Clinical trial · Observational
A Study Assessing the Health-Related Quality of Life (HRQoL) in Participants With Relapsed and/or Refractory Multiple Myeloma (RRMM) With Triple Class Exposure
Health-Related Quality of Life (HRQoL) in Patients With Relapsed and/or Refractory Multiple Myeloma (RRMM) With Triple Class Exposure in Japan
NCT05217082CI-TRIAL-00067041completedClinicalTrials.gov clinicaltrialsProvenance
- 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)
The purpose of this observational study is to assess HRQoL in relapsed and/or refractory multiple myeloma (RRMM) participants who have previously received a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 antibody.
Conditions
Conditions (1)
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 | Multiple Myeloma | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (1)
- label
- Cohort 1
- description
- Participants with relapsed/refractory multiple myeloma (RRMM) who have already received a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 antibody
Primary outcomes (7)
- measure
- Health-Related Quality of Life (HRQoL) in specific domains: Fatigue, as measured by EORTC QLQ-C30
- timeFrame
- Up to 1 year
- description
- EORTC QLQ-C30 defined as European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30
- measure
- HRQoL in specific domains: Pain, as measured by the EORTC QLQ-C30
- timeFrame
- Up to 1 year
- measure
- HRQoL in specific domains: Physical Functioning as measured by the EORTC QLQ-C30
- timeFrame
- Up to 1 year
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
Inclusion Criteria: * Must have sufficient command of the Japanese language to understand the study instructions and requirements * Must be a resident of Japan * Must have received prior treatment with: 1. a proteasome inhibitor, 2. an immunomodulatory agent, and 3. an anti-CD38 antibody Subjects must be either 2-4 months, 5-7 months, or 8-11 months post triple class therapy exposure at time of consent * Subject must be diagnosed with multiple myeloma Exclusion Criteria: * Participants enrolled in a clinical trial that includes at least one novel/ experimental agent at the point of questionnaire completion Other protocol-defined inclusion/exclusion criteria apply.
References
Publications (0)
Data not yet available
No reference posted for this study.