A Study Assessing the Health-Related Quality of Life (HRQoL) in Participants With Relapsed and/or Refractory Multiple Myeloma (RRMM) With Triple Class Exposure

Bristol-Myers Squibb35 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Multiple Myeloma

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

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.

Locations (1)

Local Institution - 0001

Morrisville, North Carolina, United States

Outcomes

Primary Outcomes

Health-Related Quality of Life (HRQoL) in specific domains: Fatigue, as measured by EORTC QLQ-C30

EORTC QLQ-C30 defined as European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30

Time frame: Up to 1 year

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

EORTC QLQ-MY20 defined as European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-MY20

Time frame: Up to 1 year

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

Data from ClinicalTrials.gov

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