Multiple MyelomaNCT06610045
The Burden of Multiple Myeloma on Patients and Caregivers Quality of Life: a Canadian Real-World Study
An observational study of Multiple Myeloma and Caregiver Subjective Burden, run by PeriPharm at 1 site in Canada.
Trial summary
The purpose of this observational study is to estimate the burden of multiple myeloma on patients and caregivers in terms of QoL. Additionally, this study will assess the correlation between QoL, obtained from commonly used and validated questionnaires, and the perceptions of both patients and caregivers… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Multiple Myeloma, Caregiver Subjective Burden, Quality of Life (QOL)
- How many people
- 400 participants
- Where
- 1 siteCanada
- Study dates
- 15 Oct 2024to 12 Mar 2025
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with myeloma and caregivers of patients with myeloma who are part of Myeloma Canada database
Who may be able to join
- 18 years of age or older;
- Part of the Myeloma Canada database;
- Identified as a patient with MM or
- Identified as a current caregiver of a patient with MM at the time of participation.
- Ability to read and understand English or French;
- Signature of informed consent form (ICF).
Who cannot join
- No exclusion criteria
Trial locations and contacts
1 site in 1 country.
Canada1 site
PROxy Network, an initiative of PeriPharm inc.
Montreal, Quebec, H2Y 2H4
About this study
The purpose of this observational study is to estimate the burden of multiple myeloma on patients and caregivers in terms of QoL. Additionally, this study will assess the correlation between QoL, obtained from commonly used and validated questionnaires, and the perceptions of both patients and caregivers respectively., obtain from a 10-point scale and a comment box.
Read the detailed description
Potential participants will be identified by Myeloma Canada using their database. Myeloma Canada is a registered non-profit organization created by, and for, Canadians impacted by multiple myeloma. As part of Myeloma Canada website, patients and caregivers can subscribe to a mailing list to receive their monthly newsletter and to participate in surveys. This database comprises about 5,000 individuals, including patients and caregivers.
An e-mail will be sent to 600 patients and 200 caregivers randomly selected to invited them to participate in the survey. Interested participants will be invited to visit the Participant Portal on the PROxy website (https://periproxy.com/en), to sign the informed consent form and complete online questionnaires. Upon request, paper-based documents (i.e., informed consent form and questionnaires) can also be sent by mail. The following questionnaires will be used:
Patients
- Patient Information Questionnaire (i.e., baseline characteristics)
- EORTC QLQ-C30
- EORTC QLQ-MY20
- EQ-5D-5L
- ESAS-R
- Patients Perspective
Caregivers
- Caregiver Information Questionnaire (i.e., baseline characteristics)
- CarGOQoL
- Caregivers Perspective
If the sample size (i.e., 300 patients and 100 caregivers) is not reached one month after the first e-mail, an invitation e-mail will be sent to an additional 600 eligible patients and/or 200 caregivers randomly selected. This scheme of participant identification will be performed until the sample size is reached.
- Being tested
- No intervention
- Keywords
- quality of life, real-world, observational, myeloma, caregiver
- Medical subject headings
- Multiple Myeloma, Neoplasms, Plasma Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No specific intervention is assess in this study.
| Study group | Role | What they receive |
|---|---|---|
| Patients with multiple myeloma | Patients with multiple myeloma member of Myeloma Canada database Receives: Other: No intervention | |
| Caregivers of patients with myeloma | Caregiver of a multiple myeloma patient member of Myeloma Canada database Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
To estimate quality of life of patients with myeloma and caregivers of patients with myeloma
Measured: From enrollment until sample size is reached
Secondary outcomes (1)
To assess the correlation between QoL scores and perception of patients and caregivers respectively
Measured: From recruitment until sample size is reached
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2024
- Study start15 Oct 2024
- Primary completion24 Feb 2025
- Study completion12 Mar 2025
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.
- 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
- Cross-sectional
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- PeriPharm
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06610045
- Sponsor's protocol ID
- PROxy202301
- Status last verified
- Mar 2025
- First submitted
- 12 Sep 2024
- Last updated
- 13 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Burden of Multiple Myeloma on Patients and Caregivers Quality of Life: a Canadian Real-World Study
- ClinicalTrials.gov ID
- NCT06610045
- Acronym / sponsor ID
- PROxy202301
- Keywords
- quality of life, real-world, observational, myeloma, caregiver
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- PeriPharmUniversity, hospital or other
- Study start
- 15 Oct 2024 (actual)
- Primary completion
- 24 Feb 2025 (actual)
- Study completion
- 12 Mar 2025 (actual)
- First posted
- 24 Sep 2024 (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 estimate the burden of multiple myeloma on patients and caregivers in terms of QoL. Additionally, this study will assess the correlation between QoL, obtained from commonly used and validated questionnaires, and the perceptions of both patients and caregivers respectively., obtain from a 10-point scale and a comment box.
Detailed description
Potential participants will be identified by Myeloma Canada using their database. Myeloma Canada is a registered non-profit organization created by, and for, Canadians impacted by multiple myeloma. As part of Myeloma Canada website, patients and caregivers can subscribe to a mailing list to receive their monthly newsletter and to participate in surveys. This database comprises about 5,000 individuals, including patients and caregivers.
An e-mail will be sent to 600 patients and 200 caregivers randomly selected to invited them to participate in the survey. Interested participants will be invited to visit the Participant Portal on the PROxy website (https://periproxy.com/en), to sign the informed consent form and complete online questionnaires. Upon request, paper-based documents (i.e., informed consent form and questionnaires) can also be sent by mail. The following questionnaires will be used:
Patients
- Patient Information Questionnaire (i.e., baseline characteristics)
- EORTC QLQ-C30
- EORTC QLQ-MY20
- EQ-5D-5L
- ESAS-R
- Patients Perspective
Caregivers
- Caregiver Information Questionnaire (i.e., baseline characteristics)
- CarGOQoL
- Caregivers Perspective
If the sample size (i.e., 300 patients and 100 caregivers) is not reached one month after the first e-mail, an invitation e-mail will be sent to an additional 600 eligible patients and/or 200 caregivers randomly selected. This scheme of participant identification will be performed until the sample size is reached.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with multiple myeloma | – | Other: No interventionPatients with multiple myeloma member of Myeloma Canada database |
| Caregivers of patients with myeloma | – | Other: No interventionCaregiver of a multiple myeloma patient member of Myeloma Canada database |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with myeloma and caregivers of patients with myeloma who are part of Myeloma Canada database
Key inclusion criteria (6 listed)
- 18 years of age or older;
- Part of the Myeloma Canada database;
- Ability to read and understand English or French;
- Signature of informed consent form (ICF).
Key exclusion criteria (1 listed)
- No exclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo specific intervention is assess in this study. | Other | Caregivers of patients with myeloma, Patients with multiple myeloma |
Primary outcome
To estimate quality of life of patients with myeloma and caregivers of patients with myeloma
Time frame: From enrollment until sample size is reached
1 secondary outcome
To assess the correlation between QoL scores and perception of patients and caregivers respectively
Time frame: From recruitment until sample size is reached
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 13 Mar 2025.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
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 and Caregiver Subjective Burden, run by PeriPharm at 1 site in Canada.
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 6 inclusion and 1 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 13 Mar 2025. 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 Canada. 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?
To estimate quality of life of patients with myeloma and caregivers of patients with myeloma (time frame: From enrollment until sample size is reached). 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 13 Mar 2025.