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3. Genomic and immune signatures predict clinical outcome in newly diagnosed multiple myeloma treated with immunotherapy regimens

Author

Maura, Francesco, Boyle, Eileen M., Coffey, David, Maclachlan, Kylee, Gagler, Dylan, Diamond, Benjamin, Ghamlouch, Hussein, Blaney, Patrick, Ziccheddu, Bachisio, Cirrincione, Anthony, Chojnacka, Monika, Wang, Yubao, Siegel, Ariel, Hoffman, James E., Kazandjian, Dickran, Hassoun, Hani, Guzman, Emily, Mailankody, Sham, Shah, Urvi A., Tan, Carlyn, Hultcrantz, Malin, Scordo, Michael, Shah, Gunjan L., Landau, Heather, Chung, David J., Giralt, Sergio, Zhang, Yanming, Arbini, Arnaldo, Gao, Qi, Roshal, Mikhail, Dogan, Ahmet, Lesokhin, Alexander M., Davies, Faith E., Usmani, Saad Z., Korde, Neha, Morgan, Gareth J., and Landgren, Ola

Published
2023
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4. Perspectives on the Risk-Stratified Treatment of Multiple Myeloma.

Author

Davies, Faith, Pawlyn, Charlotte, Usmani, Saad, San-Miguel, Jesus, Einsele, Hermann, Boyle, Eileen, Corre, Jill, Auclair, Daniel, Cho, Hearn, Lonial, Sagar, Sonneveld, Pieter, Stewart, A, Bergsagel, P, Kaiser, Martin, Weisel, Katja, Keats, Jonathan, Mikhael, Joseph, Morgan, Kathryn, Ghobrial, Irene, Orlowski, Robert, Landgren, C, Gay, Francesca, Caers, Joseph, Chng, Wee, Chari, Ajai, Walker, Brian, Kumar, Shaji, Costa, Luciano, Anderson, Kenneth, and Morgan, Gareth

Subjects
Humans, Multiple Myeloma, Prognosis
Abstract

The multiple myeloma treatment landscape has changed dramatically. This change, paralleled by an increase in scientific knowledge, has resulted in significant improvement in survival. However, heterogeneity remains in clinical outcomes, with a proportion of patients not benefiting from current approaches and continuing to have a poor prognosis. A significant proportion of the variability in outcome can be predicted on the basis of clinical and biochemical parameters and tumor-acquired genetic variants, allowing for risk stratification and a more personalized approach to therapy. This article discusses the principles that can enable the rational and effective development of therapeutic approaches for high-risk multiple myeloma.

Published
2022

5. The biological and clinical impact of deletions before and after large chromosomal gains in multiple myeloma

Author

Cirrincione, Anthony M., Poos, Alexandra M., Ziccheddu, Bachisio, Kaddoura, Marcella, Bärtsch, Marc-Andrea, Maclachlan, Kylee, Chojnacka, Monika, Diamond, Benjamin, John, Lukas, Reichert, Philipp, Huhn, Stefanie, Blaney, Patrick, Gagler, Dylan, Rippe, Karsten, Zhang, Yanming, Dogan, Ahmet, Lesokhin, Alexander M., Davies, Faith, Goldschmidt, Hartmut, Fenk, Roland, Weisel, Katja C., Mai, Elias K., Korde, Neha, Morgan, Gareth J., Usmani, Saad, Landgren, Ola, Raab, Marc S., Weinhold, Niels, and Maura, Francesco

Published
2024
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8. How to provide the needed protection from COVID-19 to patients with hematologic malignancies

Author

Ribas, Antoni, Dhodapkar, Madhav V, Campbell, Katie M, Davies, Faith E, Gore, Steven D, Levy, Ronald, and Greenberger, Lee M

Subjects
Prevention, Immunization, Cancer, Vaccine Related, Emerging Infectious Diseases, Patient Safety, Hematology, Good Health and Well Being, Adult, COVID-19, COVID-19 Vaccines, Hematologic Neoplasms, Humans, Immunization, Secondary, SARS-CoV-2
Abstract

Patients with hematologic malignancies are particularly vulnerable to COVID-19 infections, and upon a pooled data analysis of 24 publications, there is evidence that they have suboptimal antibody responses to COVID-19 vaccination and boosters. To provide them the needed additional protection from COVID-19, it is imperative to achieve a 100% full immunization rate in health care workers and adult caretakers, and to foster research to test higher doses and repeated rounds of COVID-19 vaccines and the use of passive immune prophylaxis and therapy.

Published
2021

9. Real-world comparative effectiveness of triplets containing bortezomib (B), carfilzomib (C), daratumumab (D), or ixazomib (I) in relapsed/refractory multiple myeloma (RRMM) in the US.

Author

Davies, Faith, Rifkin, Robert, Costello, Caitlin, Morgan, Gareth, Usmani, Saad, Abonour, Rafat, Palumbo, Antonio, Romanus, Dorothy, Hajek, Roman, Terpos, Evangelos, Cherepanov, Dasha, Stull, Dawn, Huang, Hui, Leleu, Xavier, Berdeja, Jesus, Lee, Hans, Weisel, Katja, Thompson, Michael, Boccadoro, Mario, Zonder, Jeffrey, Cook, Gordon, Puig, Noemi, Vela-Ojeda, Jorge, Farrelly, Eileen, Raju, Aditya, Blazer, Marlo, and Chari, Ajai

Subjects
Bortezomib, Carfilzomib, Daratumumab, Ixazomib, Lenalidomide, Pomalidomide, Proteasome inhibitor triplet therapy, Real-world, Relapsed refractory multiple myeloma, Aged, Antibodies, Monoclonal, Antineoplastic Combined Chemotherapy Protocols, Boron Compounds, Bortezomib, Female, Glycine, Humans, Male, Middle Aged, Multiple Myeloma, Neoplasm Recurrence, Local, Oligopeptides, Retrospective Studies, Treatment Outcome
Abstract

Multiple available combinations of proteasome inhibitors, immunomodulators (IMIDs), and monoclonal antibodies are shifting the relapsed/refractory multiple myeloma (RRMM) treatment landscape. Lack of head-to-head trials of triplet regimens highlights the need for real-world (RW) evidence. We conducted an RW comparative effectiveness analysis of bortezomib (V), carfilzomib (K), ixazomib (I), and daratumumab (D) combined with either lenalidomide or pomalidomide plus dexamethasone (Rd or Pd) in RRMM. A retrospective cohort of patients initiating triplet regimens in line of therapy (LOT) ≥ 2 on/after 1/1/2014 was followed between 1/2007 and 3/2018 in Optums deidentified US electronic health records database. Time to next treatment (TTNT) was estimated using Kaplan-Meier methods; regimens were compared using covariate-adjusted Cox proportional hazard models. Seven hundred forty-one patients (820 patient LOTs) with an Rd backbone (VRd, n = 349; KRd, n = 218; DRd, n = 99; IRd, n = 154) and 348 patients (392 patient LOTs) with a Pd backbone (VPd, n = 52; KPd, n = 146; DPd, n = 149; IPd, n = 45) in LOTs ≥2 were identified. More patients ≥75 years received IRd (39.6%), IPd (37.8%), and VRd (36.7%) than other triplets. More patients receiving VRd/VPd were in LOT2 vs other triplets. Unadjusted median TTNT in LOT ≥ 2: VRd, 13.9; KRd, 8.7; IRd, 11.4; DRd, not estimable (NE); and VPd, 12.0; KPd, 6.7; IPd, 9.5 months; DPd, NE. In covariate-adjusted analysis, only KRd vs DRd was associated with a significantly higher risk of next LOT initiation/death (HR 1.72; P = 0.0142); no Pd triplet was significantly different vs DPd in LOT ≥ 2. Our data highlight important efficacy/effectiveness gaps between results observed in phase 3 clinical trials and those realized in the RW.

Published
2021

10. Progression-Free Survival of Daratumumab Versus Bortezomib Triplet Combination With Lenalidomide and Dexamethasone in Transplant Ineligible Patients With Newly Diagnosed Multiple Myeloma: TAURUS Chart Review Study

Author

Gordan, Lucio Navarro, Tan, Carlyn Rose, Vescio, Robert, Ye, Jing Christine, Schinke, Carolina, Medhekar, Rohan, Fu, Alex Z., Lafeuille, Marie-Hélène, Thompson-Leduc, Philippe, Khare, Vipin, Reitan, John, Milkovich, Gary, Kaila, Shuchita, Davies, Faith, and Usmani, Saad Z.

Published
2024
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13. Correction: COVID-19 Infections and Outcomes in Patients with Multiple Myeloma in New York City: A Cohort Study from Five Academic Centers.

Author

Hultcrantz, Malin, Richter, Joshua, Rosenbaum, Cara, Patel, Dhwani, Smith, Eric, Korde, Neha, Lu, Sydney, Mailankody, Sham, Shah, Urvi, Lesokhin, Alexander, Hassoun, Hani, Tan, Carlyn, Maura, Francesco, Derkach, Andriy, Diamond, Benjamin, Rossi, Adriana, Pearse, Roger, Madduri, Deepu, Chari, Ajai, Kaminetzky, David, Braunstein, Marc, Gordillo, Christian, Reshef, Ran, Taur, Ying, Davies, Faith, Jagannath, Sundar, Niesvizky, Ruben, Lentzsch, Suzanne, Morgan, Gareth, and Landgren, Ola

Abstract

[This corrects the article DOI: 10.1158/2643-3230.BCD-20-0102.].

Published
2020

14. COVID-19 Infections and Clinical Outcomes in Patients with Multiple Myeloma in New York City: A Cohort Study from Five Academic Centers.

Author

Hultcrantz, Malin, Richter, Joshua, Rosenbaum, Cara, Patel, Dhwani, Smith, Eric, Korde, Neha, Lu, Sydney, Mailankody, Sham, Shah, Urvi, Lesokhin, Alexander, Hassoun, Hani, Tan, Carlyn, Maura, Francesco, Derkach, Andriy, Diamond, Benjamin, Rossi, Adriana, Pearse, Roger, Madduri, Deepu, Chari, Ajai, Kaminetzky, David, Braunstein, Marc, Gordillo, Christian, Reshef, Ran, Taur, Ying, Davies, Faith, Jagannath, Sundar, Niesvizky, Ruben, Lentzsch, Suzanne, Morgan, Gareth, and Landgren, Ola

Abstract

UNLABELLED: Patients with multiple myeloma have a compromised immune system, due to both the disease and antimyeloma therapies, and may therefore be particularly susceptible to COVID-19. Here, we report outcomes and risk factors for serious disease in patients with multiple myeloma treated at five large academic centers in New York City in the spring of 2020, during which it was a global epicenter of the SARS-CoV-2 pandemic. Of 100 patients with multiple myeloma (male 58%; median age 68) diagnosed with COVID-19, 75 were admitted; of these, 13 patients (17%) were placed on invasive mechanical ventilation, and 22 patients (29%) expired. Of the 25 nonadmitted patients, 4 were asymptomatic. There was a higher risk of adverse outcome (intensive care unit admission, mechanical ventilation, or death) in Hispanics/Latinos (n = 21), OR = 4.7 (95% confidence interval, 1.3-16.7), and African American Blacks (n = 33), OR = 3.5 (1.1-11.5), as compared with White patients (n = 36). Patients who met the adverse combined endpoint had overall higher levels of inflammatory markers and cytokine activation. None of the other studied risk factors were significantly associated (P > 0.05) with adverse outcome: hypertension (n = 56), OR = 2.2 (0.9-5.4); diabetes (n = 18), OR = 0.9 (0.3-2.9); age >65 years (n = 63), OR = 1.8 (0.7-4.6); high-dose melphalan with autologous stem cell transplant

Published
2020

15. Maintenance lenalidomide in newly diagnosed transplant eligible and non-eligible myeloma patients; profiling second primary malignancies in 4358 patients treated in the Myeloma XI Trial

Author

Jones, John R., Cairns, David A., Menzies, Tom, Pawlyn, Charlotte, Davies, Faith E., Sigsworth, Rachel, Brioli, Annamaria, Jenner, Matthew W., Kaiser, Martin F., Olivier, Catherine, Reed, Molly, Drayson, Mark T., Owen, Roger G., Boyd, Kevin D., Cook, Gordon, Morgan, Gareth J., and Jackson, Graham H.

Published
2023
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17. Rates of Influenza and Pneumococcal Vaccination and Correlation With Survival in Multiple Myeloma Patients

Author

Thompson, Michael A., Boccadoro, Mario, Leleu, Xavier, Vela-Ojeda, Jorge, van Rhee, Frits, Weisel, Katja C., Rifkin, Robert M., Usmani, Saad Z., Hájek, Roman, Cook, Gordon, Abonour, Rafat, Armour, Mira, Morgan, Kathryn E., Yeh, Su-Peng, Costello, Caitlin L., Berdeja, Jesus G., Davies, Faith E., Zonder, Jeffrey A., Lee, Hans C., Omel, Jim, Spencer, Andrew, Terpos, Evangelos, Hungria, Vania T.M., Puig, Noemi, Fu, Chengcheng, Ferrari, Renda H., Ren, Kaili, Stull, Dawn Marie, and Chari, Ajai

Published
2023
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18. 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

22. Chromothripsis as a pathogenic driver of multiple myeloma

Author

Maura, Francesco, Boyle, Eileen M., Rustad, Even H., Ashby, Cody, Kaminetzky, David, Bruno, Benedetto, Braunstein, Marc, Bauer, Michael, Blaney, Patrick, Wang, Yubao, Ghamlouch, Hussein, Williams, Louis, Stoeckle, James, Davies, Faith E., Walker, Brian A., Maclachlan, Kylee, Diamond, Ben, Landgren, Ola, and Morgan, Gareth J.

Published
2022
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25. Genetic subtypes of smoldering multiple myeloma are associated with distinct pathogenic phenotypes and clinical outcomes

Author

Bustoros, Mark, Anand, Shankara, Sklavenitis-Pistofidis, Romanos, Redd, Robert, Boyle, Eileen M., Zhitomirsky, Benny, Dunford, Andrew J., Tai, Yu-Tzu, Chavda, Selina J., Boehner, Cody, Neuse, Carl Jannes, Rahmat, Mahshid, Dutta, Ankit, Casneuf, Tineke, Verona, Raluca, Kastritis, Efstathis, Trippa, Lorenzo, Stewart, Chip, Walker, Brian A., Davies, Faith E., Dimopoulos, Meletios-Athanasios, Bergsagel, P. Leif, Yong, Kwee, Morgan, Gareth J., Aguet, François, Getz, Gad, and Ghobrial, Irene M.

Published
2022
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26. Plasma cells expression from smouldering myeloma to myeloma reveals the importance of the PRC2 complex, cell cycle progression, and the divergent evolutionary pathways within the different molecular subgroups

Author

Boyle, Eileen M., Rosenthal, Adam, Ghamlouch, Hussein, Wang, Yan, Farmer, Phillip, Rutherford, Michael, Ashby, Cody, Bauer, Michael, Johnson, Sarah K., Wardell, Christopher P., Wang, Yubao, Hoering, Antje, Schinke, Carolina, Thanendrarajan, Sharmilan, Zangari, Maurizio, Barlogie, Bart, Dhodapkar, Madhav V., Davies, Faith E., Morgan, Gareth J., van Rhee, Frits, and Walker, Brian A.

Published
2022
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27. Improving prognostic assignment in older adults with multiple myeloma using acquired genetic features, clonal hemopoiesis and telomere length

Author

Boyle, Eileen M., Williams, Louis, Blaney, Patrick, Ashby, Cody, Bauer, Michael, Walker, Brian A., Ghamlouch, Hussein, Choi, Jinyoung, Perrial, Emeline, Wang, Yubao, Caro, Jessica, Stoeckle, James H., Arbini, Arnaldo, Kaminetzky, David, Braunstein, Marc, Bruno, Benedetto, Razzo, Beatrice, Diamond, Benjamin, Maclachlan, Kylee, Maura, Francesco, Landgren, Ola, Litke, Rachel, Fegan, Christopher D., Keats, Johnathan, Auclair, Daniel, Davies, Faith E., and Morgan, Gareth J.

Published
2022
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34. Treatment of relapsed and refractory multiple myeloma: recommendations from the International Myeloma Working Group

Author

Moreau, Philippe, Kumar, Shaji K, San Miguel, Jesús, Davies, Faith, Zamagni, Elena, Bahlis, Nizar, Ludwig, Heinz, Mikhael, Joseph, Terpos, Evangelos, Schjesvold, Fredrik, Martin, Thomas, Yong, Kwee, Durie, Brian G M, Facon, Thierry, Jurczyszyn, Artur, Sidana, Surbhi, Raje, Noopur, van de Donk, Niels, Lonial, Sagar, Cavo, Michele, Kristinsson, Sigurdur Y, Lentzsch, Suzanne, Hajek, Roman, Anderson, Kenneth C, João, Cristina, Einsele, Hermann, Sonneveld, Pieter, Engelhardt, Monika, Fonseca, Rafael, Vangsted, Annette, Weisel, Katja, Baz, Rachid, Hungria, Vania, Berdeja, Jesus G, Leal da Costa, Fernando, Maiolino, Angelo, Waage, Anders, Vesole, David H, Ocio, Enrique M, Quach, Hang, Driessen, Christoph, Bladé, Joan, Leleu, Xavier, Riva, Eloisa, Bergsagel, Peter Leif, Hou, Jian, Chng, Wee Joo, Mellqvist, Ulf-Henrik, Dytfeld, Dominik, Harousseau, Jean-Luc, Goldschmidt, Hartmut, Laubach, Jacob, Munshi, Nikhil C, Gay, Francesca, Beksac, Meral, Costa, Luciano J, Kaiser, Martin, Hari, Parameswaran, Boccadoro, Mario, Usmani, Saad Z, Zweegman, Sonja, Holstein, Sarah, Sezer, Orhan, Harrison, Simon, Nahi, Hareth, Cook, Gordon, Mateos, Maria-Victoria, Rajkumar, S Vincent, Dimopoulos, Meletios A, and Richardson, Paul G

Published
2021
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35. Role of eEF1A isoforms in neuritogenesis and epilepsy

Author

Davies, Faith Cathryn Joy, Abbott, Catherine, and Sims, Andrew

Subjects
616.85, Eukaryotic Elongation Factor 1A, eEF1A, neurite outgrowth
Abstract

Eukaryotic Elongation Factor 1A (eEF1A) exists in two forms in vertebrates. The first form, eEF1A1, is expressed ubiquitously throughout development but is downregulated postdevelopmentally and replaced with eEF1A2, an isoform sharing 92% amino acid identity, in neurons and muscle. The primary function of eEF1A is to recruit amino-acylated tRNAs in a GTP-dependent manner to the A site of the ribosome during protein translation, but it also has non-canonical roles in the cell, some of which are isoform dependent. The reasons for the cell-type dependent switch from eEF1A1 to eEF1A2 are poorly understood. The first aim of this project was to examine the role played by eEF1A isoforms in neuritogenesis. To do this I used RNAi to significantly reduce expression of one or other isoform in neuronal cells and measure the effects this had on neurite outgrowth. Neurite outgrowth was significantly reduced in cells depleted of eEF1A1, but not eEF1A2. The complete loss of eEF1A2 is fatal, as has been demonstrated in the wasted mouse, an eEF1A2-null model characterised by muscle wastage, neurodegeneration and death at 4 weeks of age. Mice heterozygous for the wasted mutation have normal motor function. Recent work has found that heterozygous missense mutations in eEF1A2 can cause epilepsy and intellectual disability. It is not yet known whether the seven different de novo mutations identified to date confer loss or gain of function – a crucial piece of information required before possible treatments can be sought. The second aim of this project therefore was to investigate the role of eEF1A2 in epilepsy and intellectual disability. I achieved this by using CRISPR in two ways; firstly to model one of the mutations, D252H, in vitro in a neuronal cell line, and secondly to model another of the mutations, G70S, in vivo. No mice that recapitulated the human disease condition of EEF1A2G70S/+ were obtained however, due to the error-prone nature of the non-homologous end joining repair pathway activated by CRISPR-mediated DNA cleavage, 17 of the 35 mice born were found to be homozygous nulls at the Eef1a2 locus. Nine of these had fatal audiogenic seizures caused by sudden loud noises within the animal unit. Three mice were Eef1a2G70S/- and one Eef1a2G70S/G70S but these nonetheless showed a wasted phenotype, indicating that this mutant form of eEF1A2 has compromised function, at least in terms of translation elongation. Whether it has a toxic function ca not yet be known, but the severity of the phenotype in the G70S homozygous animal could suggest a gain of function. In in vitro experiments with exogenous eEF1A2 carrying the epilepsy-causing mutation R423C, protein expression of the mutant construct in immortalised cell lines was significantly higher when cotransfected with the wildtype construct, which mirrors the condition in humans, than when transfected alone, so the mutant protein could be stabilised in the presence of wildtype eEF1A2. I used CRISPR on LUHMES cells to make a mutant neuronal cell line containing the D252H mutation in eEF1A2. Due to time restraints no phenotypic differences between the wild type line and the D252H mutation line have yet been identified, but would form the focus of a future project.

Published
2017

36. Copy number evolution and its relationship with patient outcome—an analysis of 178 matched presentation-relapse tumor pairs from the Myeloma XI trial

Author

Croft, James, Ellis, Sidra, Sherborne, Amy L., Sharp, Kim, Price, Amy, Jenner, Matthew W., Drayson, Mark T., Owen, Roger G., Chown, Sally, Lindsay, Jindriska, Karunanithi, Kamaraj, Hunter, Hannah, Gregory, Walter M., Davies, Faith E., Morgan, Gareth J., Cook, Gordon, Atanesyan, Lilit, Savola, Suvi, Cairns, David A., Jackson, Graham, Houlston, Richard S., and Kaiser, Martin F.

Published
2021
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39. Genomic Profiling to Contextualize the Results of Intervention for Smoldering Multiple Myeloma

Author

Kazandjian, Dickran, primary, Diamond, Benjamin, additional, Papadimitriou, Marios, additional, Hill, Elizabeth, additional, Sklavenitis-Pistofidis, Romanos, additional, Ziccheddu, Bachisio, additional, Blaney, Patrick, additional, Chojnacka, Monika, additional, Durante, Michael, additional, Maclachlan, Kylee, additional, Young, Ryan, additional, Usmani, Saad, additional, Davies, Faith, additional, Getz, Gad, additional, Ghobrial, Irene, additional, Korde, Neha, additional, Morgan, Gareth, additional, Maura, Francesco, additional, and Landgren, Ola, additional

Published
2024
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40. Round Table Discussion on Optimal Clinical Trial Design in Precursor Multiple Myeloma

Author

Ghobrial, Irene M., primary, Gormley, Nicole, additional, Kumar, Shaji K., additional, Mateos, Maria-Victoria, additional, Bergsagel, P. Leif, additional, Chesi, Marta, additional, Dhodapkar, Madhav V., additional, Dispenzieri, Angela, additional, Fonseca, Rafael, additional, Getz, Gad, additional, Kastritis, Efstathios, additional, Kristinsson, Sigurdur Y., additional, Martinez-Climent, Jose Angel, additional, Manier, Salomon, additional, Marinac, Catherine R., additional, Maura, Francesco, additional, Morgan, Gareth J., additional, Davies, Faith E., additional, Nadeem, Omar, additional, Nuvolone, Mario, additional, Paiva, Bruno, additional, O’Donnell, Elizabeth, additional, Prosper, Felipe, additional, Shah, Urvi A., additional, Sklavenitis-Pistofidis, Romanos, additional, Sperling, Adam S., additional, Vassiliou, George S., additional, Munshi, Nikhil C., additional, Castle, Philip E., additional, Anderson, Kenneth C., additional, and San Miguel, Jesus F., additional

Published
2024
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43. Progression-free survival as a surrogate endpoint in myeloma clinical trials:an evolving paradigm

Author

Pawlyn, Charlotte, Schjesvold, Fredrik H., Cairns, David A., Wei, L. J., Davies, Faith, Nadeem, Omar, Abdulhaq, Haifaa, Mateos, Maria Victoria, Laubach, Jacob, Weisel, Katja, Ludwig, Heinz, Rajkumar, S. Vincent, Sonneveld, Pieter, Jackson, Graham, Morgan, Gareth, Richardson, Paul G., Pawlyn, Charlotte, Schjesvold, Fredrik H., Cairns, David A., Wei, L. J., Davies, Faith, Nadeem, Omar, Abdulhaq, Haifaa, Mateos, Maria Victoria, Laubach, Jacob, Weisel, Katja, Ludwig, Heinz, Rajkumar, S. Vincent, Sonneveld, Pieter, Jackson, Graham, Morgan, Gareth, and Richardson, Paul G.

Abstract

Measurement of overall survival (OS) remains the gold standard for interpreting the impact of new therapies for multiple myeloma in phase 3 trials. However, as outcomes have improved, it is increasingly challenging to use OS as the primary endpoint if timely approval of novel agents is to be ensured to enable maximum benefit for patients. Surrogate endpoints of OS, such as progression-free survival (PFS) and response to treatment, have contributed to approval decisions by the Food and Drug Administration (FDA) and European Medicines Agency as endpoints demonstrating clinical benefit, and the FDA has recently supported the use of minimal residual disease (MRD) as an accelerated approval endpoint in multiple myeloma. This review aims to address situations in which the use of PFS as a surrogate endpoint warrants careful interpretation especially for specific subgroups of patients and considers ways to ensure that studies can be designed to account for possible discordance between PFS and OS. The utility of subgroup analyses, including the potential for those not pre-specified, to identify target populations for new agents is also discussed.

Published
2024

44. The molecular make up of smoldering myeloma highlights the evolutionary pathways leading to multiple myeloma

Author

Boyle, Eileen M., Deshpande, Shayu, Tytarenko, Ruslana, Ashby, Cody, Wang, Yan, Bauer, Michael A., Johnson, Sarah K., Wardell, Christopher P., Thanendrarajan, Sharmilan, Zangari, Maurizio, Facon, Thierry, Dumontet, Charles, Barlogie, Bart, Arbini, Arnaldo, Rustad, Even H., Maura, Francesco, Landgren, Ola, Zhan, Fenghuang, van Rhee, Frits, Schinke, Carolina, Davies, Faith E., Morgan, Gareth J., and Walker, Brian A.

Published
2021
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46. Response-adapted intensification with cyclophosphamide, bortezomib, and dexamethasone versus no intensification in patients with newly diagnosed multiple myeloma (Myeloma XI): a multicentre, open-label, randomised, phase 3 trial

Author

Jackson, Graham H, Davies, Faith E, Pawlyn, Charlotte, Cairns, David A, Striha, Alina, Collett, Corinne, Waterhouse, Anna, Jones, John R, Kishore, Bhuvan, Garg, Mamta, Williams, Cathy D, Karunanithi, Kamaraj, Lindsay, Jindriska, Wilson, Jamie N, Jenner, Matthew W, Cook, Gordon, Kaiser, Martin F, Drayson, Mark T, Owen, Roger G, Russell, Nigel H, Gregory, Walter M, and Morgan, Gareth J

Published
2019
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