肿瘤细胞治疗研究
英文原题：A Study to Compare the Efficacy and Safety of Idecabtagene Vicleucel With Lenalidomide Maintenance Therapy Versus Lenalidomide Maintenance Therapy Alone in Adult Participants With Newly Diagnosed Multiple Myeloma Who Have Suboptimal Response After Autologous Stem Cell Transplantation
这是一项 III 期注册临床试验，评估细胞治疗用于多发性骨髓瘤的安全性、可行性及初步疗效。当前状态：进行中（不再招募）。计划入组 79 例。试验地点：美国 · 洛杉矶、奥兰治、萨克拉门托、丹佛（共 101 个中心）。登记号：NCT06045806。
不限性别 · ≥ 18 Years
纳入标准：年龄≥18岁的新诊断多发性骨髓瘤（NDMM）患者，已接受诱导治疗，随后接受大剂量化疗及ASCT，且之后未接受巩固或维持治疗。例外：患者接受过≤7天LEN维持治疗，且研究者记录认为短暂中断不影响总体获益-风险评估。诱导治疗已接受4-6个周期，至少含一种免疫调节药物（IMiD）和一种蛋白酶体抑制剂（PI）（可联合或不联合抗CD38单抗），并在签署同意前80-120天接受过一次ASCT。自开始诱导治疗后无已确认疾病进展；签署同意时有记录的部分缓解（PR）或非常好的部分缓解（VGPR）；ECOG≤1分（研究者可酌情允许因骨髓瘤相关骨病疼痛导致ECOG 2分者）；既往治疗所致非血液学毒性恢复至≤1级（脱发及2级神经病变除外）。排除标准：已知骨髓瘤累及中枢神经系统；非分泌型多发性骨髓瘤；全身性未控制的真菌、细菌、病毒或其他感染；原发性免疫缺陷史；既往接受异体造血干细胞移植，或任何癌症基因治疗产品、研究性细胞治疗或BCMA靶向治疗；其他方案规定的纳入/排除标准。
Inclusion Criteria * Participants aged ≥18 with Newly Diagnosed Multiple Myeloma (NDMM) who has received induction therapy followed by high-dose chemotherapy and autologous stem cell transplantation (ASCT), without subsequent consolidation or maintenance. EXCEPTION: Participant received ≤ 7 days of lenalidomide (LEN) maintenance therapy and the investigator documents that there is no impact to the overall benefit/risk assessment due to the temporary interruption of LEN. * Participant must have received 4 to 6 cycles of induction therapy, which must contain at a minimum an immunomodulatory drugs (IMiD) and a proteasome inhibitor (PI) (with or without anti-CD38 monoclonal antibody) and must have had a single ASCT 80 to 120 days prior to consent. Note: Participant must not have confirmed progression since commencing induction. * Participant must have documented response of PR or VGPR at time of consent. * Participant must have Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1 (participants with ECOG 2 due to pain because of underlying myeloma-associated bone lesions are eligible per investigator's discretion). * Participant must have recovered to ≤ Grade 1 for any nonhematologic toxicities due to prior treatments, excluding alopecia and Grade 2 neuropathy. Exclusion Criteria * Participant with known central nervous system involvement with myeloma. * Participant has non-secretory MM. * Participant has systemic and uncontrolled fungal, bacterial, viral, or other infection. * Participant has history of primary immunodeficiency. * Participant has previous history of an allogeneic hematopoietic stem cell transplantation or treatment with any gene therapy-based therapeutic for cancer or investigational cellular therapy for cancer or B-cell maturation antigen targeted therapy. * Other protocol-defined Inclusion/Exclusion criteria apply.
以上为辅助阅读译文。是否适合入组须由主治医生判断，最终以登记平台与研究者确认为准。
主要终点：Progression Free Survival (PFS) · PFS as assessed by Independent Review Committee (IRC) · Up to approximately 50 months after the first participant is randomized
次要终点：Overall Survival (OS)；Percentage of Participants with Sustained Minimal Residual Disease Negative (MRDneg) Complete Response (CR) for 12 months；Percentage of Participants with Minimal Residual Disease Negative (MRDneg) Complete Response (CR)；Event-Free Survival (EFS)；Duration of Response (DOR)；Percentage of Participants with Complete Response (CR)；Time to Progression (TTP)；Progression post-next line of treatment (PFS2)
本研究旨在比较伊德卡塔格仑（ide-cel）联合来那度胺（LEN）维持治疗与单用LEN维持治疗，在自体造血干细胞移植（ASCT）后达到次优缓解的新诊断多发性骨髓瘤（NDMM）成人患者中的疗效、安全性和耐受性。
The purpose of this study is to compare the efficacy, safety, and tolerability of ide-cel with lenalidomide (LEN) maintenance to that of LEN maintenance alone in adult participants with Newly Diagnosed Multiple Myeloma (NDMM) who have achieved a suboptimal response post autologous stem cell transplantation (ASCT).
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