ASCO 2014: Romidepsin Plus Lenalidomide is Well Tolerated for Patients with Relapsed Lymphoma and Myeloma


By Jia Ruan, MD, PhD

At a poster session of the 2014 ASCO meeting, results of a phase I trial were presented from an ongoing, multi-center, phase I/II study testing the combination of romidepsin and lenalidomide in patients with relapsed lymphoma and myeloma. Although romidepsin and lenalidomide have both been individually approved by the FDA for the treatment of lymphoma and multiple myeloma, the combination represents a novel experimental development, based on potentially synergistic mechanism of action, and non-overlapping toxicity of the two biologic agents.

The phase I portion of the trial evaluated toxicity, maximum tolerated dose, and clinical activity of the romidepsin and lenalidomide combination. Romidepsin was given intravenously on days 1, 8, and 15 and lenalidomide was given orally on days 1-21 of a 28-day cycle. From the 13 evaluable patient responses, there was an overall response rate of 54%, complete response rate of 15%, and partial response of 39%.

From these early results the investigators concluded that the combination of romidepsin and lenalidomide is well tolerated and lacks any unexpected toxicity. Responses were consistent across multiple lymphoma subtypes, and the upcoming disease specific phase II cohorts will include B-cell lymphomas, T-cell lymphomas, and multiple myeloma.


Lunning, MA. Ruan, J. Nair, S. (2014). A phase I/II trial of the combination of romidepsin and lenalidomide in patients with relapsed/refractory lymphoma and myeloma: Phase I results. [Abstract]. J Clin Oncol, 32:5s, (suppl. abstract 8582)

Author: lymphomaprogram

Located on the Upper East Side of New York City, the Lymphoma Program at Weill Cornell Medical College/NewYork Presbyterian Hospital is internationally recognized for our efforts to enable patients with non-Hodgkin lymphoma, Hodgkin disease and related disorders to have the best possible clinical outcome, including cure when possible.

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