Quality of life and treatment outcomes for relapsed/refractory multiple myeloma with advanced versus 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
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 |
|---|---|
| Enrollment | 174 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Seoul St. Mary's Hospital Academic / other |
| Drugs / interventions | immunotherapy |
| Locations | 1 site (Seocho, Seoul) |
| Trial ID | NCT07051850 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Seocho, Seoul
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.