Observational Study of Quality of Life, Efficacy, and Safety Following Administration of Advanced Immuno-Oncology Agents Versus Conventional Immunotherapies in Patients With Relapsed/Refractory Multiple Myeloma
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 174
- 试验地点
- 1
- 主要终点
- Quality of Lfe
研究概览
简要总结
This is a non-interventional observational study aiming to evaluate the quality of life, efficacy, and safety of advanced immuno-oncology agents versus conventional immuno-oncology therapies in patients with relapsed or refractory multiple myeloma. A total of 174 participants are expected to be enrolled in this study.
The study consists of three parts:
Part 1 is the screening and enrollment phase, during which inclusion and exclusion criteria will be assessed for individuals who have agreed to participate in the study. Eligible participants will be enrolled, and data will be collected on their prioritized treatment value criteria.
Part 2 is the treatment phase, during which participants will receive either conventional immuno-oncology therapy or advanced immuno-oncology agents. Participants will visit the site on Day 1 of each treatment cycle to complete patient-reported outcomes (PROs), and efficacy and safety assessments will be conducted.
Part 3 is the end-of-study visit, during which PROs will again be collected, along with final efficacy and safety assessments.
Additionally, for exploratory purposes, bone marrow and peripheral blood samples will be collected from participants at Seoul St. Mary's Hospital who have consented to sample collection and provision during the study period.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female aged 19 years or older.
- •Diagnosed with multiple myeloma and have been previously treated with at least one proteasome inhibitor, one immunomodulatory drug, and one monoclonal antibody treatment (i.e., exposed to all three classes of immunotherapy agents).
- •Diagnosed with relapsed or refractory multiple myeloma between the IRB approval date and December 2025, and scheduled to start treatment with either advanced immuno-oncology agents or conventional immuno-oncology agents within one month from screening.
- •Provided written informed consent after receiving detailed explanation about the study and voluntarily agreed to participate and comply with study requirements.
排除标准
- •Those who do not agree to participate in the study.
- •Patients diagnosed with plasma cell disorders other than multiple myeloma (e.g., lymphoma, POEMS syndrome).
- •Individuals unable to read and understand documents written in Korean.
研究组 & 干预措施
Advanced Immuno-oncology Therapy Group
干预措施: Bispecific antibody (Drug)
Advanced Immuno-oncology Therapy Group
干预措施: CAR-T Therapy (Drug)
Conventional Immuno-oncology Therapy Group
干预措施: Antibody-Drug Conjugate (Drug)
Conventional Immuno-oncology Therapy Group
干预措施: Monoclonal antibody (Drug)
Conventional Immuno-oncology Therapy Group
干预措施: Proteasome Inhibitor (Drug)
Conventional Immuno-oncology Therapy Group
干预措施: IMiD treatment (Drug)
结局指标
主要结局
Quality of Lfe
时间窗: From treatment initiation up to 12 months
Quality of life is assessed using validated patient-reported outcome (PRO) questionnaires at baseline and regular intervals during treatment.
次要结局
- Treatment Efficacy and Survival Outcomes(From treatment initiation up to 12 months)
研究者
Sung-Soo Park
professor
Seoul St. Mary's Hospital