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

  • STATUS
    Recruiting
  • End date
    Feb 6, 2029
  • participants needed
    2000
  • sponsor
    UNC Lineberger Comprehensive Cancer Center
Updated on 6 December 2021
cancer
multiple myeloma
monoclonal antibodies
leukemia
monoclonal antibody therapy
monoclonal protein
amyloidosis
polyneuropathy
plasma cell leukemia
monoclonal gammopathy
gammopathy
smoldering myeloma
p16ink4a
heavy chain deposition disease

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).

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.

Details
Condition Castleman's Disease, Multiple Myeloma, POEMS Syndrome, leukemia, Plasma cell leukemia, Amyloidosis, Amyloid, Cryoglobulinemia, Lymphoproliferative Disorder, Precancerous Conditions, Smoldering Multiple Myeloma, Leukemia (Pediatric), Light Chain Deposition Disease, Heavy Chain Deposition Disease, Precancerous condition, Lymphoproliferative disorders, smoldering myeloma, multiple myeloma (mm)
Clinical Study IdentifierNCT03717844
SponsorUNC Lineberger Comprehensive Cancer Center
Last Modified on6 December 2021

Eligibility

Yes No Not Sure

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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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