Efficacy and safety profile of long‐term exposure to lenalidomide in patients with recurrent multiple myeloma

Abstract

BACKGROUND: Lenalidomide in combination with dexamethasone (Len=Dex) is indicated for patients with recurrent=refractory multiple myeloma (RRMM) who were treated with 1 prior therapy until evidence of disease progression. The objective of the current study was to determine the efficacy and safety profile of long-term exposure to Len=Dex. METHODS: A total of 50 patients with RRMM who were treated with long-term Len for 2 years from 2 Intergroupe Francophone du My elome (IFM) centers (Lille and Nancy) were included in the current study. RESULTS: The median age of the patients was 58 years, with 30% of the patients aged > 65 years, 49% having an International Staging System stage of 2 and 3, 12% having severe renal insufficiency, and 8% demonstrating an adverse result on fluorescence in situ hybridization. Approximately 56% of the patients received treatment with Len=Dex for 3 years. The median duration of treatment with Len=Dex was 3 years (range, 2 years-7 years). The response rates for partial response or better and very good partial response or better for the overall cohort were 96% and 74%, respectively, which is similar to patients exposed to Len for 3 years. With a median follow-up of 4 years, 19 (38%) patients had stopped treatment with Len=Dex. The time to disease progression rate at 37 months was 78% and 91%, respectively, in patients exposed to Len for 2 years to < 3 years and for 3 years (P 5 025). The safety profile was manageable, similar to that of Len when administered for a shorter period of time; 16% of patients had grade 3 to 4 neutropenia, 6% had thrombopenia, 6% had anemia, and 20% experienced thromboembolic events, all of venous type. The annual incidence rate of second primary malignancy was 1.96% in the current series. CONCLUSIONS: The results of the current study confirmed that the Len=Dex combination is feasible for long-term use in patients with RRMM, with a significant benefit noted in terms of time to disease progression for prolonged treatment with Len=Dex. Cancer 2013;119:3680-6.

Venous Thromboembolism in Multiple Myeloma

“…69 A small retrospective study on 50 relapsed MM patients treated with lenalidomide and DEX longer than 2 years showed a 20% VTE rate in spite of antithrombotic prophylaxis. 70 In conclusion, the thrombotic risk associated with exposure to lenalidomide or lenalidomide/DEX persists over time with no decline in VTE rate during long exposure.…”

Multiple Myeloma and Thrombosis: Prophylaxis and Risk Prediction Tools

“…Thalidomide or lenalidomide (Len) monotherapy does not contribute significantly to the baseline VTE risk. It is reported to be around 3%-4% but can increase up to 26% with the addition of high dose dexamethasone or multi-agent chemotherapy or anthracyclines [39,40,48,[61][62][63][64]. The rates are also low with Len maintenance post-autologous stem cell transplant (ASCT) without thromboprophylaxis, and one group reported a 6% VTE rate during a median follow up of 45 months [65].…”

Prolonged Duration of Therapy Is Associated With Improved Survival in Patients Treated for Relapsed/Refractory Multiple Myeloma in Routine Clinical Care in the United States

“…These were based on subgroup analyses of large prospective trials in which treatment was given until progression or, alternatively, on small single-institution experiences. [8][9][10][11][12] In 1 study of 50 patients, those treated for > 3 years had a longer median TTP compared with those treated for 2 to 3 years, regardless of the response rate. 10 In another small retrospective study of 67 patients, OS and the overall response rate were significantly better for patients treated with lenalidomide and dexamethasone for > 12 months compared with patients who stopped treatment at < 12 months for reasons other than progression.…”