Bortezomib, pegylated-lyposomal-doxorubicin and dexamethasone (PAD) as induction therapy prior to reduced intensity autologous stem cell transplant (ASCT) followed by lenalidomide and prednisone (LP) as consolidation and lenalidomide alone as maintenance

Abstract

8518 Background: New agents have been introduced as induction treatment prior to ASCT and as consolidation or maintenance thereafter to improve complete response (CR) rates. In this study, we evaluate Bortezomib as induction preASCT, followed by consolidation/maintenance with Lenalidomide in elderly myeloma pts. Methods: Newly diagnosed MM pts aged 65–75 years were eligible. The induction included four 21-day PAD cycles (bortezomib1.3mg/m2 days 1,4,8,11, pegylated-liposomal-doxorubicin 30mg/m2 day 4 and dexamethasone 40mg days 1–4,8–11,15–18 for cycle 1 and days 1–4 for cycles 2–4). Cyclophosphamide (3g/m2) plus G-CSF was used to harvest stem-cells. Pts were then conditioned with tandem Melphalan 100mg/m2 and stem-cell support (MEL100). After ASCT pts received four 28-day LP cycles (Lenalidomide 25mg/day on days 1–21 plus Prednisone 50mg every other day) followed by Lenalidomide alone (10mg/day on days 1–21 every 28 days) as maintenance. Primary endpoints were safety (any Grade-3 non-hematologic toxicity<30%) and efficacy (near complete > response rate, nCR, >35%). According to Simon procedure, 100 pts were planned to be enrolled. Results: Ninety-four pts have been enrolled. After the 4 PAD cycles 95% of pts achieved at least partial response (PR), 60% at least very good partial response (VGPR), 23% at least nCR, and 13% CR. After tandem MEL100, 95% of pts showed PR, 80% at least VGPR, 60% at least nCR, and 33% CR. After LP consolidation regimen all patients achieved PR, 89% at least VGPR rate, 78% at least nCR, and 56% CR. During PAD, 25% of pts experienced grade3–4 hematologic toxicity, 17% grade3–4 peripheral neuropathy and 11% grade3–4 infections. During LP consolidation one DVT and one discontinuation due to prolonged anemia and thrombocytopenia were recorded. Conclusion: PAD as induction pre ASCT followed by LP as consolidation induced a high response rate with a 56% CR rate recorded at the end of a reduced intensity ASCT regimen for elderly patients. Updated results and molecular remission data will be presented at the meeting. Author Disclosure Employment or Leadership Consultant or Advisory Role Stock Ownership Honoraria Research Expert Testimony Other Remuneration Celgene, Johnson & Johnson