CHICAGO – Lenalidomide maintenance therapy significantly prolonged overall survival after autologous stem cell transplant in newly diagnosed multiple myeloma patients, including patients who had a complete response to ASCT, based on a meta-analysis presented at the annual meeting of the American Society of Clinical Oncology.
While several studies have indicated that lenalidomide maintenance reduces the risk of disease progression or death compared to a control group, none of the individual studies were powered to detect a significant improvement in overall survival, said Dr. Philip L. McCarthy, director of the Blood and Marrow Transplant Center at Roswell Park Cancer Institute, Buffalo, N.Y., who is a co-author of the meta-analysis and reported the results on behalf of Dr. Michel Attal of University Hospital, Toulouse, France.
The researchers found that three randomized controlled trials using lenalidomide post-ASCT (IFM 2005-02, CALGB 100104 [Alliance], GIMEMA RV-209) met the criteria of having patient-level data, a control arm, and primary efficacy data for newly-diagnosed patients with multiple myeloma.
After induction and single (82%) or tandem (18%) ASCT, 55% of patients in the meta-analysis had complete or very good partial responses.
From 2005 to 2009, 605 patients received lenalidomide either 10 mg/day on days 1-21 of a 28-day cycle (GIMEMA) or on days 1-28 of a 28-day cycle (IFM and CALGB); 604 patients were in a control group. With a median follow-up of 6.6 years, 491 patients (41%) had died.
Median overall survival was not reached in the lenolidamide group and was 86 months in the control group (HR = 0.74; 95% CI, 0.62-0.89; log-rank P = .001). Survival was longer in the lenolidamine group as compared to the control group at 5 years (71% vs 66%), 6 years (65% vs 58%), and 7 years (62% vs 50%), reported Dr. McCarthy.
Dr. McCarthy receives research funding from Celgene, the maker of Revlimid (lenalidomide); and is a consultant or advisor to and receives honoraria from Binding Site; Bristol-Myers Squibb; Celgene; Janssen; Karyopharm Therapeutics; and Sanofi. Dr. Attal had no disclosures.
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