Registry for Adults With Plasma Cell Disorders (PCD's)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Multiple Myeloma, Amyloidosis, Cryoglobulinemia, Castleman's Disease. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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).
Detailed description
OBJECTIVES:
Primary
1. To create a Registry (to be called the PCD Registry) of PCD patients 2. To have participating patients complete an assessment at enrollment and to repeat the assessment longitudinally over time.
Secondary
1. To gather information, including patterns of patient care, that would lend support for future research in the PCD population. Specific research questions would be explored within separate IRB-reviewed protocols. 2. To bank blood samples for future research involving adults with PCD's, specifically examining p16INK4a and other markers to be specified in future, separate, IRB-approved protocols as specific research questions are identified.
OUTLINE: Patients complete an assessment at baseline and then longitudinally over time which involves a multi-dimensional inter-disciplinary evaluation of a patient's functional status (ability to live independently at home and in the community), co-morbid medical conditions, cognition, psychological status, social functioning and support, medication review, and nutritional status. Patients' medical records are also reviewed.
Primary outcome measures
- Creation of a Registry of Plasma Cell Disorder (PCD) patients [Time frame: 10 years]
- Completion of baseline and longitudinal assessments in PCD patients [Time frame: 10 years]
Secondary outcome measures (2)
- Creation of information that would lend support for future PCD research [Time frame: 10 years]
- Response rates of assessment in PCD patients and their satisfaction with the assessment [Time frame: 10 years]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- North Carolina Cancer Hospital — Chapel Hill
Identifiers
NCT: NCT03717844 · LCCC 1728