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)

ASCO Update: Lenalidomide + Rituximab Superior to Lenalidomide Alone in Relapsed Lymphoma

John Leonard, MD

At the recent meeting of the American Society of Clinical Oncology (ASCO), Dr. John Leonard, the director of the Weill Cornell Lymphoma Program, presented the results of the CALGB 50401 trial. The trial compared lenalidomide plus rituximab versus lenalidomide alone in 94 patients with previously treated follicular lymphoma.

Although significant side effects were similar in both treatment arms, the patients treated with the lenalidomide plus rituximab were more likely to respond to treatment (75% vs. 49%) and remain on treatment compared to lenalidomide alone. Based on these results, the investigators concluded that the lenalidomide-rituximab regimen should be considered as a platform for addition of new drugs in future studies.

Click here to read the published abstract.

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