Real-World Study Demonstrates Effectiveness of Multiple Myeloma Combination Therapy


In a recent study, a combination therapy for the treatment of relapsed or refractory multiple myeloma proved to be as beneficial in routine clinical practice as it did in clinical trials used to support its approval.

Lenalidomide has demonstrated significant clinical activity against relapsed and refractory multiple. The phase III trials MM-009 and MM-010 have been used as supporting evidence for the US Food and Drug Administration approval of lenalidomide plus dexamethasone to treat patients with multiple myeloma who have received at least one prior therapy. Additionally, lenalidomide monotherapy is approved in the first-line setting for patients with multiple myeloma.

A group of German researchers at the Agaplesion Bethanien Hospital analyzed the effects of lenalidomide plus dexamethasone in 98 patients who were treated in routine clinical practice. Patients in the non-interventional study had a median age of 71 years, which was higher than the median ages of the phase III trials (64 and 63 years, respectively). A total of 47 patients in the non-interventional study received the combination therapy in the second-line setting, while 51 patients received it as a third-line or higher therapy.

The primary endpoint of the study was overall median time to progression. Results of the study will be published in Leukemia Research (May 2018;68:90-97).

Kaplan-Meier estimations for overall median time to progression was 12.0 months – 13.9 months for patients receiving second-line therapy and 10.3 months for those receiving third-line or higher therapy.

Among the total patient population, 60.2% responded to therapy, with a median overall survival (OS) of 24.3 months. However, median OS was longer (35.5 months) in patients who had received only one prior therapy; those who received two or more prior therapies had a median OS of 21.1 months.


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Treatment discontinuation occurred in cases of tumor progression (37.8%), remission (12.2%), toxicity (12.2%), or death (12.2%). Common adverse events were anemia, low blood platelets, and low white blood cell counts, all of which were comparable to the phase III clinical trials, researchers noted.

Furthermore, disease progression was observed in 34% of patients, which is likely due to the higher age of patients in the non-intervention trial compared with in the registration trials.

In their concluding remarks, researchers wrote that the combination of lenalidomide plus dexamethasone administered to patients with relapsed or refractory multiple myeloma in routine clinical practice shows similar effectiveness and safety as demonstrated in clinical trials.—Zachary Bessette