Clinical Outcome of Multiple Myeloma Patients Switching to Carfilzomib-based Regimens After Prior Bortezomib-based First-line Therapy Intolerant, a Real-world, Single-arm, Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Outcome of peripheral neuropathy
研究概览
简要总结
This is an open-label, single-arm, prospective study conducted in real-world clinical practice. It aims to evaluate the efficacy and safety in Chinese patients with newly diagnosed multiple myeloma who switch to carfilzomib-based regimens after bortezomib-based triple-drug regimen intolerance happens.
详细描述
This is an open-label, single-arm, prospective study conducted in real-world clinical practice. Chinese patients with newly diagnosed multiple myeloma will be enrolled if they switch to carfilzomib-based regimens after bortezomib-based triple-drug regimen intolerance happens.
Induction and consolidation therapy will be 6-8cycles. 6 cycles for transplant recipients and 8 cycles for non-transplant recipients. Maintenance therapy will continue until progression.
It aims to evaluate the efficacy and safety of carfilzomib based therapy in Chinese NDMM patients with intolerance to bortezomib. The primary endpoint is the rate of 2-year pFS and secondary endpoints are the rate of ORR,sCR/CR,VGPR,PR, the rate and duration of MRD, the rate of 2-year OS and safety.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •≥ 18 years of age
- •Diagnosed with multiple myeloma according to IMWG criteria.
- •Patients who have received only first-line bortezomib-based triple therapy, including bortezomib/lenalidomide/dexamethasone (VRD), bortezomib/thalidomide/dexamethasone (VTD）,bortezomib/ cyclophosphamide/dexamethasone (VCD), and bortezomib/adriamycin//dexamethasone (PAD).
- •Eastern cooperative oncology group(ECOG) score 0-2
- •Patients who develop toxicities associated with bortezomib therapy evaluated by the investigator, including the presence of Grade 1 with pain or Grade 2 peripheral neuropathy (PN), Grade 3 hepatic impairment, Grade 3 diarrhea, and any other Grade 3 non-hematologic adverse events and resulting in bortezomib dose reduction or discontinuation.
- •Patients who agree to and sign informed consents to participate in this study.
排除标准
- •Patients currently participating in other interventional clinical studies (except those currently participating in non-interventional observational studies)
- •Patients who have received prior carfilzomib treatment or participated in carfilzomib associated studies (with or without carfilzomib treatment).
- •Patients with a primary diagnosis of MM combined with plasma cell leukemia (peripheral blood monoclonal plasma cells ≥5% of the total number of differentiated mature leukocytes)
- •Patients who have not fully recovered from the reversible effects of prior chemotherapy (i.e., <= grade 1 toxicity).
- •Patients with other malignancies diagnosed prior to the MM diagnosis, excluding squamous and basal cell carcinomas of the skin, and carcinoma in situ of the cervix or breast, which can be cured within 3 years with minimal risk of recurrence.
- •Patients with an active systemic infection, active hepatitis B or C virus infection, or known positive test results for human immunodeficiency virus.
- •Evidence of current uncontrolled cardiovascular disease, including hypertension, arrhythmias (prolonged QT interval, ventricular tachycardia, ventricular flutter, ventricular fibrillation, frequent ventricular premature beats (24-hour premature loading of ≥15% of the total number of beats), grade Ⅲ atrioventricular block, and a heart rate of <30-40 bpm congestive heart failure, unstable angina, or myocardial infarction in the past 3 months,. New York Heart Association (NYHA) class III and IV heart failure. left ventricle ejection fraction（LVEF） <40% on cardiac ultrasound.
- •Participants with known chronic obstructive pulmonary disease (COPD) (defined as forced expiratory volume in 1 second [FEV1] <50% of predicted normal value), persistent asthma, or a history of asthma within the past 2 years (controlled intermittent asthma or mild persistent asthma that is allowed). Participants with known or suspected COPD must undergo FEV1 testing during screening.
- •Inability to comply with protocol/procedure.
- •Patients with hypersensitivity to the active ingredient or excipients of carfilzomib.
- •Pregnant or lactating women
研究组 & 干预措施
K-based therapy
if bortezomib related intolerance happens during front line therapy of bortezomib-based triple regimen, then carfilzomib-based therapy will be used
干预措施: Carfilzomib (Drug)
结局指标
主要结局
Outcome of peripheral neuropathy
时间窗: from enrollment to 2 years
recurrence of peripheral neuropathy
次要结局
- 2-year PFS rate(from enrollment to 2 years)
- ORR(from enrollment to 2 years)
- sCR/CR rate(from enrollment to 2 years)
- PR rate(from enrollment to 2 years)
- VGPR rate(from enrollment to 2 years)
- MRD negativity rate(from enrollment to 2 years)
- AE rate(from enrollment to 2 years)
- 2-year OS rate(from enrollment to 2 years)
- Duration of MRD negativity(from enrollment to 2 years)