1. Carfilzomib with cyclophosphamide and dexamethasone or lenalidomide and dexamethasone plus autologous transplantation or carfilzomib plus lenalidomide and dexamethasone, followed by maintenance with carfilzomib plus lenalidomide or lenalidomide alone for patients with newly diagnosed multiple myeloma (FORTE): a randomised, open-label, phase 2 trial
- Author
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Francesca Gay, Pellegrino Musto, Delia Rota-Scalabrini, Luca Bertamini, Angelo Belotti, Monica Galli, Massimo Offidani, Elena Zamagni, Antonio Ledda, Mariella Grasso, Stelvio Ballanti, Antonio Spadano, Michele Cea, Francesca Patriarca, Mattia D'Agostino, Andrea Capra, Nicola Giuliani, Paolo de Fabritiis, Sara Aquino, Angelo Palmas, Barbara Gamberi, Renato Zambello, Maria Teresa Petrucci, Paolo Corradini, Michele Cavo, Mario Boccadoro, Gay F., Musto P., Rota-Scalabrini D., Bertamini L., Belotti A., Galli M., Offidani M., Zamagni E., Ledda A., Grasso M., Ballanti S., Spadano A., Cea M., Patriarca F., D'Agostino M., Capra A., Giuliani N., de Fabritiis P., Aquino S., Palmas A., Gamberi B., Zambello R., Petrucci M.T., Corradini P., Cavo M., and Boccadoro M.
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Male ,Antibodies, Monoclonal ,Antineoplastic Combined Chemotherapy Protocols ,Bortezomib ,Combined Modality Therapy ,Cyclophosphamide ,Dexamethasone ,Female ,Follow-Up Studies ,Hematopoietic Stem Cell Transplantation ,Humans ,Lenalidomide ,Melphalan ,Middle Aged ,Multiple Myeloma ,Oligopeptides ,Prognosis ,Survival Rate ,Thalidomide ,Transplantation, Autologous ,chemistry.chemical_compound ,Maintenance therapy ,Monoclonal ,Medicine ,multiple myeloma, newly diagnosed, carfilzomib, cyclophosphamide, lenalidomide, dexamethasone, induction treatment, autologous stem-cell transplantation, maintenance treatment, phase 2, trial ,Multiple myeloma ,carfilzomib ,trial ,induction treatment ,Oncology ,Oligopeptide ,newly diagnosed ,Autologous ,Human ,medicine.drug ,medicine.medical_specialty ,Prognosi ,autologous stem-cell transplantation ,Antibodies ,Follow-Up Studie ,Internal medicine ,Autologous transplantation ,Transplantation ,Antineoplastic Combined Chemotherapy Protocol ,maintenance treatment ,business.industry ,medicine.disease ,Settore MED/15 ,Carfilzomib ,chemistry ,phase 2 ,business - Abstract
Background: Bortezomib-based induction followed by high-dose melphalan (200 mg/m2) and autologous stem-cell transplantation (MEL200-ASCT) and maintenance treatment with lenalidomide alone is the current standard of care for young and fit patients with newly diagnosed multiple myeloma. We aimed to evaluate the efficacy and safety of different carfilzomib-based induction and consolidation approaches with or without transplantation and of maintenance treatment with carfilzomib plus lenalidomide versus lenalidomide alone in newly diagnosed multiple myeloma. Methods: UNITO-MM-01/FORTE was a randomised, open-label, phase 2 trial done in 42 Italian academic and community practice centres. We enrolled transplant-eligible patients with newly diagnosed multiple myeloma aged 65 years or younger with a Karnofsky Performance Status of 60% or higher. Patients were stratified according to International Staging System stage (I vs II/III) and age (
- Published
- 2021