A Phase III, Open-label, Multicentre, Randomised Study Comparing Consolidation Treatment With AZD0120, an Autologous Dual Targeting Chimeric Antigen Receptor T-cell (CAR-T) Therapy Directed Against BCMA and CD19, Versus Autologous Stem Cell Transplant (ASCT) in Participants With Newly Diagnosed Multiple Myeloma Who Are Transplant Eligible (TE NDMM) (DURGA-6)
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- AstraZeneca
- 入组人数
- 750
- 试验地点
- 65
- 主要终点
- Progression-Free Survival (PFS)
研究概览
简要总结
The purpose of this study is to measure the efficacy of AZD0120 compared with ASCT in terms of progression-free survival (PFS) according to the International Myeloma Working Group (IMWG) criteria 2016, and MRD negative complete response (CR) rate at 9 months as assessed by Blinded Independent Central Review (BICR), in participants with TE NDMM.
Study details include:
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The study duration is estimated to be up to 13 years from the date the first participant is randomised.
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For participants in Arm A (AZD0120), the total duration of participant follow-up will be 15 years (including a Long Term Follow-up study) after the last participant has received the AZD0120 infusion.
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The treatment duration will be:- Arm A (AZD0120): lymphodepletion over 3 days, a single-day infusion of AZD0120, followed by a maximum of 2 years lenalidomide monotherapy maintenance treatment.
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Arm B (ASCT): conditioning therapy over 24 to 48 hours, ASCT, followed by a maximum of 2 years lenalidomide monotherapy maintenance treatment.
Disclosure Statement: This is an open-label, randomised study with 2 treatment arms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
None (open label)
入排标准
- 年龄范围
- 18 Years 至 130 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥18 years of age.
- •Documented diagnosis of NDMM according to IMWG diagnostic criteria.
- •Documented measurable disease at diagnosis (serum M-protein ≥ 1.0 g/dL, urine M-protein 200 mg/24 hour, or serum Ig FLC 10 mg/dL (100 mg/L) and abnormal serum Ig kappa lambda FLC ratio)
- •Must have completed 4 to 6 cycles of induction therapy with any of the following approved regimens: anti-CD38+VRd, DVTd, DRd or VRd
- •Participant must have at least SD or better per IMWG response criteria (2016) after completion of induction, and prior to randomisation.
- •ECOG performance status score of 0 or
- •Eligible for treatment with high-dose melphalan (200 mg/m²) followed by ASCT.
- •Adequate organ and bone marrow function.
排除标准
- •Known active, or prior history of CNS involvement or exhibits clinical signs of meningeal involvement of MM.
- •Primary amyloidosis, active plasma cell leukaemia (at diagnosis and/or at time of screening), Waldenstrom macroglobulinemia or POEMS syndrome.
- •Significant neurological or psychiatric condition
- •Significant medical condition that places the participant at an unacceptable risk for treatment-related complications
- •Participants who required the introduction of an additional agent therapy due to inadequate response.
- •Prior T-cell engager therapy directed at any target.
- •Prior CAR-T and/or CAR-NK cell therapy directed at any target for any indications
- •Prior any therapy that is targeted to BCMA and CD19.
结局指标
主要结局
Progression-Free Survival (PFS)
时间窗: Up to approximately 13 years.
PFS is defined as time from randomisation until progression as assessed by Blinded Independent Central Review, or death due to any cause, whichever occurs first.
Minimal Residual Disease (MRD) negative Complete Response Rate (CRR)
时间窗: Up to approximately 13 years.
MRD negative CRR is defined as the proportion of participants with a MRD negative status and who have a response of CR or a stringent CR.
次要结局
- Secondary: Overall Survival (OS)(Up to approximately 13 years.)
- Secondary: Complete Response Rate (CRR)(Up to approximately 13 years.)
- Secondary: Overall Response Rate (ORR)(Up to approximately 13 years.)
- Secondary: Duration of Response (DoR)(Up to approximately 13 years.)
- Other secondary: Time to Response (TTR)(Up to approximately 13 years.)
- Safety - Adverse Events(Up to approximately 13 years.)