5mg, 10mg, 15mg or 25mg hard capsules
21 tablet pack
In combination with dexamethasone for the treatment of multiple myeloma patients who have received at least one prior therapy.
Click here for the full drug entry on MIMS online.
Lenalidomide is an immunomodulating drug that also possesses anti-neoplastic and antiangiogenic properties.
Revlimid is structurally related to thalidomide and therefore, as part of the Revlimid Risk Minimisation Plan, only pharmacies authorised by Celgene can dispense Revlimid.
The safety and efficacy of lenalidomide has been assessed in two phase III trials (MM-009 and MM-010)1 in patients with multiple myeloma. In both trials, patients who had already received at least one prior therapy were randomised to receive lenalidomide plus dexamethasone (Len/Dex) (n=353), or placebo plus dexamethasone (Dex) (n=351).
Patients in the Len/Dex group took lenalidomide 25mg once daily on days 1—21 and a matching placebo once daily on days 22—28 of each 28-day cycle. Patients in the Dex group took placebo once daily throughout the 28-day cycle. In both groups, patients took dexamethasone 40mg once daily for four days during three weeks of each cycle. After four cycles the frequency of dexamethasone was reduced.
The primary endpoint was time to progression (TTP), and after interim analyses of both studies, the Len/Dex group had a significantly greater TTP compared with the Dex group. Complete and overall response rates in the Len/Dex group were also significantly higher.
Data presented late in 20062 showed the median TTP in MM-009 was 4.7 months for Dex versus 11.1 months for Len/Dex . In MM-010, median TTP was 4.7 versus 11.3 months, respectively.
1. Dimopoulous M Weber D, Chen C et al. Abstract # 0402. Presented at 10th Conference European Hematology Association, Sweden.
2. Weber D, Wang M, Chen C et al. Abstract # 3547. Blood 2006: 108 (11).
Further information: Celgene 08448 010045