Actively Recruiting
Quality of Life and Treatment Outcomes in RRMM Patients Receiving Advanced vs. Conventional Immunotherapies
Led by Sung-Soo Park · Updated on 2025-07-15
174
Participants Needed
1
Research Sites
24 weeks
Total Duration
On this page
Sponsors
S
Sung-Soo Park
Lead Sponsor
E
Eunpyeong St. Mary's Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Quality of Life and Treatment Outcomes in RRMM Patients Receiving Advanced vs. Conventional Immunotherapies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 19 years or older
- Diagnosed with multiple myeloma and previously treated with at least one proteasome inhibitor, one immunomodulatory drug, and one monoclonal antibody
- Diagnosed with relapsed or refractory multiple myeloma between the IRB approval date and December 2025
- Scheduled to start treatment with advanced or conventional immuno-oncology agents within one month from screening
- Provided written informed consent and agreed to comply with study requirements
You will not qualify if you...
- Do not agree to participate in the study
- Diagnosed with plasma cell disorders other than multiple myeloma (e.g., lymphoma, POEMS syndrome)
- Unable to read and understand documents written in Korean
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Seoul St. Mary Hospital
Seocho, Seoul, South Korea, 06591
Actively Recruiting
Research Team
S
Sung-Soo Park, MD.PhD
CONTACT
S
SeungHwan Shin, MD.PhD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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