TY - JOUR
T1 - 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
AU - Pozzi, Sacchi Samantha
AU - Gentile, Massimo
AU - Sacchi, Stefano
AU - Marcheselli, Raffaella
AU - Corso, Alessandro
AU - Cocito, Federica
AU - Musto, Pellegrino
AU - Guarini, Attilio
AU - Minoia, Carla
AU - Vincelli, Iolanda
AU - Ria, R.
AU - Rivolti, Elena
AU - Mele, G.
AU - Bari, Alessia
AU - Mazzone, C.
AU - Badiali, Stefania
AU - Marcheselli, Luigi
AU - Palumbo, A.
AU - Morabito, Fortunato
PY - 2016/7/12
Y1 - 2016/7/12
N2 - 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/m2 days 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.
AB - 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/m2 days 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.
KW - bendamustine
KW - clinical trial
KW - lenalidomide
KW - Multiple myeloma
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U2 - 10.1080/10428194.2016.1205741
DO - 10.1080/10428194.2016.1205741
M3 - Article
VL - 58
SP - 552
EP - 559
JO - Leukemia and Lymphoma
JF - Leukemia and Lymphoma
SN - 1042-8194
IS - 3
ER -