In a nutshell
This study examined whether lenalidomide (Revlimid) is effective as a maintenance therapy after first-line treatment for multiple myeloma. Researchers concluded that lenalidomide significantly delayed disease progression.
Some background
High-dose chemotherapy followed by stem cell transplantation is a standard treatment for newly diagnosed multiple myeloma. However, the average duration that patients remain relapse-free after transplantation is less than 3 years. This is because high-dose chemotherapy is unlikely to be able to eradicate all myeloma cells. Maintenance therapy after transplantation can reduce the risk of relapse. Lenalidomide is a type of immunotherapy that is effective in treating newly diagnosed or relapsed myeloma. It may also be suitable as a maintenance therapy for multiple myeloma after transplantation.
Methods & findings
The aim of this study was to assess the effectiveness of lenalidomide as a maintenance therapy for multiple myeloma.
614 patients less than age 65 were included. Patients had multiple myeloma that was not progressing after first-line treatment with high-dose chemotherapy and stem cell transplantation. Patients were randomly assigned to receive maintenance therapy with either lenalidomide or placebo (control drug with no active effect).
Patients were followed for an average of 30 months. 104 patients in the lenalidomide group and 160 patients in the placebo group showed disease progression during this period. The average time to progression was 41 months among patients receiving lenalidomide. This was significantly longer than for patients in the placebo group (23 months).
The probability of being progression free at 3 years was 59% for patients receiving lenalidomide. This was significantly greater compared to placebo (35%) and unaffected by age, gender, disease stage, or previous treatment regimens. The time to a treatment-related event (such as progression or death) was also significantly improved with lenalidomide (average 40 months) compared to placebo (average 23 months).
3-year overall survival rate (proportion who have not died from any cause since treatment) was similar for those treated with lenalidomide (80%) and those receiving placebo (84%). More than 70% of patients in both groups were alive at 4 years.
The incidences of severe peripheral neuropathy (damaged nerves) was similar in the two groups. Blood clots were reported more frequently in the lenalidomide group (6%) than in the placebo group (2%), as were other severe blood-related side effects.
The bottom line
Researchers concluded that maintenance therapy with lenalidomide significantly delayed disease progression among patients with multiple myeloma who underwent stem cell transplantation.
The fine print
Further studies that compare lenalidomide to other types of maintenance therapy are needed to confirm its effectiveness.
Published By :
The New England Journal of Medicine
Date :
May 10, 2012