Original Article

Annals of Hematology

, Volume 91, Issue 6, pp 875-888

First online:

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

  • Giovanni BarosiAffiliated withLaboratory of Clinical Epidemiology and Center for the Study of Myelofibrosis, Fondazione IRCCS Policlinico San MatteoUnità di Epidemiologia Clinica/Centro per lo Studio della Mielofibrosi, Fondazione IRCCS Policlinico S. Matteo Email author 
  • , Giampaolo MerliniAffiliated withAmyloidosis Research and Treatment Center and Department of Biochemistry, Fondazione IRCCS Policlinico San Matteo and University of Pavia
  • , Atto BillioAffiliated withDepartment of Ematology, Ospedale Centrale
  • , Mario BoccadoroAffiliated withDivisione di Ematologia dell’Università di Torino, AOU S. Giovanni Battista
  • , Paolo CorradiniAffiliated withDivision of Hematology, Fondazione IRCCS Istituto Nazionale dei Tumori
  • , Monia MarchettiAffiliated withUnit of Hematology, Hospital “C. Massaia”
  • , Massimo MassaiaAffiliated withDivisione di Ematologia dell’Università di Torino, AOU S. Giovanni Battista
  • , Patrizia TosiAffiliated withUnit of Hematology, Ospedale Infermi Rimini
  • , Antonio PalumboAffiliated withDivisione di Ematologia dell’Università di Torino, AOU S. Giovanni Battista
    • , Michele CavoAffiliated withIstituto di Ematologia ed Oncologia Medica “Seragnoli”, Università di Bologna
    • , Sante TuraAffiliated withUniversità di Bologna

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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).


Multiple myeloma Bortezomib Thalidomide Lenalidomide Guideline GRADE Recommendations