Clinical trial NCT03717844: Registry for Adults With Plasma Cell Disorders (PCD's)
Official title: Registry for Adults With Plasma Cell Disorders (PCD's)
Study type: OBSERVATIONAL
Overall status: RECRUITING
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
Plasma Cell Leukemia
Lead sponsor: UNC Lineberger Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2018-10-24
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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).

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.

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.

Primary outcomes:
measure: Creation of a Registry of Plasma Cell Disorder (PCD) patients
timeFrame: 10 years
measure: Completion of baseline and longitudinal assessments in PCD patients
timeFrame: 10 years
Secondary outcomes:
measure: Creation of information that would lend support for future PCD research
timeFrame: 10 years
measure: Response rates of assessment in PCD patients and their satisfaction with the assessment
timeFrame: 10 years
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: North Carolina Cancer Hospital
state: North Carolina
Study officials:
affiliation: UNC Lineberger Comprehensive Cancer Center
name: Sascha Tuchman, MD
role: PRINCIPAL_INVESTIGATOR
References: