional, Shekarkhand, Tala, additional, Serrano, Edith, additional, Hamadeh, Issam, additional, Wang, Alice, additional, Zhu, Menglei, additional, Patel, Dhwani, additional, Tan, Carlyn Rose, additional, Hultcrantz, Malin, additional, Mailankody, Sham, additional, Hassoun, Hani, additional, Shah, Urvi A, additional, Korde, Neha, additional, Maclachlan, Kylee H., additional, Landau, Heather J., additional, Scordo, Michael, additional, Shah, Gunjan L, additional, Lahoud, Oscar B, additional, Giralt, Sergio A., additional, Murata, Kazunori, additional, Hosszu, Kinga K., additional, Chung, David J., additional, Lesokhin, Alexander M, additional, and Usmani, Saad Z., additional

Published
2023
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41. Stem Cell Mobilization Yields with Daratumumab- and Lenalidomide-Containing Quadruplet Induction Therapy in Newly Diagnosed Multiple Myeloma: Findings from the MASTER and GRIFFIN Trials

Author

Chhabra, Saurabh, Callander, Natalie, Watts, Nicole L., Costa, Luciano J., Thapa, Bicky, Kaufman, Jonathan L., Laubach, Jacob, Sborov, Douglas W., Reeves, Brandi, Rodriguez, Cesar, Chari, Ajai, Silbermann, Rebecca, Anderson, Larry D., Jr, Bal, Susan, Dhakal, Binod, Nathwani, Nitya, Shah, Nina, Medvedova, Eva, Bumma, Naresh, Holstein, Sarah A., Costello, Caitlin, Jakubowiak, Andrzej, Wildes, Tanya M., Schmidt, Timothy, Orlowski, Robert Z., Shain, Kenneth H., Cowan, Andrew J., Dholaria, Bhagirathbhai, Cornell, R. Frank, Jerkins, James H., Pei, Huiling, Cortoos, Annelore, Patel, Sharmila, Lin, Thomas S., Usmani, Saad Z., Richardson, Paul G., and Voorhees, Peter M.

Published
2023
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45. Prevalence and impact of diabetes on survival of patients with multiple myeloma in different racial groups

Author

Shah, Urvi A, primary, Moshier, Erin Laverne, additional, Derkach, Andriy, additional, Huang, Yuanhui, additional, Mailankody, Sham, additional, Tan, Carlyn Rose, additional, Maclachlan, Kylee H., additional, Hultcrantz, Malin, additional, Korde, Neha, additional, Hassoun, Hani, additional, Thibaud, Santiago, additional, Sanchez, Larysa, additional, Rodriguez, Cesar, additional, Richard, Shambavi, additional, Richter, Joshua, additional, Rossi, Adriana, additional, Cho, Hearn J, additional, Lesokhin, Alexander M, additional, Chari, Ajai, additional, Usmani, Saad Z., additional, Jagannath, Sundar, additional, Parekh, Samir, additional, and Gallagher, Emily Jane, additional

Published
2023
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46. P881: DURABILITY OF RESPONSES WITH BIWEEKLY DOSING OF TECLISTAMAB IN PATIENTS WITH RELAPSED/REFRACTORY MULTIPLE MYELOMA ACHIEVING A CLINICAL RESPONSE IN THE MAJESTEC-1 STUDY

Author

Bhutani, Manisha, primary, Garfall, Alfred, additional, Uttervall, Katarina, additional, Usmani, Saad Z, additional, Karlin, Lionel, additional, Benboubker, Lotfi, additional, Nahi, Hareth, additional, San Miguel, Jesús, additional, Trancucci, Danielle, additional, Qi, Keqin, additional, Stephenson, Tara, additional, Perales-Puchalt, Alfredo, additional, Chastain, Katherine, additional, and Chari, Ajai, additional

Published
2023
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47. S202: CARTITUDE-1 FINAL RESULTS: PHASE 1B/2 STUDY OF CILTACABTAGENE AUTOLEUCEL IN HEAVILY PRETREATED PATIENTS WITH RELAPSED/REFRACTORY MULTIPLE MYELOMA

Author

Munshi, Nikhil, primary, Martin, Tom, additional, Usmani, Saad Z, additional, Berdeja, Jesus, additional, Jakubowiak, Andrzej, additional, Agha, Mounzer, additional, Cohen, Adam D, additional, Deol, Abhinav, additional, Htut, Myo, additional, Lesokhin, Alexander, additional, Lin, Yi, additional, O’donnell, Elizabeth, additional, Jackson, Carolyn C, additional, Yeh, Tzu-Min, additional, Banerjee, Arnob, additional, Zudaire, Enrique, additional, Madduri, Deepu, additional, Delcorral, Christopher, additional, Pacaud, Lida, additional, and Jagannath, Sundar, additional

Published
2023
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48. P871: IDECABTAGENE VICLEUCEL (IDE-CEL) IN PATIENTS WITH AN INADEQUATE RESPONSE TO FRONTLINE AUTOLOGOUS STEM CELL TRANSPLANTATION (ASCT): RESULTS FROM KARMMA-2 COHORT 2C

Author

Alsina, Melissa, primary, Dhodapkar, Madhav, additional, Berdeja, Jesus, additional, Patel, Krina, additional, Richard, Shambavi, additional, Vij, Ravi, additional, Leleu, Xavier, additional, Egan, Daniel, additional, Leif Bergsagel, P., additional, Ran, Reshef, additional, Usmani, Saad Z, additional, Truppel-Hartmann, Anna, additional, Basudhar, Debashree, additional, Thompson, Ethan, additional, Zheng, Xirong, additional, Zhong, Xiaobo, additional, Greggio, Chiara, additional, Popa Mckiver, Mihaela, additional, Carrasco Alfonso, Marlene, additional, and Siegel, David, additional

Published
2023
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49. P864: A PHASE 1 STUDY OF BELANTAMAB MAFODOTIN IN COMBINATION WITH STANDARD OF CARE IN NEWLY DIAGNOSED MULTIPLE MYELOMA: AN INTERIM ANALYSIS OF DREAMM-9

Author

Usmani, Saad Z, primary, Mielnik, Michał, additional, Min Byun, Ja, additional, Alonso Alonso, Aránzazu, additional, Abdallah, Al-Ola, additional, Garg, Mamta, additional, Quach, Hang, additional, Min, Chang-Ki, additional, Janowski, Wojciech, additional, Miguel, Enrique Maria Ocio San, additional, Weisel, Katja, additional, Oriol, Albert, additional, Sandhu, Irwindeep, additional, Rodríguez-Otero, Paula, additional, Ramasamy, Karthik, additional, Egger, Jacqueline, additional, Williams, Danaè, additional, MA, Jie, additional, Kaisermann, Morrys, additional, and Hus, Marek, additional

Published
2023
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