Quality of life and treatment outcomes for relapsed/refractory multiple myeloma with advanced versus conventional immunotherapies.
Official title: 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
Run by Seoul St. Mary's Hospital · NCT07051850 · Data updated 2026-11-12
This will test whether advanced immuno-oncology treatments lead to different quality of life, safety, and treatment outcomes than conventional immunotherapies in adults with relapsed or refractory multiple myeloma.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 19 Years and up |
| Sex | All |
| Enrollment | 174 (estimated) |
| Sponsor | Seoul St. Mary's Hospital Academic / other |
| Drugs / interventions | immunotherapy |
| Locations | 1 site (Seocho, Seoul) |
| Status | Recruiting |
| Started | July 14, 2025 |
| Main results expected | December 31, 2025 |
| Study ends | December 31, 2025 |
| Registry record updated | July 15, 2025 |
| Trial ID | NCT07051850 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (age ≥19) with relapsed or refractory multiple myeloma who have previously received at least one proteasome inhibitor, one immunomodulatory drug, and one monoclonal antibody and who are scheduled to start either advanced or conventional immuno-oncology treatment within one month are ideal candidates.
✕Probably not a fit
Patients with plasma cell disorders other than multiple myeloma, those unable to read Korean, people not starting eligible therapy within the enrollment window, or those who have not been exposed to the required prior treatments are unlikely to benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This non-interventional observational study will follow about 174 adults with relapsed or refractory multiple myeloma who are starting either advanced immuno-oncology agents (such as bispecific antibodies or antibody-drug conjugates) or conventional immunotherapies. Participants first undergo screening and enrollment with collection of individualized treatment value priorities, then enter a treatment phase where they receive physician-directed therapy and complete patient-reported outcome measures on Day 1 of each treatment cycle alongside routine efficacy and safety assessments. The study captures real-world effectiveness, adverse events, and quality-of-life measures without altering clinical care, and ends with a final end-of-study visit to summarize outcomes. Eligibility requires prior exposure to a proteasome inhibitor, an immunomodulatory drug, and a monoclonal antibody.
Why it matters
Potential benefit: If successful, results may help clinicians and patients choose immunotherapy options that better balance quality of life, safety, and disease control in relapsed or refractory multiple myeloma.
How similar studies have gone: Early clinical trials of bispecific antibodies and antibody-drug conjugates have shown promising efficacy in relapsed/refractory multiple myeloma, but direct real-world comparisons focusing on patient-reported quality of life versus conventional immunotherapies remain limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
Where it's running
-
Seoul St. Mary Hospital
Seocho, Seoul, South Korea Recruiting
Study contacts
- Study coordinator: Sung-Soo Park, MD.PhD
- Email: sspark@catholic.ac.kr
- Phone: +82-10-3782-2736
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.