Individualized Dynamic Frailty-tailored Therapy (DynaFiT) in Elderly Patients With Newly Diagnosed Multiple Myeloma: a Prospective and Multi-center Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 131
- 试验地点
- 1
- 主要终点
- Overall response rate (at least PR) on induction therapy
研究概览
简要总结
Frailty is dynamic and confers poor outcomes in elderly patients with newly diagnosed multiple myeloma (NDMM), mainly because of the high prevalence of treatment discontinuation due to intolerability. We designed a multi-center prospective study (DynaFiT) based on our real-life practice to evaluate the feasibility and benefits of a dynamic frailty-tailored therapy in elderly patients with different fitness/frailty statuses.
Since Dara-based treatment have recently become the new standard regimens, in this amendment of the study, daratumumab added to VRd is recommended as induction therapy regimen.
详细描述
Older patients with MM represent a heterogeneous population with different fitness/frailty statuses. Unlike fit patients who can benefit from intensive therapies due to their endurance, frail patients are often susceptible to treatment-related toxicity, leading to treatment discontinuation and poor outcomes. More importantly, frailty can diminish the prognostic impact of disease-related factors over disease trajectory. Thus, it is of utmost importance to determine the fitness/frailty status for treatment decision-making that carefully balances efficacy and safety in this vulnerable population. However, geriatric assessment is often conducted at diagnosis in clinical practice. Although baseline frailty status, as a static risk factor, is significantly associated with OS, its predictive ability decreases over time. Of note, emerging evidence indicates that the fitness/frailty status is highly dynamic because of age increase, disease trajectory, and treatment, raising the notion that frailty-tailored therapy should be designed based on the baseline fitness/frailty status and also according to its longitudinal changes during the treatment course. Thus, current frailty status better predicts OS.
To improve outcomes in elderly patients, this study was designed to investigate an entirely novel therapeutic strategy, the dynamic frailty-tailored therapy, in elderly MM patients with different fitness/frailty statuses.
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
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult males and females aged ≥65 years who were either transplant-ineligible or had no intent for immediate transplant;
- •Subject must have documented multiple myeloma as defined by the criteria below:
- •Monoclonal plasma cells in the bone marrow 10% or presence of a biopsy-proven plasmacytoma;
- •Measurable disease as defined by any of the following:
- •Serum monoclonal paraprotein (M-protein) level ≥1.0 g/dL or urine M-protein level ≥200 mg/24 hours; or
- •IgA multiple myeloma: serum M-protein level ≥0.5 g/dL or urine M-protein level ≥200 mg/24 hours; or
- •Light chain multiple myeloma: Serum immunoglobulin free light chain ≥10 mg/dL and abnormal serum immunoglobulin kappa lambda free light chain ratio.
- •Has not had prior systemic therapy for multiple myeloma;
- •The functional reserve of the organs can withstand systemic therapy;
- •Each subject (or their legally acceptable representative) must sign an informed consent form (ICF) indicating that he or she understands the purpose of and procedures required for the study and are willing to participate in the study. Subject must be willing and able to adhere to the prohibitions and restrictions specified in this protocol, as referenced in the ICF.
排除标准
- •There are active systemic viral, fungal, or bacterial infections that require systemic anti-infective treatment;
- •Severe organ dysfunction (New York Heart Association class III and IV or transaminases ≥5 normal level, except those caused by cardiac and hepatic amyloidosis secondary to MM)
- •Patients with prior history of hematologic or solid tumors treated with radiotherapy or chemotherapy(except ≥5 years);
- •Patients who currently have hematologic tumors or solid tumors that require radiotherapy or chemotherapy;
- •Non-signation of informed consent.
结局指标
主要结局
Overall response rate (at least PR) on induction therapy
时间窗: From the date of inclusion to the end of induction therapy, up to 8 months.
Overall response rate(ORR) is defined as the percentage of participants with presence of stringent complete response (sCR), complete response (CR), very good partial response (VGPR) or partial response (PR). ORR assessment will be based on International Myeloma Working Group (IMWG) response criteria.
次要结局
- Rate of treatment discontinued(TD)(The time from the date of inclusion to the date of treatment discontinued from any cause, up to 24 months.)
- Treatment related adverse event(TRAE)(Baseline, end of every induction cycle and maintenance cycle, until disease progression or treatment discontinued, up to 24 months.)
- Early mortality(EM)(The time from the date of inclusion to the date of death from any cause, up to 24 months.)
- Progression-free survival(PFS)(The time from the date of inclusion to the date of first documented evidence of disease progression or death from any cause, up to 24 months.)
- Overall survival (OS)(The time from the date of inclusion to the date of death from any cause, up to 24 months)
研究者
FengYan Jin
Clinical Professor
The First Hospital of Jilin University