title: Bendamustine, Low-dose dexamethasone, and lenalidomide (BdL) for the treatment of patients with relapsed/refractory multiple myeloma confirms very promising results in a phase I/II study.
abstract: Lenalidomide and dexamethasone are an effective treatment for naïve and relapsed multiple myeloma (MM) patients. Bendamustine is a good option for B-cell malignancies showing only partial cross resistance with alkylating agents used in MM patients. Based on these considerations, we proposed a phase I/II study testing escalating doses of bendamustine and lenalidomide and fixed low doses of dexamethasone (BdL). Fifteen patients were enrolled in phase I study. Maximum tolerated dose was established at dose "level 0": bendamustine 40 mg/m2days 1,2; lenalidomide 10 mg days 1-21; d 40 mg days 1,8,15,22 every 28-day cycle, for six cycles. We enrolled 23 patients in the phase II study. BdL combination showed mainly hematological toxicities, fever and infections. Overall response rate was 47%. After median follow up of 22 months, median PFS was 10 months. Two-years OS rate was 65%. BdL combination confirmed to be a promising treatment for patients with relapsed/refractory MM.
authors.affiliation: a Department of Diagnostic, Clinical Medicine and Public Health Medicine , University of Modena and Reggio Emilia , Modena , Italy.
authors.forename: Samantha
authors.initials: S
authors.lastname: Pozzi
authors.affiliation: b Department of Hemato-Oncology , Cosenza Hospital , Cosenza , Italy.
authors.forename: Massimo
authors.initials: M
authors.lastname: Gentile
authors.affiliation: a Department of Diagnostic, Clinical Medicine and Public Health Medicine , University of Modena and Reggio Emilia , Modena , Italy.
authors.forename: Stefano
authors.initials: S
authors.lastname: Sacchi
authors.affiliation: a Department of Diagnostic, Clinical Medicine and Public Health Medicine , University of Modena and Reggio Emilia , Modena , Italy.
authors.forename: Raffaella
authors.initials: R
authors.lastname: Marcheselli
authors.affiliation: c Fondazione IRCCS Policlinico San Matteo , Pavia , Italy.
authors.forename: Alessandro
authors.initials: A
authors.lastname: Corso
authors.affiliation: c Fondazione IRCCS Policlinico San Matteo , Pavia , Italy.
authors.forename: Federica
authors.initials: F
authors.lastname: Cocito
authors.affiliation: d IRCCS Centro di Riferimento Oncologico della Basilicata , Italy.
authors.forename: Pellegrino
authors.initials: P
authors.lastname: Musto
authors.affiliation: e National Cancer Research Centre Istituto Tumori , Italy.
authors.forename: Attilio
authors.initials: A
authors.lastname: Guarini
authors.affiliation: e National Cancer Research Centre Istituto Tumori , Italy.
authors.forename: Carla
authors.initials: C
authors.lastname: Minoia
authors.affiliation: f Bianchi-Melacrino-Morelli Hospital , Reggio Calabria , Italy.
authors.forename: Iolanda
authors.initials: I
authors.lastname: Vincelli
authors.affiliation: g Internal Medicine and Clinical Oncology , University of Bari , Bari , Italy.
authors.forename: Roberto
authors.initials: R
authors.lastname: Ria
authors.affiliation: h Medical Oncology Unit , Azienda Ospedaliera Arcispedale Santa Maria Nuova, IRCCS , Reggio Emilia , Italy.
authors.forename: Elena
authors.initials: E
authors.lastname: Rivolti
authors.affiliation: i Haematology and BMT Unit , Antonio Perrino Hospital , Brindisi , Italy.
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Mele
authors.affiliation: a Department of Diagnostic, Clinical Medicine and Public Health Medicine , University of Modena and Reggio Emilia , Modena , Italy.
authors.forename: Alessia
authors.initials: A
authors.lastname: Bari
authors.affiliation: b Department of Hemato-Oncology , Cosenza Hospital , Cosenza , Italy.
authors.forename: Carla
authors.initials: C
authors.lastname: Mazzone
authors.affiliation: a Department of Diagnostic, Clinical Medicine and Public Health Medicine , University of Modena and Reggio Emilia , Modena , Italy.
authors.forename: Stefania
authors.initials: S
authors.lastname: Badiali
authors.affiliation: a Department of Diagnostic, Clinical Medicine and Public Health Medicine , University of Modena and Reggio Emilia , Modena , Italy.
authors.forename: Luigi
authors.initials: L
authors.lastname: Marcheselli
authors.affiliation: j Myeloma Unit, Division of Hematology , Azienda Ospedaliero-Universitaria Città della Salute, University of Turin , Turin , Italy.
authors.forename: Antonio
authors.initials: A
authors.lastname: Palumbo
authors.affiliation: b Department of Hemato-Oncology , Cosenza Hospital , Cosenza , Italy.
authors.forename: Fortunato
authors.initials: F
authors.lastname: Morabito
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D000069461:Bendamustine Hydrochloride / Q000008:administration & dosage; D015415:Biomarkers; D003907:Dexamethasone / Q000008:administration & dosage; D018450:Disease Progression; D019008:Drug Resistance, Neoplasm; D005260:Female; D006801:Humans; D000077269:Lenalidomide; D008297:Male; D020714:Maximum Tolerated Dose; D008875:Middle Aged; D009101:Multiple Myeloma / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology*; D009367:Neoplasm Staging; D012008:Recurrence; D019233:Retreatment; D016019:Survival Analysis; D013792:Thalidomide / Q000008:administration & dosage / Q000031:analogs & derivatives; D016896:Treatment Outcome
chemical_list: D015415:Biomarkers; D013792:Thalidomide; D003907:Dexamethasone; D000069461:Bendamustine Hydrochloride; D000077269:Lenalidomide
keywords: Multiple myeloma; bendamustine; clinical trial; lenalidomide