The Phase II study, conducted at the Cleveland Clinic Myeloma Research Program of the Taussig Cancer Center, investigated the safety, tolerability and efficacy of the DVd combination regimen in 33 patients with newly-diagnosed multiple myeloma. In the study, patients received at least six cycles of the DVd regimen. During each cycle, patients were administered intravenous (IV) DOXIL (40 mg/m2) and vincristine (2 mg) on the first day, and oral or intravenous dexamethasone (40 mg/day) for four days. This treatment regimen was repeated every four weeks.
Eighty-eight percent (29 patients) responded to treatment with the DVd regimen. Of these patients, four (12%) achieved a complete response, defined as complete disappearance of myeloma protein from the serum and urine by immune fixation, a bone marrow biopsy demonstrating less than 3% plasma cells, the absence of monoclonal plasma cells by immune staining of the bone marrow on two occasions at least four weeks apart, and no evidence of progressive disease by any other parameters. Eighteen patients (55%) had a major response, defined as a 50 percent or greater decrease of myeloma protein from the serum and urine, while seven patients (21%) had a minor response, defined as a decrease in bone pain, an improvement of performance status by one grade, and a reduction in serum myeloma protein of 25 percent or greater. The median time to progression in the study was 23.1 months with two-year and three-year progression-free survival rat