Clinical trial NCT05217082: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Myeloma
Keywords: Multiple Myeloma
HRQoL
Relapsed
Refractory
Outcomes
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2022-02-01
Enrollment: 35
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The target population will consist of approximately 50 participants diagnosed with relapsed/refractory multiple myeloma (RRMM) with triple class therapy exposure identified by physicians.

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 criteria: 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.

Primary outcomes:
measure: Health-Related Quality of Life (HRQoL) in specific domains: Fatigue, as measured by EORTC QLQ-C30
timeFrame: Up to 1 year
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
measure: HRQoL in specific domains: Cognitive Functioning, as measured by the EORTC QLQ-C30
timeFrame: Up to 1 year
measure: HRQoL in specific domains: Global health, as measured by the EORTC QLQ-C30
timeFrame: Up to 1 year
measure: HRQoL in specific domains: Disease Symptoms as measured by the EORTC QLQ-MY20
timeFrame: Up to 1 year
measure: HRQoL in specific domains: Side effects as measured by the EORTC QLQ-MY20
timeFrame: Up to 1 year
Secondary outcomes:
measure: HRQoL in specific domains: Functional Scale as measured by the EORTC QLQ-C30
timeFrame: Up to 1 year
measure: HRQoL in specific domains: Symptoms Scale as measured by the EORTC QLQ-C30
timeFrame: Up to 1 year
measure: HRQoL in specific domains: Global Health Status as measured by the EORTC QLQ-C30
timeFrame: Up to 1 year
measure: HRQoL in specific domains: Future Perspective as measured by the EORTC QLQ-MY20
timeFrame: Up to 1 year
measure: HRQoL in specific domains: Body Image as measured by the EORTC QLQ-MY20
timeFrame: Up to 1 year
measure: HRQoL in specific domains: Generic HRQoL as measured by the EQ-5D-5L
timeFrame: Up to 1 year
Other outcomes:
Locations:
city: Morrisville
country: United States
facility: Local Institution - 0001
state: North Carolina
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: