2000 Participants Needed

Registry for Multiple Myeloma

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NM
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Overseen ByKendall Conder
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: UNC Lineberger Comprehensive Cancer Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 2 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to gather information on patients with plasma cell disorders (PCDs), such as multiple myeloma, using a geriatric assessment, which is a comprehensive evaluation of an older adult's health and functional status. The study will examine patient responses to the assessment and their satisfaction with it. An optional blood test will check a genetic marker related to aging. Patients diagnosed with a PCD, receiving care at UNC Cancer Hospitals or affiliated sites, and able to complete the assessment may be suitable for this trial. As an unphased trial, this study offers patients the chance to contribute to research that could enhance care for older adults with PCDs.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It would be best to discuss this with the study team or your doctor.

What prior data suggests that this protocol is safe for patients with plasma cell disorders?

Research has shown that geriatric assessments are generally safe. These assessments evaluate physical health, mental well-being, and social support. Being non-invasive, they do not involve surgery or entering the body, so most individuals tolerate them well. No reports of serious side effects have emerged from these assessments.

Prospective participants in a study involving a geriatric assessment can feel confident about its safety. The process resembles a detailed health check-up and helps doctors understand how various factors affect aging and health.

Why are researchers excited about this trial?

Researchers are excited about using geriatric assessment for plasma cell disorders (PCDs) because it focuses on understanding the broader health needs of older adults with these conditions, rather than just the disease itself. Unlike traditional treatments that primarily target the cancer cells, a geriatric assessment evaluates a patient's overall health, including physical function, mental health, and social support, to tailor a more personalized treatment plan. This approach can potentially improve the quality of life and treatment outcomes for older patients with PCDs, who often face unique challenges due to age-related factors.

What evidence suggests that this geriatric assessment is effective for patients with plasma cell disorders?

Research has shown that thorough health check-ups for older adults, known as comprehensive geriatric assessments (CGA), can lead to better health outcomes. One study found that CGA improved memory and thinking skills in patients three months after the check-up. Another study demonstrated that CGA lowered death rates for frail older patients six months later. Additionally, CGA helps doctors identify issues like memory problems and depression, leading to better care. These findings suggest that CGA could benefit people with plasma cell disorders, potentially enhancing their overall health and well-being.12345

Who Is on the Research Team?

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Sascha Tuchman, MD

Principal Investigator

UNC Lineberger Comprehensive Cancer Center

Are You a Good Fit for This Trial?

Inclusion Criteria

Patients have an outpatient appointment or are hospitalized inpatient at UNC Cancer Hospitals, or affiliated clinic settings or participating sites for the evaluation and management of a PCD.
Patients have a documented diagnosis of PCD defined as the presence of a monoclonal protein and/or monoclonal plasma cell population. Examples of PCDs include but are not limited to monoclonal gammopathy of uncertain significance; smoldering myeloma; multiple (active) myeloma; plasma cell leukemia; Castleman's disease; amyloidosis; light and/or heavy chain deposition disease; Polyneuropathy, Organomegaly, Endocrinopathy,Monoclonal gammopathy and Skin changes (POEMS) syndrome; and cryoglobulinemia.
Must consent to participation in this study and agree to complete the assessment at baseline and follow-up time points.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

Baseline Assessment

Participants complete a multi-dimensional inter-disciplinary evaluation of functional status, co-morbid conditions, cognition, psychological status, social functioning, medication review, and nutritional status

Initial visit

Longitudinal Assessment

Participants repeat the assessment longitudinally over time to monitor changes in functional status and other health parameters

10 years

Follow-up

Participants are monitored for safety and effectiveness after assessments

10 years

What Are the Treatments Tested in This Trial?

Interventions

  • Geriatric Assessment

Find a Clinic Near You

Who Is Running the Clinical Trial?

UNC Lineberger Comprehensive Cancer Center

Lead Sponsor

Trials
377
Recruited
95,900+

Citations

Comprehensive geriatric assessment - UpToDateINTRODUCTION. Geriatric conditions such as functional impairment and dementia are common and frequently unrecognized or inadequately ...
The effectiveness of comprehensive geriatric assessment ...This study showed a significant improvement in cognitive function favoring the CGA group at three months but found no significant difference at ...
Effectiveness of comprehensive geriatric assessment in ...CGA did not significantly reduce overall mortality in frail older inpatients compared to usual care but lowered mortality rates at the 6-month follow-up.
Effectiveness of comprehensive geriatric assessment adapted ...Our results suggest that a primary care CGA may have no impact on health-related quality of life; this finding differs from that of the Cochrane ...
geriatric assessment across healthcare settingsCGA helped general clinicians detect geriatric syndromes (eg, cognitive impairment, depression, and incontinence), resulting in better psychological care and ...
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