Patients were required to have bone marrow plasma cells 10% or greater and measurable disease defined as serum monoclonal protein level greater than 10 g/L, urine monoclonal protein level greater than or equal to 200 mg/24 hours, or measurable soft tissue plasmacytoma that had not been radiated. Patients were eligible to enter the study if they had previously untreated symptomatic multiple myeloma. Informed consent was provided according to the Declaration of Helsinki. The goal of this phase 2 clinical trial was to determine the response rate and toxicity of Rev/Dex in patients with previously untreated, newly diagnosed multiple myeloma. Thus, lenalidomide (Rev)/Dex may be a safer and more effective alternative to Thal/Dex in newly diagnosed myeloma. 15, 17, 18 Responses were observed even in patients in whom thalidomide treatment had previously failed. 15, 16 It has also shown significant activity in relapsed and refractory myeloma alone and in combination with dexamethasone, with fewer nonhematologic side effects compared with thalidomide. Lenalidomide (CC-5013) is an analog of thalidomide that has demonstrated significantly more potent preclinical activity compared with thalidomide. 14 However, grade III or greater nonhematologic toxicities were significantly higher with Thal/Dex compared with dexamethasone alone, 68% versus 43%, respectively. 12, 13 In a recent randomized trial conducted by the Eastern Cooperative Oncology Group (ECOG), the response rate with Thal/Dex was significantly higher compared with dexamethasone alone, 58% versus 42%, respectively ( P =. 9 - 12 Response rates with Thal/Dex range between 64% and 76%, which are comparable to or better than those obtained with VAD. 8 Recently the combination of thalidomide plus dexamethasone (Thal/Dex) has emerged as an alternative to VAD in newly diagnosed myeloma based on three phase 2 clinical trials and a case-control study. 2, 6, 7 However, VAD had several disadvantages, including the need for an intravenous indwelling catheter, which predisposes patients to catheter-related sepsis and thrombosis most of the activity of VAD was from the high-dose dexamethasone component. Vincristine, doxorubicin, and dexamethasone (VAD) was typically used as pretransplantation induction therapy for patients who were considered candidates for stem-cell transplantation. 4, 5 Patients eligible for stem-cell transplantation should avoid alkylator-based induction therapy to enable an adequate and safe stem-cell harvest early in the disease course. Recently, autologous stem cell transplantation has been shown to be effective in the treatment of multiple myeloma in 2 randomized clinical trials. 3 Response rates with this therapy are approximately 50%, and median survival is approximately 3 years. 1, 2 For many years, melphalan and prednisone had remained the standard therapy for this disease. ![]() Multiple myeloma is a malignant plasma-cell proliferative disorder that accounts for over 11 000 deaths each year in the United States. Rev/Dex is a highly active regimen with manageable side effects in the treatment of newly diagnosed myeloma. Fortyseven percent of patients experienced grade III or higher nonhematologic toxicity, most commonly fatigue (15%), muscle weakness (6%), anxiety (6%), pneumonitis (6%), and rash (6%). ![]() ![]() Of the 3 remaining patients not achieving an objective response, 2 had minor response (MR) and one had stable disease. Thirty-one of 34 patients achieved an objective response, including 2 (6%) achieving complete response (CR) and 11 (32%) meeting criteria for both very good partial response and near complete response, resulting in an overall objective response rate of 91%. Objective response was defined as a decrease in serum monoclonal protein level by 50% or greater and a decrease in urine M protein level by at least 90% or to a level less than 200 mg/24 hours, confirmed by 2 consecutive determinations at least 4 weeks apart. Dexamethasone was given orally 40 mg daily on days 1 to 4, 9 to 12, and 17 to 20 of each cycle. Lenalidomide was given orally 25 mg daily on days 1 to 21 of a 28-day cycle. We report the results of a phase 2 trial using lenalidomide plus dexamethasone (Rev/Dex) as initial therapy for myeloma.
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