A Phase 3, Randomized, Open-Label Study to Compare the Efficacy and Safety of Anitocabtagene Autoleucel Versus Standard of Care Therapy in Participants With Relapsed/Refractory Multiple Myeloma
概览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 192
- 试验地点
- 49
- 主要终点
- PFS, defined as the time to disease progression per IMWG criteria as determined by IRC, or death due to any cause, whichever occurs first
概览
简要总结
To compare the efficacy of anitocabtagene autoleucel versus standard of care therapy (SOCT) in participants with RRMM
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •Documented historical diagnosis of MM
- •Received 1 to 3 prior lines of antimyeloma therapy, including an IMiD and an anti-CD38 mAb. A minimum of 2 consecutive cycles of an IMiD and an anti-CD38 mAb in any prior line of therapy is required. The IMiD and anti-CD38 mAb do not need to be from the same regimen in the prior line(s) of therapy.
- •Documented evidence of progressive disease by IMWG criteria based on the investigator’s determination on or within 12 months of the last dose of the last regimen
- •Measurable disease at screening per IMWG, defined as any of the following: a) Serum M-protein level ≥ 0.5 g/dL or urine M-protein level ≥ 200 mg/24 hours; or b) Light chain MM without measurable disease in the serum or urine: serum free light chain ≥ 10 mg/dL and abnormal serum free light chain ratio
- •Only participants who are candidates to receive at least 1 of the 4 SOCT regimens (PVd, DPd, KDd, or Kd), as determined by the investigator, should be considered for this Study
- •Male or female aged 18 years or older and who have provided written informed consent
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- •Females of childbearing potential must have a medically supervised negative serum or urine pregnancy test with a sensitivity of at least 25 mIU/mL (females who have undergone surgical sterilization or who have been postmenopausal for at least 2 years are not considered to be of childbearing potential)
排除标准
- •Prior BCMA-targeted therapy
- •High-dose (eg, cumulative > 70 mg prednisone or equivalent) systemic steroid therapy or any other form of immunosuppressive therapy within 14 days before randomization
- •Live vaccine ≤ 4 weeks before randomization
- •Contraindication to fludarabine or cyclophosphamide
- •History of allergy or hypersensitivity to any study agent or study drug components. Participants with a history of severe hypersensitivity reaction including anaphylaxis due to dimethyl sulfoxide (DMSO) or gentamicin are excluded.
- •Life expectancy < 12 weeks
- •Prior T-cell engager therapy
- •Prior CAR therapy or other genetically modified T-cell therapy
- •Active or prior history of central nervous system (CNS) or meningeal involvement of MM
- •Cardiac atrial or cardiac ventricular MM involvement
结局指标
主要结局
PFS, defined as the time to disease progression per IMWG criteria as determined by IRC, or death due to any cause, whichever occurs first
PFS, defined as the time to disease progression per IMWG criteria as determined by IRC, or death due to any cause, whichever occurs first
Minimal residual disease (MRD)-negative complete response (CR) rate at 9 months, defined as the proportion of participants achieving CR/stringent CR (sCR) and MRD-negative status at 9 months. MRD negativity at 9 months is defined as negative MRD value at 9 months (± 3 months) in bone marrow assessment (< 1 in 105 nucleated cells per IMWG criteria using NGS) {Kumar 2016}. CR/sCR per IMWG criteria is determined by IRC
Minimal residual disease (MRD)-negative complete response (CR) rate at 9 months, defined as the proportion of participants achieving CR/stringent CR (sCR) and MRD-negative status at 9 months. MRD negativity at 9 months is defined as negative MRD value at 9 months (± 3 months) in bone marrow assessment (< 1 in 105 nucleated cells per IMWG criteria using NGS) {Kumar 2016}. CR/sCR per IMWG criteria is determined by IRC
次要结局
- Complete response (CR) rate (CR/stringent CR [sCR]) per IMWG criteria by IRC
- Overall minimal residual disease (MRD) negativity (minimum 10^−5)
- Overall survival (OS)
- Overall response rate
- MRD-negative CR/sCR and MRD-negative very good partial response (VGPR)+
- Sustained MRD negativity
- Duration of response
- Time to progression
- Time to next treatment
- Incidence, seriousness, and severity of all adverse events (AEs)
- Levels of anti-anitocabtagene autoleucel chimeric antigen receptor (CAR) antibodies (anitocabtagene autoleucel arm)
- Presence of replication-competent lentivirus (RCL) (anitocabtagene autoleucel arm)
- Change from baseline quality of life scores across postbaseline assessment visits as measured by: European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30). European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire – Multiple Myeloma Module (EORTC QLQ-MY20). European Quality of Life 5-Dimension 5-Level Scale (EQ-5D-5L)
- Frequency of hospitalizations, inpatient days, intensive care unit days, and reasons for hospitalization
研究者
EU CT Support
Scientific
Kite Pharma Inc.