NCT06158412招募中2 期
A Single-center, Prospective, Single-arm Clinical Study of All-trans Retinoic Acid in Combination With a KPD Regimen for the Treatment of Refractory/Relapsed Multiple Myeloma (MM)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Overall response rate (ORR)
研究概览
简要总结
To investigate the safety and efficacy of the ATRA combined with the KPD regimen in patients with refractory relapsed multiple myeloma.
详细描述
This is an open-label clinical trial study that aims to evaluate the efficacy (eg. Complete response, Overall Survival, Progression Free Survival) and adverse effects of Trans-Retinoic acid (ATRA) combined with the KPD regimen in patients with refractory relapsed multiple myeloma.
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.
- •Subjects must have a diagnosis of multiple myeloma based on the following criteria: (1) Monoclonal plasma cells in the bone marrow in ≥10% of patients at some point in time when the presence of plasmacytoma is confirmed by disease history or biopsy. (2) Measurable disease is defined as follows: Serum monoclonal gammaglobulin (M protein) level ≥ 5 g/L; or urinary M protein level ≥ 200 mg/24 hours; or serum immunoglobulin free light chain ≥ 100 mg/L (10 mg/dL) and abnormal serum immunoglobulin kap/lam light chain ratio.
- •Diagnosis of refractory/relapsed multiple myeloma: (1) Relapse is defined as the progression of disease after an initial response (≥MR) to prior therapy 60 days after cessation of therapy. (2) Refractory disease is defined as a <25% reduction in M protein or disease progression during treatment or within 60 days of stopping treatment.
- •ECOG assessment of 0, 1, or
- •Life expectancy of at least 3 months.
- •The patient/legal guardian must be able to read, understand, and sign the informed consent form (ICF).
排除标准
- •Patient who currently participating or planning to participate in any interventional clinical study.
- •The investigator considers the patient unsuitable for participation in this study.
- •Non-secretory myeloma.
- •Subjects have received antimyeloma therapy within 2 weeks or 5 pharmacokinetic half-lives, whichever is longer, prior to initiation of treatment. This includes subjects who received a cumulative dose of corticosteroids greater than or equal to a 140 mg prednisone equivalent dose or a single dose of corticosteroids greater than or equal to a 40 mg/day dexamethasone equivalent dose within 2 weeks prior to initiation of treatment.
- •Subjects who have previously received an allogeneic stem cell transplant within 1 year prior to the date of enrollment and have not used immunosuppressive medications within 1 month prior to the date of enrollment.
- •Inadequate bone marrow reserve as defined by a platelet count <30 x 109/L or absolute neutrophil count <1.0 x 109/L.
- •Subject has clinically significant lung disease, including: (1) Subject has chronic obstructive pulmonary disease (COPD) with a forced expiratory volume in 1 second (FEV1) <50% of predicted normal. Please note that patients suspected of having COPD will be required to undergo FEV1 testing and subjects must be excluded if FEV1 is <50% of predicted normal. (2) Subjects who have had moderate or severe persistent asthma within the past 2 years or currently have any category of uncontrolled asthma. (Please note that subjects who currently have controlled intermittent asthma or controlled mild persistent asthma may participate in this study)
- •Subjects with clinically significant cardiac disease, including (1) Myocardial infarction within 6 months prior to Day 1 of Cycle 1, or unstable or uncontrolled disease/condition related to or affecting cardiac function (e.g., unstable angina pectoris, congestive heart failure, New York Heart Association Class III-IV). (2) Cardiac arrhythmia (Common Terminology Criteria for Adverse Events [CTCAE], 4th Edition, Grade 4 edition grade 2 or higher) or clinically significant ECG abnormalities. (3) Screening 12-lead ECG showing a baseline QT interval (QTcF) corrected by the Friedreichian formula >470 ms.
- •Severe hepatic dysfunction (total bilirubin 3 times normal or transaminases 3 times normal) unless associated with myeloma.
- •Creatinine clearance <20 mL/min.
- •Known allergy to components of the test product, or severe allergy or hypersensitivity to humanized products.
- •The subject has a concurrent serious and/or uncontrolled medical condition (e.g., uncontrolled diabetes mellitus, infections, hypertension, etc.) that may interfere with the study procedures or results or that, in the opinion of the investigator, may pose a risk to participation in this study.
- •Subjects known to be seropositive for human immunodeficiency virus (HIV) or have active hepatitis B or C.
- •History of active malignancy within the past 5 years, except squamous and basal cell carcinoma of the skin and carcinoma in situ of the cervix, or cured within 5 years with minimal risk of recurrence in the opinion of the local investigator, in agreement with the principal investigator.
- •Subjects known or suspected of not being able to comply with the study protocol (e.g. due to alcoholism, drug dependence, or psychological disorders), or the subject has any condition that, in the investigator's belief that participation would not be in the subject's best interest (e.g., detrimental to their well-being) or would likely prevent, limit, or confound protocol-specified assessments.
- •Pregnant or lactating females.
- •Peripheral neuritis ≥ grade 3.
研究组 & 干预措施
ATRA in Combination with a KPD Regimen
Experimental
All-trans Retinoic Acid plus the KPD Regimen
干预措施: All-trans Retinoic Acid in combination with the KPD Regimen (Drug)
结局指标
主要结局
Overall response rate (ORR)
时间窗: Up to 26 months
Defined as the proportion of subjects who achieve stringent complete response (sCR), complete response (CR), very good partial response (VGPR), and partial response (PR) according to the 2016 International Myeloma Working Group (IMWG) criteria.
次要结局
- Complete response rate (CR)(Up to 26 months)
- Progression free survival (PFS)(Up to 26 months)
- Overall survival (OS)(Up to 26 months)
研究者
Bing, Xu
Principal Investigator
The First Affiliated Hospital of Xiamen University
研究点 (1)
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