CTIS2023-507751-30-00进行中（未招募）1 期
A Phase 1b/2 Dose Escalation and Cohort-Expansion Study to Determine the Safety and Efficacy of BGB 11417 as Monotherapy, in Combination With Dexamethasone, Dexamethasone/Carfilzomib, Dexamethasone/Daratumumab, and Dexamethasone/Pomalidomide in Patients With Relapsed/Refractory Multiple Myeloma and t(11;14) - BGB-11417-105
Beigene Ltd.0 个研究点目标入组 211 人开始时间: 2023年11月30日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 211
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 65+（—）
- 性别
- All
入选标准
- •ECOG performance status of 0 to 2, A confirmed diagnosis of multiple myeloma, Measurable disease defined as: (a) M-spike = 500 mg/dL, or (b) Urine protein M-spike of = 200 mg/day, or (c) Serum free light chains = 10 mg/dL, and an abnormal ?:? ratio, Participant has documented relapsed or progressive MM on or after any regimen or who are refractory to the most recent line of therapy. Relapsed MM is defined as previously treated MM that progresses and requires initiation of salvage therapy but does not meet the criteria for refractory MM. Refractory MM is defined as disease that is nonresponsive (failure to achieve minimal response or development of progressive disease) while on primary or salvage therapy or progresses within 60 days of last therapy., Patients in Part 1 should have relapsed or progressive disease and have had = 3 prior lines of therapy including a proteasome inhibitor, an IMiD, and an anti-CD38 monoclonal antibody., Patients in Part 2 (Cohorts 1 and 2) should have relapsed or progressive disease and have had = 3 prior lines of therapy including a proteasome inhibitor, an IMiD, and an anti-CD38 monoclonal antibody., Patients in Part 2 (Cohorts 3, 4 and 5): (i) Should have relapsed or progressive disease and have had = 1 prior line of therapy; (ii) Must have been exposed to a combination therapy containing an anti-CD38 monoclonal antibody; (iii) Prior treatment with carfilzomib is allowed, but the patient must not be considered carfilzomib refractory by the investigator and not have received carfilzomib within the past 6 months., Positivity for t(11;14) by a validated FISH assay in a predefined central laboratory: (a) A fresh bone marrow aspirate sample must be collected at screening and sent to central laboratory for t(11;14) FISH testing; (b) Enrollment requires centrally confirmed t(11;14) results., Adequate organ function defined as: (a) Hemoglobin = 8.0 g/dL within 7 days before first dose of study treatment, independent of growth factor support and transfusions; (b) Platelet count = 75,000/µL within 7 days before first dose of study treatment, independent of growth factor support and transfusions; (c) Absolute neutrophil count (ANC) = 1000/mm3 (ANC = [% of segmented neutrophils + % of segmented bands] x total white blood cell count) within 7 days before first dose of study treatment; (d) alanine aminotransferase (ALT) and aspartate aminotransferase (AST) = 3 x upper limit of normal (ULN) and total bilirubin = 2.0 x ULN; (e) Serum creatinine = 1.5 x ULN or creatinine clearance = 45 mL/min/1.73 m2 calculated by the MDRD-6 formula.
排除标准
- •Participant has any of the following conditions: (a) Non secretory MM (Serum free light chains < 10 mg/dL); (b) Solitary plasmacytoma; (c) Active plasma cell leukemia (5% of peripheral white blood cells); (d) Waldenström macroglobulinemia; (e) Amyloidosis; (f) Polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, skin changes (POEMS) syndrome., Chronic respiratory disease that requires continuous oxygen and/or respiratory failure requiring assisted ventilation, Significant cardiovascular disease, including but not limited to: (a) Myocardial infarction = 6 months before screening; (b) Ejection fraction = 50%; (c) Unstable angina = 3 months before screening; (d) New York Heart Association Class III or IV congestive heart failure; (e) History of clinically significant arrhythmias (eg, sustained ventricular tachycardia, ventricular fibrillation, or torsades de pointes); (f) Heart rate-corrected QT interval > 480 milliseconds based on Fridericia’s formula; (g) History of Mobitz II second-degree or third-degree heart block without a permanent pacemaker in place; (h) Uncontrolled hypertension at screening, defined as systolic blood pressure > 140 mmHg and diastolic blood pressure > 90 mmHg by = 2 consecutive measurements., Positive human immunodeficiency virus serology (HIVAb) status., Serologic status reflecting active viral hepatitis B (HBV) or viral hepatitis C (HCV) infection as follows: (a) Presence of hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb). Patients with presence of HBcAb, but absence of HBsAg, are eligible if HBV DNA is undetectable (limitation of sensitivity < 20 IU/mL), and if they are willing to undergo monthly monitoring for HBV reactivation. (b) Presence of HCV antibody. Patients with presence of HCV antibody are eligible if HCV RNA is undetectable (limitation of sensitivity < 15 IU/mL).
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