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

Samantha Pozzi, Massimo Gentile, Stefano Sacchi, Raffaella Marcheselli, Alessandro Corso, Federica Cocito, Pellegrino Musto, Attilio Guarini, Carla Minoia, Iolanda Vincelli, Roberto Ria, Elena Rivolti, Giuseppe Mele, Alessia Bari, Carla Mazzone, Stefania Badiali, Luigi Marcheselli, Giuseppe Antonio Palumbo, Fortunato Morabito

Research output: Contribution to journalArticle

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/m(2) 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.

Original languageEnglish
Pages (from-to)552-559
Number of pages8
JournalLeukemia and Lymphoma
Volume58
Issue number3
DOIs
Publication statusPublished - Dec 6 2016

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Multiple Myeloma
Dexamethasone
Therapeutics
Maximum Tolerated Dose
Alkylating Agents
B-Lymphocytes
Fever
Bendamustine Hydrochloride
lenalidomide
Infection
Neoplasms

Keywords

  • Journal Article

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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. / Pozzi, Samantha; Gentile, Massimo; Sacchi, Stefano; Marcheselli, Raffaella; Corso, Alessandro; Cocito, Federica; Musto, Pellegrino; Guarini, Attilio; Minoia, Carla; Vincelli, Iolanda; Ria, Roberto; Rivolti, Elena; Mele, Giuseppe; Bari, Alessia; Mazzone, Carla; Badiali, Stefania; Marcheselli, Luigi; Palumbo, Giuseppe Antonio; Morabito, Fortunato.

In: Leukemia and Lymphoma, Vol. 58, No. 3, 06.12.2016, p. 552-559.

Research output: Contribution to journalArticle

Pozzi, S, Gentile, M, Sacchi, S, Marcheselli, R, Corso, A, Cocito, F, Musto, P, Guarini, A, Minoia, C, Vincelli, I, Ria, R, Rivolti, E, Mele, G, Bari, A, Mazzone, C, Badiali, S, Marcheselli, L, Palumbo, GA & Morabito, F 2016, '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', Leukemia and Lymphoma, vol. 58, no. 3, pp. 552-559. https://doi.org/10.1080/10428194.2016.1205741
Pozzi, Samantha ; Gentile, Massimo ; Sacchi, Stefano ; Marcheselli, Raffaella ; Corso, Alessandro ; Cocito, Federica ; Musto, Pellegrino ; Guarini, Attilio ; Minoia, Carla ; Vincelli, Iolanda ; Ria, Roberto ; Rivolti, Elena ; Mele, Giuseppe ; Bari, Alessia ; Mazzone, Carla ; Badiali, Stefania ; Marcheselli, Luigi ; Palumbo, Giuseppe Antonio ; Morabito, Fortunato. / 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. In: Leukemia and Lymphoma. 2016 ; Vol. 58, No. 3. pp. 552-559.
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AU - Marcheselli, Raffaella

AU - Corso, Alessandro

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AU - Guarini, Attilio

AU - Minoia, Carla

AU - Vincelli, Iolanda

AU - Ria, Roberto

AU - Rivolti, Elena

AU - Mele, Giuseppe

AU - Bari, Alessia

AU - Mazzone, Carla

AU - Badiali, Stefania

AU - Marcheselli, Luigi

AU - Palumbo, Giuseppe Antonio

AU - Morabito, Fortunato

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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/m(2) 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.

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