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/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.

Keywords:

• Multiple myeloma
• lenalidomide
• bendamustine
• clinical trial

Acknowledgements

The authors would like to thank the patients for their participation in this study. We would like to thank Dr. Anna Fedina and all the collaborators of the Fondazione Italiana Linfomi (FIL) for contributing in the data collection and analysis.

Potential conflict of interest

Disclosure forms provided by the authors are available with the full text of this article at http://www.w3.org/10.1080/10428194.2016.1205741.

Funding

The study was supported in part by the Associazione Angela Serra per la Ricerca sul Cancro, Modena, Italy and by research funding from Celgene, Summit, NJ; USA. Both the investigational drugs tested in the study were kindly provided: lenalidomide by Celgene, and bendamustine by Mundipharma.