James D. Hilger

A phase II study of a modified pegylated liposomal doxorubicin (PLD), bortezomib, and dexamethasone regimen for patients with previously untreated multiple myeloma (MM).

8134 Background: PLD and bortezomib (BORT) are FDA-approved for MM patients who have received one prior therapy. We have previously demonstrated in laboratory studies that lower doses of PLD administered more frequently are better tolerated than higher doses given less often. The combination of BORT and dexamethasone (DEX) is effective for previously untreated MM patients. Prior studies by our group have shown that intravenous administration of DEX 40 mg, BORT 1.0 mg/m2 and PLD 5 mg/m2 (DVD) on days 1, 4, 8, and 11 of a 28-day cycle is effective for relapsed/refractory MM patients and well tolerated. Methods: We conducted a single-arm multi-center phase II study for previously untreated MM patients to evaluate the DVD regimen. Patients were treated to a maximum response plus two additional cycles or completed a maximum of eight cycles of therapy without disease progression. Results: Thirty-five patients were enrolled with a median age of 65 years (range, 42-82 years). Thirty and 33 patients are currently ...