HIGH DOSE CYCLOPHOSPHAMIDE AND RITUXIMAB IN MULTIPLE MYELOMA

这个子项目是利用由NIH/NCRR资助的中心拨款提供的资源的许多研究子项目之一。子项目和调查员(PI)可能从另一个NIH来源获得了主要资金，因此可能会出现在其他CRISE条目中。列出的机构是针对中心的，而不一定是针对调查员的机构。这项研究建议在环磷酰胺50 mg/kg/d之前给予两剂利妥昔单抗375 mg/m2，共4天。利妥昔单抗在环磷酰胺之前使用，以达到最大限度的淋巴减少。然后，环磷酰胺50 mg/kg/d，连续四天，以最大限度地减少成熟浆细胞的细胞数量。一旦造血功能恢复，利妥昔单抗将在骨髓瘤负担最低的时候每周服用四次，在大剂量治疗后立即服用，然后每三个月服用一次，共三次，以进一步清除可能存在的残留骨髓瘤干细胞。如果患者在之前的治疗后有原发难治性或复发的多发性骨髓瘤，并且在确诊后的任何时候都有Durie-Salmon II或III期疾病，那么他们有资格参加这项研究。其他资格标准包括对挽救治疗的敏感性、年龄和18岁、FEV和GT；50%、FVC和GT；50%、正常左心室射血分数和13号染色体缺失。

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. This study proposed the administration of two doses of rituximab 375 mg/m2 prior to cyclophosphamide 50 mg/kg/d for four days. Rituximab is being administered prior to cyclophosphamide to achieve maximal lymphoid reduction. It will then be followed by cyclophosphamide 50 mg/kg/d for four days in an effort to achieve maximal cytoreduction of the mature plasma cells. Once hematopoietic recovery occurs, rituximab will be given weekly times four at the time when the myeloma burden should be lowest, immediately following high dose therapy and then every three months for 3 doses to further eliminate residual myeloma stem cells which may be present. Patients are eligible for this study if they have primary refractory or relapsed Multiple Myeloma after prior therapy, and have Durie-Salmon Stage II or III disease at any time since diagnosis. Additional eligibility criteria include sensitivity to salvage therapy, age >18 years, FEV > 50%, FVC > 50%, normal left ventricular cardiac ejection fraction, and chromosome 13 deletion.