Abstract

In Turkey, lenalidomide plus dexamethasone (RD) has been used to treat relapsed/refractory multiple myeloma (RRMM) since 2010. This retrospective, single-center study evaluated the efficacy and tolerability of RD in patients with RRMM between October 2010 and June 2016. Patients’ records were reviewed, and overall (OS) and progression-free survival (PFS) were assessed. One hundred and twenty patients (71 males; 59.2%) were included in the study. The median number of prior lines of treatment was one (1–4); 72 patients (60.0%) received RD as second-line therapy and 51 patients (42.5%) had previously undergone autologous stem cell transplantation (ASCT). The overall response rate was 72.5%, with 19% of these patients achieving a complete response. The median length of follow-up and duration of response to RD was 14 months and 19 months, respectively. Median OS and PFS were 32 and 21 months, respectively. Prior ASCT, an overall response, and treatment with RD for >12 cycles were identified as independent prognostic factors for OS and PFS. Adverse events (AEs) occurred in 69 (57.5%) and 14 patients (11.7%) discontinued treatment due to AEs. We found RD to be safe, well tolerated, and effective in RRMM in everyday clinical practice in Turkey.

Highlights

  • Multiple myeloma (MM) is a clonal plasma cell disorder that, in symptomatic patients, is characterized by bone lesions, renal impairment, anemia, and hypercalcemia (1)

  • Prior autologous stem cell transplantation (ASCT), an overall response, and treatment with RD for >12 cycles were identified as independent prognostic factors for overall survival (OS) and progression-free survival (PFS)

  • The following data were collected from the medical records of patients with refractory multiple myeloma (RRMM) treated with RD at the Ege University Medical Faculty Hospital in İzmir, Turkey, between October 2010 and June 2016: age at diagnosis and at initiation of RD; sex; date of diagnosis; cytogenetic characteristics; disease stage; prior treatments, including prior transplantation; date of initiation of RD; lenalidomide dose reductions; treatment outcome; any adverse events (AEs); and the date of initiation of any subsequent treatment

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Summary

Introduction

Multiple myeloma (MM) is a clonal plasma cell disorder that, in symptomatic patients, is characterized by bone lesions, renal impairment, anemia, and hypercalcemia (1). Over the past [15–20] years, overall survival (OS) in MM has increased significantly with the introduction of novel agents such as proteasome inhibitors and immunomodulatory drugs (2). Improvement in OS was seen in patients aged >65 years, as well as in younger patients. The immunomodulatory agent lenalidomide was evaluated in two large, multicenter, randomized, placebocontrolled phase III trials: MM-009 in North America and MM-010 in Europe, Australia, and Israel (4,5). These trials demonstrated the superiority of lenalidomide plus dexamethasone (RD) versus dexamethasone alone in patients with relapsed/refractory multiple myeloma (RRMM), with the overall response rate (ORR) and OS being significantly increased with RD. On the basis of the results of MM-009 and -010, lenalidomide was approved by the US Food and Drug Administration and the European Medicines Agency for the treatment of RRMM

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