HIGH DOSE CYCLOPHOSPHAMIDE AND RITUXIMAB IN MULTIPLE MYELOMA

高剂量环磷酰胺和利妥昔单抗治疗多发性骨髓瘤

• 批准号: 7378921
• 负责人: CAROL A HUFF
• 金额: $ 0.47万
• 依托单位: JOHNS HOPKINS UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2005
• 资助国家: 美国
• 起止时间: 2005-12-01 至 2006-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7378921
• 关键词: DOSE; CYCLOPHOSPHAMIDE; RITUXIMAB; MULTIPLE; MYELOMA

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.

该子项目是利用NIH/NCRR资助的中心赠款提供的资源的许多研究子项目之一。子项目和研究者（PI）可能从另一个NIH来源获得主要资金，因此可以在其他CRISP条目中表示。所列机构为中心，不一定是研究者所在机构。本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，持续4天。利妥昔单抗在环磷酰胺之前给药，以达到最大的淋巴减少。 随后给予环磷酰胺50 mg/kg/d，持续4天，以实现成熟浆细胞的最大细胞减少。一旦发生造血恢复，将在骨髓瘤负荷最低时每周给予利妥昔单抗4次，在高剂量治疗后立即给予，然后每3个月给予3次，以进一步消除可能存在的残留骨髓瘤干细胞。如果患者在既往治疗后患有原发性难治性或复发性多发性骨髓瘤，并且在诊断后的任何时间患有Durie-Salmon II或III期疾病，则有资格参加本研究。其他合格标准包括对挽救治疗的敏感性、年龄>18岁、FEV > 50%、FVC > 50%、左心室心脏射血分数正常和13号染色体缺失。