2024-517140-65-00招募中2 期
A Phase 1/2, Open-Label, Platform Study to Evaluate Safety and Efficacy of the BCL-2 Inhibitor ABBV-453 given as Monotherapy or in Combination with Antimyeloma Regimens in Subjects with Multiple Myeloma
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 76
- 试验地点
- 27
- 主要终点
- Dose Limiting Toxicities (DLT)s of ABBV-453
研究概览
简要总结
To characterize the safety and tolerability of ABBV-453 monotherapy and/ or in combination with antimyeloma agents in participants with multiple myeloma (MM).
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
- 否
入选标准
- •Documented diagnosis of multiple myeloma (MM) based on standard international myeloma working group (IMWG) diagnostic criteria.
- •All participants must have measurable disease per central laboratory with at least 1 of the following assessed within 28 days prior to enrollment: -- Serum M-protein >= 0.5 g/dL (>= 5g/L); OR -- Urine M-protein >= 200 mg/24 hours; OR -- For participants without measurable serum and urine M-protein: Serum free light chain (sFLC) ≥ 10 mg/dL (100 mg/L), provided sFLC ratio is abnormal.
- •B-cell lymphoma (BCL)-2 inhibitor treatment naïve.
排除标准
- •Major surgery within 4 weeks of study treatment or planned during study participation.
- •Recent infection requiring systemic treatment that was completed <= 7 days before first dose of study treatment and/or uncontrolled active systemic infection.
结局指标
主要结局
Dose Limiting Toxicities (DLT)s of ABBV-453
Dose Limiting Toxicities (DLT)s of ABBV-453
Safety and tolerability (AEs and SAEs, clinical laboratory parameters, vital sign measurements, and ECG results).
Safety and tolerability (AEs and SAEs, clinical laboratory parameters, vital sign measurements, and ECG results).
次要结局
- Overall Response Rate (ORR)
- Progression-Free Survival (PFS)
- Duration of Response (DOR)
- Time-to-Progression (TTP)
- Time to Next Treatment
- Rate and Depth of minimal residual disease (MRD) Negativity Determined Centrally
- Overall survival (OS)
- Pharmacokinetics (PK): Cmax, Tmax, t ½ , AUC.
研究者
Global Clinical Trials Helpdesk
Scientific
AbbVie Deutschland GmbH & Co. KG
研究点 (27)
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