Registry for Adults With Plasma Cell Disorders (PCD's)

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).

Study Overview

• Status: Recruiting
• Conditions: Multiple Myeloma; Amyloidosis; Smoldering Multiple Myeloma; Plasma Cell Leukemia; Cryoglobulinemia; Light Chain Deposition Disease; Castleman's Disease; Heavy Chain Deposition Disease; Polyneuropathy Organomegaly Endocrinopathy Monoclonal Gammopathy and Skin Changes

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.

• Study Type: Observational
• Enrollment (Estimated): 2000

Contacts and Locations

• Study Contact: Name: Amy Garrett, MA; Phone Number: 919-966-0895; Email: amy_garrett@med.unc.edu
• Study Contact Backup: Name: Kirsten Nyrop, PhD; Phone Number: 919-962-5139; Email: kirsten_nyrop@med.unc.edu

Study Locations

• United States
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • Recruiting
      • North Carolina Cancer Hospital
      • Principal Investigator: Sascha Tuchman, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• 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.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Creation of a Registry of Plasma Cell Disorder (PCD) patients	10 years
Completion of baseline and longitudinal assessments in PCD patients	10 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: UNC Lineberger Comprehensive Cancer Center
• Investigators: Principal Investigator: Sascha Tuchman, MD, UNC Lineberger Comprehensive Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): February 9, 2018
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): February 1, 2029

Study Registration Dates

• First Submitted: October 22, 2018
• First Submitted That Met QC Criteria: October 22, 2018
• First Posted (Actual): October 24, 2018

Study Record Updates

• Last Update Posted (Actual): March 22, 2024
• Last Update Submitted That Met QC Criteria: March 20, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Metabolic Diseases; Nervous System Diseases; Skin Diseases; Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Congenital Abnormalities; Hematologic Diseases; Hemorrhagic Disorders; Neuromuscular Diseases; Peripheral Nervous System Diseases; Hemostatic Disorders; Blood Protein Disorders; Skin Diseases, Vascular; Proteostasis Deficiencies; Precancerous Conditions; Leukemia; Abnormalities, Multiple; Hypergammaglobulinemia; Multiple Myeloma; Neoplasms, Plasma Cell; Amyloidosis; Castleman Disease; Polyneuropathies; Smoldering Multiple Myeloma; Leukemia, Plasma Cell; Paraproteinemias; Monoclonal Gammopathy of Undetermined Significance; Cryoglobulinemia; POEMS Syndrome
• Other Study ID Numbers: LCCC 1728

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No