ASCO2015: A phase I/II Trial of the Combination of Romidepsin and Lenalidomide in Patients with Relapsed/Refractory Lymphoma and Myeloma: Activity in T-cell Lymphoma.

Picture2By Dr. Jia Ruan 

Romidepsin, a histone deacetylase inhibitor, and lenalidomide, an immunomodulatory agent, have previously shown efficacy and a lack of cumulative toxicity in the treatment of patients with relapsed/refractory lymphoma and myeloma. Results from phase I of this trial were previously reported in ASCO 2014. The maximum tolerated dose in cycle 1 for romidepsin was 14 mg/mIV on days 1, 8, and 15, while lenalidomide was 25 mg oral on days 1-21 of a 28-day cycle. In this trial patients were treated to progression or intolerance.  Results of patients with t-cell lymphoma were reported at the 2015 ASCO meeting.

21 patients (10 CTCL, 11 PTCL) with a median age of 64 were enrolled in this trial. 15 of these patients were treated at the maximum tolerated dose. 19 of these patients were evaluable for efficacy with an overall response rate of 53%. For patients the median time of response was 7.3 weeks, median event free survival was 15.5 weeks, and median overall survival was not reached. 10 out of 21 patients remained on therapy with 7 discontinued for disease progression, 3 for toxicity, and 1 for stem cell transplant. Side effects were generally expected and manageable.

Results from this study confirm that the romidepsin and lenalidomide combination has significant activity in relapsed and refractory T-cell lymphoma. This study demonstrated that novel biologic agent and combinations can be effective and well-tolerated treatment options for patients with T-cell lymphoma, who may be poor candidates for intensive therapy or have chemotherapy-resistant disease.

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)

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