2022-501346-30-00招募中3 期
A Randomized, Open-Label, Phase 3 Trial to Compare the Efficacy and Safety of Idecabtagene Vicleucel with Lenalidomide Maintenance Versus Lenalidomide Maintenance Therapy Alone in Adult Participants with Newly Diagnosed Multiple Myeloma Who Have Suboptimal Response After Autologous Stem Cell Transplantation
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 332
- 试验地点
- 54
- 主要终点
- Progression Free Survival (PFS)
研究概览
简要总结
To compare the efficacy of ide-cel with Lenalidomide maintenance to that of Lenalidomide (LEN) maintenance alone in participants who achieved suboptimal response to Autologous Stem Cell Transplantation (ASCT) as measured by Progression Free Survival (PFS).
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Participants aged ≥18 with NDMM who have received induction therapy followed by high-dose chemotherapy and ASCT, without subsequent maintenance. EXCEPTION:Participant received ≤ 7 days of 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 a minimum of 4 cycles of induction therapy that includes an IMiD anda PI (with or without anti-CD38 monoclonal antibody) prior to a single ASCT. A maximum of 6 cycles is permitted (which can include up to 2 cycles of post-ASCT consolidation if given). For participants who have not received post-ASCT consolidation therapy, the participant must be within 80 to 120 days post transplant at the time of consent. For participants treated with post-ASCT consolidation therapy, the participant must be within 30 to 60 days of the last dose of consolidation therapy at the time of consent and within 180 days post transplant at the time of consent.Note: Participant must not have confirmed progression since commencing induction. When screening results are suggestive of progression, repeat assessments must beperformed to exclude PD per International Myeloma Working Group.
- •Participant must have documented best overall response of PR or VGPR at time of randomization.
- •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.
排除标准
- •Participant with known central nervous system involvement with myeloma.
- •Participant has non-secretory MM or oligosecretory MM at diagnosis.
- •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.
研究组 & 干预措施
idecabtagene vicleucel
Experimental
Participants receiving idecabtagene vicleucel
干预措施: idecabtagene vicleucel (Drug)
结局指标
主要结局
Progression Free Survival (PFS)
Progression Free Survival (PFS)
次要结局
- Overal Surival (OS)
- Percentage of Participants with 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)
- Time to Next Treatment (TTNT)
- Number of Participants Experiencing Adverse Events (AEs).
- Number of Participants Experiencing Adverse Events of Special Interest (AESI)
- Maximum Observed Plasma Concentration (Cmax)
- Time of Maximum Observed Plasma Concentration (Tmax)
- Area Under the Curve (AUC) from time zero to 28 days post infusion (AUC [0-28D])
- Time of Last Measurable Observed Plasma Concentration (Tlast)
- Time-to-Definitive Deterioration
- Mean Change from Baseline in EORTC QLQ-C30 Selected Subscales
- Mean Change from Baseline in EORTC QLQ-MY20 Selected Subscales
研究者
GSM-CT
Scientific
Celgene Corp.
研究点 (54)
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