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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05217082
Other study ID # CA089-013
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 22, 2022
Est. completion date August 3, 2022

Study information

Verified date June 2023
Source Bristol-Myers Squibb
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 35
Est. completion date August 3, 2022
Est. primary completion date August 3, 2022
Accepts healthy volunteers No
Gender All
Age group 20 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States Local Institution - 0001 Morrisville North Carolina

Sponsors (1)

Lead Sponsor Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Up to 1 year
Primary HRQoL in specific domains: Pain, as measured by the EORTC QLQ-C30 Up to 1 year
Primary HRQoL in specific domains: Physical Functioning as measured by the EORTC QLQ-C30 Up to 1 year
Primary HRQoL in specific domains: Cognitive Functioning, as measured by the EORTC QLQ-C30 Up to 1 year
Primary HRQoL in specific domains: Global health, as measured by the EORTC QLQ-C30 Up to 1 year
Primary 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 Up to 1 year
Primary HRQoL in specific domains: Side effects as measured by the EORTC QLQ-MY20 Up to 1 year
Secondary HRQoL in specific domains: Functional Scale as measured by the EORTC QLQ-C30 Up to 1 year
Secondary HRQoL in specific domains: Symptoms Scale as measured by the EORTC QLQ-C30 Up to 1 year
Secondary HRQoL in specific domains: Global Health Status as measured by the EORTC QLQ-C30 Up to 1 year
Secondary HRQoL in specific domains: Future Perspective as measured by the EORTC QLQ-MY20 Up to 1 year
Secondary HRQoL in specific domains: Body Image as measured by the EORTC QLQ-MY20 Up to 1 year
Secondary HRQoL in specific domains: Generic HRQoL as measured by the EQ-5D-5L Up to 1 year
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