Newly diagnosed multiple myeloma patients who use Revlimid (lenalidomide) as a maintenance therapy after a stem cell transplant live significantly longer than those receiving a placebo or nothing, a meta-analysis shows.
The research deals with autologous stem cells, or those taken from a patient’s own body. Scientists refer to such transplants as ASCTs.
Researchers published the study, “Lenalidomide Maintenance After Autologous Stem-Cell Transplantation in Newly Diagnosed Multiple Myeloma: A Meta-Analysis,” in the Journal of Clinical Oncology.
The U.S. Food and Drug Administration has approved Revlimid as a maintenance therapy for multiple myeloma. Clinical trials have shown that it can prolong the time between a patient receiving a primary treatment such as a stem cell transplant and the cancer progressing — a measure scientists call progression-free survival.
While many studies have measured patients’ progression-free survival with Revlimid, none has focused on their overall survival. Part of the reason may be that assessing overall survival requires a larger patient population and longer follow-up periods.
Researchers decided to analyze the results of three randomized clinical trials to see if they could learn more about Revlimid patients’ overall survival. The studies were the CALGB 100104 trial (NCT00114101) in the United States, the IFM 05-2 trial in France, and the GIMEMA RV-MM-PI-209 trial (NCT00551928) in Italy.
The three covered 1,208 newly diagnosed myeloma patients, half of whom received Revlimid as a maintenance therapy after a stem cell transplant. The exact figures were 605 patients who received Revlimid after a transplant and 603 who received a placebo or nothing.
Patients’ median progression-free survival “was 52.8 months for the lenalidomide group and 23.5 months for the placebo or observation group [those whom doctors observed after receiving no maintenance therapy],” researchers wrote.
Median overall survival of those in the placebo or observation group was 86 months, researchers reported. They were unable to calculate median overall survival for the patients receiving Revlimid because many were still living. At the end of the follow-up period, however, the team figured that Revlimid patients’ overall survival was 25 percent longer than patients in the other group.
While those on placebo or observation were more likely to have their myeloma progress, or to die, those on Revlimid were more likely to develop another type of cancer before their myeloma progressed.
Overall, “this meta-analysis demonstrates a significant OS [overall survival] benefit and confirms the PFS benefit with lenalidomide maintenance after ASCT in patients with [newly diagnosed multiple myeloma] when compared with placebo or observation,” researchers wrote.
“Understanding the role of minimal residual disease detection and immune reconstitution after autologous HSCT [stem cell transplant], as well as developing early endpoints as surrogates for long-term outcomes, should allow us to develop clinical strategies to further improve OS,” the study concluded.