A Prospective Single-Arm Study of Melphalan, Prednisolone and Lenalidomide (MPL) as First Line Treatment in Elderly Patients with Multiple Myeloma - An Institutional Study

Abstract

Introduction  Multiple myeloma in the elderly population is rising in India. Such frail transplant-ineligible patients are less frequently included in clinical trials. Moreover, novel agents are not accessible to everyone. Melphalan-based chemotherapy regimens are frequently used in elderly myeloma patients. Our study revisited the role of melphalan, prednisone, and lenalidomide (MPL) as front-line therapy in this subgroup of patients. Objective  The aim of this study was to determine the response, tolerance, and outcome of MPL in elderly patients with newly diagnosed multiple myeloma. Materials and Methods  This prospective study was conducted at the Department of Medical Oncology at a tertiary cancer center during January 2012 to September 2013. Newly diagnosed patients with multiple myeloma >60 years who were transplant ineligible formed the study subjects. Eligible patients received oral melphalan 0.18 mg/kg from D1 to 4, prednisone 2 mg/kg from D1 to 4, and lenalidomide 10 mg from D1 to 21 q28 days. Patients who achieved complete response/very good partial response (CR/VGPR) after 6 cycles of MPL received maintenance with lenalidomide 10 mg from D1 to 21 q28 days (MPL-L) until progression or 1 year whichever was earlier. Quality of life was assessed using the Eq. 5D questionnaire. Results  Out of 46 patients, 25 were males and 21 were females. Median age was 67 years (range: 60-83 years). Majority had immunoglobulin G myeloma, followed by immunoglobulin A subtype. The median quality of life score at baseline was 50 (range: 30-70). Forty patients completed six cycles of MPL. The main toxicity was grade 1 to 2 hematological. There were no treatment-related deaths. Twenty-two (55%) achieved CR, 5 (13%) achieved VGPR, 4 (10%) achieved partial response, 6 (15%) achieved stable disease, and 3 (7%) had progressive disease. Twenty-seven patients received lenalidomide maintenance. At a median follow-up of 55 months, the 2- and 5-year progression-free survival was 60 and 18%, respectively. The overall survival at 2 and 5 years were 80 and 53%, respectively. The median number of subsequent lines of treatment was 2 (range: 1-4). The quality of life was improved and preserved in all study subjects. At 8 years, three patients had second malignant neoplasms and seven are alive. Conclusion  MPL-L is a well-tolerated and effective regimen in elderly myeloma with good overall response rates.