Multiple Myeloma Clinical Trial
Official title:
Registry for Adults With Plasma Cell Disorders (PCD's)
NCT number | NCT03717844 |
Other study ID # | LCCC 1728 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | February 9, 2018 |
Est. completion date | February 2029 |
The primary purpose of this protocol is to create a registry of patients with plasma cell disorders (PCDs), including for example the cancer multiple myeloma (MM), who complete the assessment, previously known as a "geriatric assessment," as is outlined in this protocol. Secondary objectives include measuring the response rate to participation of patients in this study, assessing patient satisfaction with the questionnaire, and gathering information that would lend support for future research into these types of assessments in patients with PCDs. Additionally the study offers an optional blood draw to look at a genetic marker of aging called p16INK4a (IRB 15-1899, IRB 15-0244).
Status | Recruiting |
Enrollment | 2000 |
Est. completion date | February 2029 |
Est. primary completion date | February 2028 |
Accepts healthy volunteers | |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. - Age =18 years. - Must consent to participation in this study and agree to complete the assessment at baseline and follow-up time points. - Must be able to read and speak English. Exclusion Criteria: - Physical or psychiatric/behavioral illnesses or problems that the treating clinician feels would preclude successful participation in the study. - There are no imaging or lab studies required to determine eligibility. |
Country | Name | City | State |
---|---|---|---|
United States | North Carolina Cancer Hospital | Chapel Hill | North Carolina |
Lead Sponsor | Collaborator |
---|---|
UNC Lineberger Comprehensive Cancer Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Creation of a Registry of Plasma Cell Disorder (PCD) patients | 10 years | ||
Primary | Completion of baseline and longitudinal assessments in PCD patients | 10 years | ||
Secondary | Creation of information that would lend support for future PCD research | Including patterns of patient care that would lend support for future research in patients with confirmed PCD's. | 10 years | |
Secondary | Response rates of assessment in PCD patients and their satisfaction with the assessment | Done by measuring:
percentage of patients contacted who consent to complete the assessment percentage of patients able to complete the self-administered portion of the assessment without assistance the length of time necessary to complete the assessment the variance and number of missing items the percentage of geriatric assessments that contain all three of the following items: Timed Up and Go Assessment, Blessed Orientation-Memor Concentration Test, and the healthcare professional-rated Karnofsky performance status. |
10 years |
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