Clinical Study Of New Therapy For Relapsed/refractory Multiple Myeloma

Objective:To investigate the efficacy and toxicity of bortezomib in combination with dexamethasone for the treatment of 18 patients with relapse/refractory multiple myeloma (MM) and to search the clinical and theoretical basis for the new treatment of relapsed /refractory MM. Methods:All of the 18 patients enrolled in our study were at least 18 years ofage, with relapsed/refractory MM. Patients were treated with bortezomib (1.3 mg/m~2) by intravenous bolus twice a week for 2 weeks (days 1,4,8 and 11), followed by an intravenous injection of dexamethasone 40mg on the same day and the day following each bortezomib dose (days 1,2,4,5,8,9,11 and 12) of a 21- day cycle. Blood routin test, cell morphology of bone narrow smear, immunoglobulin, serum protein electrophoresis, β 2-microglobulin and Bence Jones protein were tested both prior-treatment and post-treatment. Investigate the efficacy and adverse event, and compare them with conventional treatments. Results:Analysis of efficacy The median follow-up duration from the beginning of bortezomib treatment was 9(3 ～13) months. All patients were survival, and they have received 1~7 cycles of treatment. Clinical response was observed in 16 patients (88.9%), including 12 patients (66.7%) achieved near complete remission (nCR), 9 patients (50%) achieved nCR after the first cycle of treatment, 3 (16.7%) achieved partial remission (PR) and 1 (5.6%) achieved micro responded (MR). 2 (11.1%) had stable disease. The median time to a first response was 28 (21～56) days. Adverse event The most commonly adverse events of any grade in this study were fatigue (including fatigue, malaise and weakness), seen in 12 patients (66.7%), and thrombocytopenia (44.4%), peripheral neuropathy (including peripheral sensory neuropathy and peripheral neuropathy aggravated) (44.4%), varicella herpes zoster (22.2%), diarrhea (16.7%), general skin rash (5.6%). The most common grade 3 and 4 adverse eventswere thrombocytopenia (16.7%), peripheral neuropathy (11.1%), diarrhea(5.6%) and skin rash (5.6%).Conclusion:1. Bortezomib in combination with dexamethasone ,an effective treatment for patients with relapsed/refractory multiple myeloma, has been shown to provide significantly greater efficacy with less marrow cytotoxicity than conventional treatments.2. Bortezomib in combination with dexamethasone reached an even better response and a lower incidence of anaphylactic response. The drug-related adverse events have been shown to be generally predictable and manageable.3. Using prophylactic antiviral medication in patients of multiple myeloma treated with bortezomib in combination with high-dose dexamethasone can reduce the incidence of varicella herpes zoster.4. Bortezomib in combination with dexamethasone is an effective and safe treatment.