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

NCT03717844 | Recruiting

• 1 other identifier: LCCC 1728
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

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).

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

Outcome Measures

Primary Outcomes (2)

• Creation of a Registry of Plasma Cell Disorder (PCD) patients

  10 years

• Completion of baseline and longitudinal assessments in PCD patients

  10 years

Secondary Outcomes (2)

• Creation of information that would lend support for future PCD research

  10 years

• Response rates of assessment in PCD patients and their satisfaction with the assessment

  10 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• UNC Lineberger Comprehensive Cancer Center: lead

Study Sites (1)

North Carolina Cancer Hospital

Chapel Hill, North Carolina, 27599, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples will be banked for future research involving adults with PCDs, specifically examining p16INK4a and other markers to be specified in future, separate, IRB-reviewed protocols as specific research questions are identified.

MeSH Terms

Conditions

Multiple Myeloma; Amyloidosis; Cryoglobulinemia; Castleman Disease; POEMS Syndrome; Smoldering Multiple Myeloma; Leukemia, Plasma Cell

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Lymphatic Diseases; Polyneuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Precancerous Conditions; Hypergammaglobulinemia; Leukemia

Study Officials

• Sascha Tuchman, MD

  UNC Lineberger Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nicholas Mangieri

CONTACT

(919) 966-4432; nicholas_mangieri@med.unc.edu

Kendall Conder

CONTACT

(919) 966-4432; kendall_conder@med.unc.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2018
• First Posted: October 24, 2018
• Study Start: February 9, 2018
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): February 1, 2029
• Last Updated: November 20, 2025

Record last verified: 2025-11

Locations

US (1)