Registry for adults with plasma cell disorders
Registry for Adults With Plasma Cell Disorders (PCD's)
UNC Lineberger Comprehensive Cancer Center · NCT03717844
This study is creating a registry for adults with plasma cell disorders like multiple myeloma to track their health and care experiences over time while also collecting blood samples for future research.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 2000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | UNC Lineberger Comprehensive Cancer Center (other) |
| Locations | 1 site (Chapel Hill, North Carolina) |
| Trial ID | NCT03717844 on ClinicalTrials.gov |
What this trial studies
This study aims to create a registry for patients diagnosed with plasma cell disorders (PCDs) such as multiple myeloma and amyloidosis. Participants will complete a comprehensive assessment at enrollment and periodically thereafter to evaluate their functional status, co-morbid conditions, and overall well-being. The study also seeks to gather data on patient care patterns and satisfaction, while banking blood samples for future research on genetic markers related to aging. This longitudinal approach will help inform future studies and improve understanding of PCDs.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with a documented diagnosis of a plasma cell disorder who are receiving care at UNC Cancer Hospitals or affiliated clinics.
Not a fit: Patients with significant physical or psychiatric conditions that may interfere with participation or assessment may not benefit from this study.
Why it matters
Potential benefit: If successful, this registry could enhance patient care and inform future research on plasma cell disorders.
How similar studies have performed: While this approach is observational and registry-based, similar studies have successfully contributed to understanding and managing various hematological conditions.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Chapel Hill, North Carolina
- North Carolina Cancer Hospital — Chapel Hill, North Carolina, United States (RECRUITING)
Study contacts
- Principal investigator: Sascha Tuchman, MD — UNC Lineberger Comprehensive Cancer Center
- Study coordinator: Nicholas Mangieri
- Email: nicholas_mangieri@med.unc.edu
- Phone: (919) 966-4432
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Multiple Myeloma, Amyloidosis, Cryoglobulinemia, Castleman's Disease, Light Chain Deposition Disease, Heavy Chain Deposition Disease, Polyneuropathy Organomegaly Endocrinopathy Monoclonal Gammopathy and Skin Changes, Smoldering Multiple Myeloma