Clinical trial · Observational
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Multiple Myeloma (MM) | Multiple Myeloma | CURATED_EXACT | 0.85 |
| Multiple Myeloma, Relapsed | Multiple Myeloma | CURATED_BROADER | 0.78 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Antibody-Drug Conjugate | Drug | — | UNRESOLVED |
| Bispecific antibody | Drug | — | UNRESOLVED |
| CAR-T Therapy | Drug | — | UNRESOLVED |
| IMiD treatment | Drug | — | UNRESOLVED |
| Monoclonal antibody | Drug | — | UNRESOLVED |
| Proteasome Inhibitor | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Advanced Immuno-oncology Therapy Group
- interventionNames
- Drug: Bispecific antibody
- Drug: CAR-T Therapy
- label
- Conventional Immuno-oncology Therapy Group
- interventionNames
- Drug: Antibody-Drug Conjugate
- Drug: Monoclonal antibody
- Drug: Proteasome Inhibitor
- Drug: IMiD treatment
Primary outcomes (1)
- measure
- Quality of Lfe
- timeFrame
- From treatment initiation up to 12 months
- description
- Quality of life is assessed using validated patient-reported outcome (PRO) questionnaires at baseline and regular intervals during treatment.
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available