Bortezomib/Melphalan/Prednisolone Induction Therapy Followed by Lenalidomide/Dexamethasone Consolidation and Lenalidomide Maintenance in Transplant-Ineligible Patients with Newly Diagnosed MM
Ishida and colleagues reported interim results of a phase 2 trial that evaluated reduced- intensity bortezomib/melphalan/prednisolone (VMP) followed by lenalidomide/low-dose dexamethasone (Rd) consolidation therapy and lenalidomide maintenance therapy to improve outcomes of transplant-ineligible patients with newly diagnosed multiple myeloma (MM). In this Japanese trial, 82 patients with newly diagnosed MM received 5 cycles of VMP (bortezomib 1.3 mg/m2 intravenously or subcutaneously weekly; oral melphalan 6 mg/m2; and prednisone 60 mg/m2 once daily on days 1-4 of a 35-day cycle), followed by 6 cycles of Rd (lenalidomide 25 mg daily on days 1-21; dexamethasone 40 mg weekly of a 28-day cycle), and lenalidomide maintenance therapy (10 mg daily on days 1-21 of a 28-day cycle).1
Median age of the study population was 73.5 years; 16.3% of 80 evaluated patients had t(4;14), 10% had del 17p, and 41.3% had +1q21 cytogenetic abnormalities. After 5 cycles of VMP induction therapy, the best response of ?partial response (PR) was 68%, including complete response (CR) in 6% of patients, stringent CR (sCR) in 5%, very good partial response (VGPR) in 20%, and PR in 37% of patients. The best response rate (?PR) after VMP induction and 6 cycles of Rd consolidation therapy was 90%, including sCR in 6%, CR in 16%, VGPR in 39%, and PR in 29% of patients. In the subgroup of patients with unfavorable cytogenetic characteristics (del 17p or t[4;14]), 58% achieved ?VGPR and 90% achieved ?PR. Most common grade ?3 adverse events experienced by patients during VMP induction therapy were anemia (30%), neutropenia (16%), thrombocytopenia (5%), and gastrointestinal toxicity (6%). Overall, the authors concluded that reduced-intensity (5 cycles) VMP was safe and effective in transplant-ineligible patients with newly diagnosed MM, including those with high-risk cytogenetics.
- Ishida T, et al. ASH 2015. Abstract 3043.