Celgene Corporation presented the data evaluating clinical results on the treatment of newly diagnosed multiple myeloma patients with an oral combination therapy consisting of melphalan, prednisone and thalidomide at the American Society of Clinical Oncology meetings (ASCO) in New Orleans.
This open-label phase II study reported data on the clinical use of the combination melphalan, prednisone and thalidomide (MPT) in newly diagnosed multiple myeloma patients. The study was lead by A. Palumbo from the Italian Multiple Myeloma Study Group in Turino, Italy. After treatment with MPT, partial responses defined as myeloma protein reduction of greater than 50 per cent were observed in 93 per cent of patients.
Complete remissions, defined as disappearance of monoclonal protein and negative immunofixation, were observed in 26 per cent of patients, and near complete remissions, defined as disappearance of monoclonal protein and positive irnmunofixation, were seen in 19 per cent of patients. Additionally, responses with myeloma protein reduction 90-99 per cent were observed in 12 per cent of patients. The time required to obtain the maximum response was 4 months in 88 per cent of patients.
"The clinical data from this phase II trial reported clinical outcomes that MPT induced a higher response rate than any other conventional chemotherapy programme and that the complete response rate was similar to those observed after transplant," said Jerome B. Zeldis, chief medical officer of Celgene Corporation. "While the study determined that MPT increases the incidence of deep vein thrombosis and infectious, these adverse events should be clinically addressable by prophylactic anti-coagulation and antibiotics," said Jerome. "A regulatory submission of Thalomid in the treatment of multiple myeloma is presently pending FDA review," he added.
Thalidomide increased the hematologic toxicity induced by melphalan and prednisone. Grade 3-4 WHO neutropenia was observed in 14 per cent of patients and constipation occurred in 28 per cent of patients while neurological toxicity was recorded in 38 per cent of patients. The major acute adverse events were infections (26 per cent) and deep-vein thrombosis (19 per cent). One patient died from septicemia, and one from pulmonary thromboembolism. Thalidomide discontinuation was required in 36% of patients due to thromboembolic event, infection, constipation and hematologic toxicity.
Thalomid (thalidomide), manufactured by Celgene Corporation, received US FDA clearance on July 16, 1998 for the acute treatment of cutaneous manifestations of moderate to severe erythema nodosum leprosum (ENL) and as maintenance therapy for prevention and suppression of the cutaneous manifestations of ENL recurrence.
Multiple myeloma (also known as myeloma or plasma cell myeloma) is a cancer of the blood in which malignant plasma cells are overproduced in the bone marrow. It is the second most common blood cancer in the United States affecting approximately 50,000 people. About 14,600 new cases of multiple myeloma are diagnosed each year and close to 11,000 Americans are expected to die of multiple myeloma in 2004.