Recruiting

Observational Study

Sponsor:

UNC Lineberger Comprehensive Cancer Center

Code:

NCT03717844

Conditions

Multiple Myeloma

Amyloidosis

Cryoglobulinemia

Castleman's Disease

Light Chain Deposition Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

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

Study ID

NCT03717844

Start date

Feb 9, 2018

Status verified date

Nov, 2025

Completion date

Feb, 2029

Anticipated

Primary completion date

Feb, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

2000 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Creation of a Registry of Plasma Cell Disorder (PCD) patients [ Time Frame: 10 years ]
  • Completion of baseline and longitudinal assessments in PCD patients [ Time Frame: 10 years ]

Central Contacts and Locations

Central contacts

Nicholas Mangieri

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

Kendall Conder

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

Locations

North Carolina Cancer Hospital

Recruiting

Chapel Hill, North Carolina, United States, 27599

Principal Investigator:

Sascha Tuchman, MD

More Information

Sponsor

UNC Lineberger Comprehensive Cancer Center

Last update posted

Nov 20, 2025

Last verified

Nov, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by UNC Lineberger Comprehensive Cancer Center on 2025-11-20.