A Prospective, Single-Arm, Exploratory Phase II Clinical Trial of HP-001 in Combination With Dexamethasone for Relapsed/Refractory Multiple Myeloma With Extramedullary Disease
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Overall Response Rate (ORR)
研究概览
简要总结
This is a prospective, single-arm, exploratory Phase II clinical study evaluating the efficacy and safety of HP-001 capsules in combination with dexamethasone in patients with relapsed or refractory multiple myeloma (RRMM) with extramedullary disease (EMD).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years at the time of signing informed consent; male or female.
- •ECOG performance status of 0-
- •Diagnosis of multiple myeloma according to IMWG criteria, with relapsed/refractory disease after at least 1 prior systemic treatment regimen; disease progression or failure to achieve a response after the most recent line of therapy; and extramedullary disease confirmed by imaging, defined as at least 1 soft-tissue extramedullary lesion ≥2 cm, at least 1 paramedullary lesion ≥5 cm, or >2 lesions.
- •With or without measurable hematologic disease at screening. Measurable disease, if present, is defined as serum M-protein ≥1.0 g/dL, urine M-protein ≥200 mg/24 hours, or serum free light chain ≥10 mg/dL with an abnormal free light chain ratio.
- •Adequate organ function, including ANC ≥1.0 × 10⁹/L, hemoglobin ≥60 g/L, platelet count ≥50 × 10⁹/L, creatinine clearance ≥30 mL/min, total bilirubin ≤2 × ULN (≤3 × ULN for Gilbert syndrome), AST and ALT ≤2.5 × ULN, and INR or aPTT ≤1.5 × ULN.
- •Willing and able to comply with study procedures and follow-up.
排除标准
- •Smoldering multiple myeloma, monoclonal gammopathy of undetermined significance, Waldenström macroglobulinemia, POEMS syndrome, amyloidosis, or primary/secondary plasma cell leukemia.
- •Central nervous system involvement or clinical evidence of meningeal involvement.
- •Severe or uncontrolled cardiovascular disease, including unstable angina, symptomatic congestive heart failure, myocardial infarction within 6 months before enrollment, severe uncontrolled arrhythmia, or other cardiovascular/cerebrovascular conditions considered unsuitable by the investigator.
- •Major surgery within 4 weeks before the first dose or planned major surgery during the study.
- •Active infection, including HIV infection, active hepatitis B (HBV-DNA positive), active hepatitis C (HCV-RNA positive), active or latent syphilis, active tuberculosis, or other active infections considered unsuitable by the investigator.
- •Concurrent malignancy or other serious concomitant disease that may compromise participant safety or completion of the study.
- •Pregnant or breastfeeding women.
- •History of severe allergy or hypersensitivity to any component of the study treatment.
- •Any other condition that, in the investigator's judgment, makes the participant unsuitable for enrollment.
研究组 & 干预措施
HP-001 Plus Dexamethasone
Participants will receive HP-001 capsules at 0.6 mg orally once daily on Days 1-10 of each 28-day treatment cycle, in combination with dexamethasone 40 mg administered orally or intravenously on Days 1, 8, 15, and 22 of each cycle. Treatment will continue until disease progression, unacceptable toxicity, withdrawal of consent, the investigator determines that continued treatment is no longer appropriate, or completion of 24 treatment cycles, whichever occurs first.
干预措施: Dexamethasone (Drug)
HP-001 Plus Dexamethasone
Participants will receive HP-001 capsules at 0.6 mg orally once daily on Days 1-10 of each 28-day treatment cycle, in combination with dexamethasone 40 mg administered orally or intravenously on Days 1, 8, 15, and 22 of each cycle. Treatment will continue until disease progression, unacceptable toxicity, withdrawal of consent, the investigator determines that continued treatment is no longer appropriate, or completion of 24 treatment cycles, whichever occurs first.
干预措施: HP-001 (Drug)
结局指标
主要结局
Overall Response Rate (ORR)
时间窗: From the first dose to the end of Cycle 24 (each cycle is 28 days).
次要结局
- Extramedullary Disease Objective Response Rate (EMD-ORR)(From the first dose to the end of Cycle 24 (each cycle is 28 days).)
- Very Good Partial Response or Better Rate (≥VGPR Rate)(From the first dose to the end of Cycle 24 (each cycle is 28 days).)
- Complete Response or Stringent Complete Response Rate (CR/sCR Rate)(From the first dose to the end of Cycle 24 (each cycle is 28 days).)
- Time to Response (TTR)(From the first dose to the date of the first documented overall response of PR or better, assessed through the end of Cycle 24 (each cycle is 28 days).)
- Duration of Response (DoR)(From the date of the first documented overall response of PR or better to the date of disease progression or death from any cause, whichever occurs first, with follow-up through 12 months after the last dose.)
- Progression-Free Survival (PFS)(From the date of the first dose to the date of disease progression or death from any cause, whichever occurs first, with follow-up through 12 months after the last dose.)
- Overall Survival (OS)(From the date of the first dose to the date of death from any cause, with follow-up through 12 months after the last dose.)
- Incidence and Severity of Adverse Events (AEs)(Up to 2 years.)