Abstract
8524 Background: Lenalidomide (Len) in combination with high-dose dexamethasone (Dex) is approved for previously treated patients (pts) with multiple myeloma (MM). This study determined the efficacy and safety of Len monotherapy in pts with relapsed/refractory MM. Methods: Len monotherapy (30 mg qd) was given to pts with relapsed/refractory MM in a single-arm, open-label multi-center study. Len was administered daily on days 1–21 every 28 days. Concomitant Dex was not permitted. No anticoagulation prophylaxis was recommended. Treatment was continued as tolerated until disease progression. Response was assessed every month using modified EBMT criteria and toxicity using NCI-CTCv3. Results: All 222 enrolled pts had received ≥2 prior anti-MM therapies, including bortezomib (43%), thalidomide (80%), and SCT (45%); 46% had ≥4 prior therapies with a mean time from diagnosis of 4 years. At database lock, 64 pts (29%) had received treatment for >9 months. For the intention-to-treat population (n=222), the overall response (OR: CR+PR) was 26%. An additional 66% of the pts experienced stable disease (SD). OR for the efficacy-evaluable population (n=184) was 32% and 68% experienced SD. By study completion, 151 pts (69%) had progressed with a median time-to-progression (TTP) of 5.4 months. Median progression-free survival (PFS) was 4.7 months, and median overall survival (OS) was 1.9 years with 41% of pts alive after 3 years. Median duration of response was 13 months (median FU: 14 months). The most common grade 3/4 lab toxicities were neutropenia (60%), thrombocytopenia (39%) and anemia (20%). Only 4% of pts developed febrile neutropenia and DVT; no grade 3/4 peripheral neuropathy was seen. Conclusions: The encouraging OR, duration of response, TTP, PFS, and OS seen in this study demonstrate that Len monotherapy at a dose of 30 mg once daily (3 wks on, 1 wk off) is effective, durable, and well tolerated steroid-sparing therapy for heavily pretreated pts with relapsed/refractory MM. Author Disclosure Employment or Leadership Consultant or Advisory Role Stock Ownership Honoraria Research Expert Testimony Other Remuneration Celgene Celgene, Millennium Celgene Celgene, Millennium Celgene
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