Multiple MyelomaNCT05217082
A Study Assessing the Health-Related Quality of Life (HRQoL) in Participants With Relapsed and/or Refractory Multiple Myeloma (RRMM) With Triple Class Exposure
An observational study of Multiple Myeloma, run by Bristol-Myers Squibb at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Multiple Myeloma
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Feb 2022to 3 Aug 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Local Institution - 0001
Morrisville, North Carolina, 27560
About this study
Official title: Health-Related Quality of Life (HRQoL) in Patients With Relapsed and/or Refractory Multiple Myeloma (RRMM) With Triple Class Exposure in Japan
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.
- Conditions
- Multiple Myeloma
- Keywords
- Multiple Myeloma, HRQoL, Relapsed, Refractory, Outcomes
- Medical subject headings
- Multiple Myeloma, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Participants with relapsed/refractory multiple myeloma (RRMM) who have already received a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 antibody |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Up to 1 year
HRQoL in specific domains: Pain, as measured by the EORTC QLQ-C30
Measured: Up to 1 year
HRQoL in specific domains: Physical Functioning as measured by the EORTC QLQ-C30
Measured: Up to 1 year
HRQoL in specific domains: Cognitive Functioning, as measured by the EORTC QLQ-C30
Measured: Up to 1 year
HRQoL in specific domains: Global health, as measured by the EORTC QLQ-C30
Measured: 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
Measured: Up to 1 year
HRQoL in specific domains: Side effects as measured by the EORTC QLQ-MY20
Measured: Up to 1 year
Secondary outcomes (6)
HRQoL in specific domains: Functional Scale as measured by the EORTC QLQ-C30
Measured: Up to 1 year
HRQoL in specific domains: Symptoms Scale as measured by the EORTC QLQ-C30
Measured: Up to 1 year
HRQoL in specific domains: Global Health Status as measured by the EORTC QLQ-C30
Measured: Up to 1 year
HRQoL in specific domains: Future Perspective as measured by the EORTC QLQ-MY20
Measured: Up to 1 year
HRQoL in specific domains: Body Image as measured by the EORTC QLQ-MY20
Measured: Up to 1 year
HRQoL in specific domains: Generic HRQoL as measured by the EQ-5D-5L
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2022
- Study start22 Feb 2022
- Primary completion3 Aug 2022
- Study completion3 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05217082
- Sponsor's protocol ID
- CA089-013
- Status last verified
- Jun 2023
- First submitted
- 20 Jan 2022
- Last updated
- 9 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health-Related Quality of Life (HRQoL) in Patients With Relapsed and/or Refractory Multiple Myeloma (RRMM) With Triple Class Exposure in Japan
- ClinicalTrials.gov ID
- NCT05217082
- Acronym / sponsor ID
- CA089-013
- Conditions
- Multiple Myeloma
- Keywords
- Multiple Myeloma, HRQoL, Relapsed, Refractory, Outcomes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 22 Feb 2022 (actual)
- Primary completion
- 3 Aug 2022 (actual)
- Study completion
- 3 Aug 2022 (actual)
- First posted
- 1 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | – | –Participants with relapsed/refractory multiple myeloma (RRMM) who have already received a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 antibody |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- 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:
- Subject must be diagnosed with multiple myeloma
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Health-Related Quality of Life (HRQoL) in specific domains: Fatigue, as measured by EORTC QLQ-C30
Time frame: Up to 1 year
EORTC QLQ-C30 defined as European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30
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
Time frame: Up to 1 year
EORTC QLQ-MY20 defined as European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-MY20
HRQoL in specific domains: Side effects as measured by the EORTC QLQ-MY20
Time frame: Up to 1 year
6 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
HRQoL in specific domains: Global Health Status as measured by the EORTC QLQ-C30
Time frame: Up to 1 year
HRQoL in specific domains: Future Perspective as measured by the EORTC QLQ-MY20
Time frame: Up to 1 year
HRQoL in specific domains: Body Image as measured by the EORTC QLQ-MY20
Time frame: Up to 1 year
HRQoL in specific domains: Generic HRQoL as measured by the EQ-5D-5L
Time frame: Up to 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2023.
- BMS Clinical Trial InformationLink provided by the sponsor.
- Investigator Inquiry FormLink provided by the sponsor.
- FDA Safety Alerts and RecallsLink provided by the sponsor.
- BMS Clinical Trial Patient RecruitingLink provided by the sponsor.
Related trials for Multiple Myeloma
Not yet recruitingPhase 2
Study of YKST02 in Adults With Relapsed or Refractory Multiple Myeloma
Relapsed or Refractory Multiple Myeloma (RRMM)
RecruitingPhase 2
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
Multiple Myeloma
Active, not recruitingPhase 3
A Phase III Study of Eque-cel in Subjects With Len-refractory RRMM (FUMANBA-03)
Multiple Myeloma
Active, not recruitingPhase 1/2
A Window of Opportunity Trial to Learn if Linvoseltamab is Safe and Well Tolerated, and How Well it Works in Adult Participants With Recently Diagnosed Multiple Myeloma Who Have Not Already Received Treatment
Multiple Myeloma
Active, not recruitingPhase 2
Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Myeloma, run by Bristol-Myers Squibb at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health-Related Quality of Life (HRQoL) in specific domains: Fatigue, as measured by EORTC QLQ-C30 (time frame: Up to 1 year). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2023.