Lenalidomide, melphalan, and prednisone, followed by lenalidomide maintenance, improves health-related quality of life in newly diagnosed multiple myeloma patients aged 65 years or older: results of a randomized phase III trial

Abstract

The MM-015 trial assessed the effect of lenalidomide-based therapy on health-related quality of life. Patients (n=459) with newly diagnosed multiple myeloma aged 65 years or over were randomized 1:1:1 to nine 4-week cycles of lenalidomide, melphalan, and prednisone, followed by lenalidomide maintenance; or lenalidomide, melphalan, and prednisone, or melphalan and prednisone, with no maintenance therapy. Patients completed health-related quality of life questionnaires at baseline, after every third treatment cycle, and at treatment end. Health-related quality of life improved in all treatment groups during induction therapy. Patients receiving lenalidomide maintenance had the most pronounced improvements, Global Health Status/Quality of Life (P<0.05), Physical Functioning (P<0.01), and Side Effects of Treatment (P<0.05) out of 6 pre-selected health-related quality of life domains. More patients receiving lenalidomide maintenance achieved minimal important differences (P<0.05 for Physical Functioning). Therefore, lenalidomide, melphalan, and prednisone, followed by lenalidomide maintenance, improves health-related quality of life in patients with newly diagnosed multiple myeloma. (Clinicaltrials.gov identifier NCT00405756).

Figure 1.

EORTC QLQ-C30 and QLQ-MY20 mean domain scores^a with standard error bars by study arm^b during both induction and maintenance phases. ^aAn increase in Global QoL and Physical Functioning scores represents an improvement in HRQoL, while the reverse applies to the other domain scores. Data during the induction phase were previously displayed as pooled score averages from the MPR-R and MPR arms, but are now presented for each arm (see Table 1). ^bConnecting lines between separate time points are included for visualization purposes: the numbers of patients at each assessment change over time. MP: melphalan and prednisone; MPR: melphalan, prednisone, and lenalidomide; MPR-R: melphalan, prednisone, and lenalidomide, followed by lenalidomide maintenance therapy.