Initial Cytoreductive Treatment with Thalidomide Plus Bolus Vincristine/Doxorubicin and Reduced Dexamethasone (T-bVAd) Followed by Autologous Stem Cell Transplantation (ASCT) for Multiple Myeloma.

High-dose chemotherapy supported by autologous stem cell transplantation (ASCT) after the combined chemotherapy with vincristine, doxorubicin and dexamethasone (VAD) is an effective therapy for newly diagnosed, multiple myeloma. Bolus vincristine/doxorubicin intravenous administration as an outpatient route is convenient and has acceptable efficacy and toxicity. Thalidomide has recently shown significant antimyeloma activity. We studied the efficacy and toxicity of the combination of bolus vincristine/doxorubicin and reduced-dose of dexamethaxone with thalidomide (T-bVAd), administered on an outpatient basis in previously untreated multiple myeloma. From August 2005 to December 2006, 26 patients were enrolled in a prospective study. All patients received T-bVAd, which consisted of vincristine 0.4 mg intravenously i.v., doxorubicin 9 mg/m² i.v. administered as single bolus dose on days 1 to 4, and dexamethasone 20 mg per os daily for 4 days. Dexamethasone was also given on days 8 to 11, 15 to18 of the each cycle of treatment. The regimen was administered every 4 weeks for four courses. Thalidomide was given daily at a dose of 200 mg at bedtime. Response to treatment was evaluated after each cycle of treatment. After achieving response, the patients were allowed to proceed to high-dose chemotherapy with ASCT. On an intention-to-treat basis, 23 of the 26 patients (88.4%) responded to treatment. Sixteen patients (61.5%) achieved complete and seven (26.9%) partial response. Only three (11.6%) were rated as non-responders. Grade 3 or 4 toxicities consisted of neutropenia (9%), febrile neutropenia (6%), thrombocytopenia (4%) without significant nonhematologic events. Of the 23 patients who showed response, 9 proceeded to single ASCT and 7 tandem ASCT. Median event-free survival and median overall survival were not reached yet. As an induction therapy, T-bVAd administered as an outpatient regimen, seems to be efficient and well tolerated.