دورية أكاديمية
Full or intensity-reduced high-dose melphalan and single or double autologous stem cell transplant with or without bortezomib consolidation in patients with newly diagnosed multiple myeloma.
| العنوان: | Full or intensity-reduced high-dose melphalan and single or double autologous stem cell transplant with or without bortezomib consolidation in patients with newly diagnosed multiple myeloma. |
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| المؤلفون: | Straka C; Medizinische Klinik, München Klinik Schwabing, Munich, Germany., Salwender H; Asklepios Tumorzentrum, AK Altona und AK St. Georg, Hamburg, Germany., Knop S; Universitätsklinikum Würzburg, Medizinische Klinik und Poliklinik II, Würzburg, Germany., Vogel M; Janssen-Cilag GmbH, Neuss, Germany., Müller J; acromion GmbH, Frechen, Germany., Metzner B; Universitätsklinik für Innere Medizin II, Oldenburg, Germany., Langer C; Universitätsklinikum Ulm, Klinik für Innere Medizin II, Ulm, Germany., Sayer H; Universitätsklinikum Jena, Klinik für Innere Medizin II, Jena, Germany., Jung W; Universitätsmedizin Göttingen, Göttingen, Germany., Dürk HA; St. Barbara-Klinik, Hamm, Germany., Bassermann F; Klinikum rechts der Isar der Technischen Universität München, Munich, Germany., Gramatzki M; Universitätsklinikum Schleswig-Holstein, Kiel, Germany., Rösler W; Universitätsklinikum Erlangen, Erlangen, Germany., Wolf HH; Universitätsklinikum Halle, Halle (Saale), Germany., Brugger W; Schwarzwald-Baar Klinikum, Villingen-Schwenningen, Germany., Engelhardt M; Universitätsklinikum Freiburg, Freiburg, Germany., Fischer T; Universitätsklinikum Magdeburg, Magdeburg, Germany., Liebisch P; Universitätsklinikum Ulm, Klinik für Innere Medizin II, Ulm, Germany., Einsele H; Universitätsklinikum Würzburg, Medizinische Klinik und Poliklinik II, Würzburg, Germany. |
| المصدر: | European journal of haematology [Eur J Haematol] 2021 Nov; Vol. 107 (5), pp. 529-542. Date of Electronic Publication: 2021 Aug 28. |
| نوع المنشور: | Journal Article |
| اللغة: | English |
| بيانات الدورية: | Publisher: Blackwell Country of Publication: England NLM ID: 8703985 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1600-0609 (Electronic) Linking ISSN: 09024441 NLM ISO Abbreviation: Eur J Haematol Subsets: MEDLINE |
| أسماء مطبوعة: | Publication: <2005->: Oxford : Blackwell Original Publication: Copenhagen : Munksgaard, c1987- |
| مواضيع طبية MeSH: | Antineoplastic Combined Chemotherapy Protocols/*therapeutic use , Bortezomib/*administration & dosage , Consolidation Chemotherapy/*methods , Melphalan/*administration & dosage , Multiple Myeloma/*therapy, Aged ; Combined Modality Therapy ; Dose-Response Relationship, Drug ; Female ; Hematopoietic Stem Cell Transplantation ; Humans ; Male ; Middle Aged ; Multiple Myeloma/drug therapy ; Retrospective Studies ; Transplantation, Autologous |
| مستخلص: | Objective: A post hoc subgroup analysis of two phase III trials (NCT00416273, NCT00416208) was carried out to investigate the influence of 100/140 and 200 mg/m² melphalan as well as single/double autologous stem cell transplantation (ASCT) on progression-free survival (PFS). Additionally, the effect of bortezomib consolidation on PFS was analyzed. Methods: Following induction therapy and high-dose melphalan with subsequent ASCT, patients with newly diagnosed multiple myeloma (NDMM) were randomized 1:1 to either four 35-day cycles of bortezomib consolidation (1.6 mg/m² IV on days 1, 8, 15, 22) or observation. Results: Of the 340 patients included in this analysis, 13.5% received 1 × MEL100/140, 22.9% 2 × MEL100/140, 31.2% 1 × MEL200, and 32.4% 2 × MEL200. With higher cumulative melphalan dose, PFS improved (P = .0085). PFS curves of patients treated with 2 × MEL100/140 and 1 × MEL200 were very similar. The superior dose effect of MEL200 over MEL100/140 was non-existent in the bortezomib consolidation arm but pronounced in the observation arm (P = .0015). Similarly, double ASCT was only beneficial in patients without bortezomib consolidation (P = .0569). Conclusions: Full dose melphalan and double transplantation seem advantageous only as long as patients are not receiving bortezomib consolidation afterwards. (© 2021 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.) |
| References: | Kumar SK, Callander NS, Hillengass J, et al. NCCN Guidelines Insights: Multiple Myeloma, Version 1.2020. J Natl Compr Canc Netw. 2019;17(10):1154-1165. Moreau P, San Miguel J, Sonneveld P, et al. Multiple myeloma: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2017;28:iv52-iv61. Moreau P, Facon T, Attal M, et al. Comparison of 200 mg/m2 melphalan and 8 Gy total body irradiation plus 140 mg/m2 melphalan as conditioning regimens for peripheral blood stem cell transplantation in patients with newly diagnosed multiple myeloma: final analysis of the Intergroupe Francophone du Myélome 9502 randomized trial. Blood. 2002;99(3):731-735. Selby PJ, McElwain TJ, Nandi AC, et al. Multiple myeloma treated with high dose intravenous melphalan. Br J Haematol. 1987;66(1):55-62. Sharma M, Zhang MJ, Zhong X. Older patients with myeloma derive similar benefit from autologous transplantation. Biol Blood Marrow Transplant. 2014;20(11):1796-1803. El Cheikh J, Kfoury E, Calmels B, et al. Age at transplantation and outcome after autologous stem cell transplantation in elderly patients with multiple myeloma. Hematol Oncol Stem Cell Ther. 2011;4(1):30-36. Kumar SK, Dingli D, Lacy MQ, et al. Autologous stem cell transplantation in patients of 70 years and older with multiple myeloma: Results from a matched pair analysis. Am J Hematol. 2008;83(8):614-617. Mateos MV, Ocio EM, Paiva B, et al. Treatment for patients with newly diagnosed multiple myeloma in 2015. Blood Rev. 2015;29(6):387-403. Joks M, Jurczyszyn A, Machaczka M, et al. The roles of consolidation and maintenance therapy with novel agents after autologous stem cell transplantation in patients with multiple myeloma. Eur J Haematol. 2015;94(2):109-114. Al Hamed R, Bazarbachi AH, Malard F, et al. Current status of autologous stem cell transplantation for multiple myeloma. Blood Cancer J. 2019;9:44. Stadtmauer EA, Pasquini MC, Blackwell B, et al. Autologous transplantation, consolidation, and maintenance therapy in multiple myeloma: results of the BMT CTN 0702 Trial. J Clin Oncol. 2019;37:589-597. Horvath N, Spencer A, Kenealy M, et al. Phase 3 study of subcutaneous bortezomib, thalidomide, and prednisolone consolidation after subcutaneous bortezomib-based induction and autologous stem cell transplantation in patients with previously untreated multiple myeloma: the VCAT study. Leuk Lymphoma. 2019;60:2122-2133. Einsele H, Knop S, Vogel M, et al. Response-adapted consolidation with bortezomib after ASCT improves progression-free survival in newly diagnosed multiple myeloma. Leukemia. 2017;31:1463-1466. Sezer O, Beksac M, Hajek R, et al. Effects of single-agent bortezomib as post-transplant consolidation therapy on multiple myeloma-related bone disease: a randomized phase II study. Br J Haematol. 2017;178:61-71. Mellqvist UH, Gimsing P, Hjertner O, et al. Bortezomib consolidation after autologous stem cell transplantation in multiple myeloma: a Nordic Myeloma Study Group randomized phase 3 trial. Blood. 2013;121(23):4647-4654. Zhang S, Kulkarni AA, Xu B, et al. Bortezomib-based consolidation or maintenance therapy for multiple myeloma: a meta-analysis. Blood Cancer J. 2020;10(3):33. Straka C, Knop S, Vogel M, et al. Bortezomib consolidation following autologous transplant in younger and older patients with newly diagnosed multiple myeloma in two phase III trials. Eur J Haematol. 2019;103:255-267. VELCADE® (Bortezomib) Summary of Product Characteristics.Janssen-Cilag International NV. Belgium: Beerse; 2015. http://www.ema-europa.eu/docs/en_GB/documents_library/EPAR_Product_Information/human/000539/WC500048471.pdf. VELCADE (Bortezomib) Prescribing Information. Revised 10/ 2014. Millennium Pharmaceuticals Inc., Cambridge, MA, USA. http://www.velcade.com/files/PDFs/VELCADE_PRESCRIBING_INFORMATION.pdf. Blade J, Samson D, Reece D, et al. Criteria for evaluating disease response and progression in patients with multiple myeloma treated by high-dose therapy and haemopoietic stem cell transplantation.Myeloma Subcommittee of the EBMT. European Group for Blood and Marrow Transplant. Br J Haematol. 1998;102(5):1115-1123. Durie B, Harousseau J-L, Miguel JS, et al. International uniform response criteria for multiple myeloma. Leukemia. 2006;20(9):1467-1473. Auner HW, Szydlo R, Hoek J, et al. Trends in autologous hematopoietic cell transplantation for multiple myeloma in Europe: increased use and improved outcomes in elderly patients in recent years. Bone Marrow Transplant. 2015;50(2):209-215. Costa LJ, Zhang MJ, Zhong X, et al. Trends in utilization and outcomes of autologous transplantation as early therapy for multiple myeloma. Biol Blood Marrow Transplant. 2013;19(11):1615-1624. Katragadda L, McCullough LM, Dai Y, et al. Effect of melphalan 140 mg/m2 vs 200 mg/m2 on toxicities and outcomes in multiple myeloma patients undergoing single autologous stem cell transplantation-a single center experience. Clin Transplant. 2016;30(8):894-900. Dimopoulos MA, Terpos E, Chanan-Khan A, et al. Renal impairment in patients with multiple myeloma: a consensus statement on behalf of the International Myeloma Working Group. J Clin Oncol. 2010;28(33):4976-4984. Palumbo A, Triolo S, Argentino C, et al. Dose-intensive melphalan with stem cell support (MEL100) is superior to standard treatment in elderly myeloma patients. Blood. 1999;94(4):1248-1253. Badros A, Barlogie B, Siegel E, et al. Autologous stem cell transplantation in elderly multiple myeloma patients over the age of 70 years. Br J Haematol. 2001;114(3):600-607. Straka C, Liebisch P, Salwender H, et al. Autotransplant with and without induction chemotherapy in older multiple myeloma patients: long-term outcome of a randomized trial. Haematologica. 2016;101(11):1398-1406. Auner HW, Iacobelli S, Sbianchi G, et al. Melphalan 140 mg/m2 or 200 mg/m2 for autologous transplantation in myeloma: results from the Collaboration to Collect Autologous Transplant Outcomes in Lymphoma and Myeloma (CALM) study. A report by the EBMT Chronic Malignancies Working Party. Haematologica. 2018;103(3):514-521. Garderet L, Beohou E, Caillot D, et al. Upfront autologous stem cell transplantation for newly diagnosed elderly multiple myeloma patients: a prospective multicenter study. Haematologica. 2016;101(11):1390-1397. Palumbo A, Bringhen S, Petrucci MT, et al. Intermediate-dose melphalan improves survival of myeloma patients aged 50 to 70: results of a randomized controlled trial. Blood. 2004;104:3052-3057. Neukirchen J, Arat P, Teutloff C, et al. Favourable outcome of elderly patients with multiple myeloma treated with tandem Melphalan 100 high-dose therapy, autologous stem cell transplantation and novel agents - a single center experience. Blood. 2016;128(22):3460. Attal M, Harousseau J-L, Facon T, et al. Single versus double autologous stem-cell transplantation for multiple myeloma. NEJM. 2003;349:2495-2502. Cavo M, Tosi P, Zamagni E, et al. Prospective, randomized study of single compared with double autologous stem-cell transplantation for multiple myeloma: Bologna 96 clinical study. J Clin Oncol. 2007;25(17):2434-2441. Mai EK, Benner A, Bertsch U, et al. Single versus tandem high-dose melphalan followed by autologous blood stem cell transplantation in multiple myeloma: long-term results from the phase III GMMG-HD2 trial. BJH. 2016;173(5):731-741. Palumbo A, Bringhen S, Bruno B, et al. Melphalan 200 mg/m2 versus melphalan 100 mg/m2 in newly diagnosed myeloma patients: a prospective, multicenter phase 3 study. Blood. 2010;115(10):1873-1879. Gay F, Magarotto V, Crippa C, et al. Bortezomib induction, reduced-intensity transplantation, and lenalidomide consolidation-maintenance for myeloma: updated results. Blood. 2013;122(8):1376-1383. Badros A, Barlogie B, Siegel E, et al. Results of autologous stem cell transplant in multiple myeloma patients with renal failure. BJH. 2001;114(4):822-829. Cavo M, Gay F, Beksac M, et al. Autologous haematopoietic stem-cell transplantation versus bortezomib-melphalan-prednisone, with or without bortezomib-lenalidomide-dexamethasone consolidation therapy, and lenalidomide maintenance for newly diagnosed multiple myeloma (EMN02/HO95): a multicentre, randomised, open-label, phase 3 study. Lancet Haematol. 2020;7(6):e456-e468. Palumbo F, Cavalio F, Gay F, et al. Autologous transplantation and maintenance therapy in multiple myeloma. NEJM. 2014;371(10):895-905. Gay F, Olivia S, Petrucci MT, et al. Chemotherapy plus lenalidomide versus autologous transplantation, followed by lenalidomide plus prednisone versus lenalidomide maintenance, in patients with multiple myeloma: a randomised, multicentre, phase 3 trial. Lancet Oncol. 2015;16(16):1617-1629. Attal M, Lauwers-Cances V, Hulin C, et al. Lenalidomide, bortezomib, and dexamethasone with transplantation for myeloma. NEJM. 2017;376:1311-1320. Moreau P, Attal M, Hulin C, et al. Bortezomib, thalidomide, and dexamethasone with or without daratumumab before and after autologous stem-cell transplantation for newly diagnosed multiple myeloma (CASSIOPEIA): a randomised, open-label, phase 3 study. Lancet. 2019;394(10192):29-38. |
| معلومات مُعتمدة: | Janssen Pharmaceuticals |
| فهرسة مساهمة: | Keywords: ASCT; OS; PFS; bortezomib; consolidation; high-dose melphalan 100/140 mg/m² or 200 mg/m²; multiple myeloma |
| المشرفين على المادة: | 69G8BD63PP (Bortezomib) Q41OR9510P (Melphalan) |
| تواريخ الأحداث: | Date Created: 20210716 Date Completed: 20220208 Latest Revision: 20220208 |
| رمز التحديث: | 20240628 |
| DOI: | 10.1111/ejh.13690 |
| PMID: | 34270825 |
| قاعدة البيانات: | MEDLINE |
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