PHASE II STUDY OF INTERLEUKIN 12 FOR PLATEAU PHASE MULTIPLE MYELOMA

这是一项II期、随机化、多机构合作组研究，旨在评价白细胞介素-12用于维持缓解的平台期骨髓瘤患者的毒性和疗效。 由于IL-12在小鼠中引起肿瘤抗性的功效，并且由于骨髓瘤的进展与Th 1和细胞毒性T细胞活性降低的相关性，IL-12在本试验的两个组中被给予处于平台期的骨髓瘤患者以帮助维持缓解。将评价IL-12增强对肺炎球菌和流感嗜血杆菌B疫苗应答的有效性。 还将监测IL-12在加强正常免疫球蛋白中的作用。

This is a Phase II, randomized, multi-institutional cooperative-group study designed to evaluate toxicity and efficacy of interleukin-12 given to plateau phase myeloma patients in order to sustain remission. Because of IL-12's efficacy in causing tumor resistance in mice, and because of the correlation of progression in myeloma with decreased Th1 and cytotoxic Tcell activity, IL-12 is being administered in both arms of this trial to myeloma patient s in plateau phase to help sustain remission. Effectiveness of IL-12 to enhance response to pneumococcal and hemophilus influenza B vaccines will be evaluated. Effect of IL-12 in boosting normal immunoglobulins will also be monitored.