NEJM publishes results from Celgene’s REVLIMID phase III studies on MM

May 11 2012

Celgene International Sàrl, a subsidiary of Celgene Corporation (NASDAQ: CELG), today announced that results from three phase III studies evaluating the use of continuous REVLIMID^® (lenalidomide) treatment in newly diagnosed multiple myeloma (MM) patients or maintenance treatment with lenalidomide following autologous stem cell transplant were published online in the May 10, 2012 edition of the New England Journal of Medicine. All three publications highlight the expanding body of clinical evidence supporting lenalidomide treatment in these areas.

Continuous Lenalidomide Therapy (non-transplant eligible population):

The first article highlights a Celgene-sponsored study of continuous lenalidomide treatment in elderly patients newly diagnosed with multiple myeloma.

Continuous Lenalidomide Treatment for Newly Diagnosed Multiple Myeloma (MM-015)

This double-blind, phase III, multicenter, randomized study conducted by Celgene compared melphalan-prednisone-lenalidomide induction followed by lenalidomide maintenance (MPR-R), with melphalan-prednisone-lenalidomide (MPR), or melphalan-prednisone (MP) followed by placebo in 459 patients aged ≥65 years with newly-diagnosed myeloma who were not eligible for autologous stem-cell transplant.

http://www.nejm.org/doi/full/10.1056/NEJMoa1112704

Post-transplant maintenance

The two additional articles published in the edition highlighted cooperative group studies that evaluated the use of lenalidomide maintenance following autologous stem cell transplant (ASCT).

In each of the studies, one funded by the National Cancer Institute and conducted by the Cancer and Leukemia Group B (CALGB) and one by the Intergroupe Francophone du Myelome (IFM), maintenance treatment with lenalidomide following ASCT resulted in delayed time to disease progression or death compared to placebo.

Lenalidomide after Stem-Cell Transplantation for Multiple Myeloma (CALGB 100104)

The phase III CALGB study assessed 460 newly-diagnosed patients who received either lenalidomide or placebo following ASCT until disease progression.

http://www.nejm.org/doi/full/10.1056/NEJMoa1114083

Lenalidomide Maintenance after Stem-Cell Transplantation for Multiple Myeloma (IFM 2005-02)

IFM 2005-02 is a phase III, placebo-controlled trial investigating the efficacy of lenalidomide maintenance after transplantation in 614 myeloma patients.

http://www.nejm.org/doi/full/10.1056/NEJMoa1114138