26 results on '"Omel J"'
Search Results
2. International harmonization in performing and reporting minimal residual disease assessment in multiple myeloma trials
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Costa, L.J. Derman, B.A. Bal, S. Sidana, S. Chhabra, S. Silbermann, R. Ye, J.C. Cook, G. Cornell, R.F. Holstein, S.A. Shi, Q. Omel, J. Callander, N.S. Chng, W.J. Hungria, V. Maiolino, A. Stadtmauer, E. Giralt, S. Pasquini, M. Jakubowiak, A.J. Morgan, G.J. Krishnan, A. Jackson, G.H. Mohty, M. Mateos, M.V. Dimopoulos, M.A. Facon, T. Spencer, A. Miguel, J.S. Hari, P. Usmani, S.Z. Manier, S. McCarthy, P. Kumar, S. Gay, F. Paiva, B.
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body regions ,hemic and lymphatic diseases - Abstract
Minimal residual disease (MRD) assessment is incorporated in an increasing number of multiple myeloma (MM) clinical trials as a correlative analysis, an endpoint or even as a determinant of subsequent therapy. There is substantial heterogeneity across clinical trials in how MRD is assessed and reported, creating challenges for data interpretation and for the design of subsequent studies. We convened an international panel of MM investigators to harmonize how MRD should be assessed and reported in MM clinical trials. The panel provides consensus on which MM trials should include MRD, the recommended time points for MRD assessment, and expected analytical validation for MRD assays. We subsequently outlined parameters for reporting MRD results implementing the intention-to-treat principle. The panel provides guidance regarding the incorporation of newer peripheral blood-based and imaging-based approaches to detection of residual disease. Recommendations are summarized in 13 consensus statements that should be followed by sponsors, investigators, editors, and reviewers engaged in designing, performing, and interpreting MM trials. © 2020, The Author(s), under exclusive licence to Springer Nature Limited.
- Published
- 2021
3. INSIGHT MM: A large, global, prospective, non-interventional, real-world study of patients with multiple myeloma
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Costello, C. Davies, F.E. Cook, G. Vela-Ojeda, J. Omel, J. Rifkin, R.M. Berdeja, J. Puig, N. Usmani, S.Z. Weisel, K. Zonder, J.A. Terpos, E. Spencer, A. Leleu, X. Boccadoro, M. Thompson, M.A. Romanus, D. Stull, D.M. Hungria, V.
- 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. © 2019 Future Medicine Ltd.
- Published
- 2019
4. PF601 EVOLVING TREATMENT PATTERNS IN MULTIPLE MYELOMA (MM) DIFFER BY AGE AND REGION: ANALYSIS FROM INSIGHT MM, A GLOBAL, PROSPECTIVE, OBSERVATIONAL STUDY
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Chari, A., primary, Weisel, K.C., additional, Usmani, S.Z., additional, Davies, F.E., additional, van Rhee, F., additional, Rifkin, R., additional, Zonder, J.A., additional, Costello, C., additional, Thompson, M.A., additional, Berdeja, J., additional, Lee, H.C., additional, Abonour, R., additional, Omel, J., additional, Hajek, R., additional, Spencer, A., additional, Terpos, E., additional, Hungria, V., additional, Leleu, X., additional, Cook, G., additional, Vela-Ojeda, J., additional, Puig, N., additional, Armour, M., additional, Stull, D.M., additional, Demers, B., additional, Romanus, D., additional, Skacel, T., additional, Ren, K., additional, and Boccadoro, M., additional
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- 2019
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5. PS1384 TREATMENT CHOICES AND OUTCOMES FOR PATIENTS WITH MULTIPLE MYELOMA AFTER RELAPSE ON LENALIDOMIDE MAINTENANCE THERAPY: RESULTS FROM THE CONNECT® MM REGISTRY
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Jagannath, S., primary, Narang, M., additional, Ailawadhi, S., additional, Rifkin, R.M., additional, Terebelo, H.R., additional, Toomey, K., additional, Durie, B.G., additional, Hardin, J.W., additional, Gasparetto, C.J., additional, Wagner, L., additional, Omel, J., additional, Srinivasan, S., additional, Kitali, A., additional, Agarwal, A., additional, and Abonour, R., additional
- Published
- 2019
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6. The Effect of Age and Other Patient Characteristics on Outcomes Among Nontransplanted Patients Who Were Treated With First-Line Lenalidomide, Bortezomib, and Dexamethasone: Results From the Connect Ⓡ MM Registry.
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Abonour R, Lee HC, Rifkin R, Ailawadhi S, Omel J, Hardin JW, Narang M, Toomey K, Gasparetto C, Wagner LI, Terebelo H, Mouro J, Dhanasiri S, Liu L, Yu E, and Jagannath S
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- Humans, Female, Male, Aged, Middle Aged, Age Factors, Treatment Outcome, Prospective Studies, Adult, Aged, 80 and over, Dexamethasone therapeutic use, Dexamethasone pharmacology, Bortezomib therapeutic use, Bortezomib pharmacology, Lenalidomide therapeutic use, Lenalidomide pharmacology, Multiple Myeloma drug therapy, Multiple Myeloma mortality, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Antineoplastic Combined Chemotherapy Protocols pharmacology, Registries
- Abstract
Background: Lenalidomide (R), bortezomib (V), and dexamethasone (d) is a standard-of-care regimen in newly diagnosed multiple myeloma (NDMM); however, characteristics and outcomes for nontransplanted patients receiving frontline RVd are not well understood., Patients: The Connect
Ⓡ MM Registry is a large, US, multicenter, prospective observational cohort study of NDMM patients., Methods: This analysis investigated characteristics and outcomes of patients who received RVd alone or followed by Rd or R (RVd ± Rd/R) who did not undergo frontline autologous stem cell transplantation., Results: As of August 2021, 314 of 1979 nontransplanted patients received RVd ± Rd/R as initial therapy. Of these, 135 were aged ≤ 65 years and 179 were > 65 years. 108 patients had time to relapse (TTR) of ≤ 12 months and 182 had TTR > 12 months. Baseline characteristics were comparable regardless of TTR and age group except renal function, which was more commonly impaired in older patients. Among patients aged ≤ 65 and > 65 years, median duration of first-line treatment was 6.3 and 9.0 months, median time to next line for those who received second-line therapy was 15.5 and 15.2 months, median progression-free survival (PFS) was 19.3 and 23.0 months, and median overall survival was 60.0 and 59.1 months, respectively. High-risk disease (per IMWG criteria) and high serum calcium were associated with higher hazard of progression or death; the adjusted PFS hazard ratio with respect to age (≤ 65 vs. > 65 years) based on multivariable analysis was 1.18 (0.89-1.57; P = .25)., Conclusion: These results indicate RVd is active across age groups and provide a better understanding of outcomes with RVd in NDMM., (Copyright © 2024. Published by Elsevier Inc.)- Published
- 2024
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7. Real-World Utilization of Radiation Therapy in Multiple Myeloma: An Analysis of the Connect MM Registry.
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Ballas L, Ailawadhi S, Narang M, Gasparetto CJ, Lee HC, Hardin JW, Durie BGM, Toomey K, Omel J, Wagner LI, Abonour R, Terebelo HR, Joshi P, Yu E, Liu L, Rifkin RM, and Jagannath S
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- Adult, Humans, Prospective Studies, Ethnicity, Registries, Multiple Myeloma radiotherapy, Osteoporosis
- Abstract
Purpose: Radiation therapy (RT) is an important treatment modality for patients with multiple myeloma (MM). Although patients are living longer with MM, they are more likely to have comorbidities related to treatment, such as bone pain; however, RT can provide symptom relief. To date, the characterization of patients who have received RT in the real-world setting has been limited., Methods and Materials: The Connect® MM Registry is a large, US multicenter, prospective observational cohort study of adult patients with newly diagnosed MM from mostly community sites. RT utilization and outcomes were analyzed quarterly throughout treatment. Factors associated with RT use were identified via multivariable analysis., Results: A total of 3011 patients were enrolled in the Connect MM Registry with 903 patients (30%) having received RT at any time. There was a significant difference (P < .05) in overall RT use among patients with an Eastern Cooperative Oncology Group performance status of 0 to 1 versus ≥2, International Staging System disease stage I/II versus III, a history of plasmacytoma or a novel agent in their first regimen, and any number of bone lesions or severe osteoporosis/fracture. RT use was associated with having bone lesions or severe osteoporosis (vs not having bone lesions). Additionally, RT use was associated with ethnicity (Hispanic vs not) and Connect MM Registry cohort (cohort 1 [enrolled 2009-2011] vs 2 [enrolled 2012-2016]). In the 6 months before death, increased RT use was associated with increasing number of treatment lines (P < .0001) and high- versus standard-risk disease (per International Myeloma Working Group criteria; P = .0028)., Conclusions: Real-world results from the Connect MM Registry show RT is frequently used and is associated with clinical factors, including performance status and disease stage. Earlier in MM diagnosis, RT may be used as an adjunct to palliate symptoms or delay systemic therapy. Toward the end of life, RT is more frequently used for palliation when treatment options are often limited., Competing Interests: Disclosures Dr Ballas reports travel fees associated with a leadership role with the American Board of Radiology and fees for providing expert legal testimony. Dr Ailawadhi reports consulting fees from GSK, Sanofi, Bristol Myers Squibb (BMS), Takeda, BeiGene, Janssen, Regeneron, Cellectar, and Pfizer; serving on a scientific steering committee for BMS; and research funding for his institution from GSK, BMS, Pharmacyclics, Amgen, Janssen, Cellectar, AbbVie, Ascentage, and Sanofi. Dr Gasparetto reports payments or honoraria, and travel fees from Sanofi, Karyopharm, and BMS; serving on a scientific steering committee for BMS; and serving on advisory boards for Pfizer, Janssen, and BMS. Dr Lee reports grants or contracts from Amgen, BMS, Janssen, GSK, Regeneron, and Takeda; consulting fees from BMS, Celgene, Genentech, Janssen, Regeneron, GSK, Sanofi, Pfizer, Monte Rosa Therapeutics, Takeda, and Allogene Therapeutics; and serving on a scientific steering committee for BMS. Dr Rifkin is a current employee of McKesson and reports serving on data safety monitoring boards for CARsgen; advisory boards for Amgen, BMS, Coherus, Fresenius Kabi, Genmab, and Janssen; and a scientific steering committee for BMS. Dr Jagannath reports consultancy fees from BMS, Janssen, Legend Biotech, Regeneron, Takeda, Sanofi, and Karyopharm; serving on steering committees and data safety monitoring or advisory boards for Janssen, BMS, and Sanofi; support for attending IMS, ASH, and ASCO; and leadership or fiduciary roles with IMS, SOHO, and ASH. Dr Narang, James W. Hardin, Brian G. M. Durie, Kathleen Toomey, James Omel, Lynne Wagner, Rafat Abonour, Howard R. Terebelo report serving on a scientific steering committee for BMS. Dr Joshi, Edward Yu, and Liang Liu are employees of BMS., (Copyright © 2023 American Society for Radiation Oncology. Published by Elsevier Inc. All rights reserved.)
- Published
- 2024
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8. Waldenström Macroglobulinemia/Lymphoplasmacytic Lymphoma, Version 2.2024, NCCN Clinical Practice Guidelines in Oncology.
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Kumar SK, Callander NS, Adekola K, Anderson LD Jr, Baljevic M, Baz R, Campagnaro E, Castillo JJ, Costello C, D'Angelo C, Derman B, Devarakonda S, Elsedawy N, Garfall A, Godby K, Hillengass J, Holmberg L, Htut M, Huff CA, Hultcrantz M, Kang Y, Larson S, Lee H, Liedtke M, Martin T, Omel J, Robinson T, Rosenberg A, Sborov D, Schroeder MA, Sherbenou D, Suvannasankha A, Valent J, Varshavsky-Yanovsky AN, Snedeker J, and Kumar R
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- Humans, Lymphoma, B-Cell, Waldenstrom Macroglobulinemia therapy, Waldenstrom Macroglobulinemia drug therapy
- Abstract
The treatment of Waldenström macroglobulinemia/lymphoplasmacytic lymphoma (WM/LPL) has evolved to include several new options. The NCCN Guidelines for WM/LPL provide a framework on which to base decisions regarding diagnosis, treatment, assessment of response to treatment, and follow-up of both newly diagnosed and previously treated WM/LPL.
- Published
- 2024
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9. Multiple Myeloma, Version 2.2024, NCCN Clinical Practice Guidelines in Oncology.
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Kumar SK, Callander NS, Adekola K, Anderson LD Jr, Baljevic M, Baz R, Campagnaro E, Castillo JJ, Costello C, D'Angelo C, Devarakonda S, Elsedawy N, Garfall A, Godby K, Hillengass J, Holmberg L, Htut M, Huff CA, Hultcrantz M, Kang Y, Larson S, Lee HC, Liedtke M, Martin T, Omel J, Robinson T, Rosenberg A, Sborov D, Schroeder MA, Sherbenou D, Suvannasankha A, Valent J, Varshavsky-Yanovsky AN, Kumar R, and Snedeker J
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- Humans, Antibodies, Monoclonal therapeutic use, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Medical Oncology, Neoplasm Recurrence, Local drug therapy, Multiple Myeloma therapy, Multiple Myeloma drug therapy
- Abstract
The treatment of relapsed/refractory multiple myeloma (MM) has evolved to include several new options. These include new combinations with second generation proteasome inhibitors (PI); second generation immunomodulators, monoclonal antibodies, CAR T cells, bispecific antibodies, selinexor, venetoclax, and many others. Most patients with MM undergo several cycles of remissions and relapse, and therefore need multiple lines of combination therapies. Selecting treatment options for relapsed/refractory MM requires consideration of resistance status to specific classes, and patient-specific factors such as age and other comorbidities should be considered. The NCCN Guidelines for MM provide a framework on which to base decisions regarding workup, treatment, and follow-up of newly diagnosed and previously treated MM. This manuscript outlines the recommendations from NCCN Guidelines for MM specific to relapsed/refractory disease.
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- 2023
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10. Minimal residual disease response-adapted therapy in newly diagnosed multiple myeloma (MASTER): final report of the multicentre, single-arm, phase 2 trial.
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Costa LJ, Chhabra S, Medvedova E, Dholaria BR, Schmidt TM, Godby KN, Silbermann R, Dhakal B, Bal S, Giri S, D'Souza A, Hall AC, Hardwick P, Omel J, Cornell RF, Hari P, and Callander NS
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- Male, Humans, Female, Middle Aged, Aged, Lenalidomide therapeutic use, Neoplasm, Residual, Treatment Outcome, Antineoplastic Combined Chemotherapy Protocols adverse effects, Dexamethasone adverse effects, Multiple Myeloma diagnosis, Multiple Myeloma drug therapy
- Abstract
Background: For patients with newly diagnosed multiple myeloma, reaching minimal residual disease (MRD) negativity after treatment is associated with improved outcomes; however, the use of MRD to modulate therapy remains elusive. We present the final analysis of the MASTER trial of daratumumab, carfilzomib, lenalidomide, and dexamethasone (Dara-KRd) therapy in patients with newly diagnosed multiple myeloma, in which MRD status is used to modulate treatment duration and cessation., Methods: MASTER was a multicentre, single-arm, phase 2 trial conducted in five academic medical centres in the USA. Eligible participants were 18 years or older with newly diagnosed multiple myeloma (measurable by serum or urine protein electrophoresis or serum free light chains), a life expectancy of at least 12 months, and an Eastern Cooperative Oncology Group performance status of 0-2, and had received no previous treatment for multiple myeloma except up to one cycle of therapy containing bortezomib, cyclophosphamide, and dexamethasone. The study was enriched for participants with high-risk chromosome abnormalities (HRCAs). During the induction phase, participants received four 28-day cycles of Dara-KRd, each comprising daratumumab (16 mg/kg intravenously on days 1, 8, 15, and 22), carfilzomib (56 mg/m
2 intravenously on days 1, 8, and 15), lenalidomide (25 mg orally on days 1-21), and dexamethasone (40 mg orally or intravenously on days 1, 8, 15, and 22); induction was followed by autologous haematopoietic stem-cell transplantation and up to two phases of consolidation with Dara-KRd. We assessed MRD by next-generation sequencing after or during each phase. The primary endpoint was reaching MRD negativity (<10-5 ). Participants who reached MRD negativity after or during two consecutive phases stopped treatment and began observation with MRD surveillance (MRD-SURE); participants who did not reach two consecutive MRD-negative results received maintenance lenalidomide. Secondary endpoints included progression-free survival and cumulative incidence of progression. All analyses were conducted in the intention-to-treat population. This trial is registered with ClinicalTrials.gov, NCT03224507, and is complete., Findings: Between Mar 21, 2018, and Oct 23, 2020, 123 participants were recruited to the study, of whom 70 (57%) were men, 53 (43%) were women, 94 (76%) were non-Hispanic White, 25 (20%) were non-Hispanic Black, and four (3%) were of another race or ethnicity. The median age of participants was 61 years (IQR 55-68), and 24 (20%) were aged 70 years or older. The median duration of follow up was 42·2 months (IQR 34·5-46·0). Of the 123 participants, 53 (43%) had no HRCAs, 46 (37%) had one HRCA, and 24 (20%) had two or more HRCAs. For 118 (96%) of 123 participants, MRD was evaluable by next-generation sequencing; the remaining five had an absence of sufficiently unique clonogenic sequences to enable tracking by the assay. Of these 118 participants, 96 (81%, 95% CI 73-88) reached MRD of less than 10-5 (comprising 39 [78%, 64-88] of 50 participants with no HRCAs, 38 [86%, 73-95] of 44 participants with one HRCA, and 19 [79%, 58-93] of 24 participants with two or more HRCAs) and 84 (71%, 62-79) reached MRD-SURE and treatment cessation. 36-month progression-free survival among all 123 participants was 88% (95% CI 78-95) for participants with no HRCAs, 79% (67-88) for those with one HRCA, and 50% (30-70) for those with two or more HRCAs. For the 84 participants reaching MRD-SURE, the 24-month cumulative incidence of progression from cessation of therapy was 9% (95% CI 1-19) for participants with no HRCAs, 9% (1-18) for those with one HRCA, and 47% (23-72) for those with two or more HRCAs. 61 participants (comprising 52% of 118 MRD-evaluable participants and 73% of 84 participants who reached MRD-SURE) remain free of therapy and MRD-negative as of Feb 7, 2023. The most common grade 3-4 adverse events were neutropenia (43 patients, 35%), lymphopenia (28 patients, 23%), and hypertension (13 patients, 11%). Three treatment-emergent deaths were recorded: two sudden deaths and one due to viral infection, none of which were judged to be treatment-related., Interpretation: This approach provided positive outcomes and a pathway for treatment cessation in most patients with newly diagnosed multiple myeloma. Outcomes for patients with ultra-high-risk multiple myeloma, defined as those with two or more HRCAs, remain unsatisfactory, and these patients should be prioritised for trials with early introduction of therapies with novel mechanisms of action., Funding: Amgen and Janssen Pharmaceuticals., Competing Interests: Declaration of interests LJC reports honoraria from Amgen, Celgene, Janssen Pharmaceuticals, Karyopharm Therapeutics, and Sanofi; consulting or advisory roles with AbbVie, Amgen, Celgene, and Karyopharm Therapeutics; participation on a speakers' bureau for Amgen and Sanofi; and research funding from Janssen Pharmaceuticals, Amgen, BMS, Genentech, and AbbVie. SC reports honoraria from GlaxoSmithKline, Sanofi, and Janssen Pharmaceuticals and grants and contracts from Janssen Pharmaceuticals, C4 Therapeutics, AbbVie, and CARsgen Therapeutics. BRD reports consulting or advisory roles at, travel support from, and research funding to their institution (Vanderbilt University Medical Center, Nashville, TN, USA) from Janssen Pharmaceuticals. TMS reports consulting or advisory roles with Janssen Pharmaceuticals, Sanofi, and BioLineRx; honoraria from Janssen Pharmaceuticals and Sanofi; and support for travel from Sanofi. RS reports consulting or advisory roles with Sanofi/Aventis, Janssen Pharmaceuticals, and Pfizer; honoraria from Curio Bioscience and OncLive; and support for travel from Adaptive Biotechnologies. BD reports honoraria from BMS, Karyopharm Therapeutics, GlaxoSmithKline, and Natera and consulting or advisory roles with Genentech, Pfizer, Arcellx, and Janssen Pharmaceuticals. SB reports consulting or advisory roles with AbbVie, Janssen Pharmaceuticals, and BMS and research funding from the Amyloid Foundation. SG reports honoraria from Sanofi and Carevive and research funding from Janssen Pharmaceuticals and Sanofi. AD'S reports consulting or advisory roles with Pfizer, Janssen Pharmaceuticals, Protera Technologies, and BMS and grants or contracts from Takeda Pharmaceuticals, Teneobio, Prothena, AbbVie, Caelum Biosciences, and Novartis, all to their institution (Medical College of Wisconsin, Milwaukee, WI, USA). RFC reports stock in AbbVie. PHari reports a leadership or fiduciary role at Iovance Biotherapeutics. All other authors declare no competing interests., (Copyright © 2023 Elsevier Ltd. All rights reserved.)- Published
- 2023
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11. Rates of Influenza and Pneumococcal Vaccination and Correlation With Survival in Multiple Myeloma Patients.
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Thompson MA, Boccadoro M, Leleu X, Vela-Ojeda J, van Rhee F, Weisel KC, Rifkin RM, Usmani SZ, Hájek R, Cook G, Abonour R, Armour M, Morgan KE, Yeh SP, Costello CL, Berdeja JG, Davies FE, Zonder JA, Lee HC, Omel J, Spencer A, Terpos E, Hungria VTM, Puig N, Fu C, Ferrari RH, Ren K, Stull DM, and Chari A
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- Humans, Prospective Studies, Hospitalization, Vaccination, Multiple Myeloma, Influenza, Human prevention & control
- Abstract
Background: Infections are a common reason for hospitalization and death in multiple myeloma (MM). Although pneumococcal vaccination (PV) and influenza vaccination (FV) are recommended for MM patients, data on vaccination status and outcomes are limited in MM., Materials and Methods: We utilized data from the global, prospective, observational INSIGHT MM study to analyze FV and PV rates and associated outcomes of patients with MM enrolled 2016-2019., Results: Of the 4307 patients enrolled, 2543 and 2500 had study-entry data on FV and PV status. Overall vaccination rates were low (FV 39.6%, PV 30.2%) and varied by region. On separate multivariable analyses of overall survival (OS) by Cox model, FV in the prior 2 years and PV in the prior 5 years impacted OS (vs. no vaccination; FV: HR, 0.73; 95% CI, 0.60-0.90; P = .003; PV: HR, 0.51; 95% CI, 0.42-0.63; P < .0001) when adjusted for age, region, performance status, disease stage, cytogenetics at diagnosis, MM symptoms, disease status, time since diagnosis, and prior transplant. Proportions of deaths due to infections were lower among vaccinated versus non-vaccinated patients (FV: 9.8% vs. 15.3%, P = .142; PV: 9.9% vs. 18.0%, P = .032). Patients with FV had generally lower health resource utilization (HRU) versus patients without FV; patients with PV had higher or similar HRU versus patients without PV., Conclusion: Vaccination is important in MM and should be encouraged. Vaccination status should be recorded in prospective clinical trials as it may affect survival. This trial was registered at www., Clinicaltrials: gov as #NCT02761187., (Copyright © 2023 The Authors. Published by Elsevier Inc. All rights reserved.)
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- 2023
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12. Systemic Light Chain Amyloidosis, Version 2.2023, NCCN Clinical Practice Guidelines in Oncology.
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Kumar SK, Callander NS, Adekola K, Anderson LD Jr, Baljevic M, Campagnaro E, Castillo JJ, Costello C, D'Angelo C, Devarakonda S, Elsedawy N, Garfall A, Godby K, Hillengass J, Holmberg L, Htut M, Huff CA, Hultcrantz M, Kang Y, Larson S, Lee HC, Liedtke M, Martin T, Omel J, Rosenberg A, Sborov D, Valent J, Berardi R, and Kumar R
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- Humans, Plasma Cells, Amyloid, Amyloidosis diagnosis, Amyloidosis therapy, Amyloidosis etiology
- Abstract
Primary systemic light chain amyloidosis (SLCA) is characterized by production of light chains that get converted to amyloid fibrils with an affinity for visceral organs and causing organ dysfunction. The therapy for SLCA is directed to recovering the function of the affected organs by targeting the abnormal plasma cell clone and slowing deposition of amyloid fibrils. The NCCN Guidelines for SLCA provide recommendations for workup, diagnosis, and treatment of primary as well as previously treated SLCA.
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- 2023
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13. Daratumumab, Carfilzomib, Lenalidomide, and Dexamethasone With Minimal Residual Disease Response-Adapted Therapy in Newly Diagnosed Multiple Myeloma.
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Costa LJ, Chhabra S, Medvedova E, Dholaria BR, Schmidt TM, Godby KN, Silbermann R, Dhakal B, Bal S, Giri S, D'Souza A, Hall A, Hardwick P, Omel J, Cornell RF, Hari P, and Callander NS
- Subjects
- Antibodies, Monoclonal, Antineoplastic Combined Chemotherapy Protocols adverse effects, Dexamethasone, Humans, Lenalidomide, Middle Aged, Neoplasm, Residual drug therapy, Oligopeptides, Multiple Myeloma drug therapy, Multiple Myeloma genetics
- Abstract
Purpose: The MASTER trial combined daratumumab, carfilzomib, lenalidomide, and dexamethasone (Dara-KRd) in newly diagnosed multiple myeloma (NDMM), using minimal residual disease (MRD) by next-generation sequencing (NGS) to inform the use and duration of Dara-KRd post-autologous hematopoietic cell transplantation (AHCT) and treatment cessation in patients with two consecutive MRD-negative assessments., Methods: This multicenter, single-arm, phase II trial enrolled patients with NDMM with planed enrichment for high-risk cytogenetic abnormalities (HRCAs). Patients received Dara-KRd induction, AHCT, and Dara-KRd consolidation, according to MRD status. MRD was evaluated by NGS at the end of induction, post-AHCT, and every four cycles (maximum of eight cycles) of consolidation. Primary end point was achievement of MRD negativity (< 10
-5 ). Patients with two consecutive MRD-negative assessments entered treatment-free MRD surveillance., Results: Among 123 participants, 43% had none, 37% had 1, and 20% had 2+ HRCA. Median age was 60 years (range, 36-79 years), and 96% had MRD trackable by NGS. Median follow-up was 25.1 months. Overall, 80% of patients reached MRD negativity (78%, 82%, and 79% for patients with 0, 1, and 2+ HRCA, respectively), 66% reached MRD < 10-6 , and 71% reached two consecutive MRD-negative assessments during therapy, entering treatment-free surveillance. Two-year progression-free survival was 87% (91%, 97%, and 58% for patients with 0, 1, and 2+ HRCA, respectively). Cumulative incidence of MRD resurgence or progression 12 months after cessation of therapy was 4%, 0%, and 27% for patients with 0, 1, or 2+ HRCA, respectively. Most common serious adverse events were pneumonia (6%) and venous thromboembolism (3%)., Conclusion: Dara-KRd, AHCT, and MRD response-adapted consolidation leads to high rate of MRD negativity in NDMM. For patients with 0 or 1 HRCA, this strategy creates the opportunity of MRD surveillance as an alternative to indefinite maintenance.- Published
- 2022
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14. Impact of autologous hematopoietic cell transplantation on disease burden quantified by next-generation sequencing in multiple myeloma treated with quadruplet therapy.
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Bal S, Dhakal B, Silbermann RW, Schmidt TM, Dholaria B, Giri S, Chhabra S, Medvedova E, Godby KN, D'Souza A, Hall AC, Hardwick P, Omel J, Cornell RF, Hari P, Callander NS, and Costa LJ
- Subjects
- Cost of Illness, High-Throughput Nucleotide Sequencing, Humans, Neoplasm, Residual diagnosis, Transplantation, Autologous, Hematopoietic Stem Cell Transplantation adverse effects, Multiple Myeloma diagnosis, Multiple Myeloma genetics, Multiple Myeloma therapy
- Abstract
The incremental impact of autologous hematopoietic cell transplantation (AHCT) on disease burden with quadruplet induction in newly diagnosed multiple myeloma (NDDM) can be reappraised with the serial assessment of minimal residual disease (MRD). We describe the impact of AHCT on MM burden assessed by next-generation sequencing (NGS) for patients enrolled in a clinical trial utilizing quadruplet induction, AHCT, followed by MRD-adapted consolidation. We describe quantitative changes in MRD burden with AHCT and explore patient and disease features influencing the magnitude of MRD reduction with AHCT. Among 123 included patients, 109 underwent AHCT and had MRD assessment pre and post AHCT. Forty percent achieved MRD < 10
-5 post-induction, increasing to 70% after AHCT. Of the 65 patients (60%) who remained MRD positive post-induction, 54 (83%) had a reduction in MRD burden with AHCT. The median reduction in MRD with AHCT was 1.10 log10 (range, -1.26 to 3.41). Patients with high-risk cytogenetic abnormalities (HRCA) had greater reduction in MRD burden (p = .02) after AHCT. Median relative reduction was 0.91 log10 (range, -0.75 to 2.14), 1.26 log10 (range, -0.21 to 3.26) and 1.34 log10 (range, -1.28 to 3.41) for patients with 0, 1 and 2+ HRCA, respectively. The presence of HRCA was the only factor associated with greater than 1 log10 reduction in MRD burden with AHCT. Serial NGS MRD demonstrates the incremental effect of AHCT in MM marrow burden in the context of quadruplet induction, particularly in high-risk MM., (© 2022 Wiley Periodicals LLC.)- Published
- 2022
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15. NCCN Guidelines® Insights: Multiple Myeloma, Version 3.2022.
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Callander NS, Baljevic M, Adekola K, Anderson LD, Campagnaro E, Castillo JJ, Costello C, Devarakonda S, Elsedawy N, Faiman M, Garfall A, Godby K, Hillengass J, Holmberg L, Htut M, Huff CA, Hultcrantz M, Kang Y, Larson S, Liedtke M, Martin T, Omel J, Sborov D, Shain K, Stockerl-Goldstein K, Weber D, Berardi RA, Kumar R, and Kumar SK
- Subjects
- Humans, Multiple Myeloma diagnosis, Multiple Myeloma therapy
- Abstract
The NCCN Guidelines for Multiple Myeloma provide recommendations for diagnosis, initial workup, treatment, follow-up, and supportive care for patients with various plasma cell neoplasms, including multiple myeloma. These NCCN Guidelines Insights highlight some of the important updates/changes specific to the treatment of patients with multiple myeloma in the 2022 version of the guidelines.
- Published
- 2022
- Full Text
- View/download PDF
16. International harmonization in performing and reporting minimal residual disease assessment in multiple myeloma trials.
- Author
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Costa LJ, Derman BA, Bal S, Sidana S, Chhabra S, Silbermann R, Ye JC, Cook G, Cornell RF, Holstein SA, Shi Q, Omel J, Callander NS, Chng WJ, Hungria V, Maiolino A, Stadtmauer E, Giralt S, Pasquini M, Jakubowiak AJ, Morgan GJ, Krishnan A, Jackson GH, Mohty M, Mateos MV, Dimopoulos MA, Facon T, Spencer A, Miguel JS, Hari P, Usmani SZ, Manier S, McCarthy P, Kumar S, Gay F, and Paiva B
- Subjects
- Clinical Trials as Topic, Diagnostic Imaging, Disease Management, Drug Collateral Sensitivity, Global Health, Humans, Molecular Diagnostic Techniques methods, Molecular Diagnostic Techniques standards, Multiple Myeloma therapy, Neoplastic Cells, Circulating metabolism, Neoplastic Cells, Circulating pathology, Outcome Assessment, Health Care, Population Surveillance, Reproducibility of Results, Smoldering Multiple Myeloma epidemiology, Smoldering Multiple Myeloma pathology, Time Factors, Multiple Myeloma epidemiology, Multiple Myeloma pathology, Neoplasm, Residual diagnosis, Neoplasm, Residual epidemiology
- Abstract
Minimal residual disease (MRD) assessment is incorporated in an increasing number of multiple myeloma (MM) clinical trials as a correlative analysis, an endpoint or even as a determinant of subsequent therapy. There is substantial heterogeneity across clinical trials in how MRD is assessed and reported, creating challenges for data interpretation and for the design of subsequent studies. We convened an international panel of MM investigators to harmonize how MRD should be assessed and reported in MM clinical trials. The panel provides consensus on which MM trials should include MRD, the recommended time points for MRD assessment, and expected analytical validation for MRD assays. We subsequently outlined parameters for reporting MRD results implementing the intention-to-treat principle. The panel provides guidance regarding the incorporation of newer peripheral blood-based and imaging-based approaches to detection of residual disease. Recommendations are summarized in 13 consensus statements that should be followed by sponsors, investigators, editors, and reviewers engaged in designing, performing, and interpreting MM trials.
- Published
- 2021
- Full Text
- View/download PDF
17. Multiple Myeloma, Version 3.2021, NCCN Clinical Practice Guidelines in Oncology.
- Author
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Kumar SK, Callander NS, Adekola K, Anderson L, Baljevic M, Campagnaro E, Castillo JJ, Chandler JC, Costello C, Efebera Y, Faiman M, Garfall A, Godby K, Hillengass J, Holmberg L, Htut M, Huff CA, Kang Y, Hultcrantz M, Larson S, Liedtke M, Martin T, Omel J, Shain K, Sborov D, Stockerl-Goldstein K, Weber D, Keller J, and Kumar R
- Subjects
- Bone Marrow, Humans, Medical Oncology, Plasma Cells, Plasmacytoma, Multiple Myeloma diagnosis, Multiple Myeloma therapy
- Abstract
Multiple myeloma is a malignant neoplasm of plasma cells that accumulate in bone marrow, leading to bone destruction and marrow failure. This manuscript discusses the management of patients with solitary plasmacytoma, smoldering multiple myeloma, and newly diagnosed multiple myeloma.
- Published
- 2020
- Full Text
- View/download PDF
18. NCCN Guidelines Insights: Multiple Myeloma, Version 1.2020.
- Author
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Kumar SK, Callander NS, Hillengass J, Liedtke M, Baljevic M, Campagnaro E, Castillo JJ, Chandler JC, Cornell RF, Costello C, Efebera Y, Faiman M, Garfall A, Godby K, Holmberg L, Htut M, Huff CA, Kang Y, Landgren O, Malek E, Martin T, Omel J, Raje N, Sborov D, Singhal S, Stockerl-Goldstein K, Tan C, Weber D, Johnson-Chilla A, Keller J, and Kumar R
- Subjects
- Humans, Multiple Myeloma
- Abstract
The NCCN Guidelines for Multiple Myeloma provide recommendations for diagnosis, workup, treatment, follow-up, and supportive care for patients with monoclonal gammopathy of renal significance, solitary plasmacytoma, smoldering myeloma, and multiple myeloma. These NCCN Guidelines Insights highlight some of the important updates and changes in the 1.2020 version of the NCCN Guidelines for Multiple Myeloma.
- Published
- 2019
- Full Text
- View/download PDF
19. Treatment of Multiple Myeloma: ASCO and CCO Joint Clinical Practice Guideline.
- Author
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Mikhael J, Ismaila N, Cheung MC, Costello C, Dhodapkar MV, Kumar S, Lacy M, Lipe B, Little RF, Nikonova A, Omel J, Peswani N, Prica A, Raje N, Seth R, Vesole DH, Walker I, Whitley A, Wildes TM, Wong SW, and Martin T
- Subjects
- Clinical Trials, Phase II as Topic, Humans, Medical Oncology methods, Randomized Controlled Trials as Topic, Systematic Reviews as Topic, Medical Oncology standards, Multiple Myeloma therapy
- Abstract
Purpose: To provide evidence-based recommendations on the treatment of multiple myeloma to practicing physicians and others., Methods: ASCO and Cancer Care Ontario convened an Expert Panel of medical oncology, surgery, radiation oncology, and advocacy experts to conduct a literature search, which included systematic reviews, meta-analyses, randomized controlled trials, and some phase II studies published from 2005 through 2018. Outcomes of interest included survival, progression-free survival, response rate, and quality of life. Expert Panel members used available evidence and informal consensus to develop evidence-based guideline recommendations., Results: The literature search identified 124 relevant studies to inform the evidence base for this guideline., Recommendations: Evidence-based recommendations were developed for patients with multiple myeloma who are transplantation eligible and those who are ineligible and for patients with relapsed or refractory disease.
- Published
- 2019
- Full Text
- View/download PDF
20. INSIGHT MM: a large, global, prospective, non-interventional, real-world study of patients with multiple myeloma.
- Author
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Costello C, Davies FE, Cook G, Vela-Ojeda J, Omel J, Rifkin RM, Berdeja J, Puig N, Usmani SZ, Weisel K, Zonder JA, Terpos E, Spencer A, Leleu X, Boccadoro M, Thompson MA, Romanus D, Stull DM, and Hungria V
- Subjects
- Adolescent, Adult, Aged, Aged, 80 and over, Disease Progression, Follow-Up Studies, Humans, International Agencies, Middle Aged, Multiple Myeloma pathology, Neoplasm Recurrence, Local pathology, Prospective Studies, Treatment Outcome, Young Adult, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Multiple Myeloma drug therapy, Neoplasm Recurrence, Local drug therapy, Quality of Life
- 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
- Full Text
- View/download PDF
21. Role of Bone-Modifying Agents in Multiple Myeloma: American Society of Clinical Oncology Clinical Practice Guideline Update.
- Author
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Anderson K, Ismaila N, Flynn PJ, Halabi S, Jagannath S, Ogaily MS, Omel J, Raje N, Roodman GD, Yee GC, and Kyle RA
- Subjects
- Female, Humans, Male, United States, Bone Density Conservation Agents pharmacology, Bone Density Conservation Agents therapeutic use, Multiple Myeloma drug therapy, Multiple Myeloma pathology
- Abstract
Purpose To update guideline recommendations on the role of bone-modifying agents in multiple myeloma. Methods An update panel conducted a targeted systematic literature review by searching PubMed and the Cochrane Library for randomized controlled trials, systematic reviews, meta-analyses, clinical practice guidelines, and observational studies. Results Thirty-five relevant studies were identified, and updated evidence supports the current recommendations. Recommendations For patients with active symptomatic multiple myeloma that requires systemic therapy with or without evidence of lytic destruction of bone or compression fracture of the spine from osteopenia on plain radiograph(s) or other imaging studies, intravenous administration of pamidronate 90 mg over at least 2 hours or zoledronic acid 4 mg over at least 15 minutes every 3 to 4 weeks is recommended. Denosumab has shown to be noninferior to zoledronic acid for the prevention of skeletal-related events and provides an alternative. Fewer adverse events related to renal toxicity have been noted with denosumab compared with zoledronic acid and may be preferred in this setting. The update panel recommends that clinicians consider reducing the initial pamidronate dose in patients with preexisting renal impairment. Zoledronic acid has not been studied in patients with severe renal impairment and is not recommended in this setting. The update panel suggests that bone-modifying treatment continue for up to 2 years. Less frequent dosing has been evaluated and should be considered in patients with responsive or stable disease. Continuous use is at the discretion of the treating physician and the risk of ongoing skeletal morbidity. Retreatment should be initiated at the time of disease relapse. The update panel discusses measures regarding osteonecrosis of the jaw. Additional information is available at www.asco.org/hematologic-malignancies-guidelines and www.asco.org/guidelineswiki .
- Published
- 2018
- Full Text
- View/download PDF
22. NCCN Guidelines Insights: Multiple Myeloma, Version 3.2018.
- Author
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Kumar SK, Callander NS, Alsina M, Atanackovic D, Biermann JS, Castillo J, Chandler JC, Costello C, Faiman M, Fung HC, Godby K, Hofmeister C, Holmberg L, Holstein S, Huff CA, Kang Y, Kassim A, Liedtke M, Malek E, Martin T, Neppalli VT, Omel J, Raje N, Singhal S, Somlo G, Stockerl-Goldstein K, Weber D, Yahalom J, Kumar R, and Shead DA
- Subjects
- Humans, Multiple Myeloma epidemiology, Multiple Myeloma etiology, Multiple Myeloma diagnosis, Multiple Myeloma therapy
- Abstract
The NCCN Guidelines for Multiple Myeloma provide recommendations for diagnosis, evaluation, treatment, including supportive-care, and follow-up for patients with myeloma. These NCCN Guidelines Insights highlight the important updates/changes specific to the myeloma therapy options in the 2018 version of the NCCN Guidelines., (Copyright © 2018 by the National Comprehensive Cancer Network.)
- Published
- 2018
- Full Text
- View/download PDF
23. Multiple Myeloma, Version 3.2017, NCCN Clinical Practice Guidelines in Oncology.
- Author
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Kumar SK, Callander NS, Alsina M, Atanackovic D, Biermann JS, Chandler JC, Costello C, Faiman M, Fung HC, Gasparetto C, Godby K, Hofmeister C, Holmberg L, Holstein S, Huff CA, Kassim A, Liedtke M, Martin T, Omel J, Raje N, Reu FJ, Singhal S, Somlo G, Stockerl-Goldstein K, Treon SP, Weber D, Yahalom J, Shead DA, and Kumar R
- Subjects
- Antineoplastic Agents supply & distribution, Antineoplastic Combined Chemotherapy Protocols standards, Asymptomatic Diseases, Chemotherapy, Adjuvant methods, Chemotherapy, Adjuvant standards, Humans, Immunoglobulins blood, Magnetic Resonance Imaging, Maintenance Chemotherapy methods, Maintenance Chemotherapy standards, Multiple Myeloma blood, Myeloma Proteins analysis, Positron Emission Tomography Computed Tomography, Radiotherapy, Adjuvant methods, Radiotherapy, Adjuvant standards, Serologic Tests, Standard of Care, Stem Cell Transplantation standards, Treatment Outcome, Antineoplastic Agents therapeutic use, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Medical Oncology standards, Multiple Myeloma diagnosis, Multiple Myeloma therapy, Stem Cell Transplantation methods
- Abstract
Multiple myeloma (MM) is caused by the neoplastic proliferation of plasma cells. These neoplastic plasma cells proliferate and produce monoclonal immunoglobulin in the bone marrow causing skeletal damage, a hallmark of multiple myeloma. Other MM-related complications include hypercalcemia, renal insufficiency, anemia, and infections. The NCCN Multiple Myeloma Panel members have developed guidelines for the management of patients with various plasma cell dyscrasias, including solitary plasmacytoma, smoldering myeloma, multiple myeloma, systemic light chain amyloidosis, and Waldenström's macroglobulinemia. The recommendations specific to the diagnosis and treatment of patients with newly diagnosed MM are discussed in this article., (Copyright © 2017 by the National Comprehensive Cancer Network.)
- Published
- 2017
- Full Text
- View/download PDF
24. Recent trends in multiple myeloma incidence and survival by age, race, and ethnicity in the United States.
- Author
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Costa LJ, Brill IK, Omel J, Godby K, Kumar SK, and Brown EE
- Abstract
Prior improvements in multiple myeloma (MM) survival were not fully observed in racial and ethnic minorities and older individuals. We hypothesized that improvements in MM management in recent years have reduced these disparities. We used the Surveillance, Epidemiology, and End Results registries to calculate the incidence and relative survival rates (RSRs) of MM in the United States for patients diagnosed from 1993 to 1997 (prethalidomide), 1998 to 2002 (introduction of thalidomide), 2003 to 2007 (bortezomib and lenalidomide), and 2008 to 2012 (upfront bortezomib and lenalidomide, early availability of carfilzomib and pomalidomide). MM incidence increased significantly among non-Hispanic whites (NHWs) and non-Hispanic black (NHB) men, but not among NHB women and Hispanics. Improvement in 5-year RSRs (1993-1997 vs 2008-2012) was seen among patients of all age and race/ethnicity groups. Ten-year RSRs (1993-1997 vs 2003-2007) improved for patients <65 years of age (19.6%-35%; P < .001), but not for patients ≥75 years of age (7.8%-9.3%; P = .3). Among patients 65 to 74 years of age, 10-year RSRs improved for NHWs (11.3% vs 20.5%; P < .001) and Hispanics (10.6% vs 20.2%; P = .02), but not for NHBs (12.6% vs 19.5%; P = .06.). These findings confirm consistent improvement in survival for MM patients and point to the challenge of further extending these improvements to older and minority patients., Competing Interests: Conflict-of-interest disclosure: The authors declare no competing financial interests.
- Published
- 2017
- Full Text
- View/download PDF
25. The role of cytotoxic therapy with hematopoietic stem cell transplantation in the treatment of diffuse large B cell lymphoma: update of the 2001 evidence-based review.
- Author
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Oliansky DM, Czuczman M, Fisher RI, Irwin FD, Lazarus HM, Omel J, Vose J, Wolff SN, Jones RB, McCarthy PL Jr, and Hahn T
- Subjects
- Combined Modality Therapy, Evidence-Based Medicine, Humans, Practice Guidelines as Topic, Cytotoxins therapeutic use, Hematopoietic Stem Cell Transplantation methods, Lymphoma, Large B-Cell, Diffuse therapy
- Abstract
Clinical research published since the 2001 evidence-based review on the role of hematopoietic stem cell transplantation (SCT) in the treatment of diffuse large B cell lymphoma (DLBCL) in adults is presented and critically evaluated in this update. Treatment recommendations that remain unchanged from the original review include: (1) autologous SCT as salvage therapy is recommended for patients with chemosensitive relapsed DLBCL; and (2) autologous SCT is not recommended for patients who achieve a partial response to an abbreviated induction regimen. New treatment recommendations based on new published data include: (1) autologous SCT as first-line therapy is not recommended for any IPI group; (2) planned tandem or multiple sequential autologous SCT is not recommended; (3) peripheral blood is the standard stem cell source for autologous SCT; (4) age is not a contraindication for autologous SCT, although outcomes in older adults are not as good as in younger adults. There are insufficient data to make recommendations on the routine use of rituximab maintenance after autologous SCT, autologous versus allogeneic SCT, fewer versus more cycles of induction therapy prior to autologous SCT, or the use of reduced intensity versus myeloablative conditioning regimens. Areas of needed research in the treatment of DLBCL with SCT were identified and are presented in the review., (2011 American Society for Blood and Marrow Transplantation. Published by Elsevier Inc. All rights reserved.)
- Published
- 2011
- Full Text
- View/download PDF
26. Another point of view--C-section rates.
- Author
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Omel JL
- Subjects
- Female, Humans, Nebraska, Pregnancy, Rural Population, Cesarean Section statistics & numerical data
- Published
- 1989
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