Actively Recruiting

Age: 19Years +
All Genders
NCT07051850

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

Age: 19Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Trial Site Locations

Total: 1 location

1

Seoul St. Mary Hospital

Seocho, Seoul, South Korea, 06591

Actively Recruiting

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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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Quality of Life and Treatment Outcomes in RRMM Patients Receiving Advanced vs. Conventional Immunotherapies | DecenTrialz