Lenalidomide (L) in Combination with Dexamethasone (D) Improves Survival and Time to Progression in Elderly Patients (pts) with Relapsed or Refractory (rel/ref) Multiple Myeloma (MM).

Abstract Introduction: Treatment of elderly pts (age >65 years) with rel/ref MM remains a challenge due to concurrent comorbid conditions and poor tolerability to chemotherapy limiting therapeutic options. Recently, 2 phase III randomized clinical trials (MM-090 and MM-010) demonstrated superiority of the LD combination over D alone in previously treated MM pts. We examined the clinical benefit of LD combination in elderly pts enrolled in these 2 clinical trials. Methods: This is a retrospective data analysis of pts enrolled on the MM-090 and MM-010. All elderly pts (>65 years) were identified and parameters of clinical outcome (overall response, OR; time to progression, TTP; overall survival, OS) recorded. To determine the clinical benefit of L in elderly pt population, we compared the group of elderly pts who received LD combination with those who received D + placebo as well as with the group of younger pts who received the LD combination in these studies. Results: Collectively, 704 pts were enrolled with 285 identified as elderly. In the elderly group, 146 pts were randomized to LD combination and 139 to D + placebo. There were no significant differences in baseline characteristics of these two groups. In the elderly group who received LD, median time from diagnosis was 3.3 yrs (range 0.5–14.7) and 77.4% had received ≥ 2 prior therapies (prior D and/or thalidomide in 69% and 32% respectively). Using the Blade criteria, the overall response (ORR) was significantly better in pts on combination treatment vs. D alone (58.9% vs. 20.9%; p<0.001). On an intent-to-treat analysis, the median time to progression (TTP; primary endpoint) for pts treated with D alone was 20 vs. 60 wks on combination (p<0.001) and the median overall survival was 79 wks and has not been reached (p=<0.001) in the combination group, respectively. We then compared the elderly pts with the younger pts who received LD combination. The ORR and median TTP was (58.9% vs. 60.9%) and (60 wks vs. 47.3 wks), respectively. The OS was 128 wks in the younger pts and is not reached in the elderly. Conclusion: L when combined with D improves ORR, prolongs TTP and OS in elderly pts with rel/ref MM and thus offers an important treatment option for this pt population. This clinical benefit of L achieved in the elderly is comparable to that in the younger pts and thus is irrespective of age of the pt treated. The availability of L as an oral formulation provides an added benefit in the management of elderly pts population.