---
title: A Study Assessing the Health-Related Quality of Life (HRQoL) in Participants With Relapsed and/or Refractory Multiple Myeloma (RRMM) With Triple Class Exposure
nct_id: NCT05217082
overall_status: COMPLETED
sponsor: Bristol-Myers Squibb
study_type: OBSERVATIONAL
primary_condition: Multiple Myeloma
countries: United States
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT05217082.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT05217082"
ct_last_update_post_date: 2023-06-09
last_seen_at: "2026-05-12T06:56:43.685Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# A Study Assessing the Health-Related Quality of Life (HRQoL) in Participants With Relapsed and/or Refractory Multiple Myeloma (RRMM) With Triple Class Exposure

**Official Title:** Health-Related Quality of Life (HRQoL) in Patients With Relapsed and/or Refractory Multiple Myeloma (RRMM) With Triple Class Exposure in Japan

**NCT ID:** [NCT05217082](https://clinicaltrials.gov/study/NCT05217082)

## Key Facts

- **Status:** COMPLETED
- **Study Type:** OBSERVATIONAL
- **Target Enrollment:** 35
- **Lead Sponsor:** Bristol-Myers Squibb
- **Conditions:** Multiple Myeloma
- **Start Date:** 2022-02-22
- **Completion Date:** 2022-08-03
- **CT.gov Last Update:** 2023-06-09

## Brief Summary

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.

## Eligibility

- **Minimum age:** 20 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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.
```

## Arms

- **Cohort 1** — Participants with relapsed/refractory multiple myeloma (RRMM) who have already received a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 antibody

## Primary Outcomes

- **Health-Related Quality of Life (HRQoL) in specific domains: Fatigue, as measured by EORTC QLQ-C30** _(time frame: Up to 1 year)_ — EORTC QLQ-C30 defined as European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30
- **HRQoL in specific domains: Pain, as measured by the EORTC QLQ-C30** _(time frame: Up to 1 year)_
- **HRQoL in specific domains: Physical Functioning as measured by the EORTC QLQ-C30** _(time frame: Up to 1 year)_
- **HRQoL in specific domains: Cognitive Functioning, as measured by the EORTC QLQ-C30** _(time frame: Up to 1 year)_
- **HRQoL in specific domains: Global health, as measured by the EORTC QLQ-C30** _(time frame: Up to 1 year)_
- **HRQoL in specific domains: Disease Symptoms as measured by the EORTC QLQ-MY20** _(time frame: Up to 1 year)_ — EORTC QLQ-MY20 defined as European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-MY20
- **HRQoL in specific domains: Side effects as measured by the EORTC QLQ-MY20** _(time frame: Up to 1 year)_

## Secondary Outcomes

- **HRQoL in specific domains: Functional Scale as measured by the EORTC QLQ-C30** _(time frame: Up to 1 year)_
- **HRQoL in specific domains: Symptoms Scale as measured by the EORTC QLQ-C30** _(time frame: Up to 1 year)_
- **HRQoL in specific domains: Global Health Status as measured by the EORTC QLQ-C30** _(time frame: Up to 1 year)_
- **HRQoL in specific domains: Future Perspective as measured by the EORTC QLQ-MY20** _(time frame: Up to 1 year)_
- **HRQoL in specific domains: Body Image as measured by the EORTC QLQ-MY20** _(time frame: Up to 1 year)_
- **HRQoL in specific domains: Generic HRQoL as measured by the EQ-5D-5L** _(time frame: Up to 1 year)_

## Locations (1)

- Local Institution - 0001, Morrisville, North Carolina, United States

## Recent Field Changes (last 30 days)

- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `locations.local institution - 0001|morrisville|north carolina|united states` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT05217082.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT05217082*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*