Revlimid Maintenance Following Stem Cell Transplant in Multiple Myeloma Patients Appears to Improve Overall Survival

Researchers at Buffalo, New York’s Roswell Park Cancer Institute (RPCI) have showed that maintenance lenalidomide (marketed as Revlimid) following autologous hematopoietic stem cell (HSC) transplant improves the overall survival of multiple myeloma patients.

The findings from the study “Lenalidomide (LEN) maintenance (MNTC) after high-dose melphalan and autologous stem cell transplant (ASCT) in multiple myeloma (MM): A meta-analysis (MA) of overall survival (OS)” were recently presented at the 2016 American Society of Clinical Oncology Annual Meeting in Chicago.

A number of studies had already shown that maintenance therapy with lenalidomide in multiple myeloma patients reduced the risk of disease progression. However, no definitive results regarding overall survival had been published.

Now, researchers performed a prospective meta-analysis of trials that used lenalidomide following HSC transplant in newly diagnosed multiple myeloma patients. Out of the 17 identified trials, only three conducted by the Intergroupe Francophone du Myélome (IFM), the Alliance for Clinical Trials in Oncology (CALGB), and Gruppo Italiano Malattie Ematologiche dell’Adulto (GIMEMA), met the inclusion criteria.

The three trials involved 1,209 patients who had been randomly assigned from 2005 to 2009 to receive 10 mg per day lenalidomide (Revlimid) on days 1 to 21 of 28 (GIMEMA) or 1 to 28 of 28 (CALGB and IFM) or a placebo following autologous HSC transplant. At a median follow-up of 6.6 months, 41 percent of patients (491 patients) had died.

Following HSC-transplant and lenalidomide maintenance, 55 percent of patients had achieved a complete response or a very good partial response. For the 605-subject lenalidomide group, median overall survival had not been reached compared to 86 months in the placebo group.

In fact, the results demonstrated that lenalidomide maintenance significantly prolonged patients’ overall survival post-HSC transplant. Compared with the placebo group, overall survival was higher in the lenalidomide group at five years (71 percent vs. 66 percent), six years (65 percent vs. 58 percent), and seven years (62 percent vs. 50 percent). Furthermore, the benefit in overall survival was consistent across subgroups.

“Lenalidomide maintenance following autologous stem cell transplant can now be considered a standard of care for people with multiple myeloma,” Dr. Philip McCarthy, M.D., senior author on the meta-analysis and principal investigator of the U.S. study, CALGB (Alliance) 100104, said in a press release. “The improvements over the last decade in terms of both survival and quality of life for patients with this disease are striking, and very encouraging.”

McCarthy is also director of Blood & Marrow Transplant at Roswell Park Cancer Institute.