Source: DGNews  |  Posted 1 year ago

By Bruce Sylvester

CHICAGO -- June 7, 2010 -- Maintenance therapy with lenalidomide has slowed disease progression by 54% in patients with multiple myeloma who had already received high-dose chemotherapy and an autologous stem-cell transplant, according to findings reported here at the 2010 Annual Meeting of the American Society of Clinical Oncology (ASCO).

"If these results are confirmed in the final analysis, then it will suggest that maintenance therapy with lenalidomide can improve quality of life in patients with myeloma and delay the need for relapse therapy," explained lead investigator Michel Attal, PhD, Purpan Hospital, Toulouse, France, speaking here on June 6.

Final reporting of the data on progression-free survival and overall survival are expected in December 2010.

From July 2006 to August 2008, the investigators enrolled patients under 65 years of age with nonprogressive disease after a first-line autologous stem-cell transplantation had been performed (within the prior 6 months). Subjects were randomised to receive consolidation therapy with lenalidomide (25 mg/day, 21 days/month for 2 months) followed by maintenance therapy with either lenalidomide until relapse (10 to 15 mg/day, n = 307) or placebo (n = 307).

Patient characteristics in each group were similar.

In December 2009, with a median follow up of 24 months from randomisation, the researchers performed the first preplanned interim analysis.

The investigators reported that lenalidomide maintenance therapy significantly improved 3-year progression-free survival, with 68% of patients in the lenalidomide group showing no disease progression compared with 35% in the placebo group.

The researchers also reported that there was benefit from lenalidomide maintenance whether or not a patient had achieved a complete response after autologous stem-cell transplantation.

Two-year overall survival rates were similar, at 95% for both groups, and maintenance with lenalidomide was well tolerated.

Funding for this study was provided by the Intergroupe Francophone du Myelome.

[Presentation title: Lenalidomide Maintenance After Transplantation for Myeloma. Abstract 8018]