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NCT Number: NCT03717844

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).

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Key information

Conditions

Multiple Myeloma Abnormalities, Multiple Amyloidosis Blood Protein Disorders Cardiovascular Diseases Castleman Disease Castleman's Disease Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Cryoglobulinemia Heavy Chain Deposition Disease Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Hypergammaglobulinemia Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, Plasma Cell Light Chain Deposition Disease Lymphatic Diseases Lymphoproliferative Disorders Metabolic Diseases Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Nervous System Diseases Neuromuscular Diseases Nutritional and Metabolic Diseases POEMS Syndrome Paraproteinemias Peripheral Nervous System Diseases Plasma Cell Leukemia Polyneuropathies Polyneuropathy Organomegaly Endocrinopathy Monoclonal Gammopathy and Skin Changes Precancerous Conditions Proteostasis Deficiencies Skin Diseases Skin Diseases, Vascular Skin and Connective Tissue Diseases Smoldering Multiple Myeloma Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

North Carolina Cancer Hospital

Chapel Hill, North Carolina, 27599, United States

Location status: Recruiting

Location contact

Sascha Tuchman, MD

PRINCIPAL_INVESTIGATOR

About this study

OBJECTIVES:

Primary

  • To create a Registry (to be called the PCD Registry) of PCD patients
  • To have participating patients complete an assessment at enrollment and to repeat the assessment longitudinally over time.

Secondary

  • 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.
  • 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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Creation of a Registry of Plasma Cell Disorder (PCD) patients

    Time frame: 10 years

  2. Completion of baseline and longitudinal assessments in PCD patients

    Time frame: 10 years

Secondary outcomes

  1. Creation of information that would lend support for future PCD research

    Time frame: 10 years

    Including patterns of patient care that would lend support for future research in patients with confirmed PCD's.

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

    Time frame: 10 years

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Kendall Conder

CONTACT

[email protected]

(919) 966-4432

Nicholas Mangieri

CONTACT

[email protected]

(919) 966-4432

Sponsors and collaborators

Lead sponsor

UNC Lineberger Comprehensive Cancer Center

Other

Registry information

Important dates

Study start
2018
Primary completion
2028
Study completion
2029
First posted
Oct 24, 2018
Registry last updated
Nov 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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