NCT05217082

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 20, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 1, 2022

Completed
21 days until next milestone

Study Start

First participant enrolled

February 22, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 3, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 3, 2022

Completed
Last Updated

June 9, 2023

Status Verified

June 1, 2023

Enrollment Period

5 months

First QC Date

January 20, 2022

Last Update Submit

June 8, 2023

Conditions

Multiple Myeloma

Keywords

Multiple MyelomaHRQoLRelapsedRefractoryOutcomes

Outcome Measures

Primary Outcomes (7)

  • 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

  • HRQoL in specific domains: Pain, as measured by the EORTC QLQ-C30

    Up to 1 year

  • HRQoL in specific domains: Physical Functioning as measured by the EORTC QLQ-C30

    Up to 1 year

  • HRQoL in specific domains: Cognitive Functioning, as measured by the EORTC QLQ-C30

    Up to 1 year

  • HRQoL in specific domains: Global health, as measured by the EORTC QLQ-C30

    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

    Up to 1 year

  • HRQoL in specific domains: Side effects as measured by the EORTC QLQ-MY20

    Up to 1 year

Secondary Outcomes (6)

  • HRQoL in specific domains: Functional Scale as measured by the EORTC QLQ-C30

    Up to 1 year

  • HRQoL in specific domains: Symptoms Scale as measured by the EORTC QLQ-C30

    Up to 1 year

  • HRQoL in specific domains: Global Health Status as measured by the EORTC QLQ-C30

    Up to 1 year

  • HRQoL in specific domains: Future Perspective as measured by the EORTC QLQ-MY20

    Up to 1 year

  • HRQoL in specific domains: Body Image as measured by the EORTC QLQ-MY20

    Up to 1 year

  • +1 more secondary outcomes

Study Arms (1)

Cohort 1

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

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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:
  • a proteasome inhibitor,
  • an immunomodulatory agent, and
  • 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

You may not qualify if:

  • Participants enrolled in a clinical trial that includes at least one novel/ experimental agent at the point of questionnaire completion

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Local Institution - 0001

Morrisville, North Carolina, 27560, United States

Location

Related Links

MeSH Terms

Conditions

Multiple MyelomaRecurrence

Condition Hierarchy (Ancestors)

Neoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 20, 2022

First Posted

February 1, 2022

Study Start

February 22, 2022

Primary Completion

August 3, 2022

Study Completion

August 3, 2022

Last Updated

June 9, 2023

Record last verified: 2023-06

Locations

US(1)