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

Multiple Myeloma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05217082
• Other study ID #: CA089-013
• Status: Completed
• 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
• 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.

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

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

External Links

•   BMS Clinical Trial Information
•   BMS Clinical Trial Patient Recruiting
•   FDA Safety Alerts and Recalls
•   Investigator Inquiry Form