Multiple MyelomaNCT04999085
Geriatric-assessment Interventions to Address Functional Deficits in Older Adults w Multiple Myeloma
A study testing Supportive care interventions in people with Multiple Myeloma and Myeloma, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.
Trial summary
Myeloma is the second most common type of blood cancer in the United States. Myeloma most commonly affects older adults. While some younger individuals do get myeloma, the average age when people are first diagnosed with myeloma is around 69 to 70. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Multiple Myeloma, Myeloma, Disability Physical
- What is being tested?
- Supportive care interventions
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2021to 4 Aug 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients age 60 years or older with a confirmed diagnosis of multiple myeloma currently undergoing or planned to begin treatment for multiple myeloma.
- Enrollment in an existing registry of individuals with plasma cell disorder (ClinicalTrials.gov identifier NCT03717844; institutional protocol # LCCC1728)
- Be willing and capable of providing informed consent.
- Presence of at least one intervenable deficit on the most recent registry assessment:
- Activities of daily living score < 14.
- Instrumental activities of living score < 14.
Show all 13Show fewer
- Timed Up and Go test = 14 seconds (or unable to complete the test).
- One fall in the prior 6 months.
- Eyesight poor or worse.
- Hearing poor or worse.
- Number of daily medications 10 or greater.
- Mental Health Index-13 Depression score 12 or greater.
- Mental Health Index-13 Anxiety score 6 or greater.
Who cannot join
- Has dementia, altered mental status, or any psychiatric or co-morbid condition prohibiting the understanding or rendering of informed consent.
Trial locations and contacts
1 site in 1 country.
United States1 site
The N.C. Cancer Hospital
Chapel Hill, North Carolina, 27514
About this study
Official title: Geriatric-assessment-guided Interventions to Address Functional Deficits in Older Adults Undergoing Treatment for Multiple Myeloma
Myeloma is the second most common type of blood cancer in the United States. Myeloma most commonly affects older adults. While some younger individuals do get myeloma, the average age when people are first diagnosed with myeloma is around 69 to 70.
Along with having a higher risk for myeloma, older adults have an increased chance of developing other health problems or issues. However, not everyone ages in the same way. Some older adults experience major changes in health or degree of independence at relatively younger ages, while others remain quite healthy for many years. The specific issues that develop with age can also vary from person to person. One older adult may face difficulties with vision or hearing, while another may develop memory problems.
Read more
Historically, cancer doctors have not done a very good job identifying these non-cancer issues. As a result, research has focused on better ways to systematically pick up on issues that may impact cancer outcomes or quality of life. The outgrowth of this research is assessments and questionnaires referred to as "comprehensive geriatric assessments," which evaluate the health and functionality of older adults thoroughly but efficiently. In both myeloma and other types of cancer, problems identified through geriatric assessments have been shown to predict how likely people are to develop side effects of cancer treatment and predict how long people are likely to live with cancer.
Prior research has not addressed how best to help with the issues picked up through a geriatric assessment among patients undergoing treatment for myeloma, although a number of effective interventions have been shown to benefit older adults with similar problems in other settings. Therefore, the current study will test a strategy of systematically screening older adults undergoing myeloma treatment for geriatric-assessment-related deficits and referring participants to appropriate services and resources. The geriatric assessment in this study includes tests of mobility, memory, vision, hearing, and nutrition as well as questions about symptoms and social support. Individuals who have deficits in one of these areas will be referred to relevant services and resources such as physical therapy, a pharmacist, or the cancer center support program. They will then repeat the same assessment three months later, and the results will be compared to their original assessment to see if the deficit has improved, with particular attention to mobility and social support.
Read the detailed description
STUDY OUTLINE
Study participants complete a baseline Geriatric Assessment and European Organization for Research and Treatment of Cancer (EORTC) Quality of Life of Cancer Patients (QLQ) Core 30 (C30) and Myeloma supplement (MY20) questionnaires, either at the time of enrollment or as part of previous research studies.
Based on these assessments, an intervention strategy is developed by Study Team. These interventions largely consist of referrals to relevant specialists and existing services. These recommendations are communicated to the study participant, and participant-approved intervention referrals are made.
Following an initial appointment with these specialists, further follow-up will be determined based on the subject and specialist without input from the Study Team.
At three months from enrollment, study participants will be asked to complete a follow-up geriatric assessment, repeat EORTC questionnaires, and a satisfaction /feedback survey.
Duration of Therapy:
For patients referred to specialists as above, the duration of treatment or care with the specialist will be determined based on an agreement between the specialist and study participant.
Duration of Follow-up:
As part of this study, participants will only be followed through the three-month follow-up assessment described above. For subjects participating in or recruited from other research studies, follow-up according to those other protocols will continue.
- Conditions
- Multiple Myeloma, Myeloma, Disability Physical, Disabilities Multiple
- Being tested
- Supportive care interventions
- Keywords
- Geriatric assessment, Supportive care, Disability, Functional assessment
- 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.
Supportive care interventionsOther
Subjects will be referred to specialists and/or supportive care interventions based on issues/deficits identified on a baseline geriatric assessment. These interventions will be selected based on deficits or problems identified on baseline assessments. These include referral to physical/occupational therapy for those with physical deficits (Activities of Daily Living impairment, Instrumental Activities of Daily Living impairment, Timed Up and Go, or falls), to optometry/ophthalmology (for visual impairment), to audiology (for hearing impairment), to pharmacist (for polypharmacy), and to cancer center support program (for Mental Health Index 13 criteria).
| Study group | Role | What they receive |
|---|---|---|
| Supportive Care | Experimental | Not described Receives: Other: Supportive care interventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intervention Attendance (Feasibility)
Attendance at at least one appointment for a specialty / supportive care resource to which the subject is referred. The result is reported as the number of participants who attend at least one such appointment.
Measured: Up to 3 months from enrollment
Secondary outcomes (1)
Subject Satisfaction With Program (Acceptability)
Subject satisfaction with the intervention program, will be assessed by a single-item 5-point from 1 to 5, Likert scale response, with higher scores indicating greater satisfaction and lower scores indicating less satisfaction. The mean score reported by study participants will be reported.
Measured: 3 months from enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2021
- Study start1 Dec 2021
- Primary completion4 Aug 2023
- Study completion4 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by UNC Lineberger Comprehensive Cancer CenterThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single-arm pilot study of supportive care interventions
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Conquer Cancer Foundation
- Responsible party
- Sponsor
- Investigators
- Christopher E Jensen, MD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04999085
- Sponsor's protocol ID
- LCCC 2101
- Other IDs
- 2021YIA-7316118933
- Status last verified
- Feb 2025
- First submitted
- 2 Aug 2021
- Last updated
- 28 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- 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 28 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Geriatric-assessment-guided Interventions to Address Functional Deficits in Older Adults Undergoing Treatment for Multiple Myeloma
- ClinicalTrials.gov ID
- NCT04999085
- Acronym / sponsor ID
- LCCC 2101
- Conditions
- Multiple Myeloma, Myeloma, Disability Physical, Disabilities Multiple
- Keywords
- Geriatric assessment, Supportive care, Disability, Functional assessment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- UNC Lineberger Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- Conquer Cancer Foundation
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 4 Aug 2023 (actual)
- Study completion
- 4 Aug 2023 (actual)
- First posted
- 10 Aug 2021 (actual)
- Results
- Posted 25 Sep 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Myeloma is the second most common type of blood cancer in the United States. Myeloma most commonly affects older adults. While some younger individuals do get myeloma, the average age when people are first diagnosed with myeloma is around 69 to 70.
Along with having a higher risk for myeloma, older adults have an increased chance of developing other health problems or issues. However, not everyone ages in the same way. Some older adults experience major changes in health or degree of independence at relatively younger ages, while others remain quite healthy for many years. The specific issues that develop with age can also vary from person to person. One older adult may face difficulties with vision or hearing, while another may develop memory problems.
Historically, cancer doctors have not done a very good job identifying these non-cancer issues. As a result, research has focused on better ways to systematically pick up on issues that may impact cancer outcomes or quality of life. The outgrowth of this research is assessments and questionnaires referred to as "comprehensive geriatric assessments," which evaluate the health and functionality of older adults thoroughly but efficiently. In both myeloma and other types of cancer, problems identified through geriatric assessments have been shown to predict how likely people are to develop side effects of cancer treatment and predict how long people are likely to live with cancer.
Prior research has not addressed how best to help with the issues picked up through a geriatric assessment among patients undergoing treatment for myeloma, although a number of effective interventions have been shown to benefit older adults with similar problems in other settings. Therefore, the current study will test a strategy of systematically screening older adults undergoing myeloma treatment for geriatric-assessment-related deficits and referring participants to appropriate services and resources. The geriatric assessment in this study includes tests of mobility, memory, vision, hearing, and nutrition as well as questions about symptoms and social support. Individuals who have deficits in one of these areas will be referred to relevant services and resources such as physical therapy, a pharmacist, or the cancer center support program. They will then repeat the same assessment three months later, and the results will be compared to their original assessment to see if the deficit has improved, with particular attention to mobility and social support.
Detailed description
STUDY OUTLINE
Study participants complete a baseline Geriatric Assessment and European Organization for Research and Treatment of Cancer (EORTC) Quality of Life of Cancer Patients (QLQ) Core 30 (C30) and Myeloma supplement (MY20) questionnaires, either at the time of enrollment or as part of previous research studies.
Based on these assessments, an intervention strategy is developed by Study Team. These interventions largely consist of referrals to relevant specialists and existing services. These recommendations are communicated to the study participant, and participant-approved intervention referrals are made.
Following an initial appointment with these specialists, further follow-up will be determined based on the subject and specialist without input from the Study Team.
At three months from enrollment, study participants will be asked to complete a follow-up geriatric assessment, repeat EORTC questionnaires, and a satisfaction /feedback survey.
Duration of Therapy:
For patients referred to specialists as above, the duration of treatment or care with the specialist will be determined based on an agreement between the specialist and study participant.
Duration of Follow-up:
As part of this study, participants will only be followed through the three-month follow-up assessment described above. For subjects participating in or recruited from other research studies, follow-up according to those other protocols will continue.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-arm pilot study of supportive care interventions
| Arm | Type | Receives |
|---|---|---|
| Supportive Care | Experimental | Other: Supportive care interventions |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Patients age 60 years or older with a confirmed diagnosis of multiple myeloma currently undergoing or planned to begin treatment for multiple myeloma.
- Enrollment in an existing registry of individuals with plasma cell disorder (ClinicalTrials.gov identifier NCT03717844; institutional protocol # LCCC1728)
- Be willing and capable of providing informed consent.
- Activities of daily living score < 14.
- Instrumental activities of living score < 14.
Key exclusion criteria (1 listed)
- Has dementia, altered mental status, or any psychiatric or co-morbid condition prohibiting the understanding or rendering of informed consent.
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 |
|---|---|---|
| Supportive care interventionsSubjects will be referred to specialists and/or supportive care interventions based on issues/deficits identified on a baseline geriatric assessment. These interventions will be selected based on deficits or problems identified on baseline assessments. These include referral to physical/occupational therapy for those with physical deficits (Activities of Daily Living impairment, Instrumental Activities of Daily Living impairment, Timed Up and Go, or falls), to optometry/ophthalmology (for visual impairment), to audiology (for hearing impairment), to pharmacist (for polypharmacy), and to cancer center support program (for Mental Health Index 13 criteria). | Other | Supportive Care |
Primary outcome
Intervention Attendance (Feasibility)
Time frame: Up to 3 months from enrollment
Attendance at at least one appointment for a specialty / supportive care resource to which the subject is referred. The result is reported as the number of participants who attend at least one such appointment.
1 secondary outcome
Subject Satisfaction With Program (Acceptability)
Time frame: 3 months from enrollment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- University of North Carolina (UNC) Lineberger Comprehensive Cancer CenterLink provided by the sponsor.
- 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.
Christopher E Jensen, MD principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supportive care interventions in people with Multiple Myeloma and Myeloma, run by UNC Lineberger Comprehensive Cancer Center 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 13 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 28 Feb 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 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?
Yes. Results are posted in the registry (first posted 25 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Intervention Attendance (Feasibility) (time frame: Up to 3 months from enrollment). 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 28 Feb 2025.