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Immuno-Oncology Agents vs Conventional Immunotherapies in Relapsed/Refractory Multiple Myeloma - Quality of Life & Safety Study

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Study Aim

This study observes how multiple myeloma patients receiving immuno-oncology agents or conventional immunotherapies experience differences in quality of life and safety.

What is being collected

Data Collection

Collected from today forward - Prospective
No DNA Sample
Who is being recruted

Blood Protein Disorders+16

+ Cardiovascular Diseases

+ Hematologic Diseases

Over 19 Years
+7 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.
Observational
Study Start: July 2025
See protocol details

Summary

Principal SponsorSung-Soo Park
Study ContactSung-Soo Park, MD.PhDMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: July 14, 2025

Actual date on which the first participant was enrolled.

This study focuses on understanding the quality of life, effectiveness, and safety of newer advanced immuno-oncology treatments compared to traditional immunotherapy treatments for people with relapsed or refractory multiple myeloma, a type of blood cancer. Relapsed or refractory means that the cancer has either returned after treatment or is not responding to current treatments. The study includes 174 participants and aims to determine whether newer treatments provide better outcomes and improved quality of life for patients dealing with this challenging condition. Participants in the study go through three phases. Initially, they are screened to ensure they meet the study's criteria. In the treatment phase, they receive either traditional or advanced immuno-oncology treatments and regularly report on their quality of life. Doctors assess the effectiveness and safety of the treatments at each visit. At the end of the study, final assessments are made. Some participants also provide bone marrow and blood samples to help explore additional scientific questions. This study is observational, meaning it collects data without altering participants' treatments outside of normal care practices.

Official TitleObservational 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
NCT07051850
Principal SponsorSung-Soo Park
Study ContactSung-Soo Park, MD.PhDMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

174 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Cohort

These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 19 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Blood Protein DisordersCardiovascular DiseasesHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersImmune System DiseasesImmunoproliferative DisordersLymphoproliferative DisordersMultiple MyelomaNeoplasmsNeoplasms by Histologic TypeParaproteinemiasPathologic ProcessesRecurrencePathological Conditions, Signs and SymptomsVascular DiseasesHemostatic DisordersDisease AttributesNeoplasms, Plasma Cell

Criteria

4 inclusion criteria required to participate
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.
3 exclusion criteria prevent from participating
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.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

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Seoul St. Mary Hospital

Seocho, South KoreaOpen Seoul St. Mary Hospital in Google Maps
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One Study Center