RecruitingNCT07051850

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

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


Sponsor

Sung-Soo Park

Enrollment

174 participants

Start Date

Jul 14, 2025

Study Type

OBSERVATIONAL

Conditions

Summary

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.


Eligibility

Min Age: 19 Years

Plain Language Summary

Simplified for easier understanding

This observational study compares quality of life and treatment outcomes in people with relapsed or treatment-resistant multiple myeloma (a blood cancer) who are receiving either newer advanced immunotherapy (such as CAR T-cell therapy or bispecific antibodies) or conventional immunotherapy drugs. **You may be eligible if:** - You are 19 or older - You have been diagnosed with multiple myeloma and have previously been treated with at least one proteasome inhibitor, one immunomodulatory drug, and one monoclonal antibody - You have been diagnosed with relapsed or refractory multiple myeloma and are about to start a new treatment within one month of screening - You are willing to give written consent and follow study requirements - You can read and understand documents written in Korean **You may NOT be eligible if:** - You do not agree to participate - You have been diagnosed with a different plasma cell disorder (e.g., lymphoma or POEMS syndrome) - You cannot read or understand Korean-language documents Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGBispecific antibody

It uses a dual targeting mechanism to enhance specificity and immune activation. It is an off-the-shelf treatment, and doesn't require a manufacturing process of patient cells.

DRUGAntibody-Drug Conjugate

It is a targeted therapy consisting of a monoclonal antibody linked to a cytotoxic drug. The antibody binds to a specific antigen on cancer cells, delivering the cytotoxic agent directly to the tumor, minimizing systemic toxicity.

DRUGMonoclonal antibody

Monoclonal antibodies are lab-engineered antibodies that target specific antigens expressed on cancer cells. These commonly target CD20 (rituximab or obinutuzumab) to mediate immune destruction.

DRUGProteasome Inhibitor

It blocks the activity of proteasomes, which role is degrading damaged proteins. This disruption induces apoptosis in cancer cells. Common agents include bortezomib and carfilzomib.

DRUGIMiD treatment

Immune modulatory drugs modulate the immune response by enhancing T-cell and NK cell activty to disrupt tumor progression. Common drugs include lenalidomide and thalidomide.

DRUGCAR-T Therapy

It uses the patient's own T cells, and requires a manufacturing process to modify and expand T cells before infusion. It directly targets B cell specific antigens, such as CD19 or CD20.


Locations(1)

Seoul St. Mary Hospital

Seocho, Seoul, South Korea

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07051850


Related Trials