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SIE, SIES, GITMO evidence-based guidelines on novel agents (thalidomide, bortezomib, and lenalidomide) in the treatment of multiple myeloma

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Abstract

In this project, we produced drug-specific recommendations targeting the use of new agents for multiple myeloma (MM). We used the GRADE (Grades of Recommendation, Assessment, Development, and Evaluation) system which separates the judgments on quality of evidence from the judgment about strength of recommendations. We recommended thalidomide and bortezomib in MM patients candidates to autologous stem cell transplantation (ASCT) (weak positive). We did not recommend novel agents as maintenance therapy after ASCT (weak negative). In patients not candidate to ASCT, thalidomide or bortezomib (strong positive) associated with melphalan and prednisone were recommended. In these patients, no specific course of action could be recommended as for maintenance therapy. In patients who are refractory or relapsing after first-line therapy, we recommended bortezomib and pegylated liposomal doxorubicin, or lenalidomide and dexamethasone combinations (weak positive).

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Acknowledgements

Funding of the project was provided by SIE, SIES, and GITMO societies and from at-arm’s-length contribution from Celgene, Janssen Cilag and Novartis (Italy) provided to the SIE. The SIE administered all aspects of the meetings. The funding sources had no role in identifying statements, abstracting data, synthesizing results, grading evidence, or preparing the manuscript or in the decision to submit the manuscript for publication.

Authorship contribution

GB and ST designed research; GB, AB, and MM performed the systematic review of literature, graded the evidence, and prepared the summary tables of evidence. GM, MB, PC, MM, PT, AP, MC, and ST formed the Panel of experts who discussed the summaries of evidence and produced recommendations. GB wrote the preliminary version of the paper. All authors participated in writing significant sections of the paper.

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Correspondence to Giovanni Barosi.

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Barosi, G., Merlini, G., Billio, A. et al. SIE, SIES, GITMO evidence-based guidelines on novel agents (thalidomide, bortezomib, and lenalidomide) in the treatment of multiple myeloma. Ann Hematol 91, 875–888 (2012). https://doi.org/10.1007/s00277-012-1445-y

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