NCT03717844 Registry for Adults With Plasma Cell Disorders (PCD's)
| NCT ID | NCT03717844 |
| Status | Recruiting |
| Phase | — |
| Sponsor | UNC Lineberger Comprehensive Cancer Center |
| Condition | Multiple Myeloma |
| Study Type | OBSERVATIONAL |
| Enrollment | 2,000 participants |
| Start Date | 2018-02-09 |
| Primary Completion | 2028-02 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 2,000 participants in total. It began in 2018-02-09 with a primary completion date of 2028-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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).
Eligibility Criteria
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.
Contact & Investigator
Sascha Tuchman, MD
PRINCIPAL INVESTIGATOR
UNC Lineberger Comprehensive Cancer Center
Frequently Asked Questions
Who can join the NCT03717844 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Multiple Myeloma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03717844 currently recruiting?
Yes, NCT03717844 is actively recruiting participants. Contact the research team at nicholas_mangieri@med.unc.edu for enrollment information.
Where is the NCT03717844 trial being conducted?
This trial is being conducted at Chapel Hill, United States.
Who is sponsoring the NCT03717844 clinical trial?
NCT03717844 is sponsored by UNC Lineberger Comprehensive Cancer Center. The principal investigator is Sascha Tuchman, MD at UNC Lineberger Comprehensive Cancer Center. The trial plans to enroll 2,000 participants.